Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075894
Status:
COMPLETED
Last Update Posted:
2009-01-13
First Post:
2004-01-09
Brief Title:
Alanosine in Treating Patients With Progressive or Recurrent Malignant Gliomas
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Open-Label Non-Randomized Multicenter Single Agent Study Of Intravenous SDX-102 For The Treatment Of Patients With MTAP-Deficient High Grade Recurrent Malignant Gliomas
Status:
COMPLETED
Status Verified Date:
2006-08
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 such as alanosine use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE This phase I trial is studying the side effects and best dose of alanosine in treating patients with high-grade progressive or recurrent malignant gliomas
PURPOSE This phase I trial is studying the side effects and best dose of alanosine in treating patients with high-grade progressive or recurrent malignant gliomas
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of alanosine SDX-102 with or without enzyme-inducible antiepileptic drugs EIAEDs in patients with methylthioadenosine phosphorylase MTAP-deficient high-grade progressive or recurrent malignant gliomas
Determine the pharmacokinetics of this drug administered concurrently with EIAEDs in these patients
OUTLINE This is an open-label nonrandomized multicenter dose-escalation study Patients are stratified according to concurrent anticonvulsant drug use drugs that induce hepatic metabolic enzymes vs drugs that cause modest or no induction of hepatic metabolic enzymes OR no anticonvulsant drug
Patients receive alanosine SDX-102 IV continuously for 5 days Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of SDX-102 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
After completion of study therapy patients are followed at 1 week and then every 2 months thereafter
PROJECTED ACCRUAL A total of 18 patients will be accrued for this study
Determine the maximum tolerated dose of alanosine SDX-102 with or without enzyme-inducible antiepileptic drugs EIAEDs in patients with methylthioadenosine phosphorylase MTAP-deficient high-grade progressive or recurrent malignant gliomas
Determine the pharmacokinetics of this drug administered concurrently with EIAEDs in these patients
OUTLINE This is an open-label nonrandomized multicenter dose-escalation study Patients are stratified according to concurrent anticonvulsant drug use drugs that induce hepatic metabolic enzymes vs drugs that cause modest or no induction of hepatic metabolic enzymes OR no anticonvulsant drug
Patients receive alanosine SDX-102 IV continuously for 5 days Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of SDX-102 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
After completion of study therapy patients are followed at 1 week and then every 2 months thereafter
PROJECTED ACCRUAL A total of 18 patients will be accrued for this study
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 |
|---|---|---|---|
| NABTT-0303 | None | None | None |