Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00124605
Status:
COMPLETED
Last Update Posted:
2013-01-07
First Post:
2005-07-26
Brief Title:
Arsenic Trioxide and Pamidronate in Treating Patients With Advanced Solid Tumors or Multiple Myeloma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of Arsenic Trioxide in Combination With Pamidronate Disodium
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Drugs used in chemotherapy such as arsenic trioxide and pamidronate work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Arsenic trioxide and pamidronate may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Pamidronate may also stop the growth of cancer cells by blocking blood flow to the cancer Giving arsenic trioxide together with pamidronate may kill more cancer cells This phase I trial is studying the side effects and best dose of arsenic trioxide and pamidronate in treating patients with advanced solid tumors or multiple myeloma
Detailed Description:
PRIMARY OBJECTIVES
I To describe the toxicities of the combination of arsenic trioxide in combination with pamidronate disodium at four dose levels
II To assess the pharmacokinetics of pamidronate disodium when given in combination with arsenic trioxide
III Utilizing 2-color immunofluorescence IF to determine if the treatment with combination of arsenic trioxide and pamidronate disodium affects the phosphorylation of epidermal growth factor receptor EGFR IV In patients with multiple myeloma utilizing western blot to evaluate the pre- and post-treatment levels of protein tyrosine phosphatase 1B in lysates of multiple myeloma cells
V To obtain preliminary data for response to this regimen in this patient population
OUTLINE This is a dose-escalation multicenter study
Patients receive pamidronate IV and over 2 hours on days 1 and 15 and arsenic trioxide IV over 2 hours on days 1-5 and 15-19 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of pamidronate and arsenic trioxide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL Approximately 12-24 patients will be accrued for this study
I To describe the toxicities of the combination of arsenic trioxide in combination with pamidronate disodium at four dose levels
II To assess the pharmacokinetics of pamidronate disodium when given in combination with arsenic trioxide
III Utilizing 2-color immunofluorescence IF to determine if the treatment with combination of arsenic trioxide and pamidronate disodium affects the phosphorylation of epidermal growth factor receptor EGFR IV In patients with multiple myeloma utilizing western blot to evaluate the pre- and post-treatment levels of protein tyrosine phosphatase 1B in lysates of multiple myeloma cells
V To obtain preliminary data for response to this regimen in this patient population
OUTLINE This is a dose-escalation multicenter study
Patients receive pamidronate IV and over 2 hours on days 1 and 15 and arsenic trioxide IV over 2 hours on days 1-5 and 15-19 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of pamidronate and arsenic trioxide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL Approximately 12-24 patients will be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PHI-45 | None | None | None |
| U01CA062505 | NIH | None | None |
| CDR0000434807 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062505 |