Liposomal Tretinoin in Treating Patients With Recurrent or Refractory Hodgkin's Disease
- Registration Number
- NCT00005969
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of liposomal tretinoin in treating patients who have recurrent or refractory Hodgkin's disease.
- Detailed Description
OBJECTIVES: I. Determine the response rate, failure free survival, and progression free survival of patients with recurrent or refractory Hodgkin's disease treated with tretinoin liposome. II. Determine the toxicities of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior response to treatment (refractory vs recurrent vs post marrow transplant). Patients receive tretinoin liposome IV over 30 minutes every other day for 28 days. Treatment continues every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are eligible for stem cell or marrow transplant receive at least 2 courses before crossing over to transplant. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 105 patients (35 per strata) will be accrued for this study over 2-3 years.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Liposomal Tretinoin Chemotherapy Liposome by vein (IV) over 30 minutes every other day for 28 days and Chemotherapy. Liposomal Tretinoin Tretinoin Liposome Liposome by vein (IV) over 30 minutes every other day for 28 days and Chemotherapy.
- Primary Outcome Measures
Name Time Method Patient Response Rate 28 Day Cycles
- Secondary Outcome Measures
Name Time Method