Combination Chemotherapy in Patients With Advanced or Recurrent Mycosis Fungoides

Lymphoma Clinical Trial

Official title:

PROTOCOL FOR THE MANAGEMENT OF MYCOSIS FUNGOIDES AND THE SEZARY SYNDROME

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00002557
• Other study ID #: CDR0000063440
• Secondary ID: SAFR-CT-MF-2NCI-
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: December 17, 2013
• Start date: June 1993

Study information

• Verified date: August 2000
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Mycosis Fungoides

Intervention

Drug:
• CHOP regimen

• doxorubicin hydrochloride

• etoposide

• leucovorin calcium

• methotrexate

Locations

Country	Name	City	State
South Africa	University of Cape Town School of Medicine	Cape Town

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

South Africa,