Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003102
Status:
COMPLETED
Last Update Posted:
2023-10-04
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Advanced Kidney Cancer
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
Phase III Study of 131I-Labeled Chimeric Antibody G250 131I-cG250 in Patients With Advanced Renal Carcinoma
Status:
COMPLETED
Status Verified Date:
2023-10
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 III trial to study the effectiveness of monoclonal antibody therapy in treating patients with advanced kidney cancer
PURPOSE Phase III trial to study the effectiveness of monoclonal antibody therapy in treating patients with advanced kidney cancer
Detailed Description:
This is a dose-escalation study Initially patients receive a scout dose of iodine-131 radiolabeled chimeric monoclonal antibody G250 131I-cG250 administered intravenously IV over 10 minutes to determine whole body clearance One week later patients receive incremental doses of 131I-cG250 IV over 10 minutes at 2-3 day intervals for 2-6 weeks Dose escalation begins at least 8 weeks after the last infusion of 131I-cG250 In the absence of dose-limiting toxicity in the first 3 patients treated subsequent cohorts of 3 patients each receive escalating doses of 131I-cG250 on the same schedule If dose-limiting toxicity occurs in 2 of 6 patients treated at a given dose level then dose escalation ceases and the next lower dose is declared the maximum tolerated dose MTD Treatment continues once recovery from all toxic effects occurs beginning 8 to 12 weeks following the last dose of 131I-cG250 Patients achieving complete remission partial remission or stable disease were eligible to receive up to 3 courses of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-97049 | OTHER | None | None |
| NCI-H97-0004 | OTHER | None | None |
| LUD 96-006 | OTHER | Ludwig Institute for Cancer Research | None |