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	Treatment or Intervention	Phase
recurrent childhood Hodgkin's disease recurrent adult Hodgkin's disease	Drug: tretinoin liposome	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  12 Years and above

Criteria

PROTOCOL 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

Study chairs or principal investigators

Andreas H. Sarris,  Study Chair,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000067952; MDA-ID-99255; NCI-103
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  July 5, 2000
ClinicalTrials.gov Identifier:  NCT00005969
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08