Sodium Stibogluconate and IFNa-2b Followed By CDDP, VLB and DTIC Treating Pts.With Advanced Melanoma or Other Cancers
- Conditions
- Stage IV Melanoma
- Interventions
- Biological: recombinant interferon alfa-2b
- Registration Number
- NCT00498979
- Lead Sponsor
- Case Comprehensive Cancer Center
- Brief Summary
RATIONALE: Sodium stibogluconate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers. Drugs used in chemotherapy, such as cisplatin, vinblastine, and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sodium stibogluconate and interferon alfa-2b together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of sodium stibogluconate when given together with interferon alfa-2b, cisplatin, vinblastine, and dacarbazine in treating patients with advanced melanoma or other cancer.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description recombinant interferon alfa-2b recombinant interferon alfa-2b recombinant interferon alfa-2b recombinant interferon alfa-2b sodium stibogluconate recombinant interferon alfa-2b recombinant interferon alfa-2b cisplatin recombinant interferon alfa-2b recombinant interferon alfa-2b dacarbazine recombinant interferon alfa-2b recombinant interferon alfa-2b vinblastine recombinant interferon alfa-2b
- Primary Outcome Measures
Name Time Method Safety of the combination of sodium stibogluconate and interferon alfa-2b with chemotherapy 2 years
- Secondary Outcome Measures
Name Time Method Effects of sodium stibogluconate on interferon alfa-2b induced gene modulation and signal transduction pathways by measuring the serum soluble gene product 2 years Effectiveness of sodium stibogluconate in inhibiting the protein tyrosine phosphatases SHP-1 and SHP-2 assayed from peripheral blood leukocytes 2 years Pharmacokinetics of sodium stibogluconate in serum at escalating doses 2 years Clinical response to the combination of sodium stibogluconate and interferon alfa-2b as priming for combination chemotherapy 2 years
Trial Locations
- Locations (1)
Cleveland Clinic Taussig Institute, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States