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Southeast
Below are current clinical trials listed by the state of the principle investigator. The list may not include every trial that is available. Some clinical trials are multi-center trials and may be available in more than the one state of the listed principle investigator. You should check with your physician to see if the trial is multi-center.
Alabama: Birmingham
Arkansas: Hot Springs
Florida: Clermont
Florida: Ormond Beach
Florida: Miami
Florida: Tampa
Georgia: Atlanta
Maryland: Bethesda
North Carolina: Durham
North Carolina: Winston-Salem
Tennesee: Germantown
Tennesee: Nashville
West Virginia: Morgantown
ALABAMA: BIRMINGHAM
Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sézary Syndrome
PURPOSE: The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.
ELIGIBILITY
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
* A biopsy compatible with the diagnosis of MF and sezary syndrome with a CD4 positive phenotype within 6 months of study entry
* Refractory to or intolerant to at least two prior therapies, one being Targretin® (or combinations hereof).
* Signed informed consent
Exclusion Criteria:
* Prior treatment with combination chemotherapy within four weeks
* Prior treatment with Total Skin Electron Beam (TSEB) therapy within 6 months.
* Prior treatment with Campath (alemtuzumab)
* Prior treatment with more than three regimens of single agent chemotherapy
* Treatment within 4 weeks prior to study with topical Targretin®, skin directed therapies or systemic anticancer therapies.
* Serious intercurrent medical condition
* Acute or chronic infectious disease.
* Patient with a history of intermittent relapsing herpes simplex skin affections on prophylactic treatment with acyclovir and valacyclovir and patients taking dicloxillin for carriage of staphylococcus aureus maybe included.
* Breast feeding women or women with a positive pregnancy test
* Patients of childbearing potential must practice adequate contraception
CONTACT:
Zena Muzyczenko
1-866-887-1291
mf@us.genmab.com
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127881
ALABAMA: BIRMINGHAM
Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma
PURPOSE: This study will enroll subjects with CTCL stages IB, IIA, IIB, III and IVA. The goal of this study is to determine if the investigational drug Forodesine Hydrochloride is a safe and effective treatment for cutaneous T-cell lymphoma or Sézary syndrome. Approximately 150 patients will participate in this study in up to 50 centers across North America, Europe, and Australia.
INCLUSION:
1. Males or non-pregnant femails aged ≥ 18 years
2. Histologically confirmed diagnosis of CTCL, including mycosis fungoides and/or Sézary syndrome
3. Subjects with CTCL stages IB, IIA, IIB, III and IVA
4. Must have failed 3 forms of systemic therapy, one of which must have been oral bexarotene, unless not tolerated or was medically contraindicated
EXCLUSION:
1. Proven or suspected extracutaneous visceral CTCL involvement (presence of lymphadenopathy is permitted)
2. Previous treatment with Forodesine
3. Concurrent treatment with any other anti-CTCL therapy
Protocal number: BioCryst Protocol BCX1777-203
Sponsor: BioCryst Pharmaceuticals Inc.
Identifier for www.clinicaltrials.gov: NCT00501735
CONTACT
Jennifer Edmondson, 919-859-7912
Mary Bordeaux, 843-545-8888
ALABAMA: BIRMINGHAM
A Phase II Study of Oral LBH589 in Adult Patients with Refractory Cutaneous T-Cell Lymphoma
PURPOSE: In light of the need for new treatment options for patients with previously treated CTCL, the purpose of this multinational, non randomized, phase II study is to assess the efficacy of oral LBH589 as single agent in patients with CTCL whose disease has progressed following or has not responded to at least two prior systemic treatment regimens.
Key Eligibility Criteria: Inclusion
1. Written informed consent obtained prior to any screening procedures
2. Age ≥ 18 years old
3. Patients with biopsy-confirmed mycosis fungoides or Sézary syndrome stages IB-IVA. Patients who have SS with bone marrow involvement are also eligible. Patients with transformed CTCL are eligible. Disease stage for eligibility is based on the stage at time of study enrollment. However, patients with any history of visceral involvement of their CTCL will not be eligible for this study.
4. Patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimens. Systemic regimens include oral bexarotene, PUVA, photophoresis, oral corticosteroids, total skin electron bean therapy, immunotherapy, chemotherapy such as methotrexate, biological response modifiers such as and interferon. Topical steroids alone are not considered as a treatment regimen.
5. Patients must have had disease progression on or following their most recent treatment regimen. Patients are also eligible if they had an inadequate response to their most recent treatment regimen defined as stable disease as the best response after at least 3 months of therapy.
6. Patients will be accrued to one of two groups:
• Group 1: Patients previously treated with oral bexarotene. This group includes patients who had:
1. Disease progression on following treatment oral bexarotene, OR
2. An inadequate response to oral bexarotene treatment defined as stable disease as the best response after at least 3 months of treatment, OR
3. Intolerance of oral bexoratene defined as patients who discontinued oral bexoratene treatment due to adverse events.
• Group 2: Patients who have not had prior oral bexarotene treatment.
Please contact the study site to see if you meet the other criteria for this study.
CONTACT INFORMATION
Lauren C. Hughey, MD
EFH414
1530 3rd Ave. South
Birmingham, AL 35294-0009
Phone: (205) 996-7546
Fax: (205) 934-5766
Email: lchughey@uabmc.edu
Misty Winslett, RN
3rd Floor The Kirklin Clinic
2000 6th Ave. South
Birmingham, AL 35233-0271
Phone: (205) 502-9967
Fax: (205) 502-9963
Email: mwinslett@uabmc.edu
ALABAMA: BIRMINGHAM
Clinical Trial of PXD101 in Patients With T-Cell Lymphomas
Purpose
The purpose of this open-label, non-randomized trial is to assess the effectiveness of PXD101 in patients with recurrent or refractory cutaneous or peripheral and other types of T-cell lymphomas. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor. Various members of this class of drugs have shown activity in preclinical studies and in initial clinical trials of multiple myeloma and lymphoma.
Inclusion Criteria:
* Male or female with age > or = to 18 years.
* A histologically confirmed diagnosis of cutaneous T-cell lymphoma (CTCL) or peripheral T-cell lymphoma (PTCL) or other T-cell non-Hodgkin's lymphoma (NHL).
* Patients must have failed at least one line of prior systemic therapy. No limitation in number of prior therapies. CTCL patients who are refractory or intolerant to oral Targretin are also eligible.
* The presence of measurable disease (defined as > or = to 1 cm with radiographic imaging) for PTCL or stage IB or greater disease for CTCL and assessable by the severity-weighted assessment tool (SWAT).
* Patients must have had a chest x-ray, computed tomography (CT) scan or CT/positron emission tomography (PET) scan or SWAT assessment within 2 weeks prior to enrollment for the CTCL patients or within 4 weeks prior to enrollment for PTCL patients and after completion of any prior cytotoxic chemotherapy. Patients with a history of bone marrow involvement must have a bone marrow biopsy within 4 weeks of study enrollment.
* Adequate bone marrow and hepatic function including the following:
o White blood cell (WBC) > or = to 3,000 cells/mm3, absolute neutrophil count > or = to 1,500 cells/mm3, platelets > or = to 50,000/mm3
o Total bilirubin < or = to 1.5 x upper normal limit.
o AST (SGOT), ALT (SGPT) and alkaline phosphatase < or = to 2.5 x upper normal limit
o Hemoglobin > or = 9.0 g/dL.
* Serum potassium within normal range.
* Karnofsky performance status > or = to 70%.
* Estimated life expectancy > 3 months.
* Signed informed consent approved by the Institutional Review Board (IRB).
Exclusion Criteria:
* Patients who have received anti-cancer therapies within 4 weeks of first PXD101 administration should be excluded unless toxicity from prior anti-cancer therapy has resolved or returned to baseline and cancer disease status warrants.
* Any use of investigational drugs within 4 weeks prior to study registration.
* Major surgery within 4 weeks of study drug administration.
* Prior allogeneic bone marrow transplant.
* A diagnosis of adult T-cell lymphoma/leukemia (ATLL) or precursor T-lymphoblastic lymphoma.
* Co-existing active infection or any co-existing medical condition likely to interfere with trial procedures. However, patients with progressing CTCL whose open skin lesions are frequently infected may not be excluded from this trial at the discretion of Investigators.
* Clinically significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, and congestive heart failure related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months or a left ventricular ejection fraction < 40% (by echocardiogram [ECHO] or multigated acquisition scan [MUGA]) within 3 months of study enrollment.
* A marked baseline prolongation of QT/QTc interval.
* Patients with renal insufficiency defined as a calculated creatinine clearance of < 45 mL/min/1.73 m2.
* Patients with a history of allergic reactions attributed to compounds of similar chemical or biological composition to PXD101 and L-arginine.
* Clinically significant central nervous system disorders with altered mental status or psychiatric disorders precluding understanding of the informed consent process and/or completion of the necessary studies.
* Patients requiring treatment for other malignant diseases or less than 5 years post-treatment completion for an invasive malignant disease (excluding non-melanotic skin cancers or cervical cancer in-situ). Patients with any history of melanoma should be excluded.
* Pregnant or breast-feeding women, and women of childbearing age and potential, who are not willing to use effective contraception. Male patients and/or their fertile female partners who are not willing to use contraceptives during the trial.
* Known infection with HIV, human T-cell leukemia virus type-1 (HTLV-1), hepatitis B or hepatitis C.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00274651
CuraGen Clinical Trial Call Center 1-877-462-4363 info@curagen.com
Alabama
University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States; Recruiting
Call for Information 877-462-4363 info@curagen.com
Boni Elewski, M.D., Principal Investigator
ARKANSAS: HOT SPRINGS
Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma
PURPOSE: This study will enroll subjects with CTCL stages IB, IIA, IIB, III and IVA. The goal of this study is to determine if the investigational drug Forodesine Hydrochloride is a safe and effective treatment for cutaneous T-cell lymphoma or Sézary syndrome. Approximately 150 patients will participate in this study in up to 50 centers across North America, Europe, and Australia.
INCLUSION:
1. Males or non-pregnant femails aged ≥ 18 years
2. Histologically confirmed diagnosis of CTCL, including mycosis fungoides and/or Sézary syndrome
3. Subjects with CTCL stages IB, IIA, IIB, III and IVA
4. Must have failed 3 forms of systemic therapy, one of which must have been oral bexarotene, unless not tolerated or was medically contraindicated
EXCLUSION:
1. Proven or suspected extracutaneous visceral CTCL involvement (presence of lymphadenopathy is permitted)
2. Previous treatment with Forodesine
3. Concurrent treatment with any other anti-CTCL therapy
Protocal number: BioCryst Protocol BCX1777-203
Sponsor: BioCryst Pharmaceuticals Inc.
Identifier for www.clinicaltrials.gov: NCT00501735
CONTACT
Jennifer Edmondson, 919-859-7912
Mary Bordeaux, 843-545-8888
FLORIDA: CLERMONT
Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma
PURPOSE: This study will enroll subjects with CTCL stages IB, IIA, IIB, III and IVA. The goal of this study is to determine if the investigational drug Forodesine Hydrochloride is a safe and effective treatment for cutaneous T-cell lymphoma or Sézary syndrome. Approximately 150 patients will participate in this study in up to 50 centers across North America, Europe, and Australia.
INCLUSION:
1. Males or non-pregnant femails aged ≥ 18 years
2. Histologically confirmed diagnosis of CTCL, including mycosis fungoides and/or Sézary syndrome
3. Subjects with CTCL stages IB, IIA, IIB, III and IVA
4. Must have failed 3 forms of systemic therapy, one of which must have been oral bexarotene, unless not tolerated or was medically contraindicated
EXCLUSION:
1. Proven or suspected extracutaneous visceral CTCL involvement (presence of lymphadenopathy is permitted)
2. Previous treatment with Forodesine
3. Concurrent treatment with any other anti-CTCL therapy
Protocal number: BioCryst Protocol BCX1777-203
Sponsor: BioCryst Pharmaceuticals Inc.
Identifier for www.clinicaltrials.gov: NCT00501735
CONTACT
Jennifer Edmondson, 919-859-7912
Mary Bordeaux, 843-545-8888
FLORIDA: ORMOND BEACH
Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma
PURPOSE: This study will enroll subjects with CTCL stages IB, IIA, IIB, III and IVA. The goal of this study is to determine if the investigational drug Forodesine Hydrochloride is a safe and effective treatment for cutaneous T-cell lymphoma or Sézary syndrome. Approximately 150 patients will participate in this study in up to 50 centers across North America, Europe, and Australia.
INCLUSION:
1. Males or non-pregnant femails aged ≥ 18 years
2. Histologically confirmed diagnosis of CTCL, including mycosis fungoides and/or Sézary syndrome
3. Subjects with CTCL stages IB, IIA, IIB, III and IVA
4. Must have failed 3 forms of systemic therapy, one of which must have been oral bexarotene, unless not tolerated or was medically contraindicated
EXCLUSION:
1. Proven or suspected extracutaneous visceral CTCL involvement (presence of lymphadenopathy is permitted)
2. Previous treatment with Forodesine
3. Concurrent treatment with any other anti-CTCL therapy
Protocal number: BioCryst Protocol BCX1777-203
Sponsor: BioCryst Pharmaceuticals Inc.
Identifier for www.clinicaltrials.gov: NCT00501735
CONTACT
Jennifer Edmondson, 919-859-7912
Mary Bordeaux, 843-545-8888
FLORIDA: MIAMI
A Phase II Study of Oral LBH589 in Adult Patients with Refractory Cutaneous T-Cell Lymphoma
PURPOSE: In light of the need for new treatment options for patients with previously treated CTCL, the purpose of this multinational, non randomized, phase II study is to assess the efficacy of oral LBH589 as single agent in patients with CTCL whose disease has progressed following or has not responded to at least two prior systemic treatment regimens.
Key Eligibility Criteria: Inclusion
1. Written informed consent obtained prior to any screening procedures
2. Age ≥ 18 years old
3. Patients with biopsy-confirmed mycosis fungoides or Sézary syndrome stages IB-IVA. Patients who have SS with bone marrow involvement are also eligible. Patients with transformed CTCL are eligible. Disease stage for eligibility is based on the stage at time of study enrollment. However, patients with any history of visceral involvement of their CTCL will not be eligible for this study.
4. Patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimens. Systemic regimens include oral bexarotene, PUVA, photophoresis, oral corticosteroids, total skin electron bean therapy, immunotherapy, chemotherapy such as methotrexate, biological response modifiers such as and interferon. Topical steroids alone are not considered as a treatment regimen.
5. Patients must have had disease progression on or following their most recent treatment regimen. Patients are also eligible if they had an inadequate response to their most recent treatment regimen defined as stable disease as the best response after at least 3 months of therapy.
6. Patients will be accrued to one of two groups:
• Group 1: Patients previously treated with oral bexarotene. This group includes patients who had:
1. Disease progression on following treatment oral bexarotene, OR
2. An inadequate response to oral bexarotene treatment defined as stable disease as the best response after at least 3 months of treatment, OR
3. Intolerance of oral bexoratene defined as patients who discontinued oral bexoratene treatment due to adverse events.
• Group 2: Patients who have not had prior oral bexarotene treatment.
Please contact the study site to see if you meet the other criteria for this study.
CONTACT INFORMATION
Francisco A. Kerdel, MD
1400 NW 12th Avenue, Suite 4
Miami, FL 33136
Phone: (305) 324-2110
Fax: (305) 325-0919
Email: fadcresearch@bellsouth.net
Annika Grant
1400 NW 12th Avenue, Suite 4
Miami, FL 33136
Phone: (305) 324-2110
Fax: (305) 325-0919
Email: fadcresearch@bellsouth.net
FLORIDA: TAMPA
Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sézary Syndrome
PURPOSE: The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.
ELIGIBILITY
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
* A biopsy compatible with the diagnosis of MF and sezary syndrome with a CD4 positive phenotype within 6 months of study entry
* Refractory to or intolerant to at least two prior therapies, one being Targretin® (or combinations hereof).
* Signed informed consent
Exclusion Criteria:
* Prior treatment with combination chemotherapy within four weeks
* Prior treatment with Total Skin Electron Beam (TSEB) therapy within 6 months.
* Prior treatment with Campath (alemtuzumab)
* Prior treatment with more than three regimens of single agent chemotherapy
* Treatment within 4 weeks prior to study with topical Targretin®, skin directed therapies or systemic anticancer therapies.
* Serious intercurrent medical condition
* Acute or chronic infectious disease.
* Patient with a history of intermittent relapsing herpes simplex skin affections on prophylactic treatment with acyclovir and valacyclovir and patients taking dicloxillin for carriage of staphylococcus aureus maybe included.
* Breast feeding women or women with a positive pregnancy test
* Patients of childbearing potential must practice adequate contraception
CONTACT:
Zena Muzyczenko
1-866-887-1291
mf@us.genmab.com
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127881
GEORGIA: ATLANTA
Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sézary Syndrome
PURPOSE: The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.
ELIGIBILITY
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
* A biopsy compatible with the diagnosis of MF and sezary syndrome with a CD4 positive phenotype within 6 months of study entry
* Refractory to or intolerant to at least two prior therapies, one being Targretin® (or combinations hereof).
* Signed informed consent
Exclusion Criteria:
* Prior treatment with combination chemotherapy within four weeks
* Prior treatment with Total Skin Electron Beam (TSEB) therapy within 6 months.
* Prior treatment with Campath (alemtuzumab)
* Prior treatment with more than three regimens of single agent chemotherapy
* Treatment within 4 weeks prior to study with topical Targretin®, skin directed therapies or systemic anticancer therapies.
* Serious intercurrent medical condition
* Acute or chronic infectious disease.
* Patient with a history of intermittent relapsing herpes simplex skin affections on prophylactic treatment with acyclovir and valacyclovir and patients taking dicloxillin for carriage of staphylococcus aureus maybe included.
* Breast feeding women or women with a positive pregnancy test
* Patients of childbearing potential must practice adequate contraception
CONTACT:
Zena Muzyczenko
1-866-887-1291
mf@us.genmab.com
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127881
GEORGIA: ATLANTA
Summary: Phase IIb Clinical Trial for the treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides) refractory to or intolerant of Targretin plus one other standard therapy.
The study is an open-label trial of a daily oral medication for CTCL. All patients will receive the study medication; no patients will receive placebo. Eligible patients will receive the study medication and study-related physicals and procedures at no cost. Blood draws and skin biopsies will be performed periodically (optional).
Patient inclusion criteria includes:
* Male or female aged 18 years or older.
* Biopsy proven CTCL, stage IB or higher including Sezary syndrome.
* Persistent, progressive, or recurrent disease in spite of at least two prior therapies, one being Targretin.
Patient exclusion criteria includes:
* Prior treatment with an HDAC inhibitor.
* Cancer within the last 5 years (except some skin cancers).
* Breast feeding or pregnant women.
CONTACT INFORMATION:
Bridget Bradley, RN
Emory University Department of Dermatology
1365 Clifton Road NE, Ste A1200
Atlanta, GA 30322
Telephone: 404-778-3084
Fax: 404-778-5395
Email: skinresearch@emory.edu
MARYLAND: BETHESDA
New stem cell transplant study for patients with mycosis fungoides or Sézary syndrome
Researchers at the National Institutes of Health (NIH) are investigating a new method of treating people ages 18-70 with advanced mycosis fungoides or Sézary syndrome using a stem cell transplant. If you or someone you know has mycosis fungoides or Sézary syndrome, you may be able to participate in this clinical trial. For more information and to find out if you qualify, call 1-866-444-2214 (TTY: 1-866-411-1010) or visit www.clinicaltrials.gov. Refer to study 02-H-0250. The NIH is part of the Department of Health and Human Services.
MARYLAND: BETHESDA
Phase I Study of Topical Romidepsin (Depsipeptide) in Early Stage Cutaneous T-Cell Lymphoma
Objectives:
• To determine the highest tolerated dose of topical romidepsin that can be given to patients with early-stage CTCL
• To evaluate the effectiveness of topical romidepsin in patients with early-stage ctcl.
• To determine how the body handles topical romidepsin
Eligibility:
•
Patients 18 of age and older with early-stage CTCL
Contact Information:
Susan L. Booher, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Bethesda, Maryland 20892
Phone: (301) 402-1474
Fax: (301) 402-2943
Electronic Address: boohers@mail.nih.gov
MARYLAND: BETHESDA
Stem Cell Transplantation for Mycosis Fungoides/Sézary Syndrome NIH protocol 02-H-0250
If you are between the ages of 18-70 years old and have been diagnosed with Mycosis Fungoides/Sézary Syndrome, you may be eligible for a stem cell transplantation procedure available at the National Institutes of Health (NIH). Under evaluation in this research study is the use of new methods of transplant preparation and post transplant therapy to reduce the risk of graft versus host disease and minimize hospital stay.
You must have an HLA-matched family member to participate. We will do the blood testing free of charge to see if your family member is a match. We pay for all medical costs related to the transplant procedure. You must be available to live near NIH for approximately four months. We also provide a small daily allowance to help with living expenses while you are on the study and living away from home.
For more information please contact our research recruiter @ 301-594-8013or email bloodstudy@nhlbi.nih.gov
Protocol information (The following links will open in a new window and take you to an outside site)
http://clinicaltrials.gov/ct/show/NCT00042640?order=1
http://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2002-H-0250.htm
http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=257524&version=HealthProfessional&protocolsearchid=930998
MARYLAND: BETHESDA
Phase II Study of UCN-01 in Patients with Relapsed or Refractory Systemic Anaplastic Large Cell or Mature T-Cell Lymphomas (NCI-04-C-0173). See the protocol summary at http://cancer.gov/clinicaltrials/NCI-04-C-0173.
OBJECTIVE: In this trial, researchers are trying to determine whether a new drug called UCN-01 will help kill cancer cells in patients who have a type of lymphoma called anaplastic large cell lymphoma. This type of lymphoma starts in white blood cells called T cells. Anaplastic lymphoma primarily affects children. UCN-01 belongs to a group of drugs called protein kinase inhibitors. Protein kinases are enzymes in cells that help activate or deactivate other proteins, which may play a role in tumor cell growth.
ELEGIBILITY REQUIREMENTS: Researchers will recruit 18-37 patients aged 9 or over who have been diagnosed with anaplastic large cell lymphoma or mature T-cell lymphoma that has not responded to treatment or has recurred following previously successful treatment. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/NCI-04-C-0173.
CONTACT INFORMATION: For more information, contact the NCI Clinical Studies Support Center at 1-888-NCI-1937. The toll-free call is confidential.
MARYLAND: BETHESDA
A phase II open label study of depsipeptide to evaluate response in patients with cutaneous T-cell lymphoma (CTCL)
OBJECTIVE: Evaluate the efficacy and safety of a new anticancer drug called depsipeptide in cutaneous T-cell lymphoma (CTCL). CTCL includes the diagnosis mycosis fungoides, Sézary syndrome and other related conditions.
ELEGIBILITY REQUIREMENTS: Patients must be age greater than or equal to 18 years. Please contact the closest clinical study location for additional information.
STUDY SPONSOR: National Cancer Institute (NCI)
CONTACT INFORMATION:
Dr. Susan Bates
National Cancer Institute Cancer Center
Bethesda, MD
Contact: Robin Frye (301)402-5958
MARYLAND: BETHESDA
A Phase I/II Study of HLA-matched Mobilized Peripheral Blood Hematopoietic Stem Cell Transplantation for Advanced Mycosis Fungoides/Sézary Syndrome Using Nonmyeloablative Conditioning with Campath-1H
Researchers at the National Institutes of Health (NIH) are investigating a new method of treating people ages 18-70 with advanced Mycosis Fungoides or Sézary Syndrome using a stem cell transplant. If you or someone you know has Mycosis Fungoides or Sézary Syndrome, you may be able to participate in this clinical trial. For more information and to find out if you qualify, call 1-800-411-1222 (TTY: 1-866-411-1010) or click here to view the study. (Link will open in a new window and take you to an outside site.)
NORTH CAROLINA: DURHAM
If you have previously treated mycosis fungoides, but have not used topical nitrogen mustard within the last 2 years, you may be eligible for this trial
Duke University Medical Center is currently is looking for subjects to participate in a research study of a topical investigational drug for patients with mycosis fungoides.
This is a 12-month study. Study drug and procedures will be made available to you at no cost.
To qualify you must:
• Be diagnosed with mycosis fungoides stage I – IIA
• Have not been treated with nitrogen mustard in the last two years
• Not be pregnant or nursing
• Not have had radiation therapy within one year of study start
• Be free of other serious illness
CONTACT INFORMATION:
Duke University Medical Center
Durham, NC 27710
Principal Investigator: Elise A. Olsen, M.D.
PH: 919-668-5613
Olsen001@mc.duke.edu
Coordinator: Carrie Betts
P: 919-668-5610
Carrie.betts@duke.edu
ClinicalTrials.gov identifier: NCT00168064
NORTH CAROLINA: DURHAM
Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sézary Syndrome
PURPOSE: The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.
ELIGIBILITY
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
* A biopsy compatible with the diagnosis of MF and sezary syndrome with a CD4 positive phenotype within 6 months of study entry
* Refractory to or intolerant to at least two prior therapies, one being Targretin® (or combinations hereof).
* Signed informed consent
Exclusion Criteria:
* Prior treatment with combination chemotherapy within four weeks
* Prior treatment with Total Skin Electron Beam (TSEB) therapy within 6 months.
* Prior treatment with Campath (alemtuzumab)
* Prior treatment with more than three regimens of single agent chemotherapy
* Treatment within 4 weeks prior to study with topical Targretin®, skin directed therapies or systemic anticancer therapies.
* Serious intercurrent medical condition
* Acute or chronic infectious disease.
* Patient with a history of intermittent relapsing herpes simplex skin affections on prophylactic treatment with acyclovir and valacyclovir and patients taking dicloxillin for carriage of staphylococcus aureus maybe included.
* Breast feeding women or women with a positive pregnancy test
* Patients of childbearing potential must practice adequate contraception
CONTACT:
Zena Muzyczenko
1-866-887-1291
mf@us.genmab.com
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127881
NORTH CAROLINA: WINSTON-SALEM
Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma
PURPOSE: This study will enroll subjects with CTCL stages IB, IIA, IIB, III and IVA. The goal of this study is to determine if the investigational drug Forodesine Hydrochloride is a safe and effective treatment for cutaneous T-cell lymphoma or Sézary syndrome. Approximately 150 patients will participate in this study in up to 50 centers across North America, Europe, and Australia.
INCLUSION:
1. Males or non-pregnant femails aged ≥ 18 years
2. Histologically confirmed diagnosis of CTCL, including mycosis fungoides and/or Sézary syndrome
3. Subjects with CTCL stages IB, IIA, IIB, III and IVA
4. Must have failed 3 forms of systemic therapy, one of which must have been oral bexarotene, unless not tolerated or was medically contraindicated
EXCLUSION:
1. Proven or suspected extracutaneous visceral CTCL involvement (presence of lymphadenopathy is permitted)
2. Previous treatment with Forodesine
3. Concurrent treatment with any other anti-CTCL therapy
Protocal number: BioCryst Protocol BCX1777-203
Sponsor: BioCryst Pharmaceuticals Inc.
Identifier for www.clinicaltrials.gov: NCT00501735
CONTACT
Jennifer Edmondson, 919-859-7912
Mary Bordeaux, 843-545-8888
NORTH CAROLINA: WINSTON-SALEM
A Phase II Study of Oral LBH589 in Adult Patients with Refractory Cutaneous T-Cell Lymphoma
PURPOSE: In light of the need for new treatment options for patients with previously treated CTCL, the purpose of this multinational, non randomized, phase II study is to assess the efficacy of oral LBH589 as single agent in patients with CTCL whose disease has progressed following or has not responded to at least two prior systemic treatment regimens.
Key Eligibility Criteria: Inclusion
1. Written informed consent obtained prior to any screening procedures
2. Age ≥ 18 years old
3. Patients with biopsy-confirmed mycosis fungoides or Sézary syndrome stages IB-IVA. Patients who have SS with bone marrow involvement are also eligible. Patients with transformed CTCL are eligible. Disease stage for eligibility is based on the stage at time of study enrollment. However, patients with any history of visceral involvement of their CTCL will not be eligible for this study.
4. Patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimens. Systemic regimens include oral bexarotene, PUVA, photophoresis, oral corticosteroids, total skin electron bean therapy, immunotherapy, chemotherapy such as methotrexate, biological response modifiers such as and interferon. Topical steroids alone are not considered as a treatment regimen.
5. Patients must have had disease progression on or following their most recent treatment regimen. Patients are also eligible if they had an inadequate response to their most recent treatment regimen defined as stable disease as the best response after at least 3 months of therapy.
6. Patients will be accrued to one of two groups:
• Group 1: Patients previously treated with oral bexarotene. This group includes patients who had:
1. Disease progression on following treatment oral bexarotene, OR
2. An inadequate response to oral bexarotene treatment defined as stable disease as the best response after at least 3 months of treatment, OR
3. Intolerance of oral bexoratene defined as patients who discontinued oral bexoratene treatment due to adverse events.
• Group 2: Patients who have not had prior oral bexarotene treatment.
Please contact the study site to see if you meet the other criteria for this study.
CONTACT INFORMATION
Denise Levitan, MD
Medical Center Blvd
Winston-Salem, NC 27157
Phone: (336) 716-5847
Fax: (336) 716-5687
Email: dlevitan@wfubmc.edu
TENNESEE: GERMANTOWN
A Phase II Study of Oral LBH589 in Adult Patients with Refractory Cutaneous T-Cell Lymphoma
PURPOSE: In light of the need for new treatment options for patients with previously treated CTCL, the purpose of this multinational, non randomized, phase II study is to assess the efficacy of oral LBH589 as single agent in patients with CTCL whose disease has progressed following or has not responded to at least two prior systemic treatment regimens.
Key Eligibility Criteria: Inclusion
1. Written informed consent obtained prior to any screening procedures
2. Age ≥ 18 years old
3. Patients with biopsy-confirmed mycosis fungoides or Sézary syndrome stages IB-IVA. Patients who have SS with bone marrow involvement are also eligible. Patients with transformed CTCL are eligible. Disease stage for eligibility is based on the stage at time of study enrollment. However, patients with any history of visceral involvement of their CTCL will not be eligible for this study.
4. Patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimens. Systemic regimens include oral bexarotene, PUVA, photophoresis, oral corticosteroids, total skin electron bean therapy, immunotherapy, chemotherapy such as methotrexate, biological response modifiers such as and interferon. Topical steroids alone are not considered as a treatment regimen.
5. Patients must have had disease progression on or following their most recent treatment regimen. Patients are also eligible if they had an inadequate response to their most recent treatment regimen defined as stable disease as the best response after at least 3 months of therapy.
6. Patients will be accrued to one of two groups:
• Group 1: Patients previously treated with oral bexarotene. This group includes patients who had:
1. Disease progression on following treatment oral bexarotene, OR
2. An inadequate response to oral bexarotene treatment defined as stable disease as the best response after at least 3 months of treatment, OR
3. Intolerance of oral bexoratene defined as patients who discontinued oral bexoratene treatment due to adverse events.
• Group 2: Patients who have not had prior oral bexarotene treatment.
Please contact the study site to see if you meet the other criteria for this study.
CONTACT INFORMATION
C. Michael Jones, MD
7710 Wolf River Circle
Germantown, TN 38138
Phone: (901) 685-5969
Fax: (901) 685-6424
Email: cmj@jonescancerclinic.com
Lori Lynch, RN
7710 Wolf River Circle
Germantown, TN 38138
Phone: (901) 685-5969
Fax: (901) 685-6424
Email: llynch@jonescancerclinic.com
TENNESSEE: NASHVILLE
Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sézary Syndrome
PURPOSE: The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.
ELIGIBILITY
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
* A biopsy compatible with the diagnosis of MF and sezary syndrome with a CD4 positive phenotype within 6 months of study entry
* Refractory to or intolerant to at least two prior therapies, one being Targretin® (or combinations hereof).
* Signed informed consent
Exclusion Criteria:
* Prior treatment with combination chemotherapy within four weeks
* Prior treatment with Total Skin Electron Beam (TSEB) therapy within 6 months.
* Prior treatment with Campath (alemtuzumab)
* Prior treatment with more than three regimens of single agent chemotherapy
* Treatment within 4 weeks prior to study with topical Targretin®, skin directed therapies or systemic anticancer therapies.
* Serious intercurrent medical condition
* Acute or chronic infectious disease.
* Patient with a history of intermittent relapsing herpes simplex skin affections on prophylactic treatment with acyclovir and valacyclovir and patients taking dicloxillin for carriage of staphylococcus aureus maybe included.
* Breast feeding women or women with a positive pregnancy test
* Patients of childbearing potential must practice adequate contraception
CONTACT:
Zena Muzyczenko
1-866-887-1291
mf@us.genmab.com
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127881
TENNESEE: NASHVILLE
Private Designer Vaccine? Consider Photopheresis
Photopheresis is an effective therapy for patients with blood involvement or Sézary Syndrome and is FDA approved for the treatment of CTCL. Photopheresis was first used by Dr. Richard Edelson and gave dramatic results in erythrodermic patients. Photopheresis combines a drug (psoralen or UVADEX), ultraviolet light, and the process of apheresis (removing blood cells). White blood cells are collected from the patient, treated with the drug, radiated with light, and then returned to the patient's blood circulation. The treated white blood cells are then thought to be presented to the patient's immune system inducing a vaccination against their malignancy, which is specific for each patient.
Early MF patients occasionally have blood involvement detected on flow cytometry, a sensitive test that can pick up malignant clones early. Therakos, Inc. has initiated a multicenter trial for patients with early disease who may have a small amount of abnormal cells in their blood. The trial will include up to 50 patients with Stage IA to IIA MF. Patients will be treated with photopheresis two days per month for up to six months and continue on trial if the photopheresis therapy is working.
CONTACT INFORMATION:
Jon Zic, MD
Brigitta Brannon, CCRC
Vabnderbilt University Medical Center
A2310-B Medical Center North
Nashville, TN 37232-2600
Phone: 615-936-1133
Fax: 615-343-4365
WEST VIRGINIA: MORGANTOWN
A phase II open label study of depsipeptide to evaluate response in patients with cutaneous T-cell lymphoma (CTCL)
OBJECTIVE: Evaluate the efficacy and safety of a new anticancer drug called depsipeptide in cutaneous T-cell lymphoma (CTCL). CTCL includes the diagnosis mycosis fungoides, Sézary syndrome and other related conditions.
ELEGIBILITY REQUIREMENTS: Patients must be age greater than or equal to 18 years. Please contact the closest clinical study location for additional information.
STUDY SPONSOR: National Cancer Institute (NCI)
CONTACT INFORMATION:
Dr. Solveig Ericson
West Virginia University
Morgantown, WV
Contact: Robin Weisenborn (304)293-3709
