Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003395
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
1999-11-01
Brief Title:
Arsenic Trioxide in Treating Patients With Advanced Hematologic Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Dose-Ranging Study of Arsenic Trioxide in Advanced Hematologic Cancers
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 hematologic cancer
PURPOSE Phase I trial to study the effectiveness of arsenic trioxide in treating patients who have advanced hematologic cancer
Detailed Description:
OBJECTIVES I Develop a safe weight-based extended-dosing regimen of arsenic trioxide suitable for outpatient therapy in patients with advanced hematologic cancers II Determine the pattern of clinical adverse experience in patients treated with this drug III Evaluate evidence of clinical responsiveness that may provide leads for further testing in patients treated with this drug
OUTLINE This is a dose-escalation study Patients receive arsenic trioxide IV over 1-4 hours on days 1-25 Courses repeat every 3-5 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 4-6 patients receive escalating doses of arsenic trioxide until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity Patients are followed for 1 month
PROJECTED ACCRUAL Approximately 48 patients will be accrued for this study
OUTLINE This is a dose-escalation study Patients receive arsenic trioxide IV over 1-4 hours on days 1-25 Courses repeat every 3-5 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 4-6 patients receive escalating doses of arsenic trioxide until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity Patients are followed for 1 month
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-G98-1449 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066395 | REGISTRY | None | None |