Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003305
Status:
COMPLETED
Last Update Posted:
2014-01-06
First Post:
1999-11-01
Brief Title:
Aminopterin in Treating Patients With Refractory Leukemia
Sponsor:
Genzyme a Sanofi Company
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Aminopterin in Adults and Children With Refractory Acute Leukemia Grant Application Title A Phase II Trial of Aminopterin in Acute Leukemia
Status:
COMPLETED
Status Verified Date:
2008-08
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 cancer cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of aminopterin in treating patients who have refractory leukemia
PURPOSE Phase II trial to study the effectiveness of aminopterin in treating patients who have refractory leukemia
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of aminopterin in patients with refractory leukemia and minimal previous exposure to antifolate agents II Determine the antileukemic activity of aminopterin in adults and children with acute myelogenous and acute lymphoblastic leukemia for whom conventional therapy has failed III Confirm that aminopterin can be administered for four consecutive weeks when followed with minimal leucovorin calcium rescue and determine the minimal amount of leucovorin calcium required for each patient IV Confirm bioavailability data on oral aminopterin by performing limited sampling pharmacokinetics V Correlate blast uptake of aminopterin in vitro with clinical response
OUTLINE This is an open label study Patients are stratified according to age and type of leukemia Stratum I Under 20 years old with acute lymphoblastic leukemia ALL in second or greater relapse Stratum II Greater than 20 years old with ALL in first or greater relapse Stratum III Patients of any age with acute myelogenous leukemia AML in first or greater relapse Patients receive aminopterin every 12 hours for 2 doses weekly for 4 weeks Aminopterin is administered intravenously over 20 minutes for the first second and fourth doses and orally for the third dose The fifth and all subsequent doses are administered orally if bioavailability is acceptable Patients receive oral leucovorin calcium every 12 hours for 2 doses beginning 24 hours after the last dose of aminopterin each week If toxicity is limited for 2 consecutive weeks the dose of leucovorin calcium is decreased to 1 dose administered 24 hours after the last dose of aminopterin each week If this schedule is tolerated for 2 consecutive weeks then leucovorin calcium is discontinued Patients continue therapy for up to 15 months in the absence of disease progression or unacceptable toxicity Patients are followed every 6 months
PROJECTED ACCRUAL This study will accrue a maximum of 25 patients per stratum for a total of 75 patients within 3 years
OUTLINE This is an open label study Patients are stratified according to age and type of leukemia Stratum I Under 20 years old with acute lymphoblastic leukemia ALL in second or greater relapse Stratum II Greater than 20 years old with ALL in first or greater relapse Stratum III Patients of any age with acute myelogenous leukemia AML in first or greater relapse Patients receive aminopterin every 12 hours for 2 doses weekly for 4 weeks Aminopterin is administered intravenously over 20 minutes for the first second and fourth doses and orally for the third dose The fifth and all subsequent doses are administered orally if bioavailability is acceptable Patients receive oral leucovorin calcium every 12 hours for 2 doses beginning 24 hours after the last dose of aminopterin each week If toxicity is limited for 2 consecutive weeks the dose of leucovorin calcium is decreased to 1 dose administered 24 hours after the last dose of aminopterin each week If this schedule is tolerated for 2 consecutive weeks then leucovorin calcium is discontinued Patients continue therapy for up to 15 months in the absence of disease progression or unacceptable toxicity Patients are followed every 6 months
PROJECTED ACCRUAL This study will accrue a maximum of 25 patients per stratum for a total of 75 patients within 3 years
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-V99-1534 | None | None | None |
| ILEX-AMT-0021997 | None | None | None |
| UTSMC-AMT-0021997 | None | None | None |
| UTSMC-FDR001458 | None | None | None |