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.

Condition	Treatment or Intervention	Phase
Leukemia Testicular Cancer ovarian epithelial cancer Lymphoma Breast Cancer Multiple Myeloma kidney tumor	Drug: interleukin-12	Phase I

Further Study Details: 

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.

PROTOCOL 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 rest for up to 6 treatment 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 at which fewer than 2 of 5 patients experience dose-limiting toxicity. Patients are followed until death.

PROJECTED ACCRUAL: A total of 17-27 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--Prior/Concurrent Therapy--

• Biologic therapy: See Disease Characteristics; No concurrent biologic therapy
• Chemotherapy: See Disease Characteristics
• Endocrine therapy: No concurrent systemic corticosteroids (other than replacement doses); At least 3 weeks since prior corticosteroids
• Radiotherapy: See Disease Characteristics
• Surgery: Not specified
• Other: No concurrent investigational agents

--Patient Characteristics--

• Age: 18 and over
• 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 AND 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 ascites or pleural effusions; No clinically significant autoimmune disease; HIV negative

Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5265,  United States

Study chairs or principal investigators

Michael J. Robertson,  Study Chair,  Indiana University Cancer Center   

Study ID Numbers:  CDR0000065848; IUMC-9708-05; NCI-T97-0027
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003107
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08