Clinical trial NCT00005969: Liposomal Tretinoin in Treating Patients With Recurrent or Refractory Hodgkin's Disease
Official title: Phase II Study of ATRAGEN (Liposomal Tretinoin) in Patients With Relapsed or Refractory Hodgkin's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Lymphoma
Keywords: recurrent adult Hodgkin lymphoma
recurrent/refractory childhood Hodgkin lymphoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-04-28
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

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

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

Primary outcomes:
measure: Patient Response Rate
timeFrame: 28 Day Cycles
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Andreas H. Sarris, MD, PhD
role: STUDY_CHAIR
References: