Liposomal Tretinoin in Treating Patients With Recurrent or Refractory Hodgkin's Disease
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|ClinicalTrials.gov Identifier: NCT00005969|
Recruitment Status : Withdrawn (Study withdrawn.)
First Posted : April 28, 2004
Last Update Posted : February 20, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: Chemotherapy Drug: Tretinoin Liposome||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of ATRAGEN (Liposomal Tretinoin) in Patients With Relapsed or Refractory Hodgkin's Disease|
|Study Start Date :||September 1999|
|Primary Completion Date :||January 2001|
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
- Patient Response Rate [ Time Frame: 28 Day Cycles ]
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): NCT00005969
|Study Chair:||Andreas H. Sarris, MD, PhD||M.D. Anderson Cancer Center|