Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142415
Status:
COMPLETED
Last Update Posted:
2022-10-28
First Post:
2005-08-31
Brief Title:
Phase III Dose-escalation Study of Lutetium-177-labeled cG250 in Patients With Advanced Renal Cancer
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
Phase III Study of Increasing Doses of Lutetium-177 Labeled Chimeric Monoclonal Antibody cG250 177Lu-DOTA-cG250 in Patients With Advanced Renal Cancer
Status:
COMPLETED
Status Verified Date:
2022-10
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:
This was a Phase III single-center dose-escalation study 177-Lutetium-14710-tetraazacyclododecane-14710-tetraacetic acid-cG250 177-Lu-DOTA-cG250 was administered at a starting dose of 30 mCim2 of 177-Lu fixed dose of 10 mg cG250 and escalated in increments of 10 mCim2 of 177-Lu in sequentially enrolled cohorts according to a standard 3 3 design until determination of the maximum tolerated dose MTD The primary objectives were to determine the safety targeting and dosimetry of 177-Lu-DOTA-cG250 in subjects with advanced renal cell carcinoma The secondary objective was measurement of tumor response according to the Response Evaluation Criteria in Solid Tumors RECIST version 10
Detailed Description:
Prior to administration of 177-Lu-DOTA-cG250 subjects received 5 mCi10 mg of the 111-Indium-DOTA-cG250 111-In-DOTA-cG250 antibody an imaging dose Whole body and blood measurements of radioactivity were obtained on at least 3 occasions for 1 week to determine targeting and dosimetry If at least one known and evaluable metastatic lesion was visualized with 111-In-DOTA-cG250 a single dose of therapeutic 177-Lu-DOTA-cG250 was administered the following week In the absence of disease progression and after recovery from toxicity subjects may have been retreated no sooner than 12 weeks after the previous treatment with a dose of no more than 75 of the previous dose for a total of not more than 3 treatments Only subjects with normal pharmacokinetics on the diagnostic 111-In-DOTA-cG250 study indicative of human anti-chimeric antibody HACA negativity were eligible for re-treatment
Subjects in the initial cohort were enrolled sequentially to receive 30 mCim2 of 177-Lu-DOTA-cG250 fixed dose of 10 mg cG250 In the absence of a dose-limiting toxicity the dose was escalated in each subsequent cohort in 10 mCim2 increments of 177-Lu At least 3 subjects per dose level were followed for up to 12 weeks with imaging biochemical and hematologic tests Safety was monitored continuously throughout the study
Subjects in the initial cohort were enrolled sequentially to receive 30 mCim2 of 177-Lu-DOTA-cG250 fixed dose of 10 mg cG250 In the absence of a dose-limiting toxicity the dose was escalated in each subsequent cohort in 10 mCim2 increments of 177-Lu At least 3 subjects per dose level were followed for up to 12 weeks with imaging biochemical and hematologic tests Safety was monitored continuously throughout the study
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