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Midwest
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.
Illinois: Chicago
Iowa: Iowa City
Kansas: Lenexa
Michigan: Detroit, Ann Arbor
Minnesota: Minneapolis
Ohio: Canton
Ohio: Cincinnati
Ohio: Cleveland
Ohio: Columbus
Wisconsin: Madison
ILLINOIS: CHICAGO
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
Northwestern University 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:
Northwestern University
Chicago, IL 60611
Principal Investigator: Joan Guitart, M.D.
PH: 312-695-1413
j-guitart@northwestern.edu
Coordinator: Sara Ortiz
P: 312-695-6829
s-ortiz@northwestern.edu
ClinicalTrials.gov identifier: NCT00168064
ILLINOIS: CHICAGO
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
ILLINOIS: CHICAGO
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
Timothy M. Kuzel, MD
676 N. St. Clair, Suite 850
Chicago, IL 60611
Phone: (312) 908-5250
Fax: (312) 908-1372
Email: t-kuzel@northwestern.edu
Lindsay Peters, RN
676 N. St. Clair, Suite 1200
Chicago, IL 60611
Phone: (312) 695-1005
Fax: (312) 695-1352
ILLINOIS: CHICAGO
Study to Evaluate the Safety and Efficacy of Adeno-IFN Gamma in Cutaneous B-Cell Lymphoma
PURPOSE: The primary objective of this study is to evaluate the efficacy of a four-month dosing period of intra-lesional injection of TG1042 in patients with relapsing CBCL.
Patients will receive intra-tumoral injections of an adenoviral vector construct containing the human interferon gamma gene (TG1042), in an attempt to enhance immune responses with anti-tumor activity. This local administration induces tumour cell killing at the injected tumour sites.
INCLUSION:
Primary CBCL including (according to WHO/EORTC classification 2005) :
* Primary cutaneous marginal zone B-cell lymphoma
* Primary cutaneous follicle center B-cell lymphoma
* Primary cutaneous diffuse large B-cell other than leg type
* See full description for further inclusion details
EXCLUSION:
* Primary cutaneous diffuse large B-cell lymphoma, leg type.
* Primary cutaneous intravascular large B-cell lymphoma.
* Extracutaneous involvement (sign of B-cell lymphoma on thoraco-abdominal CT scan and/or PET scan and/or on bone marrow biopsy).
* No histologic documentation of CBCL.
* History of known Human Immuno-deficiency Virus, Human Hepatitis B or C positive serology or other active systemic infections.
* Serious uncontrolled, concomitant medical disorders.
* Concomitant therapy for CBCL: surgical resection, radiotherapy, corticosteroid, chemotherapy, rituximab…(not limited listing)
* Major surgery in previous 4 weeks preceding the 1st injection.
* Pregnancy at study entry or who become pregnant during the study or women who are breast feeding.
* Males and females of reproductive potential who refuse to use adequate protection against pregnancy (intra-uterine device, hormonal contraception or diaphragm/condom and spermicide) during the conduct of the study and for three months after the last injection.
* Participation in another experimental protocol during the study period and within 4 weeks prior to the first injection.
* Patient previously included in this study.
* Non compliance with the study.
Sponsor: Transgene
Identifier for www.clinicaltrials.gov: NCT00394693
CONTACT
Northwestern University Medical School
Chicago, Illinois, United States, 60611
Contact: Joan GUITART, M.D. 312-695-4174 j-guitart@northwestern.edu
Principal Investigator: Joan GUITART, M.D.
ILLINOIS: CHICAGO
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:
Michael Tharp, MD
Ruby Page, RN
Department of Dermatology
1725 West Harrison Street
Suite 264
Chicago, IL 60612
Phone: 312-563-4001
Fax: 312-563-2263
ILLINOIS: CHICAGO
A Multicenter, Dose-randomized evaluation of Targretin Capsules and PUVA in Patients with Stage IB-IIA Cutaneous T-cell Lymphoma
OBJECTIVE: Evaluate the safety and efficacy of Targretin capsules in combination with PUVA therapy.
ELEGIBILITY REQUIREMENTS: Age 18 or over with histologically confirmed Stage IB-IIA CTCL. Discontinued use of any anticancer therapy orcorticosteroids 30 days prior to initiating therapy.
CONTACT INFORMATION:
Northwestern University
J. Guitart MD PH: 312-695-2816
IOWA: IOWA CITY
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
Vincent Liu, MD
University of Iowa
200 Hawkins Drive W204 GH
Iowa City, IA 52242
Phone: (319) 384-6012
Fax: (319) 356-8317
Email: vincent.liu@uiowa.edu
Mary Shannon, RN
Holden Comprehensive Cancer Center
200 Hawkins Drive 5970JPP
Iowa City, IA 52242
Phone: (319) 356-3516
Fax: (319) 356-7251
Email: mary-shannon@uiowa.edu
KANSAS: LENEXA
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
Kansas City Cancer Center, Lenexa, Kansas, 66214, United States; Recruiting
Call for Information, M.D. 877-462-4363 info@curagen.com
Robert Belt, MD, Principal Investigator
MICHIGAN: DETROIT, ANN ARBOR
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
MINNESOTA: MINNEAPOLIS
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:
Kimberly Bohjanan, MD
Cathy Boeck, RN
Department of Dermatology
University of Minnesota
4-240 Phillips Wangensteen Building
516 Delaware Street SE
Minneapolis, MN 55455
Phone: 612-625-4973
Fax: 612-626-3318
OHIO: CANTON
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
OHIO: CINCINNATI
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
Deborah Breneman, MD
University Dermatology Consultants
222 Piedmont Avenue Suite 5300
Cincinnati, OH 45219
Phone: 513-475-7577
Fax: 513-475-7574
Email: debra.breneman@uc.edu
Vivian Berger, LPN, CCRC
University Dermatology Consultants
222 Piedmont Avenue Suite 5300
Cincinnati, OH 45219
Phone: 513-475-7576
Fax: 513-475-7574
Email: bergervr@ucmail.uc.edu
OHIO: CLEVELAND
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
OHIO: CLEVELAND
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
Case Western Reserve University, Cleveland, Ohio, 44106, United States; Recruiting
Call for Information 877-462-4363 info@curagen.com
Mary Laughlin, M.D., Principal Investigator
Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States; Recruiting
Call for Information 877-462-4363 info@curagen.com
Brad Pohlman, M.D., Principal Investigator
OHIO: CLEVELAND
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:
Elma D. Baron, MD
Heather Scull, MS
Department of Dermatology
University Hospitals of Cleveland/Case Western Reserve University
11100 Euclid Ave.
512 Wearn
Cleveland, OH 44106
Phone: 216-368-4971
Fax: 216-368-0212
OHIO: CLEVELAND
CTCL Clinical Trials Available at the Ohio State University Comprehensive Cancer Center
* An open Label Study of ONTAK® (denileukin diftitox, DAB389IL-2) to Estimate Response in Cutaneous T-Cell Lymphoma (CTCL) according to CD25 Status (open to accrual)
* Phase II trial of Depsipeptide in Patients with Cutaneous T-cell Lymphoma and Relapsed Peripheral T-cell Lymphoma (open to accrual)
* Phase I trial of alemtuzumab (campath-1H) in combination with CHOP for patients with relapsed and refractory T-cell lymphomas (cutaneous or systemic) (open to accrual)
* A Phase II multi-Dose Study of SGN-30 (anti-CD30 mAb) in patients with refractory or recurrent anaplastic large cell lymphoma and Hodgkin’s disease (anticipated opening: January 2005).
CONTACT INFORMATION:
Pierluigi Porcu, M.D.,
Assistant Professor of Medicine
Division of Hematology/Oncology,
The Ohio State University
B-407 Starling Loving Hall,
320 West 10th Avenue
Columbus, OH, 43210
614-293-8723 (Phone)
614-293-7527 (Fax)
porcu-1@medctr.osu.edu
Maria Tucker, RN
Lymphoma Disease Coordinator
614-293-8828 (Phone)
614-293-8193 (Fax)
tucker-6@medctr.osu.edu
OHIO: CLEVELAND
Phase I Study of Photodynamic Therapy with Silicon Phthalocyanine 4 (Pc 4) in Patients with Cutaneous Malignancies
OBJECTIVE: Determine the maximum tolerated dose and pharmacokinetics of Pc 4 when administered with a fixed dose of light in patients with advanced cutaneous malignancies.
ELEGIBILITY REQUIREMENTS: Histologically confirmed tumor for which no potential curative therapy exists. Age 18 and over. No concurrent immunotherapy/chemotherapy, aspirin, NSAIDS, or photosensitizing agent e.g. sulfa drugs, furosemide, etc.
CONTACT INFORMATION:
Ireland Cancer Center, Division of Hematology/Oncology
Scot C. Remick MD PH 216-844-5412
Cleveland, OH
OHIO: CLEVELAND
Phase I Study of O6-Benzylguanine and Carmustine in Patients with Cutaneous T-Cell Lymphoma
OBJECTIVE: Determine the kinetics of O6-alkylguanine DNA alkyltransferase depletion in skin lesions of patients with cutaneous T-cell lymphoma and the toxicity of topical carmustine when administered after O6-benzylguanine in these patients.
ELEGIBILITY REQUIREMENTS: Histologically confirmed cutaneous T-cell lymphoma stage IA, IB, or IIA. Must have failed 1 conventional treatment other than topical corticosteroids. Must be able to biopsy tumor. Age 18 and over.
CONTACT INFORMATION:
Ireland Cancer Center
Dept of Dermatology
Kevin D. Cooper, MD
216-844-7394
OHIO: COLUMBUS
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
WISCONSIN: MADISON
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
University of Wisconsin 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
ClinicalTrials.gov identifier: NCT00168064
WISCONSIN: MADISON
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
Beth Berry
Jennifer Edmondson, 919-859-7912
Mary Bordeaux, 843-545-8888
