Completed

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

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What is being tested

tretinoin

Drug
Who is being recruted

Hemic and Lymphatic Diseases+8

+ Immune System Diseases

+ Immunoproliferative Disorders

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 1991
See protocol details

Summary

Principal SponsorNorthwestern University
Last updated: May 30, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 1991

Actual date on which the first participant was enrolled.

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.

NCT00002479
Principal SponsorNorthwestern University
Last updated: May 30, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLymphoma, T-CellLymphomaLymphoma, T-Cell, Cutaneous

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, United StatesOpen Robert H. Lurie Comprehensive Cancer Center, Northwestern University in Google Maps
CompletedOne Study Center