Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083447
Status:
WITHDRAWN
Last Update Posted:
2009-01-07
First Post:
2004-05-24
Brief Title:
Study of Therapy With TransMID Compared to Best Standard of Care in Patients With Glioblastoma Multiforme
Sponsor:
Xenova Biomedix
Organization:
Xenova Biomedix
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:
WITHDRAWN
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study has been withdrawn because the drug would not meet trial criteria for efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
TransMID treatment or best standard of care for patients with advanced glioblastoma multiforme
Glioblastoma multiforme GBM is a type of brain tumour GBM tumours are usually treated with surgery and radiotherapy Unfortunately this type of brain tumour may continue to grow or come back recur despite treatment
This trial will compare a new drug called TransMID with the best standard treatment that is currently available TransMID is a drug that is a combination of a protein called transferrin and a poison called diphtheria toxin
Cancer cells need iron in order to continue to grow They need more iron than normal cells Transferrin helps cells to take up available iron So the cancer cells are attached to the transferrin in TransMID and the diphtheria poison kills them The aim of this treatment is to kill the cancer cells while not affecting the normal brain cells This treatment for brain tumours may have fewer side effects than other treatments because it targets cancer cells
The best standard treatment will involve giving chemotherapy You may have chemotherapy as part of the treatment when you are diagnosed Or it may be kept in reserve to treat your brain tumour if it comes back or continues to grow Your cancer specialist consultant will decide which chemotherapy drugs you should have
Glioblastoma multiforme GBM is a type of brain tumour GBM tumours are usually treated with surgery and radiotherapy Unfortunately this type of brain tumour may continue to grow or come back recur despite treatment
This trial will compare a new drug called TransMID with the best standard treatment that is currently available TransMID is a drug that is a combination of a protein called transferrin and a poison called diphtheria toxin
Cancer cells need iron in order to continue to grow They need more iron than normal cells Transferrin helps cells to take up available iron So the cancer cells are attached to the transferrin in TransMID and the diphtheria poison kills them The aim of this treatment is to kill the cancer cells while not affecting the normal brain cells This treatment for brain tumours may have fewer side effects than other treatments because it targets cancer cells
The best standard treatment will involve giving chemotherapy You may have chemotherapy as part of the treatment when you are diagnosed Or it may be kept in reserve to treat your brain tumour if it comes back or continues to grow Your cancer specialist consultant will decide which chemotherapy drugs you should have
Detailed Description:
This is a Multicenter open label randomized study comparing TransMID with a chemotherapeutic regimen considered to be best standard of care and consisting of either nitrosoureas platinum compounds temozolomide procarbazine PCV procarbazine lomustine CCNU vincristine CPT-11 or Etoposide A planned interim analysis of the primary efficacy endpoint will be conducted after approximately 50 of the required events have been observed
In order for a patient to be eligible for enrollment into this trial heshe must be diagnosed with glioblastoma multiforme which has been confirmed histologically and have undergone conventional treatment including surgery biopsy or debulking andor radiation therapy andor chemotherapy have a recurrent andor progressive tumor 10 cm and 40 cm in diameter
In order for a patient to be eligible for enrollment into this trial heshe must be diagnosed with glioblastoma multiforme which has been confirmed histologically and have undergone conventional treatment including surgery biopsy or debulking andor radiation therapy andor chemotherapy have a recurrent andor progressive tumor 10 cm and 40 cm in diameter
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