Liposomal Tretinoin in Treating Patients With Recurrent or Refractory Hodgkin's Disease
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of ATRAGEN (Liposomal Tretinoin) in Patients With Relapsed or Refractory Hodgkin's Disease|
- Patient Response Rate [ Time Frame: 28 Day Cycles ] [ Designated as safety issue: No ]
|Study Start Date:||September 1999|
|Primary Completion Date:||January 2001 (Final data collection date for primary outcome measure)|
Experimental: Liposomal Tretinoin
Liposome by vein (IV) over 30 minutes every other day for 28 days and Chemotherapy.
Drug: Tretinoin Liposome
Liposome by vein (IV) over 30 minutes every other day for 28 days
Other Name: ATRAGEN
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005969
|Study Chair:||Andreas H. Sarris, MD, PhD||M.D. Anderson Cancer Center|