Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399113
Status:
COMPLETED
Last Update Posted:
2011-07-14
First Post:
2006-11-13
Brief Title:
Safety Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma
Sponsor:
Pain Therapeutics
Organization:
PainT
Study Overview
Official Title:
An Open-Label Phase I Safety Pharmacokinetic Dosimetry Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2011-07
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:
The purpose of this first-in-man study is to evaluate the safety of 188Re-PTI-6D2 in patients with metastatic melanoma All patients will receive a tracer dose of 188Re-PTI-6D2 in order to provide information on how the monoclonal antibody is distributed throughout the body and to assess tumor targeting No therapeutic dose of radiation will be given in the first study
Detailed Description:
This study will evaluate the safety and feasibility of the administration of 188Re-PTI-6D2 in patients with metastatic melanoma Patients with confirmed Stage IIIc unresectable or Stage IV melanoma who meet all eligibility criteria will undergo a thorough physical examination and baseline tumor imaging whole body 18FDG PETCT and MRI brain to document all sites of tumor
Treatment will be administered on an inpatient basis An initial cohort of 3 patients will receive a tracer dose of 188Re-PTI-6D2 without any preceding unlabeled antibody The tracer dose will consist of 10 mCi of rhenium-labeled antibody the amount of antibody in mg will depend on specific activity and is estimated to range from 2 to 10 mg Additional cohorts of three patients each will receive 10 mg 20 mg and 50 mg of unlabeled PTI-6D2 immediately preceding administration of the tracer dose Patients will undergo serial gamma scans and SPECTCT imaging at specified time points Blood samples will be obtained prior to dosing and at specified intervals for PK measurements of the mAb as well as for measurement of serum radioactivity Urine will also be collected for all patients to measure excreted radioactivity Patients will be closely monitored for safety throughout the duration of the study
Patients will remain at the study center for 48 hours after infusion to allow adequate time for post-treatment safety observation monoclonal antibody clearance and rhenium decay Prior to the escalation of the dose of unlabeled PTI-6D2 safety data from the inpatient period and 2-week follow-up visit for the three patients at the current dose level will be reviewed If there is no evidence of a safety risk the dose of unlabeled PTI-6D2 will be escalated for the next cohort of patients Dose escalation of unlabeled antibody will occur according to a specific scheme
Treatment will be administered on an inpatient basis An initial cohort of 3 patients will receive a tracer dose of 188Re-PTI-6D2 without any preceding unlabeled antibody The tracer dose will consist of 10 mCi of rhenium-labeled antibody the amount of antibody in mg will depend on specific activity and is estimated to range from 2 to 10 mg Additional cohorts of three patients each will receive 10 mg 20 mg and 50 mg of unlabeled PTI-6D2 immediately preceding administration of the tracer dose Patients will undergo serial gamma scans and SPECTCT imaging at specified time points Blood samples will be obtained prior to dosing and at specified intervals for PK measurements of the mAb as well as for measurement of serum radioactivity Urine will also be collected for all patients to measure excreted radioactivity Patients will be closely monitored for safety throughout the duration of the study
Patients will remain at the study center for 48 hours after infusion to allow adequate time for post-treatment safety observation monoclonal antibody clearance and rhenium decay Prior to the escalation of the dose of unlabeled PTI-6D2 safety data from the inpatient period and 2-week follow-up visit for the three patients at the current dose level will be reviewed If there is no evidence of a safety risk the dose of unlabeled PTI-6D2 will be escalated for the next cohort of patients Dose escalation of unlabeled antibody will occur according to a specific scheme
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