Tretinoin in Treating Patients With Mycosis Fungoides or Sezary Syndrome

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00002479
First received: November 1, 1999
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: tretinoin
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Trial of Tretinoin (TRA) in Patients With Mycosis Fungoides/Sezary Syndrome

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Study Start Date: October 1991
Study Completion Date: August 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002479

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Study Chair: Timothy M. Kuzel, MD Robert H. Lurie Cancer Center
  More Information

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.

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00002479     History of Changes
Other Study ID Numbers: NCI T91-0136, NU-T91-0136, NCI-T91-0136O
Study First Received: November 1, 1999
Last Updated: May 17, 2012
Health Authority: United States: Federal Government

Keywords provided by Northwestern University:
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

Additional relevant MeSH terms:
Lymphoma
Mycoses
Mycosis Fungoides
Sezary Syndrome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Tretinoin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on April 15, 2014