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Phase II Trial of Tretinoin (TRA) in Patients with Mycosis Fungoides/Sezary Syndrome

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Tretinoin in Treating Patients With Mycosis Fungoides or Sezary Syndrome

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Completed over 18 NCI NU-T91-0136
NCI-T91-0136O, NCT00002479, T91-0136

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.

Entry 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)

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

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

Expected Enrollment

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.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  Tretinoin, All-trans-Retinoic Acid,
TRA, NSC-122758.

Published Results

Siegel RS, Martone B, Guitart J, et al.: Phase II trial of all-TRA in the treatment of relapsed/refractory mycosis fungoides. 94(1 suppl): A423, 96a, 1999.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Timothy Kuzel, MD, Protocol chair
Ph: 312-695-6180

Registry Information

Official Title		Phase II Trial of Tretinoin (TRA) in Patients with Mycosis Fungoides/Sezary Syndrome

Trial Start Date		1991-10-08

Registered in ClinicalTrials.gov		NCT00002479

Date Submitted to PDQ		1991-10-08

Information Last Verified		2000-08-01

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.