Combination Chemotherapy in Patients With Advanced or Recurrent Mycosis Fungoides

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Unknown status

CT.gov ID

NCT00002557

Collaborator

(none)

Enrollment

Location

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 etoposide with or without doxorubicin and methotrexate in treating patients who have mycosis fungoides.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: CHOP regimen Drug: doxorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: methotrexate	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

3 participants

Primary Purpose:

Treatment

Official Title:

PROTOCOL FOR THE MANAGEMENT OF MYCOSIS FUNGOIDES AND THE SEZARY SYNDROME

Study Start Date :

Jun 1, 1993

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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