Overview
Bexarotene and Interferon Alfa in Treating Patients With Cutaneous T-Cell Lymphoma
Status:
Completed
Completed
Trial end date:
2009-12-01
2009-12-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Memorial Sloan Kettering Cancer CenterCollaborator:
National Cancer Institute (NCI)Treatments:
Bexarotene
Interferon-alpha
Interferons
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