Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369564
Status:
COMPLETED
Last Update Posted:
2021-08-11
First Post:
2006-08-24
Brief Title:
Glutamic Acid in Reducing Nerve Damage Caused by Vincristine in Young Patients With Cancer
Sponsor:
University of South Florida
Organization:
University of South Florida
Study Overview
Official Title:
Glutamic Acid to Decrease Vincristine Toxicity in Children With Cancer
Status:
COMPLETED
Status Verified Date:
2018-09
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 Glutamic acid may help lessen or prevent nerve damage caused by vincristine It is not yet known whether glutamic acid is more effective than a placebo in preventing nerve damage in patients receiving vincristine for Wilms tumor rhabdomyosarcoma acute lymphoblastic leukemia or non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying glutamic acid to see how well it works compared to a placebo in reducing nerve damage caused by vincristine in young patients receiving vincristine for Wilms tumor rhabdomyosarcoma acute lymphoblastic leukemia or non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying glutamic acid to see how well it works compared to a placebo in reducing nerve damage caused by vincristine in young patients receiving vincristine for Wilms tumor rhabdomyosarcoma acute lymphoblastic leukemia or non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Compare the effect of glutamic acid vs placebo in terms of decreasing neurotoxicity as measured by a scored neurologic examination in young patients undergoing vincristine-containing treatment for Wilms tumor rhabdomyosarcoma acute lymphoblastic leukemia or non-Hodgkins lymphoma
Secondary
Compare the frequency and types of neurotoxicity observed in patients treated with glutamic acid versus placebo
Determine if a greater proportion of patients receiving glutamic acid are able to receive 100 of their scheduled doses of vincristine versus those not treated with glutamic acid
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to disease and duration of planned vincristine-containing treatment Wilms tumor or rhabdomyosarcoma with treatment planned for 9 consecutive weeks stratum 1 vs acute lymphoblastic leukemia or non-Hodgkins lymphoma with treatment planned for 4 consecutive weeks stratum 2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 stratum 2 for a total of 4 doses of vincristine or week 10 stratum 1 for a total of 9 doses of vincristine
Arm II Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 stratum 2 for a total of 4 doses of vincristine or week 10 stratum 1 for a total of 9 doses of vincristine
All patients undergo neurologic examination at baseline and at 5 weeks Patients in stratum 1 also undergo additional neurologic examination at week 10
PROJECTED ACCRUAL A total of 250 patients will be accrued for this study
Primary
Compare the effect of glutamic acid vs placebo in terms of decreasing neurotoxicity as measured by a scored neurologic examination in young patients undergoing vincristine-containing treatment for Wilms tumor rhabdomyosarcoma acute lymphoblastic leukemia or non-Hodgkins lymphoma
Secondary
Compare the frequency and types of neurotoxicity observed in patients treated with glutamic acid versus placebo
Determine if a greater proportion of patients receiving glutamic acid are able to receive 100 of their scheduled doses of vincristine versus those not treated with glutamic acid
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to disease and duration of planned vincristine-containing treatment Wilms tumor or rhabdomyosarcoma with treatment planned for 9 consecutive weeks stratum 1 vs acute lymphoblastic leukemia or non-Hodgkins lymphoma with treatment planned for 4 consecutive weeks stratum 2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 stratum 2 for a total of 4 doses of vincristine or week 10 stratum 1 for a total of 9 doses of vincristine
Arm II Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 stratum 2 for a total of 4 doses of vincristine or week 10 stratum 1 for a total of 9 doses of vincristine
All patients undergo neurologic examination at baseline and at 5 weeks Patients in stratum 1 also undergo additional neurologic examination at week 10
PROJECTED ACCRUAL A total of 250 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 |
|---|---|---|---|
| 5U10CA081920-11 | NIH | Childrens Oncology Group | httpsreporternihgovquickSearch5U10CA081920-11 |
| SCUSF 0402 | OTHER | None | None |
| ACCL 0731 | OTHER | None | None |