Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma

Sponsor

Stanford University (Other)

Overall Status

Completed

CT.gov ID

NCT00002715

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

318

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

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

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 1989

Actual Primary Completion Date :

Jan 1, 2007

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combination Chemotherapy (Stanford V) A combination chemotherapy regimen consisting of mechlorethamine, doxorubicin hydrochloride, vinblastine, vincristine, bleomycin, etoposide and prednisone, administered on a compressed schedule	Biological: Bleomycin sulfate A component of the Stanford V regimen. Drug: Stanford V regimen Drug: Doxorubicin hydrochloride A component of the Stanford V regimen. Drug: Etoposide A component of the Stanford V regimen. Drug: Mechlorethamine hydrochloride A component of the Stanford V regimen. Drug: Prednisone A component of the Stanford V regimen. Drug: Vinblastine A component of the Stanford V regimen. Drug: Vincristine sulfate A component of the Stanford V regimen.

Arm

Intervention/Treatment

Experimental: Combination Chemotherapy (Stanford V)

A combination chemotherapy regimen consisting of mechlorethamine, doxorubicin hydrochloride, vinblastine, vincristine, bleomycin, etoposide and prednisone, administered on a compressed schedule

Biological: Bleomycin sulfate