Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199875
Status:
COMPLETED
Last Update Posted:
2022-10-10
First Post:
2005-09-13
Brief Title:
Treatment of Patients With Advanced Renal Cancer With a Radiolabeled Antibody Yttrium-90 Conjugated Chimeric G250
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
Cohort Study of Increasing Doses of Yttrium-90 Conjugated to Chimeric Monoclonal Antibody cG250 90Y-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 1 open-label dose-escalation study of yttrium-90 conjugated chimeric G250 90Y-DOTA-cG250 in patients with advanced measurable clear cell renal cell carcinoma RCC Study objectives were to determine the safety targeting and dosimetry of 90Y-DOTA-cG250 using indium-111 conjugated chimeric G250 111In-DOTA-cG250 as a surrogate as well as to evaluate the immunogenicity of cG250
Detailed Description:
Patients were enrolled sequentially into cohorts of 3 to 6 patients until determination of the maximum tolerated dose MTD of 90Y-DOTA-cG250 defined as the dose level below the dose at which 2 patients experienced dose-limiting toxicity DLT In an attempt to mitigate liver uptake and toxicity patients initially received a nontherapeutic injection with 111In-DOTA-cG250 at an imaging dose of 5 mCi of 111In 10 mg of cG250 on Day 1 Whole body and blood measurements of radioactivity were obtained on at least 3 occasions for 1 week to determine targeting and dosimetry Provided that protocol-specified criteria were met including targeting to lesions 2 cm detected on computed tomography CT scan a single dose of therapeutic 90Y-DOTA-cG250 was administered on Day 8 9 or 10 The starting dose of 90Y-DOTA-cG250 was 02 mCikg of 90Y 10 mg of cG250 administered as an intravenous IV infusion with escalation of the 90Y dose in subsequent cohorts in 005 to 01 mCikg increments
Patients were treated in an outpatient setting and were observed for at least 2 hours following each infusion at which point vital signs and blood samples were obtained Patients were followed for 6 to 8 weeks post-treatment or after recovery from toxicity with imaging biochemical serological and hematologic tests to determine the safety of 90Y-DOTA-cG250 and to inform dose-escalation decisions Extent of disease evaluations preferably by positron emission tomography PETCT or standard CT were performed at baseline and 6 to 8 weeks post-treatment or after recovery from toxicity Long-term follow-up was performed when possible every 12 weeks thereafter for up to 2 years
Patients were treated in an outpatient setting and were observed for at least 2 hours following each infusion at which point vital signs and blood samples were obtained Patients were followed for 6 to 8 weeks post-treatment or after recovery from toxicity with imaging biochemical serological and hematologic tests to determine the safety of 90Y-DOTA-cG250 and to inform dose-escalation decisions Extent of disease evaluations preferably by positron emission tomography PETCT or standard CT were performed at baseline and 6 to 8 weeks post-treatment or after recovery from toxicity Long-term follow-up was performed when possible every 12 weeks thereafter for up to 2 years
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC IRB 05-031 | OTHER | MSKCC IRB | None |