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Bexarotene and Interferon Alfa in Treating Patients With Cutaneous T-Cell Lymphoma
This study is ongoing, but not recruiting participants.
Study NCT00030849   Information provided by National Cancer Institute (NCI)
First Received: February 14, 2002   Last Updated: February 6, 2009   History of Changes

February 14, 2002
February 6, 2009
October 2001
 
 
 
Complete list of historical versions of study NCT00030849 on ClinicalTrials.gov Archive Site
 
 
 
Bexarotene and Interferon Alfa in Treating Patients With Cutaneous T-Cell Lymphoma
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.

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.

Phase II
Interventional
Treatment
Lymphoma
  • Biological: recombinant interferon alfa
  • Drug: bexarotene
 
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 Mar 15; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00030849
 
CDR0000069202, MSKCC-01128, NCI-G01-2049
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: David J. Straus, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
October 2004

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