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

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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)

Tracking Information
First Submitted Date  ICMJE February 14, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date April 4, 2013
Study Start Date  ICMJE October 2001
Actual Primary Completion Date September 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bexarotene and Interferon Alfa in Treating Patients With Cutaneous T-Cell Lymphoma
Official Title  ICMJE Phase II Trial Of Oral Bexarotene (Targretin) Combined With Interferon Alfa-2b (Intron-A) For Patients With Cutaneous T-Cell Lymphoma
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE
  • Biological: recombinant interferon alfa
  • Drug: bexarotene
Study Arms  ICMJE Not Provided
Publications * Straus DJ, Duvic M, Kuzel T, Horwitz S, Demierre MF, Myskowski P, Steckel S. Results of a phase II trial of oral bexarotene (Targretin) combined with interferon alfa-2b (Intron-A) for patients with cutaneous T-cell lymphoma. Cancer. 2007 May 1;109(9):1799-803.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date September 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00030849
Other Study ID Numbers  ICMJE CDR0000069202
MSKCC-01128
NCI-G01-2049
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: David J. Straus, MD Memorial Sloan Kettering Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP