Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088400
Status:
COMPLETED
Last Update Posted:
2016-09-22
First Post:
2004-07-23
Brief Title:
Comparison of TransMID vs Standard Treatment of Cancerous Brain Tumors
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase III Multicenter Study of IntratumoralInterstitial Therapy With TransMID Compared to Best Standard of Care in Patients With Progressive andor Recurrent Non-Resectable Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2016-09
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:
Study Objectives
Primary Objective
To evaluate the efficacy of intratumoralinterstitial therapy with TransMID compared to best standard of care in patients with progressive andor recurrent non-resectable glioblastoma multiforme
Secondary Objectives
To assess the safety of intratumoralinterstitial therapy with TransMID compared to best standard of care in patients with progressive andor recurrent non-resectable glioblastoma multiforme
To evaluate possible differences in efficacy andor safety with TransMID associated with differing degrees of transferrin receptor expression in tumor tissue and serum anti-diphtheria toxin antibody titer levels
Study Design
Multicenter open label randomized study comparing TransMID with a chemotherapeutic regimen considered to be best standard of care and consisting of either nitrosureas platinum compounds temozolomide procarbazine or PCV procarbazine lomustine CCNU vincristine A planned interim analysis of the primary efficacy endpoint will be conducted after approximately 50 percent of the required events have been observed
Primary Objective
To evaluate the efficacy of intratumoralinterstitial therapy with TransMID compared to best standard of care in patients with progressive andor recurrent non-resectable glioblastoma multiforme
Secondary Objectives
To assess the safety of intratumoralinterstitial therapy with TransMID compared to best standard of care in patients with progressive andor recurrent non-resectable glioblastoma multiforme
To evaluate possible differences in efficacy andor safety with TransMID associated with differing degrees of transferrin receptor expression in tumor tissue and serum anti-diphtheria toxin antibody titer levels
Study Design
Multicenter open label randomized study comparing TransMID with a chemotherapeutic regimen considered to be best standard of care and consisting of either nitrosureas platinum compounds temozolomide procarbazine or PCV procarbazine lomustine CCNU vincristine A planned interim analysis of the primary efficacy endpoint will be conducted after approximately 50 percent of the required events have been observed
Detailed Description:
Study Objectives
Primary Objective
To evaluate the efficacy of intratumoralinterstitial therapy with TransMID compared to best standard of care in patients with progressive andor recurrent non-resectable glioblastoma multiforme
Secondary Objectives
To assess the safety of intratumoralinterstitial therapy with TransMID compared to best standard of care in patients with progressive andor recurrent non-resectable glioblastoma multiforme
To evaluate possible differences in efficacy andor safety with TransMID associated with differing degrees of transferrin receptor expression in tumor tissue and serum anti-diphtheria toxin antibody titer levels
Study Design
Multicenter open label randomized study comparing TransMID with a chemotherapeutic regimen considered to be best standard of care and consisting of either nitrosureas platinum compounds temozolomide procarbazine or PCV procarbazine lomustine CCNU vincristine A planned interim analysis of the primary efficacy endpoint will be conducted after approximately 50 percent of the required events have been observed
Primary Objective
To evaluate the efficacy of intratumoralinterstitial therapy with TransMID compared to best standard of care in patients with progressive andor recurrent non-resectable glioblastoma multiforme
Secondary Objectives
To assess the safety of intratumoralinterstitial therapy with TransMID compared to best standard of care in patients with progressive andor recurrent non-resectable glioblastoma multiforme
To evaluate possible differences in efficacy andor safety with TransMID associated with differing degrees of transferrin receptor expression in tumor tissue and serum anti-diphtheria toxin antibody titer levels
Study Design
Multicenter open label randomized study comparing TransMID with a chemotherapeutic regimen considered to be best standard of care and consisting of either nitrosureas platinum compounds temozolomide procarbazine or PCV procarbazine lomustine CCNU vincristine A planned interim analysis of the primary efficacy endpoint will be conducted after approximately 50 percent of the required events have been observed
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-N-0244 | None | None | None |