Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002738
Status:
COMPLETED
Last Update Posted:
2013-03-07
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia Osteosarcoma or Non-Hodgkins Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Trial of Trimetrexate and Leucovorin in The Treatment of Recurrent Childhood Acute Lymphoblastic Leukemia
Status:
COMPLETED
Status Verified Date:
2013-03
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 such as trimetrexate glucuronate and leucovorin use different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells
PURPOSE This phase II trial is studying how well combination chemotherapy works in treating children with recurrent acute lymphoblastic leukemia recurrent osteosarcoma or refractory non-Hodgkins lymphoma
PURPOSE This phase II trial is studying how well combination chemotherapy works in treating children with recurrent acute lymphoblastic leukemia recurrent osteosarcoma or refractory non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the efficacy of trimetrexate glucuronate with leucovorin calcium rescue in children with recurrent acute lymphoblastic leukemia recurrent osteogenic sarcoma or refractory non-Hodgkins lymphoma resistant to methotrexate
Evaluate the toxicity of this treatment regimen in this patient population
OUTLINE Patients are stratified according to disease acute lymphocytic leukemia non-Hodgkins lymphoma vs osteogenic sarcoma
Patients receive trimetrexate glucuronate orally or IV every 12 hours on days 1-21 and oral leucovorin calcium every 12 hours on days 1-24 Treatment repeats every 4 weeks Patients with stable or responsive disease may receive up to 4 courses of therapy
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study within 2 years
Determine the efficacy of trimetrexate glucuronate with leucovorin calcium rescue in children with recurrent acute lymphoblastic leukemia recurrent osteogenic sarcoma or refractory non-Hodgkins lymphoma resistant to methotrexate
Evaluate the toxicity of this treatment regimen in this patient population
OUTLINE Patients are stratified according to disease acute lymphocytic leukemia non-Hodgkins lymphoma vs osteogenic sarcoma
Patients receive trimetrexate glucuronate orally or IV every 12 hours on days 1-21 and oral leucovorin calcium every 12 hours on days 1-24 Treatment repeats every 4 weeks Patients with stable or responsive disease may receive up to 4 courses of therapy
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study within 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 |
|---|---|---|---|
| P30CA008748 | NIH | None | None |
| MSKCC-95093 | None | None | None |
| NCI-V96-0840 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |