Bexarotene and Interferon Alfa in Treating Patients With Cutaneous T-Cell Lymphoma

April 2, 2013 updated by: Memorial Sloan Kettering Cancer Center

Phase II Trial Of Oral Bexarotene (Targretin) Combined With Interferon Alfa-2b (Intron-A) For Patients With Cutaneous T-Cell Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining bexarotene with interferon alfa in treating patients who have cutaneous T-cell lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the response rate and response duration in patients with cutaneous T-cell lymphoma when treated with bexarotene and, in the absence of a complete response, interferon alfa.
  • Determine the safety and toxicity in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral bexarotene once daily for 8 weeks.

Patients with a complete response (CR) after 8 weeks continue bexarotene alone for at least another 8 weeks in the absence of unacceptable toxicity.

Patients who progress or relapse during bexarotene therapy or who achieve less than a CR after 8 weeks begin receiving interferon alfa subcutaneously 3 times a week and oral bexarotene daily for at least another 8 weeks in the absence of continuing disease progression or unacceptable toxicity.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 20-45 patients will be accrued for this study within 2 years.

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
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Sylvester Comprehensive Cancer Center
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10016
        • NYU School of Medicine's Kaplan Comprehensive Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • Abramson Cancer Center of the University of Pennsylvania Medical Center
    • Texas
      • Houston, Texas, United States, 77030-4009
        • University of Texas - MD Anderson Cancer Center

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:

  • Histologically confirmed cutaneous T-cell lymphoma

    • Stage IB, IIA, IIB, III, or IV
  • Measurable or assessable disease

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Hemoglobin at least 9 g/dL
  • WBC at least 1,500/mm^3
  • Platelet count at least 70,000/mm^3

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • SGOT and SGPT no greater than 3 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 3 times ULN
  • Fasting triglyceride normal (normalization with an antilipemic agent is allowed prior to study)
  • No severe decompensated liver disease (e.g., cirrhosis, autoimmune hepatitis, or any other significant liver dysfunction)

Renal:

  • Calcium no greater than 11.5 mg/dL
  • Creatinine no greater than 2 times ULN

Cardiovascular:

  • No myocardial infarction in the past 6 months
  • No unstable angina
  • No class III or IV congestive heart failure
  • No ventricular tachyarrhythmias

Pulmonary:

  • No pulmonary infiltrates or clinical pulmonary impairment

Other:

  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 forms of effective contraception for 1 month before, during, and for 1 month after study therapy
  • No known allergy or sensitivity to interferon alfa or bexarotene or other components of study drugs
  • No uncontrolled thyroid disorder
  • No other concurrent serious medical illness that would preclude study
  • No infection
  • No history of pancreatitis
  • No history of neuropsychiatric disorders requiring hospitalization
  • No history of autoimmune disease that would pose significant risk
  • Must be willing and able to avoid prolonged exposure to the sun or ultraviolet light

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No concurrent systemic anticancer chemotherapy

Endocrine therapy:

  • No concurrent systemic corticosteroids

Radiotherapy:

  • No concurrent localized radiotherapy to target lesions unless considered
  • to have shown progressive disease

Surgery:

  • Not specified

Other:

  • At least 30 days since prior systemic doses of more than 15,000 IU per day of vitamin A or any other retinoid class drug
  • At least 30 days since prior participation in any other investigational drug study
  • No concurrent systemic anti-psoriatic drugs or therapies
  • No concurrent systemic other anticancer drugs or therapies
  • No concurrent gemfibrozil
  • No other concurrent investigational medication

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

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: David J. Straus, MD, Memorial Sloan Kettering Cancer Center

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

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, 2001

Primary Completion (Actual)

September 1, 2004

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

February 14, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

April 4, 2013

Last Update Submitted That Met QC Criteria

April 2, 2013

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069202
  • MSKCC-01128
  • NCI-G01-2049

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.

Clinical Trials on Lymphoma

Clinical Trials on recombinant interferon alfa

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe