Combination Chemotherapy in Patients With Advanced or Recurrent Mycosis Fungoides
Recruitment status was Active, not recruiting
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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 | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: CHOP regimen Drug: doxorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: methotrexate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | PROTOCOL FOR THE MANAGEMENT OF MYCOSIS FUNGOIDES AND THE SEZARY SYNDROME |
| Estimated Enrollment: | 3 |
| Study Start Date: | 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.
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| South Africa | |
| University of Cape Town School of Medicine | |
| Cape Town, South Africa, 7925 | |
| Study Chair: | Nicolas Novitzky, MD, PhD | University of Cape Town |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002557 History of Changes |
| Other Study ID Numbers: | CDR0000063440, SAFR-CT-MF-2, NCI-F94-0015 |
| Study First Received: | November 1, 1999 |
| Last Updated: | January 3, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Mycoses Mycosis Fungoides Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, T-Cell, Cutaneous Lymphoma, T-Cell Lymphoma, Non-Hodgkin Doxorubicin Etoposide Methotrexate |
Leucovorin Levoleucovorin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Phytogenic Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Antidotes Protective Agents Abortifacient Agents, Nonsteroidal |
ClinicalTrials.gov processed this record on May 22, 2013