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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Timothy M. Kuzel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NCI T91-0136

NCT ID:

NCT00002479

Start Date:

October 1991

Completion Date:

August 2002

Related Keywords:

  • Lymphoma
  • stage I cutaneous T-cell non-Hodgkin lymphoma
  • stage II cutaneous T-cell non-Hodgkin lymphoma
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • Lymphoma
  • Mycoses
  • Mycosis Fungoides
  • Sezary Syndrome

Name

Location
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611