Expired Study
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Boston, Massachusetts 02215


Phase I trial to study the effectiveness of interleukin-12 in treating patients who have advanced cancer. 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.

Study summary:

OBJECTIVES: I. Determine the toxicity profile and maximum tolerated dose (MTD) of intravenous interleukin-12 (IL-12) administered biweekly for 6-18 weeks in the presence and absence of a test dose in patients with metastatic or unresectable malignancies. II. Determine the optimal timing for administration of an IL-12 test dose, based on its impact on secondary biologic parameters in these patients. III. Determine the antitumor effects of IL-12 administered according to this schedule, with and without a test dose, in these patients. IV. Determine the effect of a test dose on toxicity profile, MTD, tumor response and various biologic phenomena in serum, and, where possible, tumor and liver in these patients. OUTLINE: This is a 3-part dose escalation study. In Part A, patients receive intravenous interleukin-12 (IL-12) twice a week for 6 weeks. Courses are repeated until patients achieve a complete response or there is disease progression. Dose escalation of IL-12 continues in cohorts of 3-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose below that at which 2 of 6 patients experience dose limiting toxicity (DLT). In Part B, patients receive a single test dose of IL-12 administered intravenously at a 1, 2, or 3 week interval prior to starting the multidose twice a week regimen as in Part A. Cohorts of 4 patients will receive IL-12 at the MTD obtained in Part A. In Part C, patients receive IL-12 at one dose level above the MTD obtained in Part A using the optimal schedule for the test dose determined in Part B. Dose escalation continues in cohorts of 3-6 patients until the MTD is determined. The MTD is defined as the dose below that at which 2 of 6 patients experience DLT. Patients may continue to receive IL-12 until they have no measurable disease or until disease progression.


DISEASE CHARACTERISTICS: - Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective - Advanced measurable or evaluable disease that is clearly progressive - No brain metastases PATIENT CHARACTERISTICS: - Age: 18 and over - Performance status: ECOG 0-1 Karnofsky 80-100% - Life expectancy: At least 3 months - WBC greater than 4,000/mm3 - Platelet count greater than 100,000/mm3 - Bilirubin less than 1.5 mg/dL - SGOT/SGPT less than 2 times normal - Creatinine less than 1.5 mg/dL - Creatinine clearance at least 60 mL/min - No congestive heart failure - No coronary artery disease - No serious cardiac arrhythmias - No evidence of prior myocardial infarction on EKG - Not pregnant or nursing - Fertile patients must use effective contraception - Not HIV positive - No seizure disorders - No active infection that requires antibiotic therapy - No significant medical disease other than the malignancy PRIOR CONCURRENT THERAPY: - No more than 2 prior biological response modifier treatment regimen - No immunotherapy within the past 4 weeks - No prior interleukin-12 - No more than 2 prior chemotherapy regimens - At least 4 weeks since chemotherapy and recovered - At least 6 weeks since nitrosoureas or mitomycin and recovered - No concurrent chemotherapy - At least 4 weeks since hormone therapy and recovered - No concurrent hormone therapy - No concurrent corticosteroids - At least 4 weeks since radiotherapy and recovered - No concurrent radiotherapy - No organ allografts - At least 2 weeks since intravenous antibiotics



Primary Contact:

Study Chair
Michael B. Atkins, MD
Beth Israel Deaconess Medical Center

Backup Contact:


Location Contact:

Boston, Massachusetts 02215
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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