Suspended

PROTOCOL FOR THE MANAGEMENT OF MYCOSIS FUNGOIDES AND THE SEZARY SYNDROME

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What is being tested

CHOP regimen

+ doxorubicin hydrochloride

+ etoposide

Drug
Who is being recruted

Hemic and Lymphatic Diseases+8

+ Immune System Diseases

+ Immunoproliferative Disorders

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 1993
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: December 18, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 1993

Actual date on which the first participant was enrolled.

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.

NCT00002557
Principal SponsorNational Cancer Institute (NCI)
Last updated: December 18, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

3 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLymphoma, T-CellLymphomaLymphoma, T-Cell, Cutaneous

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Cape Town School of Medicine

Cape Town, South AfricaOpen University of Cape Town School of Medicine in Google Maps
SuspendedOne Study Center