Not Signed In -
Langerhans Cell Histiocytosis |
LCH |
Clinical Trial: Combination Chemotherapy in Patients With Advanced or Recurrent Mycosis Fungoides
This study is no longer recruiting patients.
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Purpose
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 | Treatment or Intervention | Phase |
|---|---|---|
| stage III cutaneous T-cell lymphoma stage IV cutaneous T-cell lymphoma recurrent cutaneous T-cell lymphoma | Drug: doxorubicin Drug: etoposide Drug: leucovorin calcium Drug: methotrexate | Phase II |
MedlinePlus related topics: Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Oral VP-16 for Stage III/IV or Recurrent Mycosis Fungoides/Sezary Syndrome with Sequential Addition of DOX and MTX for Poorly Responding Disease
Study start: June 1993
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.
PROTOCOL 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.
Eligibility
Criteria
PROTOCOL ENTRY 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
--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
--Patient Characteristics--
- Age: Not specified
Location Information
South Africa
University of Cape Town School of Medicine, Cape Town, 7925, South Africa
Nicolas Novitzky, Study Chair, University of Cape Town
More Information
Clinical trial summary from the National Cancer Institute's PDQ®
Record last reviewed: July 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002557
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Langerhans Cell Histiocytosis (Cleveland Clinic)
- Langerhans Cell Histiocytosis (child (Cleveland Clinic)
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