Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Bleomycin sulfate; Stanford V regimen; Doxorubicin hydrochloride; Etoposide; Mechlorethamine hydrochloride; Prednisone; Vinblastine; Vincristine sulfate
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): A component of the Stanford V regimen.; A component of the Stanford V regimen.; A component of the Stanford V regimen.; A component of the Stanford V regimen.; A component of the Stanford V regimen.; A component of the Stanford V regimen.; A component of the Stanford V regimen.
Intervention MeSH terms: Prednisone; Doxorubicin; Liposomal doxorubicin; Bleomycin; Etoposide; Vincristine; Vinblastine; Mechlorethamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
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