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NCT00667615 · ClinicalTrials.gov registry record · Phase 1
Trial of Vorinostat in Combination With Cyclophosphamide, Etoposide, Prednisone and Rituximab for Elderly Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)
A Phase 1 study of Lymphoma and Hodgkin's Disease, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 5
- Study locations
NCT00667615: Completed Phase 1 study of Lymphoma and Hodgkin's Disease, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00667615 is a Phase 1 study of Lymphoma and Hodgkin's Disease that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 30 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (94% lower). The trial reports 5 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00667615, a Phase 1 study of Lymphoma and Hodgkin's Disease, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study is to replace a drug with many side effects, procarbazine, with a new novel drug, vorinostat, in a drug combination for the treatment of patients with diffuse large B-cell lymphoma. Vorinostat is the first of a new type of chemotherapy drug, known as a histone deacetylase inhibitor, to be approved by the Food and Drug Administration. It is approved for the treatment of certain lymphomas of the skin. It alters the cancer cell pathway by preventing cancer cells from reproducing. Vorinostat will be added to a combination of four other effective chemotherapy drugs that have been used for many years for the treatment of diffuse large B-cell lymphoma: rituximab, cyclophosphamide, etoposide and prednisone. The doses of vorinostat will be increased or decreased depending on the side effects that occur in each of the first few patients in the trial to find the safest dose with the least side effects. This is termed the phase I part of the clinical trial. Once the best dose of vorinostat is found, the rest of the patients in the clinical trial will be treated with this dose. This is termed the phase II part of the trial. The object of the trial is to find out what effects, good and/or bad, the combination of vorinostat, rituximab, cyclophosphamide, etoposide and prednisone will have on you and your lymphoma.
Primary Outcome
Maximum Tolerated Dose (MTD) of Vorinostat reflects the highest dose of Ridaforolimus and Vorinostat that did not cause a new Grade 2 toxicity in \>= 50% of participants
Conditions Studied
Interventions
- DRUG rituximab, cyclophosphamide, etoposide, prednisone, vorinostat and QOL questionnaire, peg-filgrastim or filgrastim
Study Locations (5)
New York
- Memorial Sloan Kettering Cancer Center @ Suffolk - Commack
- Memorial Sloan Kettering Cancer Center - New York
- Weill Cornell Medical Center - New York
- Memorial Sloan Kettering Cancer Center @ Phelps - Sleepy Hollow
New Jersey
- Memorial Sloan Kettering Cancer Center @ BaskingRidge - Basking Ridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2008-04 |
| Est. Completion | 2017-02 |
| Phase | Phase 1 |
What the finished NCT00667615 record still lists
NCT00667615 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which rituximab, cyclophosphamide, etoposide, prednisone, vorinostat and QOL questionnaire, peg-filgrastim or filgrastim is the first listed.
NCT00667615 lists 5 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT00667615 about?
NCT00667615 is a clinical study titled "Trial of Vorinostat in Combination With Cyclophosphamide, Etoposide, Prednisone and Rituximab for Elderly Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)". The purpose of this study is to replace a drug with many side effects, procarbazine, with a new novel drug, vorinostat, in a drug combination for the treatment of patients with diffuse large B-cell lymphoma. Vorinostat is the first of a new type of chemotherapy drug, known as a histone deacetylase i...
What is the current status of trial NCT00667615?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2008-04. Estimated completion is 2017-02.
What conditions does trial NCT00667615 study?
This clinical trial studies the following conditions: Lymphoma, Hodgkin's Disease.
What interventions are being tested in trial NCT00667615?
The interventions under investigation include: rituximab, cyclophosphamide, etoposide, prednisone, vorinostat and QOL questionnaire, peg-filgrastim or filgrastim (DRUG).
Who is sponsoring clinical trial NCT00667615?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00667615 being conducted?
This trial has 5 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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