RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill metastatic cancer cells. Interferon alfa may interfere with the growth of the cancer cells. Combining interleukin-2 and interferon alfa may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of interleukin-2 plus interferon alfa in treating adults with metastatic cancer.

Condition	Treatment or Intervention	Phase
Lymphoma Leukemia	Drug: interferon alfa  Drug: interleukin-2	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the response rate, failure-free survival, and overall survival of interleukin-2 and interferon alpha administered subcutaneously on an outpatient basis for 8 weeks to patients with metastatic cancer.

II. Determine the toxicities associated with this therapy.

PROTOCOL OUTLINE: Biological Response Modifier Therapy. Interleukin-2 (Cetus), IL-2, NSC-373364; Interferon alpha (Schering), IFN-A, NSC-377523.

PROJECTED ACCRUAL: Up to 30 patients with various malignancies will be entered.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed metastatic cancer of any type
• Measurable or evaluable disease required, i.e.: Bidimensionally measurable lesions on physical exam, x-ray, CT, MRI, or other radiologic procedure; Any lesion apparent on radiologic exam that is not measurable in 2 perpendicular diameters; Previously irradiated lesions acceptable provided subsequent progression is documented
• No active brain metastases; Previously treated brain metastases allowed provided measurable/evaluable disease exists outside the CNS

--Prior/Concurrent Therapy--

• No concurrent therapy with other anticancer agents; No concurrent immunosuppressive agents (e.g., cyclosporin)
• Biologic therapy: Prior interferon alpha allowed
• Chemotherapy: At least 4 weeks since systemic chemotherapy with recovery required
• Endocrine therapy: No concurrent corticosteroids
• Radiotherapy: At least 4 weeks since radiotherapy
• Surgery: Adequate recovery required
• Other: No prior organ allograft

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2
• Hematopoietic: (within 14 days prior to entry) WBC at least 3,000; Platelets at least 100,000; Hematocrit at least 30% (may be transfused)
• Hepatic: (within 14 days prior to entry); Bilirubin less than 2.0 mg/dl; PT and PTT normal
• Renal: (within 14 days prior to entry) Creatinine less than 2.0 mg/dl
• Cardiovascular: No MI within 6 months; No medication for arrhythmia; No medication for CHF; Hypertension that is stable off medication allowed
• Pulmonary: pO2 at least 60 mm Hg in patients with primary lung cancer or symptomatic pulmonary disease; Reasonable respiratory reserve; No dyspnea at rest; No requirement for supplemental oxygen
• Other: No familial history of malignant hyperthermia; No chronic underlying immunodeficiency disease; No HIV seropositivity; No active infection requiring antibiotic therapy; No other serious intercurrent illness; No concurrent malignancy; No pregnant or nursing women; Adequate contraception required of fertile women

California
      Hoag Memorial Hospital Presbyterian, Newport Beach,  California,  92658,  United States
Indiana
      Bloomington Hospital, Bloomington,  Indiana,  47402,  United States
      St. Vincent Hospital and Health Care Center Research Department, Indianapolis,  Indiana,  46260,  United States
Nebraska
      Bergan Mercy Medical Center, Omaha,  Nebraska,  68124,  United States
Tennessee
      Baptist Regional Cancer Center - Knoxville, Knoxville,  Tennessee,  37901,  United States

Study chairs or principal investigators

Robert O. Dillman,  Study Chair,  Cancer Biotherapy Research Group   

Study ID Numbers:  CDR0000077942; CBRG-9211; NCI-V92-0148; NBSG-9211
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002504
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08