Interleukin-2 Plus Interferon Alfa in Treating Adults With Metastatic Cancer

Lymphoma Clinical Trial

Official title:

OUTPATIENT SUBCUTANEOUS IL-2 AND ALPHA INTERFERON IN THE MANAGEMENT OF METASTATIC CANCER

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002504
• Other study ID #: CDR0000077942
• Secondary ID: CBRG-9211NBSG-92
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: May 10, 2011
• Start date: August 1992
• Est. completion date: February 1999

Study information

• Verified date: May 2011
• Source: Hoag Memorial Hospital Presbyterian
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 1999
• Est. primary completion date: February 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myeloproliferative Disorders
• Neoplasm Metastasis
• Neoplasms, Plasma Cell
• Plasmacytoma
• Precancerous Conditions
• Precancerous/Nonmalignant Condition
• Preleukemia
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Biological:
• aldesleukin

• recombinant interferon alfa

Locations

Country	Name	City	State
United States	Bloomington Hospital	Bloomington	Indiana
United States	St. Vincent Hospital and Health Care Center Research Department	Indianapolis	Indiana
United States	Baptist Regional Cancer Center - Knoxville	Knoxville	Tennessee
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Bergan Mercy Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Hoag Memorial Hospital Presbyterian	Cancer Biotherapy Research Group

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dillman RO, Soori G, Tai DF, et al.: Outpatient subcutaneous (SC) interleukin-2 (IL-2) and interferon alpha (IFN) in the management of metastatic cancer: a preliminary report. J Immunother 20(5): 404, 1997.