Tretinoin in Treating Patients With Mycosis Fungoides or Sezary Syndrome

May 17, 2012 updated by: Northwestern University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1991

Primary Completion (Actual)

August 1, 2002

Study Completion (Actual)

August 1, 2002

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

August 20, 2004

First Posted (Estimate)

August 23, 2004

Study Record Updates

Last Update Posted (Estimate)

May 30, 2012

Last Update Submitted That Met QC Criteria

May 17, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI T91-0136
  • NU-T91-0136
  • NCI-T91-0136O

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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