Phase II Study of ATRAGEN (Liposomal Tretinoin) in Patients With Relapsed or Refractory Hodgkin's Disease
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Patient Response Rate
28 Day Cycles
Andreas H. Sarris, MD, PhD
M.D. Anderson Cancer Center
United States: Federal Government