 |
|
|
|
 |
A Phase I/II Trial of Vorinostat in Combination with Cyclophosphamide, Etoposide, Prednisone, and Rituximab for Elderly Patients with Relapsed Diffuse Large B-Cell Lymphoma
[Protocol 08-045]
- Full Title :
- A PHASE I/II TRIAL OF VORINOSTAT IN COMBINATION WITH CYCLOPHOSPHAMIDE, ETOPOSIDE, PREDNISONE AND RITUXIMAB FOR ELDERLY PATIENTS WITH RELAPSED DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL)
- Purpose :
The purpose of this study is to replace a drug with many side effects, procarbazine, with a new drug, vorinostat, in a drug combination for the treatment of elderly patients with relapsed diffuse large B-cell lymphoma (DLBCL). Vorinostat, a drug called a histone deacetylase inhibitor, is approved for the treatment of certain lymphomas of the skin. It alters the cancer cell pathway by preventing cancer cells from reproducing.
In this study, vorinostat will be added to a combination of four other effective chemotherapy drugs that have been used for many years for the treatment of DLBCL: rituximab, cyclophosphamide, etoposide, and prednisone. In the phase I portion of the study, the doses of vorinostat will be increased or decreased depending on the side effects observed in each of the first few patients to find the highest safest dose that can be given.
Once the optimal dose of vorinostat is determined, the remaining patients in the clinical trial will be treated with this dose in the phase II portion of the study. The goal of the study is to determine the safety and effectiveness of vorinostat, rituximab, cyclophosphamide, etoposide, and prednisone in elderly patients with DLBCL that has returned despite previous treatment. Patients will also complete a questionnaire explaining how the treatment affects their quality of life.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of DLBCL that has returned despite one or two prior regimens of chemotherapy (not including autologous stem cell transplantation).
- Patients may not be candidates for autologous stem cell transplantation.
- At least 30 days must have passed since completion of prior therapy and entry into the study, and patients must have recovered from any side effects.
- Patients may not have had previous treatment with a histone deacetylase inhibitor.
- Patients must not be confined to a bed or chair for more than half of their normal waking hours.
- Patients must be age 60 or older.
For more information and to inquire about eligibility for this study, please contact Dr. David J. Straus at 212-639-8365.
|
|
|
|
|
