Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Liposomal Tretinoin in Treating Patients With Recurrent or Refractory Hodgkin's Disease

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 12 and over NCI MDA-ID-99255 NCI-103, NCT00005969, 103

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.

Entry Criteria

Disease Characteristics:

Histologically confirmed recurrent or refractory Hodgkin's disease
 Recurrent after partial or complete response after initial therapy OR
 Refractory after no response or progression after initial therapy

At least 2 prior treatment regimens (radiotherapy considered separate if not
part of planned combined modality)

Bidimensionally measurable disease

No active CNS disease

Prior/Concurrent Therapy:

Biologic therapy:
 No more than 1 prior autologous stem cell or marrow transplant 
 No prior allogenic stem cell or marrow transplant 

Chemotherapy:
 See Disease Characteristics
 Must be recovered from last regimen
 No prior retinoids, including tretinoin

Endocrine therapy:
 No concurrent steroids

Radiotherapy:
 See Disease Characteristics
 Must be recovered from last regimen

Surgery:
 Not specified

Patient Characteristics:

Age:
 12 and over

Performance status:
 Zubrod 0-2

Life expectancy:
 Not specified

Hematopoietic:
 Absolute neutrophil count at least 500/mm3
 Platelet count at least 20,000/mm3

Hepatic:
 Bilirubin no greater than 1.5 mg/dL
 SGPT less than 4 times upper limit of normal

Renal:
 Creatinine no greater than 3.0 mg/dL

Other:
 Not pregnant or nursing
 Fertile patients must use effective contraception
 Must not be eligible or willing to undergo treatment of a higher priority
 HIV negative
 No other prior malignancies within the last 5 years except basal cell
  carcinoma of the skin or carcinoma in situ of the cervix treated with
  curative intent
 No other concurrent serious illness or active infection
 No mental or social reasons that may preclude study

Expected Enrollment

A total of 105 patients (35 per strata) will be accrued for this study over 
2-3 years.

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.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Andreas Sarris, MD, PhD, Protocol chair		Ph: 713-792-2860; 800-392-1611

Registry Information
Official Title		Phase II Study of ATRAGEN (Liposomal Tretinoin) in Patients with Relapsed or Refractory Hodgkin's Disease
Registered in ClinicalTrials.gov		NCT00005969
Date Submitted to PDQ		2000-05-04
Information Last Verified		2001-11-01
NCI Grant/Contract Number		P30-CA16672

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