Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098761
Status:
COMPLETED
Last Update Posted:
2011-06-30
First Post:
2004-12-08
Brief Title:
VNP40101M in Treating Young Patients With Recurrent Progressive or Refractory Primary Brain Tumors
Sponsor:
Pediatric Brain Tumor Consortium
Organization:
Pediatric Brain Tumor Consortium
Study Overview
Official Title:
Phase I Study Of Cloretazine VNP40101M In Children With Recurrent Progressive Or Refractory Primary Brain Tumors
Status:
COMPLETED
Status Verified Date:
2011-06
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 VNP40101M work in 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 VNP40101M in treating young patients with recurrent progressive or refractory primary brain tumors
PURPOSE This phase I trial is studying the side effects and best dose of VNP40101M in treating young patients with recurrent progressive or refractory primary brain tumors
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose and dose-limiting toxicity of VNP40101M in pediatric patients with recurrent progressive or refractory primary brain tumors
Secondary
Determine the pharmacokinetics of this drug and its active metabolite VNP4090CE in these patients
Determine the efficacy of this drug in these patients
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to receiving 1 of the following prior therapies craniospinal irradiation yes vs no autologous bone marrow transplant yes vs no and 2 myelosuppressive chemotherapy or myelosuppressive biologic therapy regimens yes vs no
Patients receive VNP40101M IV over 30 minutes on days 1-5 Treatment repeats every 42 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 2-6 patients per stratum receive escalating doses of VNP40101M until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 25 of patients experience dose-limiting toxicity A total of 12 patients are treated at the MTD
Patients are followed for 3 months
PROJECTED ACCRUAL A total of 4-60 patients 2-30 per stratum will be accrued for this study within 18 months
Primary
Determine the maximum tolerated dose and dose-limiting toxicity of VNP40101M in pediatric patients with recurrent progressive or refractory primary brain tumors
Secondary
Determine the pharmacokinetics of this drug and its active metabolite VNP4090CE in these patients
Determine the efficacy of this drug in these patients
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to receiving 1 of the following prior therapies craniospinal irradiation yes vs no autologous bone marrow transplant yes vs no and 2 myelosuppressive chemotherapy or myelosuppressive biologic therapy regimens yes vs no
Patients receive VNP40101M IV over 30 minutes on days 1-5 Treatment repeats every 42 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 2-6 patients per stratum receive escalating doses of VNP40101M until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 25 of patients experience dose-limiting toxicity A total of 12 patients are treated at the MTD
Patients are followed for 3 months
PROJECTED ACCRUAL A total of 4-60 patients 2-30 per stratum will be accrued for this study within 18 months
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 |
|---|---|---|---|
| VION-VNP40101M | None | None | None |
| PBTC-017 | None | None | None |