Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031928
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2002-03-08
Brief Title:
Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Intrathecal Mafosfamide
Status:
COMPLETED
Status Verified Date:
2003-11
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 tumor cells from dividing so they stop growing or die
PURPOSE Phase I trial to determine the effectiveness of mafosfamide in treating patients who have progressive or refractory meningeal tumors
PURPOSE Phase I trial to determine the effectiveness of mafosfamide in treating patients who have progressive or refractory meningeal tumors
Detailed Description:
OBJECTIVES
Determine the qualitative and quantitative toxicity of mafosfamide in patients with progressive or refractory meningeal malignancy
Determine the maximum tolerated dose of this drug in these patients
Determine the cerebrospinal fluid pharmacokinetics of this drug in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive intrathecal mafosfamide over 20 minutes twice weekly for 6 weeks induction therapy Patients then receive intrathecal mafosfamide once weekly for 4 weeks consolidation therapy twice a month for 4 months and then monthly thereafter maintenance therapy in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of mafosfamide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 3000 patients will be accrued for this study
Determine the qualitative and quantitative toxicity of mafosfamide in patients with progressive or refractory meningeal malignancy
Determine the maximum tolerated dose of this drug in these patients
Determine the cerebrospinal fluid pharmacokinetics of this drug in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive intrathecal mafosfamide over 20 minutes twice weekly for 6 weeks induction therapy Patients then receive intrathecal mafosfamide once weekly for 4 weeks consolidation therapy twice a month for 4 months and then monthly thereafter maintenance therapy in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of mafosfamide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 3000 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 |
|---|---|---|---|
| BCM-H-3241 | None | None | None |
| NCI-90-C-0095K | None | None | None |