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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00030849

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Duration (Months)

Study Details

Study Description

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

Study Type:

Interventional

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 :

Oct 1, 2001

Actual Primary Completion Date :

Sep 1, 2004

Actual Study Completion Date :

Dec 1, 2009

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Miami Sylvester Comprehensive Cancer Center	Miami	Florida	United States	33136
2	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York	United States	10016
3	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
4	Abramson Cancer Center of the University of Pennsylvania Medical Center	Philadelphia	Pennsylvania	United States	19104-4283
5	University of Texas - MD Anderson Cancer Center	Houston	Texas	United States	77030-4009