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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00030849
First received: February 14, 2002
Last updated: April 2, 2013
Last verified: December 2009
  Purpose

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 Intervention Phase
Lymphoma
Biological: recombinant interferon alfa
Drug: bexarotene
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2001
Study Completion Date: December 2009
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00030849

Locations
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
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
Investigators
Study Chair: David J. Straus, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00030849     History of Changes
Other Study ID Numbers: CDR0000069202, MSKCC-01128, NCI-G01-2049
Study First Received: February 14, 2002
Last Updated: April 2, 2013
Health Authority: United States: Federal Government

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:
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
Interferon-alpha
Interferons
Bexarotene
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Anticarcinogenic Agents
Protective Agents

ClinicalTrials.gov processed this record on September 30, 2014