Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003630
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
1999-11-01
Brief Title:
Arsenic Trioxide in Treating Patients With Advanced Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase I Study of Arsenic Trioxide
Status:
COMPLETED
Status Verified Date:
2013-06
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of arsenic trioxide in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of arsenic trioxide in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose MTD of arsenic trioxide in adult and pediatric patients with advanced solid tumors II Determine the pattern of clinical adverse experience of arsenic trioxide in this patient population III Evaluate evidence of clinical responsiveness to this treatment regimen
OUTLINE This is a dose escalation open label study Patients are stratified by age pediatric vs adult Patients receive arsenic trioxide IV over 1-2 hours once daily for 3 consecutive days then once weekly for 5 weeks Patients with stable or responding disease receive additional courses of therapy every 8 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity Patients receive escalating doses of arsenic trioxide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 or more patients out of 6 experience dose limiting toxicity Patients are followed for at least 1 month after treatment
PROJECTED ACCRUAL Approximately 48 patients will be accrued for this study
OUTLINE This is a dose escalation open label study Patients are stratified by age pediatric vs adult Patients receive arsenic trioxide IV over 1-2 hours once daily for 3 consecutive days then once weekly for 5 weeks Patients with stable or responding disease receive additional courses of therapy every 8 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity Patients receive escalating doses of arsenic trioxide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 or more patients out of 6 experience dose limiting toxicity Patients are followed for at least 1 month after treatment
PROJECTED ACCRUAL Approximately 48 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 |
|---|---|---|---|
| NCI-G98-1479 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066713 | REGISTRY | None | None |