Finding studies
Finding studies
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Lead
Case Comprehensive Cancer Center
With
OBJECTIVES: Primary * To determine the safety of the combination of sodium stibogluconate and interferon alfa-2b with chemotherapy. * To confirm the activity of sodium stibogluconate in augmenting cytokine effects. Secondary * To quantify the effects of sodium stibogluconate on interferon alfa-2b induced gene modulation and signal transduction pathways by measuring the serum soluble gene products. * To define the effectiveness of sodium stibogluconate in inhibiting the protein tyrosine phosphatases SHP-1 and SHP-2 assayed from peripheral blood leukocytes of patients receiving sodium stibogluconate in combination with interferon alfa-2b. * To define the pharmacokinetics of sodium stibogluconate in serum at escalating doses. * To assess clinical response to the combination of sodium stibogluconate and interferon alfa-2b as priming for combination chemotherapy. OUTLINE: * Course 1: Patients receive sodium stibogluconate IV over 15 minutes on day 1 and days 15-18; interferon alfa-2b subcutaneously (SC) on days 8-12 and 15-18; cisplatin IV over 30-60 minutes and vinblastine IV on days 19 and 20; and dacarbazine. After a 2-week rest period, patients proceed to course 2. * Course 2 and all subsequent courses: Patients receive sodium stibogluconate IV over 15 minutes and interferon alfa-2b SC on days 1-4; cisplatin IV over 30-60 minutes and vinblastine IV on days 5 and 6; dacarbazine. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\* NOTE: \*Patients with stage IV disease who have no evidence of disease \[NED} receive only 4 courses of therapy. Cohorts of 6 patients receive escalating doses of sodium stibogluconate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which dose-limiting toxicity occurs (i.e., no more than 1 patient at a given dose experiences DLT). Patients undergo blood sample collection periodically for immunological and pharmacokinetic studies. Samples are analyzed for serum soluble gene products and protein tyrosine phosphatase inhibition.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
