Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Boston, Massachusetts 02215


Purpose:

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.


Criteria:

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


NCT ID:

NCT00003330


Primary Contact:

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


Backup Contact:

N/A


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: September 19, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.