Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma

A Phase II Pilot Study of Short Term (12 Week) Combination Chemotherapy (Stanford V) in Unfavorable Hodgkin's Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002715

Enrollment

Registered

2003-01-27

Start date

1989-04-30

Completion date

2015-10-31

Last updated

2020-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

Stage I adult Hodgkin lymphoma, Stage II adult Hodgkin lymphoma, Stage III adult Hodgkin lymphoma, Stage IV adult Hodgkin lymphoma, Adult lymphocyte predominant Hodgkin lymphoma, Adult lymphocyte depletion Hodgkin lymphoma, Adult nodular sclerosis Hodgkin lymphoma, Adult mixed cellularity Hodgkin lymphoma

Brief summary

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.

Detailed description

OBJECTIVES: * 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.