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Phase II Study of ATRAGEN (Liposomal Tretinoin) in Patients With Relapsed or Refractory Hodgkin's Disease

Phase 2
12 Years
Not Enrolling

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Trial Information

Phase II Study of ATRAGEN (Liposomal Tretinoin) in Patients With Relapsed or Refractory Hodgkin's Disease

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.

Inclusion 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patient Response Rate

Outcome Time Frame:

28 Day Cycles

Safety Issue:


Principal Investigator

Andreas H. Sarris, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

September 1999

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma