Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003022
Status:
COMPLETED
Last Update Posted:
2013-07-03
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase I Study of Intrathecal 131-I-3F8 Monoclonal Antibody in Patients With GD2 Positive Leptomeningeal Neoplasms
Status:
COMPLETED
Status Verified Date:
2013-07
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 Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have leptomeningeal metastases
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have leptomeningeal metastases
Detailed Description:
OBJECTIVES
Define the clinical toxicities of intrathecal iodine I 131 monoclonal antibody 3F8 I-3F8 in patients with GD2 positive leptomeningeal neoplasms
Determine whether I-3F8 can detect GD2 positive leptomeningeal tumors
Measure the cerebrospinal fluid CSF levels and serum pharmacokinetics of I-3F8 in these patients
OUTLINE This is a dose escalation study
Patients receive a single injection of intraventricular or intrathecal iodine I 131 monoclonal antibody 3F8 Patients without objective disease progression and no grade 3 or 4 toxicity 6 weeks after the first dose may receive a second injection
Cohorts of at least 3 patients are entered at escalating doses of I-3F8 If grade 3 or worse toxicity occurs in 1 or more of 3 patients at a given dose level then 3 additional patients are accrued at that level If 2 or more of 6 patients at a given dose level experience grade 3 or worse toxicity then that dose is declared the maximum tolerated dose MTD
Patients are followed weekly for 4 weeks
PROJECTED ACCRUAL Approximately 3-30 patients will be accrued for this study over 2-3 years
Define the clinical toxicities of intrathecal iodine I 131 monoclonal antibody 3F8 I-3F8 in patients with GD2 positive leptomeningeal neoplasms
Determine whether I-3F8 can detect GD2 positive leptomeningeal tumors
Measure the cerebrospinal fluid CSF levels and serum pharmacokinetics of I-3F8 in these patients
OUTLINE This is a dose escalation study
Patients receive a single injection of intraventricular or intrathecal iodine I 131 monoclonal antibody 3F8 Patients without objective disease progression and no grade 3 or 4 toxicity 6 weeks after the first dose may receive a second injection
Cohorts of at least 3 patients are entered at escalating doses of I-3F8 If grade 3 or worse toxicity occurs in 1 or more of 3 patients at a given dose level then 3 additional patients are accrued at that level If 2 or more of 6 patients at a given dose level experience grade 3 or worse toxicity then that dose is declared the maximum tolerated dose MTD
Patients are followed weekly for 4 weeks
PROJECTED ACCRUAL Approximately 3-30 patients will be accrued for this study over 2-3 years
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 |
|---|---|---|---|
| NCI-G97-1267 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000065607 | REGISTRY | None | None |