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Combination Chemotherapy in Patients With Advanced or Recurrent Mycosis Fungoides

NCT ID: NCT00002557

Last Updated: 2013-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lymphoma

Keywords

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stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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CHOP regimen

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

etoposide

Intervention Type DRUG

leucovorin calcium

Intervention Type DRUG

methotrexate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Principal Investigators

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Nicolas Novitzky, MD, PhD

Role: STUDY_CHAIR

University of Cape Town

Locations

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University of Cape Town School of Medicine

Cape Town, , South Africa

Site Status

Countries

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South Africa

Other Identifiers

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SAFR-CT-MF-2

Identifier Type: -

Identifier Source: secondary_id

NCI-F94-0015

Identifier Type: -

Identifier Source: secondary_id

CDR0000063440

Identifier Type: -

Identifier Source: org_study_id