Completed

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

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What is being tested

aldesleukin

+ recombinant interferon alfa

Biological
Who is being recruted

Lymphadenopathy+80

+ Amyloidosis

+ Blood Coagulation Disorders

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 1992
See protocol details

Summary

Principal SponsorHoag Memorial Hospital Presbyterian
Last updated: May 12, 2011
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1992

Actual date on which the first participant was enrolled.

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.

NCT00002504
Principal SponsorHoag Memorial Hospital Presbyterian
Last updated: May 12, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

LymphadenopathyAmyloidosisBlood Coagulation DisordersBlood Platelet DisordersBlood Protein DisordersBone Marrow DiseasesCardiovascular DiseasesCell Transformation, NeoplasticChronic DiseaseDNA Virus InfectionsHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersHerpesviridae InfectionsHypergammaglobulinemiaImmune System DiseasesImmunoproliferative DisordersInfectionsLeukemia, LymphoidLeukemia, MyeloidLymphatic DiseasesLymphoproliferative DisordersMetabolic DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplastic ProcessesNutritional and Metabolic DiseasesParaproteinemiasPathologic ProcessesPathological Conditions, Signs and SymptomsThrombocytosisTumor Virus InfectionsVascular DiseasesVirus DiseasesLeukemia, B-CellLeukemia, T-CellLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLymphoma, B-CellLymphoma, T-CellBone Marrow NeoplasmsHematologic NeoplasmsEpstein-Barr Virus InfectionsHemostatic DisordersDisease AttributesMyelodysplastic-Myeloproliferative DiseasesProteostasis DeficienciesCarcinogenesisImmunoglobulin Light-chain AmyloidosisBlast CrisisBurkitt LymphomaHodgkin DiseaseImmunoblastic LymphadenopathyLeukemiaLeukemia, Hairy CellLymphomaLymphoma, FollicularLymphoma, Non-HodgkinWaldenstrom MacroglobulinemiaMonoclonal Gammopathy of Undetermined SignificanceMultiple MyelomaMyelodysplastic SyndromesMyeloproliferative DisordersPolycythemia VeraPrecancerous ConditionsThrombocythemia, EssentialLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Biphenotypic, AcuteLeukemia, ProlymphocyticLeukemia, Myeloid, Accelerated PhaseLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, AcuteLeukemia, Myelomonocytic, ChronicLymphoma, Large-Cell, ImmunoblasticLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, AnaplasticLymphoma, B-Cell, Marginal ZoneLymphoma, Mantle-CellLeukemia, Large Granular LymphocyticPrecursor Cell Lymphoblastic Leukemia-LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaNeoplasms, Plasma CellPrimary Myelofibrosis

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 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 Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Hoag Memorial Hospital Presbyterian

Newport Beach, United StatesOpen Hoag Memorial Hospital Presbyterian in Google Maps

Bloomington Hospital

Bloomington, United States

St. Vincent Hospital and Health Care Center Research Department

Indianapolis, United States

Bergan Mercy Medical Center

Omaha, United States
Completed5 Study Centers