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

• ClinicalTrials.gov Identifier: NCT00030849
• Recruitment Status: Completed
• First Posted: January 27, 2003
• Last Update Posted: April 4, 2013
• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by: National Cancer Institute (NCI)

Tracking Information

• First Submitted Date: February 14, 2002
• First Posted Date: January 27, 2003
• Last Update Posted Date: April 4, 2013
• Study Start Date: October 2001
• Actual Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Bexarotene and Interferon Alfa in Treating Patients With Cutaneous T-Cell Lymphoma
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Primary Purpose: Treatment
• Condition: Lymphoma

Intervention

• Biological: recombinant interferon alfa
• Drug: bexarotene

• Study Arms: 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.

Recruitment Information

• Recruitment Status: Completed
• Enrollment: Not Provided
• Original Enrollment: Not Provided
• Actual Study Completion Date: December 2009
• Actual Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00030849
• Other Study ID Numbers: CDR0000069202; MSKCC-01128; NCI-G01-2049
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: National Cancer Institute (NCI)

Investigators

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

• PRS Account: National Cancer Institute (NCI)
• Verification Date: December 2009