Tretinoin in Treating Patients With Mycosis Fungoides or Sezary Syndrome
Information source: Northwestern University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma
Intervention: tretinoin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Northwestern University Official(s) and/or principal investigator(s):
Timothy M. Kuzel, MD, Study Chair, Affiliation: Robert H. Lurie 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 tretinoin in treating patients who
have any stage mycosis fungoides or Sezary syndrome.
Clinical Details
Official title: Phase II Trial of Tretinoin (TRA) in Patients With Mycosis Fungoides/Sezary Syndrome
Study design: Primary Purpose: Treatment
Detailed description:
OBJECTIVES: I. Determine the efficacy of tretinoin (TRA) in patients with mycosis
fungoides/Sezary syndrome. II. Evaluate the spectrum of toxicity of TRA in this patient
population.
OUTLINE: Nonrandomized study. Single-agent Chemotherapy. Tretinoin, All-trans-Retinoic Acid,
TRA, NSC-122758.
PROJECTED ACCRUAL: If 1 or more of the first 15 evaluable patients experience an objective
response, then 20 additional patients will be entered. It is anticipated that the accrual
rate will be 1-2 patients per month.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS: Biopsy-proven mycosis fungoides/Sezary syndrome Stage I-IV
disease No CNS involvement At least 1 measurable lesion required (skin, lymph nodes,
visceral lesion, or peripheral blood counts)
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-3 Hematopoietic: WBC at
least 3,000/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin no more than 2. 0
mg/dL Transaminases no more than 2 x normal Alkaline phosphatase no more than 2 x normal
Renal: Creatinine no more than 2. 0 mg/dL Other: No active systemic infection No
significant organ failure uncontrolled with medication No pregnant or lactating women
Effective contraception required of fertile women
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior systemic therapy
Chemotherapy: At least 4 weeks since prior topical chemotherapeutics or systemic therapy
Endocrine therapy: At least 4 weeks since prior topical (including steroid) therapy or
systemic therapy Radiotherapy: Not specified Surgery: Not specified
Locations and Contacts
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois 60611, United States
Additional Information
Starting date: October 1991
Last updated: May 17, 2012
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