Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma
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|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|