A PHASE II PILOT STUDY OF SHORT TERM (12 WEEK) COMBINATION CHEMOTHERAPY (STANFORD V) IN UNFAVORABLE HODGKIN'S DISEASE

Trial Information

A PHASE II PILOT STUDY OF SHORT TERM (12 WEEK) COMBINATION CHEMOTHERAPY (STANFORD V) IN UNFAVORABLE HODGKIN'S DISEASE

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.