Information obtained from ClinicalTrials.gov on May 22, 2013Link to the current ClinicalTrials.gov record.http://clinicaltrials.gov/show/NCT00002504CDR0000077942CBRG-9211NBSG-9211NCI-V92-0148NCT00002504Interleukin-2 Plus Interferon Alfa in Treating Adults With Metastatic CancerOUTPATIENT SUBCUTANEOUS IL-2 AND ALPHA INTERFERON IN THE MANAGEMENT OF METASTATIC CANCERHoag Memorial Hospital PresbyterianOtherCancer Biotherapy Research GroupOtherHoag Memorial Hospital PresbyterianUnited States: Federal GovernmentNo
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.
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.
CompletedAugust 1992February 1999February 1998Phase 2InterventionalPrimary Purpose: TreatmentChronic Myeloproliferative DisordersLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesPrecancerous/Nonmalignant ConditionUnspecified Adult Solid Tumor, Protocol SpecificBiologicalaldesleukinBiologicalrecombinant interferon alfa
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
Both18 YearsN/ANoRobert O. Dillman, MD, FACPStudy ChairCancer Biotherapy Research GroupHoag Memorial Hospital PresbyterianNewport BeachCalifornia92658United StatesBloomington HospitalBloomingtonIndiana47402United StatesSt. Vincent Hospital and Health Care Center Research DepartmentIndianapolisIndiana46260United StatesBergan Mercy Medical CenterOmahaNebraska68124United StatesBaptist Regional Cancer Center - KnoxvilleKnoxvilleTennessee37901United StatesUnited Stateshttp://cancer.gov/clinicaltrials/CBRG-9211Clinical trial summary from the National Cancer Institute's PDQ® databaseDillman 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.May 2011May 10, 2011November 1, 1999Robert O. Dillman, MDHoag Memorial Hospital Presbyterianstage IV adult Hodgkin lymphomamonoclonal gammopathy of undetermined significancerecurrent adult Hodgkin lymphomaisolated plasmacytoma of boneextramedullary plasmacytomarefractory multiple myelomaWaldenstrom macroglobulinemiastage IV chronic lymphocytic leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarelapsing chronic myelogenous leukemiarefractory chronic lymphocytic leukemiaunspecified adult solid tumor, protocol specificchronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiameningeal chronic myelogenous leukemiauntreated adult acute lymphoblastic leukemiauntreated adult acute myeloid leukemiaadult acute myeloid leukemia in remissionadult acute lymphoblastic leukemia in remissionpolycythemia verachronic idiopathic myelofibrosisessential thrombocythemiauntreated hairy cell leukemiaprogressive hairy cell leukemia, initial treatmentrefractory hairy cell leukemiachronic myelomonocytic leukemiaT-cell large granular lymphocyte leukemiaacute undifferentiated leukemiastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomastage IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomasecondary acute myeloid leukemiade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesprolymphocytic leukemiaprimary systemic amyloidosisstage IV mantle cell lymphomarecurrent mantle cell lymphomaangioimmunoblastic T-cell lymphomaanaplastic large cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomaNoNoNeoplasmsLeukemiaLymphomaLymphoma, Non-HodgkinMultiple MyelomaNeoplasms, Plasma CellPlasmacytomaMyelodysplastic SyndromesPreleukemiaMyeloproliferative DisordersNeoplasm MetastasisPrecancerous ConditionsLymphoma, Large-Cell, ImmunoblasticInterferon-alphaInterferon Alfa-2aInterferonsAldesleukin