Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00498979
Status:
COMPLETED
Last Update Posted:
2020-07-24
First Post:
2007-07-10
Brief Title:
Sodium Stibogluconate and IFNa-2b Followed By CDDP VLB and DTIC Treating PtsWith Advanced Melanoma or Other Cancers
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase I Evaluation of Sodium Stibogluconate in Combination With Interferon α-2b Followed by Cisplatin Vinblastine and Dacarbazine for Patients With Melanoma or Malignancies Potentially Responsive to SSG andor Interferons
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None