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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00020436 |
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with T-cell lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: romidepsin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Trial Of Depsipeptide In Patients With Cutaneous T-Cell Lymphoma And Relapsed Peripheral T-Cell Lymphoma |
| Estimated Enrollment: | 197 |
| Study Start Date: | December 2000 |
| Estimated Primary Completion Date: | April 2001 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 197 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following diagnoses:
Histologically confirmed cutaneous T-cell lymphoma (CTCL) (mycosis fungoides or Sezary syndrome)
Stage IB or IIA
Refractory to, intolerant of, or at a 6-month or longer response plateau on at least 2 of the following prior therapies:
Stage IIB-IVB
Other mature T-cell lymphoma* not listed above including, but not limited to:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Cardiology consultation and/or Holter monitoring required for any 1 of the following:
No cardiac arrhythmia requiring anti-arrhythmic medication
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
No more than 2 prior systemic cytotoxic chemotherapy regimens (for patients with cutaneous T-cell lymphoma)
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
No concurrent medications that prolong the QTc interval
Contacts and Locations| United States, Arizona | |
| Mayo Clinic Scottsdale | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| Sierra Hematology Oncology Medical Center - Sacramento | |
| Sacremento, California, United States, 95819 | |
| United States, District of Columbia | |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Maryland | |
| NCI - Center for Cancer Research | |
| Bethesda, Maryland, United States, 20892 | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
| Bethesda, Maryland, United States, 20892-1182 | |
| United States, Massachusetts | |
| Boston University Cancer Research Center | |
| Boston, Massachusetts, United States, 02118 | |
| United States, New York | |
| Don Monti Comprehensive Cancer Center at North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10029 | |
| NYU Cancer Institute at New York University Medical Center | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| UPMC Cancer Centers | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Australia, South Australia | |
| Institute of Medical and Veterinary Science | |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Victoria | |
| Peter MacCallum Cancer Centre | |
| East Melbourne, Victoria, Australia, 8006 | |
| Australia, Western Australia | |
| Sir Charles Gairdner Hospital - Perth | |
| Perth, Western Australia, Australia, 6009 | |
| Study Chair: | Richard Piekarz, MD, PhD | National Cancer Institute (NCI) |
More Information
| Responsible Party: | University of Chicago Cancer Research Center ( Everett E. Vokes ) |
| Study ID Numbers: | CDR0000068466, NCI-01-C-0049, NCI-1312 |
| Study First Received: | July 11, 2001 |
| Last Updated: | June 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00020436 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
stage II cutaneous T-cell non-Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma anaplastic large cell lymphoma stage II mycosis fungoides/Sezary syndrome |
stage III mycosis fungoides/Sezary syndrome stage IV mycosis fungoides/Sezary syndrome recurrent mycosis fungoides/Sezary syndrome recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents Romidepsin Antibiotics, Antineoplastic Lymphoma, T-Cell, Peripheral Pharmacologic Actions |
Lymphatic Diseases Neoplasms Therapeutic Uses Lymphoma, T-Cell Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Lymphoma, T-Cell, Cutaneous |