Rituximab Followed by Combination Chemotherapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00006669|
Recruitment Status : Unknown
Verified May 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : May 4, 2004
Last Update Posted : February 9, 2009
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to kill cancer cells. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab followed by combination chemotherapy in treating patients who have refractory or recurrent non-Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: rituximab Biological: sargramostim Drug: EPOCH regimen Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisone Drug: vincristine sulfate||Phase 2|
OBJECTIVES: I. Determine the response rate in patients with refractory or recurrent CD20+ intermediate grade B-cell non-Hodgkin's lymphoma treated with rituximab followed by etoposide, vincristine, doxorubicin, cyclophosphamide, and prednisone (EPOCH). II. Determine the toxicity of the regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive rituximab IV over 4-10 hours on day 1 followed by etoposide, vincristine, and doxorubicin IV continuously on days 4-7, cyclophosphamide IV over 5-30 minutes on day 8 and oral prednisone on days 4-8. Patients also receive sargramostim (GM-CSF) subcutaneously beginning on day 9 until blood counts recover. Treatment repeats every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Trial of EPOCH and Rituxan Combined Therapy in Patients With Refractory or Relapsed CD20 Positive Intermediate Grade B-Cell Non-Hodgkin's Lymphoma|
|Study Start Date :||September 1999|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006669
|United States, District of Columbia|
|Washington Cancer Institute|
|Washington, District of Columbia, United States, 20010|
|United States, Maryland|
|Franklin Square Hospital Center|
|Baltimore, Maryland, United States, 21237|
|Study Chair:||Sein Aung, MD||Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center|