Liposomal Tretinoin in Treating Patients With Recurrent or Refractory Hodgkin's Disease
Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma
Intervention: Chemotherapy (Drug); Tretinoin Liposome (Drug)
Phase: Phase 2
Status: Withdrawn
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s):
Andreas H. Sarris, MD, PhD, Study Chair, Affiliation: M.D. Anderson Cancer Center
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.
Clinical Details
Official title: Phase II Study of ATRAGEN (Liposomal Tretinoin) in Patients With Relapsed or Refractory Hodgkin's Disease
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Patient Response Rate
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
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
UT MD Anderson Cancer Center Website
Starting date: September 1999
Last updated: February 17, 2012
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