Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00002715|
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : July 2, 2009
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: bleomycin sulfate Drug: Stanford V regimen Drug: doxorubicin hydrochloride Drug: etoposide Drug: mechlorethamine hydrochloride Drug: prednisone Drug: vinblastine Drug: vincristine sulfate||Phase 2|
- Determine the feasibility of short term chemotherapy with the Stanford V regimen (mechlorethamine, doxorubicin, vinblastine, prednisone, vincristine, bleomycin, and etoposide) followed by, as indicated, consolidative radiotherapy in patients with stage IIB, IIIA, IIIB, or IV Hodgkin's lymphoma.
- Determine the initial response to 8 weeks of Stanford V chemotherapy in these patients.
- Assess the complete and partial response rate to 12 weeks of Stanford V chemotherapy in these patients.
- Determine the acute toxicity associated with this treatment.
- Determine the disease free interval and survival following Stanford V chemotherapy with or without consolidative radiotherapy in these patients.
OUTLINE: All patients are treated on Regimen A with the Stanford V Regimen; those with initial bulky, residual, or splenic disease who achieve a CR/PR proceed to Regimen B.
- Regimen A: Patients receive mechlorethamine IV on weeks 1, 5, and 9; doxorubicin and vinblastine IV on weeks 1, 3, 5, 7, 9, and 11; vincristine and bleomycin IV on weeks 2, 4, 6, 8, 10, and 12; etoposide IV over 30-45 minutes for 2 consecutive days on weeks 3, 7, and 11; and prednisone orally every other day on days 1-84. Treatment continues for 8-12 weeks, depending on response, in the absence of disease progression or unacceptable toxicity.
- Regimen B: Patients begin radiotherapy 2-4 weeks after completion of Regimen A. Patients receive radiotherapy to lungs, pleura, and other extralymphatic sites for approximately 5 weeks.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 50 patients will be entered if at least 16 of the first 22 patients respond. As of 03/96, it is expected that a total of 45 patients each with stage III/IV disease and 40 with unfavorable stage II disease will be accrued.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Official Title:||A PHASE II PILOT STUDY OF SHORT TERM (12 WEEK) COMBINATION CHEMOTHERAPY (STANFORD V) IN UNFAVORABLE HODGKIN'S DISEASE|
|Study Start Date :||April 1989|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002715
|United States, California|
|Stanford Cancer Center at Stanford University Medical Center|
|Stanford, California, United States, 94305|
|Study Chair:||Sandra J. Horning, MD||Stanford University|