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NCT00007345 · ClinicalTrials.gov registry record · Phase 2
Depsipeptide to Treat Patients With Cutaneous T-Cell Lymphoma and Peripheral T-Cell Lymphoma
A Phase 2 study of Peripheral T-Cell Lymphoma and Cutaneous T Cell Lymphoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 131
- Enrollment target
- 13
- Study locations
NCT00007345: Completed Phase 2 study of Peripheral T-Cell Lymphoma and Cutaneous T Cell Lymphoma, sponsored by National Cancer Institute (NCI).
NCT00007345 is a Phase 2 study of Peripheral T-Cell Lymphoma and Cutaneous T Cell Lymphoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 131 participants, above the 102-participant average among 34 other Peripheral T-Cell Lymphoma trials with a reported enrollment target (28% higher). The trial reports 13 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00007345, a Phase 2 study of Peripheral T-Cell Lymphoma and Cutaneous T Cell Lymphoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 131 participants
- Enrollment target
- 13
- Study locations
Study Summary
Background: NSC630176 is a depsipeptide fermentation product from Chromobacterium violaceum with potent cytotoxic activity against human tumor cell lines and in vivo efficacy against both human tumor xenografts and murine tumors (1-3). NSC 630176, herein referred to as depsipeptide, shows a lack of cross resistance with several commonly used cytotoxic agents such as vincristine, 5-fluorouracil, mitomycin C and cyclophosphamide (2). However, it has been defined as a P-glycoprotein (Pgp) substrate by COMPARE analysis of the National Cancer Institute (NCI) drug screen cytotoxicity profile (4). Depsipeptide is a member of a novel class of antineoplastic agents, the histone deacetylase inhibitors. In the phase I trial conducted at the National Cancer Institute (NCI), responses were observed at the maximum tolerated dose (MTD) in patients with cutaneous and peripheral T-cell lymphoma. Objectives: In patients with cutaneous T-cell lymphoma, the primary end points to be examined are overall response rate, complete response rate and duration of response. In patients with relapsed peripheral T-cell lymphoma, the endpoints to be examined are overall response rate and complete response rate. To evaluate the tolerability of depsipeptide with extended cycles of therapy. Eligibility: Patients with cutaneous T-cell lymphoma (mycosis fungoides or Sezary syndrome) or other peripheral T-cell lymphomas are eligible. Design: Depsipeptide will be administered at 14 mg/m\^2, over 4 hours on days 1, 8 and 15. This trial will accrue in six cohorts; Arm 1, patients with cutaneous T-cell lymphoma who have had less than or equal to two prior cytotoxic chemotherapy regimens; Arm 2, patients with peripheral T-cell lymphoma who have had less than or equal to two prior cytotoxic chemotherapy regimens; Arm 3, patients with cutaneous and peripheral T-cell lymphoma who have had more than two prior cytotoxic chemotherapy regimens; Arm 4, patients with other mature T-cell lymphomas; Arm 5,
Conditions Studied
Interventions
- DRUG Romidepsin
Study Locations (13)
Other
- Royal Adelaide Hospital - Adelaide
- Peter MacCallum Cancer Centre - Melbourne
- Sir Charles Gairdner Hospital - Perth
California
- City of Hope National Cancer Center - Duarte
- Mercy General Hospital - Sacramento
Arizona
- Mayo Clinic Scottsdale - Scottsdale
Arkansas
- University of Arkansas - Little Rock
District of Columbia
- Georgetown University - Washington D.C.
Illinois
- Northwestern University - Chicago
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
New York
- North Shore University Hospital - Manhasset
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2001-03-08 |
| Est. Completion | 2015-07-27 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00007345
The ClinicalTrials.gov registry entry for NCT00007345 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 102-participant average among 34 other Peripheral T-Cell Lymphoma trials with a reported enrollment target (28% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Peripheral T-Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Romidepsin is the first listed.
NCT00007345 reports 13 study locations spanning 10 distinct geographic areas - top geographies include Other, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT00007345 about?
NCT00007345 is a clinical study titled "Depsipeptide to Treat Patients With Cutaneous T-Cell Lymphoma and Peripheral T-Cell Lymphoma". Background: NSC630176 is a depsipeptide fermentation product from Chromobacterium violaceum with potent cytotoxic activity against human tumor cell lines and in vivo efficacy against both human tumor xenografts and murine tumors (1-3). NSC 630176, herein referred to as depsipeptide, shows a lack o...
What is the current status of trial NCT00007345?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 131 participants. The study started on 2001-03-08. Estimated completion is 2015-07-27.
What conditions does trial NCT00007345 study?
This clinical trial studies the following conditions: Peripheral T-Cell Lymphoma, Cutaneous T Cell Lymphoma.
What interventions are being tested in trial NCT00007345?
The interventions under investigation include: Romidepsin (DRUG).
Who is sponsoring clinical trial NCT00007345?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00007345 being conducted?
This trial has 13 study locations across Arizona, Arkansas, California, District of Columbia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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