Ignite Creation Date:
2024-05-06 @ 1:48 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01906385
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2012-01-11
Brief Title:
Maximum Tolerated Dose Safety and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma ReSPECT
Sponsor:
Plus Therapeutics
Organization:
Plus Therapeutics
Study Overview
Official Title:
A Dual Phase 12 Investigator Initiated Study to Determine the Maximum Tolerated Dose Safety and Efficacy of 186Rhenium Nanoliposomes 186RNL in Recurrent Glioma CTRC 12-02
Status:
RECRUITING
Status Verified Date:
2024-06
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 is a multi-center sequential cohort open-label volume and dose escalation study of the safety tolerability and distribution of 186RNL given by convection enhanced delivery to patients with recurrent or progressive malignant glioma after standard surgical radiation andor chemotherapy treatment The study uses a modified Fibonacci dose escalation followed by an expansion at the maximum tolerated dose MTD to determine efficacy The starting absorbed dose is 1mCi in a volume of 0660mL
Detailed Description:
The Phase I portion of the clinical study evaluates a single dose of 186RNL radionuclide clinical study drug administered through a convection enhanced delivery catheter CED catheter in participants with recurrent Glioma GBM The clinical study treatment consists of a single administered dose of 186RNL per participant The clinical study will include the evaluation of multiple separate dose levels dose escalation Three to six participants may be treated at each dose The maximum number of participants to be enrolled in the study is approximately 21 The clinical study treatment will be administered following CED placement by the clinical study physician Participants will be followed for up to 36 months after the clinical study drug is administered
The Phase II portion of the clinical study is a multicenter single arm prospective study utilizing a non-DLT dose obtained from the dose escalation portion of IND 116117 NIH-NCI Grant 223 mCi total 186RNL activity at a concentration of 25 mCimL and 88 mL total volume The maximum number of participants to be enrolled in the Phase II study is approximately 34 The clinical study treatment will be administered following CED placement by the clinical study physician Participants will be followed for up to 36 months after the clinical study drug is administered
The US Food and Drug Administration FDA has not approved 186RNL for this specific disease
The Phase II portion of the clinical study is a multicenter single arm prospective study utilizing a non-DLT dose obtained from the dose escalation portion of IND 116117 NIH-NCI Grant 223 mCi total 186RNL activity at a concentration of 25 mCimL and 88 mL total volume The maximum number of participants to be enrolled in the Phase II study is approximately 34 The clinical study treatment will be administered following CED placement by the clinical study physician Participants will be followed for up to 36 months after the clinical study drug is administered
The US Food and Drug Administration FDA has not approved 186RNL for this specific disease
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 |
|---|---|---|---|
| 1R01CA235800-01A1 | NIH | WIRB | httpsreporternihgovquickSearch1R01CA235800-01A1 |
| 14-450X | OTHER | None | None |
| 20141749 | OTHER | None | None |