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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00030849
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 4, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Lymphoma Biological: recombinant interferon alfa Drug: bexarotene Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase II Trial Of Oral Bexarotene (Targretin) Combined With Interferon Alfa-2b (Intron-A) For Patients With Cutaneous T-Cell Lymphoma
Study Start Date : October 2001
Actual Primary Completion Date : September 2004
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030849


Locations
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United States, Florida
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, New York
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
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Study Chair: David J. Straus, MD Memorial Sloan Kettering Cancer Center
More Information
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Publications of Results:

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ClinicalTrials.gov Identifier: NCT00030849    
Other Study ID Numbers: CDR0000069202
MSKCC-01128
NCI-G01-2049
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: December 2009
Keywords provided by National Cancer Institute (NCI):
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
recurrent cutaneous T-cell non-Hodgkin lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Lymphoma, Non-Hodgkin
Interferons
Interferon-alpha
Bexarotene
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs