RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by
stimulating a person's white blood cells to kill cancer cells.
PURPOSE: Phase I trial to study the effectiveness of interleukin-12 in treating patients who
have hematologic cancer or solid tumor.
OBJECTIVES: I. Assess the safety and maximum tolerated dose of interleukin-12 (IL-12) in
patients with hematologic malignancies or solid tumors who have undergone high-dose
chemotherapy and autologous stem cell transplantation. II. Evaluate the hematologic and
immunologic effects of IL-12 in these patients.
OUTLINE: This is a dose-escalation study. Patients receive interleukin-12 (IL-12) IV as a
single test dose followed by 2 weeks of rest. Patients then receive IL-12 IV daily for 5
days followed by 16 days of rest for up to 6 courses. Cohorts of 3-5 patients receive
escalating doses of IL-12 until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose preceding that at which 2 of 5 patients experience dose-limiting
toxicity. Patients are followed until death.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
DISEASE CHARACTERISTICS: Histologically proven hematologic malignancies or solid tumors
Undergone high-dose chemotherapy or chemoradiotherapy with autologous bone marrow and/or
peripheral blood stem cell transplantation Confirmation of complete remission is required
for acute leukemia No significant CNS disease No clinically significant ascites or pleural
effusions Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 and over Sex: Not specified Menopausal status: Not
specified Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic:
Absolute neutrophil count at least 1,000/mm3 Hemoglobin at least 9 g/dL (transfusion
allowed) Platelet count at least 50,000/mm3 (transfusion independent) No clinically
significant coagulopathy (unless due to cancer and resolved) Hepatic: Bilirubin no greater
than 2 mg/dL SGOT no greater than 2 times upper limit of normal No chronic or acute
hepatitis Hepatitis B surface antigen negative Renal: Creatinine no greater than 2 mg/dL
No symptomatic hypercalcemia Calcium less than 12 mg/dL Cardiovascular: No uncontrolled
angina No arrhythmias requiring drug or device therapy No symptomatic congestive heart
failure Pulmonary: No clinically significant pulmonary dysfunction Metabolic: No
uncontrolled diabetes mellitus No untreated hyper or hypothyroidism No Cushing's disease
Gastrointestinal: No clinically significant gastrointestinal hemorrhages No uncontrolled
peptic ulcer disease No history of inflammatory bowel disease Other: Not pregnant or
nursing Negative pregnancy test Fertile patients must use effective contraception No
serious infection requiring IV antibiotics No psychosis No clinically significant
autoimmune disease HIV negative
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent
biologic therapy Chemotherapy: See Disease Characteristics Endocrine therapy: At least 3
weeks since prior corticosteroids No concurrent systemic corticosteroids (other than
replacement doses) Radiotherapy: See Disease Characteristics Surgery: Not specified Other:
No other concurrent investigational agents