Combination Chemotherapy in Patients With Advanced or Recurrent Mycosis Fungoides
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00002557|
Recruitment Status : Unknown
Verified August 2000 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : July 19, 2004
Last Update Posted : December 18, 2013
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 or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: CHOP regimen Drug: doxorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: methotrexate||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3 participants|
|Official Title:||PROTOCOL FOR THE MANAGEMENT OF MYCOSIS FUNGOIDES AND THE SEZARY SYNDROME|
|Study Start Date :||June 1993|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002557
|University of Cape Town School of Medicine|
|Cape Town, South Africa, 7925|
|Study Chair:||Nicolas Novitzky, MD, PhD||University of Cape Town|