PROTOCOL FOR THE MANAGEMENT OF MYCOSIS FUNGOIDES AND THE SEZARY SYNDROME
N/A
N/A
Both
Lymphoma
Trial Information
PROTOCOL FOR THE MANAGEMENT OF MYCOSIS FUNGOIDES AND THE SEZARY SYNDROME
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.
Inclusion Criteria
DISEASE CHARACTERISTICS: Stage III/IV mycosis fungoides or Sezary syndrome Stage I/II
cutaneous T-cell lymphoma in relapse following interferon therapy also eligible
PATIENT CHARACTERISTICS: Age: Not specified
PRIOR CONCURRENT THERAPY: Biologic therapy: Prior interferon alpha for Stage I/II disease
allowed Chemotherapy: Prior isotretinoin for Stage I/II disease allowed Endocrine therapy:
Prior topical steroids for Stage I/II disease allowed Radiotherapy: Prior ultraviolet
therapy for Stage I/II disease allowed Prior x-ray therapy for Stage I/II disease allowed
Surgery: Not specified
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Nicolas Novitzky, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Cape Town
Authority:
United States: Federal Government
Study ID:
CDR0000063440
NCT ID:
NCT00002557
Start Date:
June 1993
Completion Date:
Related Keywords:
- Lymphoma
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- Lymphoma
- Mycoses
- Mycosis Fungoides
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