Home: Clinical Trials: Finding Clinical Trials
Northeast
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.
Massachusetts: Boston
New York: Ithica
New York: New York
New York: Syracuse
Pennsylvania: Pittsburgh
Pennsylvania: Philadelphia
MASSACHUSETTS: BOSTON
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
MASSACHUSETTS: BOSTON
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
Marie France Demierre
Boston Medical Center, 720
Harrison Avenue, DOB 801A
Boston, MA 02118
Phone: (617) 638-7131
Fax: (617) 638-8551
Email: MarieFramce.Demierre@bmc.org
Becky Brown, RN
732 Harrison Avenue, RM 301A
Boston, MA 02118
Phone: (617) 414-1828
Fax: (617) 414-1831
Email: becky.brown@bmc.org
MASSACHUSETTS: BOSTON
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
Brigham and Women's Hospital 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
Been previously treated with prior topical therapies, but not nitrogen mustard within the last 2 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
Clinical Unit For Research Trials In Skin (CURTIS)
Brigham and Women's Hospital
Boston, MA 02115
Principal Investigator: Alexa B. Kimball, M.D., M.P.H.
P: 617-726-5066 (CU for Research Trials)
akimball@partners.org
Coordinator: Alicia VanCott, RN
P: 617-726-1660
avancott@partners.org
ClinicalTrials.gov identifier: NCT00168064
MASSACHUSETTS: BOSTON
Summary: If you have Mycosis Fungoides and have tried skin directed treatments (PUVA, UVB or, topical steroids), you may be eligible for this clinical trial.
Brigham and Women's Hospital is currently seeking subjects to participate in a research study, to evaluate how effective and safe two different preparations of Nitrogen Mustard ointment, applied directly to the skin, are at treating Mycosis Fungoides (MF).
This is a 12-month treatment study. Study drug and procedures will be made available to you at no cost.
To qualify you must:
- Be diagnosed by skin biopsy with Mycosis Fungoides Stage I or IIA
- Have been treated previously with topical therapies including PUVA, UVB and topical steroids
- Not have been treated with Nitrogen Mustard or Carmustine
- Be willing and able to give informed consent and commit to all study visits.
- Not be pregnant or nursing
- Be free of other serious illnesses
CONTACT INFORMATION;
Principal Investigator: Alexandra B. Kimball, MD, MPH
PH: 617-726-5066
Clinical Unit for Research Trials in Skin (CURTIS)
Brigham and Women's Hospital
221 Longwood Ave
Boston, MA 02115
harvardskinstudies@partners.org
MASSACHUSETTES: BOSTON
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
Boston University Medical Center, Boston, Massachusetts, 02118, United States; Recruiting
Call for Information 877-462-4363 info@curagen.com
Adam Lerner, M.D., Principal Investigator
Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States; Recruiting
Call for Information 877-462-4363 info@curagen.com
Eric Jacobson, M.D., Principal Investigator
MASSACHUSETTS: BOSTON
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:
Marie-France Demierre, MD
Thomas Ruenger, MD
Marsha Stevens, RN
Skin Oncology Program
Boston Medical Center
720 Harrison Avenue, DOB 801A
Boston, MA 02118
Phone: 617-683-7629
Fax: 617-638-7840
NEW YORK: ITHICA
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. Steven Allen
North Shore University Hospital
Manhasset, NY
Contact: Vivian O'Mara, R.N. (516)562-8940
Dr. John P. Leonard
Cornell University
New York
Contact: Michelle Ashe (212)746-5269
NEW YORK: NEW YORK
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
Columbia 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:
Columbia University Medical Center
New York, NY 10032
Principal Investigator: Elizabeth H. Knobler, M.D.
PH: 212-305-8959
ehk3@columbia.edu
Coordinator: Carol Coppola, RN
P: 212-305-6953
Cc2241@columbia.edu
ClinicalTrials.gov identifier: NCT00168064
NEW YORK: NEW YORK
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
NEW YORK: NEW YORK
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
NYU Medical Center, New York, New York, 10016, United States; Recruiting
Call for Information 877-462-4363 info@curagen.com
Kenneth Hymes, M.D., Principal Investigator
NEW YORK: NEW YORK
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
New York University 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
• Been previously treated with prior topical therapies, but not nitrogen mustard within the last 2 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:
New York University School of Medicine
New York, NY 10016
Principal Investigator: Bruce Strober, M.D.
PH: 212-263-5244
Strober@nyc.rr.com
Coordinator: Elizabeth Camacho
P: 212-263-5244
Camace02@nyumc.org
ClinicalTrials.gov identifier: NCT00168064
NEW YORK: SYRACUSE
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
PENNSYLVANIA: PITTSBURGH
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
PENNSYLVANIA: PITTSBURGH
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
Larisa Geskin, MD
Lothrop Hall, Suite 101
190 Lothrop Street
Pittsburgh, PA 15213
Phone: (412) 648-3161
Fax: (412) 648-8117
Email: geskinlj@upmc.edu
Sue McCann, RN
Lothrop Hall, Suite 145
190 Lothrop Street
Pittsburgh, PA 15213
Phone: (412) 642-3782
Fax: (412) 648-6530
Email: mccannsa@upmc.edu
PENNSYLVANIA: PITTSBURGH
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:
Larisa Geskin, MD
Sue McCann, RN
Department of Dermatology
Suite 145 Lothrop Hall
Pittsburgh, PA 15213
Phone: 412-624-3782 or 412-684-6530
Fax: 412-684-6697
PENNSYLVANIA: PITTSBURGH
Phase II Evaluation of Immunization Against Tumor Cells in Subjects With Sézary Syndrome Using Autologous Mature Dendritic Cells
OBJECTIVE: To evaluate Cutaneous T-Cell Lymphoma (CTCL)-specific tumor immunity resulting from Dendritic Cell (DC)-based immunization using tumor cells as a source of antigen in a phase II clinical trial
ELIGIBILITY REQUIREMENTS: Histologically confirmed diagnosis of: Sézary syndrome. Age 18 and over. Not pregnant or nursing. Must be willing to discontinue concomitant medications for CTCL for duration of the study including: oral steroids above 10 mg, PUVA or UVB, Electron Beam,Chemotherapeutic agents, Bexarotene, ECP.
CONTACT INFORMATION:
University of Pittsburgh Medical Center
Larisa Geskin, M.D. (412) 648-3252
geskinlj@msx.upmc.edu
Pittsburgh, PA
PENNSYLVANIA: PHILADELPHIA
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
PENNSYLVANIA: PHILADELPHIA
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
Fox Chase Cancer Center 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
• Been previously treated with prior topical therapies, but not nitrogen mustard within the last 2 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:
Fox Chase Cancer Center
Philadelphia, PA 19111
Principal Investigator: Stuart Lessin, M.D.
PH: 215-728-2191
Stuart.Lessin@fccc.edu
Clinical Research Coordinator: Cecilia McAleer
PH: 215-728-2981
Cecilia.mcaleer@fccc.edu
ClinicalTrials.gov identifier: NCT00168064
PENNSYLVANIA: PHILADELPHIA
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
The University of Pennsylvania 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
• Been previously treated with prior topical therapies, but not nitrogen mustard within the last 2 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:
Hospital of the University of Pennsylvania
Philadelphia, PA 19104
Principal Investigator: Alain Rook MD
PH: 215-662-6009
Arook@mail.med.upenn.edu
Coordinator: Debbie Leahy
P: 215-662-6722
Deborah.Leahy@uphs.upenn.edu
ClinicalTrials.gov identifier: NCT00168064
