Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020111
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2001-07-11
Brief Title:
Arsenic Trioxide in Treating Young Patients With Refractory Leukemia or Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial and Pharmacokinetic Study of Arsenic Trioxide in Pediatric Patients With Refractory Leukemia or Lymphoma
Status:
COMPLETED
Status Verified Date:
2005-02
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 work in different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE This phase I trial is studying the side effects and best dose of arsenic trioxide in treating young patients with leukemia or lymphoma
PURPOSE This phase I trial is studying the side effects and best dose of arsenic trioxide in treating young patients with leukemia or lymphoma
Detailed Description:
OBJECTIVES
Determine the toxic effects of arsenic trioxide in pediatric patients with refractory leukemia or lymphoma
Determine the maximum tolerated dose of this drug in this patient population
Determine the plasma pharmacokinetics of this drug in these patients
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to disease acute promyelocytic leukemia APL vs non-APL
Stratum I APL patients Patients receive standard-dose arsenic trioxide IV over 2 hours daily 5 days a week for 4 weeks Treatment continues every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity
Stratum II Non-APL patients Cohorts of 3-6 patients receive escalating doses of arsenic trioxide according to the stratum 1 schedule above until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are accrued to receive treatment with arsenic trioxide at the recommended phase II dose
Leukemia patients in both strata without progressive disease who have not achieved complete remission after the first 20 doses may continue to receive arsenic trioxide for 2 additional weeks
Patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A maximum of 18 patients will be accrued for stratum I of this study within 2-3 years A total of 3-30 patients will be accrued for stratum II of this study within 1-2 years
Determine the toxic effects of arsenic trioxide in pediatric patients with refractory leukemia or lymphoma
Determine the maximum tolerated dose of this drug in this patient population
Determine the plasma pharmacokinetics of this drug in these patients
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to disease acute promyelocytic leukemia APL vs non-APL
Stratum I APL patients Patients receive standard-dose arsenic trioxide IV over 2 hours daily 5 days a week for 4 weeks Treatment continues every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity
Stratum II Non-APL patients Cohorts of 3-6 patients receive escalating doses of arsenic trioxide according to the stratum 1 schedule above until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are accrued to receive treatment with arsenic trioxide at the recommended phase II dose
Leukemia patients in both strata without progressive disease who have not achieved complete remission after the first 20 doses may continue to receive arsenic trioxide for 2 additional weeks
Patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A maximum of 18 patients will be accrued for stratum I of this study within 2-3 years A total of 3-30 patients will be accrued for stratum II of this study within 1-2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T99-0080 | None | None | None |
| NCI-00-C-0070J | None | None | None |