OUTPATIENT SUBCUTANEOUS IL-2 AND ALPHA INTERFERON IN THE MANAGEMENT OF METASTATIC CANCER
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Precancerous/Nonmalignant Condition, Unspecified Adult Solid Tumor, Protocol Specific
Both
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Precancerous/Nonmalignant Condition, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
OUTPATIENT SUBCUTANEOUS IL-2 AND ALPHA INTERFERON IN THE MANAGEMENT OF 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Robert O. Dillman, MD, FACP
Investigator Role:
Study Chair
Investigator Affiliation:
Cancer Biotherapy Research Group
Authority:
United States: Federal Government
Study ID:
CDR0000077942
NCT ID:
NCT00002504
Start Date:
August 1992
Completion Date:
February 1999
Related Keywords:
- Chronic Myeloproliferative Disorders
- Leukemia
- Lymphoma
- Multiple Myeloma and Plasma Cell Neoplasm
- Myelodysplastic Syndromes
- Precancerous/Nonmalignant Condition
- Unspecified Adult Solid Tumor, Protocol Specific
- stage IV adult Hodgkin lymphoma
- monoclonal gammopathy of undetermined significance
- recurrent adult Hodgkin lymphoma
- isolated plasmacytoma of bone
- extramedullary plasmacytoma
- refractory multiple myeloma
- Waldenstrom macroglobulinemia
- stage IV chronic lymphocytic leukemia
- recurrent adult acute myeloid leukemia
- recurrent adult acute lymphoblastic leukemia
- relapsing chronic myelogenous leukemia
- refractory chronic lymphocytic leukemia
- unspecified adult solid tumor, protocol specific
- chronic phase chronic myelogenous leukemia
- accelerated phase chronic myelogenous leukemia
- blastic phase chronic myelogenous leukemia
- meningeal chronic myelogenous leukemia
- untreated adult acute lymphoblastic leukemia
- untreated adult acute myeloid leukemia
- adult acute myeloid leukemia in remission
- adult acute lymphoblastic leukemia in remission
- polycythemia vera
- chronic idiopathic myelofibrosis
- essential thrombocythemia
- untreated hairy cell leukemia
- progressive hairy cell leukemia, initial treatment
- refractory hairy cell leukemia
- chronic myelomonocytic leukemia
- T-cell large granular lymphocyte leukemia
- acute undifferentiated leukemia
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV adult Burkitt lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent adult Burkitt lymphoma
- stage IV adult T-cell leukemia/lymphoma
- recurrent adult T-cell leukemia/lymphoma
- secondary acute myeloid leukemia
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- prolymphocytic leukemia
- primary systemic amyloidosis
- stage IV mantle cell lymphoma
- recurrent mantle cell lymphoma
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- Neoplasms
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Neoplasm Metastasis
- Precancerous Conditions
- Lymphoma, Large-Cell, Immunoblastic
Name | Location |
|---|---|
| Hoag Memorial Hospital Presbyterian | Newport Beach, California 92658 |
| Bloomington Hospital | Bloomington, Indiana 47402 |
| St. Vincent Hospital and Health Care Center Research Department | Indianapolis, Indiana 46260 |
| Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
| Baptist Regional Cancer Center - Knoxville | Knoxville, Tennessee 37901 |
