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

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.

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Key information

Conditions

Chronic Myeloproliferative Disorders Amyloidosis Blast Crisis Blood Coagulation Disorders Blood Platelet Disorders Blood Protein Disorders Bone Marrow Diseases Bone Marrow Neoplasms Burkitt Lymphoma Carcinogenesis Cardiovascular Diseases Cell Transformation, Neoplastic Chronic Disease DNA Virus Infections Disease Attributes Epstein-Barr Virus Infections Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Hodgkin Disease Hypergammaglobulinemia Immune System Diseases Immunoblastic Lymphadenopathy Immunoglobulin Light-chain Amyloidosis Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Biphenotypic, Acute Leukemia, Hairy Cell Leukemia, Large Granular Lymphocytic Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic-Phase Leukemia, Myelomonocytic, Chronic Leukemia, Prolymphocytic Leukemia, T-Cell Lymphadenopathy Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Metabolic Diseases Monoclonal Gammopathy of Undetermined Significance Multiple Myeloma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Neoplastic Processes Nutritional and Metabolic Diseases Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Polycythemia Vera Precancerous Conditions Precancerous/Nonmalignant Condition Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Primary Myelofibrosis Proteostasis Deficiencies Thrombocythemia, Essential Thrombocytosis Tumor Virus Infections Unspecified Adult Solid Tumor, Protocol Specific Vascular Diseases Virus Diseases Waldenstrom Macroglobulinemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aldesleukin

Biological

recombinant interferon alfa

Biological

Sponsors and collaborators

Lead sponsor

Hoag Memorial Hospital Presbyterian

Other

Collaborators

Cancer Biotherapy Research Group

Registry information

Official study title

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

Important dates

Study start: 1992
Primary completion: 1998
Study completion: 1999
First posted: Jul 26, 2004
Registry last updated: May 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed