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NCT00972478 · ClinicalTrials.gov registry record · Phase 1
Vorinostat, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma
A Phase 1 study of Ann Arbor Stage III Non-Hodgkin Lymphoma and Ann Arbor Stage IV Non-Hodgkin Lymphoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 83
- Enrollment target
- 20
- Study locations
NCT00972478: Active Phase 1 study of Ann Arbor Stage III Non-Hodgkin Lymphoma and Ann Arbor Stage IV Non-Hodgkin Lymphoma, sponsored by National Cancer Institute (NCI).
NCT00972478 is a Phase 1 study of Ann Arbor Stage III Non-Hodgkin Lymphoma and Ann Arbor Stage IV Non-Hodgkin Lymphoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 83 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00972478, a Phase 1 study of Ann Arbor Stage III Non-Hodgkin Lymphoma and Ann Arbor Stage IV Non-Hodgkin Lymphoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 83 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase I/II trial is studying the side effects and best dose of vorinostat when given together with rituximab and combination chemotherapy and to see how well it works in treating patients with newly diagnosed stage II, stage III, or stage IV diffuse large B-cell lymphoma. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving vorinostat together with rituximab and combination chemotherapy may kill more cancer cells.
Primary Outcome
Safe dose of Vorinostat (in combination with R-CHOP) at which 3/10 or fewer patients have doselimiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite).
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- OTHER Laboratory Biomarker Analysis
- DRUG Doxorubicin Hydrochloride
- DRUG Prednisone
- BIOLOGICAL Rituximab
Study Locations (20)
California
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- City of Hope Comprehensive Cancer Center - Duarte
- Kaiser Permanente-Fremont - Fremont
- Kaiser Permanente-Fresno - Fresno
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Kaiser Permanente-Modesto - Modesto
- Kaiser Permanente-Oakland - Oakland
- Kaiser Permanente-Redwood City - Redwood City
- Kaiser Permanente-Richmond - Richmond
- Kaiser Permanente-Roseville - Roseville
- Kaiser Permanente-South Sacramento - Sacramento
- Kaiser Permanente Sacramento Medical Center - Sacramento
- Kaiser Permanente-San Francisco - San Francisco
Arizona
- University of Arizona Cancer Center-Orange Grove Campus - Tucson
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- NEA Baptist Memorial Hospital - Jonesboro
Alabama
- Providence Hospital - Mobile
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2010-11-15 |
| Est. Completion | 2026-03-06 |
| Phase | Phase 1 |
What the registry record for NCT00972478 still lists
NCT00972478 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% higher).
The record links to 3 conditions, with Ann Arbor Stage III Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00972478 names 20 study sites across 4 states, led by California, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT00972478 about?
NCT00972478 is a clinical study titled "Vorinostat, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma". This phase I/II trial is studying the side effects and best dose of vorinostat when given together with rituximab and combination chemotherapy and to see how well it works in treating patients with newly diagnosed stage II, stage III, or stage IV diffuse large B-cell lymphoma. Vorinostat may stop th...
What is the current status of trial NCT00972478?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 83 participants. The study started on 2010-11-15. Estimated completion is 2026-03-06.
What conditions does trial NCT00972478 study?
This clinical trial studies the following conditions: Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Ann Arbor Stage II Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT00972478?
The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Doxorubicin Hydrochloride (DRUG), Prednisone (DRUG), Rituximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00972478?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00972478 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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