Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003073
Status:
UNKNOWN
Last Update Posted:
2010-03-23
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia Lymphoma or Solid Tumors
Sponsor:
Pacira Pharmaceuticals Inc
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Dose Escalation Study of Intrathecal DepoFoam Encapsulated Cytarabine DTC 101 in Pediatric Patients With Advanced Meningeal Malignancies
Status:
UNKNOWN
Status Verified Date:
2002-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 study the effectiveness of liposomal cytarabine in treating young patients who have recurrent or refractory meningeal leukemia lymphoma or solid tumors
PURPOSE Phase I trial to study the effectiveness of liposomal cytarabine in treating young patients who have recurrent or refractory meningeal leukemia lymphoma or solid tumors
Detailed Description:
OBJECTIVES I Determine the qualitative or quantitative toxic effects and tolerability of liposomal cytarabine Depofoam encapsulated cytarabine DTC 101 in pediatric patients with recurrent or refractory meningeal malignancies II Define a safe dose of DTC 101 in these patients for future clinical studies III Determine the plasma and CSF pharmacokinetics of DTC 101 in these patients
OUTLINE This is a dose escalation multicenter study Patients are placed in one of three age-related strata stratum 1 3 to 21 years of age stratum 2 at least 2 but less than 3 years of age stratum 3 at least 1 but less than 2 years of age Patients receive an induction dose of intrathecal liposomal cytarabine Depofoam encapsulated cytarabine DTC 101 administered once every 2 weeks for 2 courses Patients who have achieved a partial response or received significant clinical benefit with stable disease may receive a third induction dose of DTC 101 2 weeks following the second dose In the absence of progressive disease patients can proceed to consolidation therapy During consolidation therapy intrathecal DTC 101 is administered once every 4 weeks for 2 courses beginning 4 weeks after the last induction dose Patients experiencing a complete or significant response can proceed to maintenance therapy Patients receive a maintenance dose of intrathecal DTC 101 once every 8 weeks for a total of 6 doses beginning 4 weeks after the second consolidation dose At least 3 patients are evaluated at each dose level Dose escalation to the next level proceeds when a minimum of 3 patients per cohort has successfully completed induction therapy and been evaluated Patients will be followed at 1 2 3 6 9 and 12 months post treatment until relapse or death
PROJECTED ACCRUAL A minimum of 12-15 patients will be accrued for each stratum over 18 to 24 months
OUTLINE This is a dose escalation multicenter study Patients are placed in one of three age-related strata stratum 1 3 to 21 years of age stratum 2 at least 2 but less than 3 years of age stratum 3 at least 1 but less than 2 years of age Patients receive an induction dose of intrathecal liposomal cytarabine Depofoam encapsulated cytarabine DTC 101 administered once every 2 weeks for 2 courses Patients who have achieved a partial response or received significant clinical benefit with stable disease may receive a third induction dose of DTC 101 2 weeks following the second dose In the absence of progressive disease patients can proceed to consolidation therapy During consolidation therapy intrathecal DTC 101 is administered once every 4 weeks for 2 courses beginning 4 weeks after the last induction dose Patients experiencing a complete or significant response can proceed to maintenance therapy Patients receive a maintenance dose of intrathecal DTC 101 once every 8 weeks for a total of 6 doses beginning 4 weeks after the second consolidation dose At least 3 patients are evaluated at each dose level Dose escalation to the next level proceeds when a minimum of 3 patients per cohort has successfully completed induction therapy and been evaluated Patients will be followed at 1 2 3 6 9 and 12 months post treatment until relapse or death
PROJECTED ACCRUAL A minimum of 12-15 patients will be accrued for each stratum over 18 to 24 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 |
|---|---|---|---|
| NCI-V97-1336 | None | None | None |
| SKYEPHARMA-96-002 | None | None | None |
| DTC-96-002 | None | None | None |