Combination Chemotherapy in Patients With Advanced or Recurrent Mycosis Fungoides
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 etoposide with or without doxorubicin and methotrexate in treating patients who have mycosis fungoides.
Drug: CHOP regimen
Drug: doxorubicin hydrochloride
Drug: leucovorin calcium
|Study Design:||Primary Purpose: Treatment|
|Official Title:||PROTOCOL FOR THE MANAGEMENT OF MYCOSIS FUNGOIDES AND THE SEZARY SYNDROME|
|Study Start Date:||June 1993|
OBJECTIVES: I. Assess the response rate in patients with Stage III/IV or recurrent mycosis fungoides or Sezary syndrome treated with oral etoposide, with the addition of doxorubicin, then methotrexate for poor responders. II. Assess changes in the hematologic and immunologic status of the tumor in these patients.
OUTLINE: Patients are treated sequentially on Regimens A, B, and C depending on response. The following acronyms are used: CF Leucovorin calcium, NSC-3590 DOX Doxorubicin, NSC-123127 MTX Methotrexate, NSC-740 VP-16 Etoposide, NSC-141540 Regimen A: Single-Agent Chemotherapy. VP-16. Regimen B: 2-Drug Combination Chemotherapy. VP-16/DOX. Regimen C: 3-Drug Combination Chemotherapy. VP-16/DOX/MTX.
PROJECTED ACCRUAL: Study duration will be at least 3 years with an anticipated accrual of 3 patients/year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002557
|University of Cape Town School of Medicine|
|Cape Town, South Africa, 7925|
|Study Chair:||Nicolas Novitzky, MD, PhD||University of Cape Town|