Study of Therapy With TransMID™ Compared to Best Standard of Care in Patients With Glioblastoma Multiforme
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|ClinicalTrials.gov Identifier: NCT00083447|
Recruitment Status : Withdrawn (This study has been withdrawn because the drug would not meet trial criteria for efficacy)
First Posted : May 26, 2004
Last Update Posted : January 7, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Drug: TransMID™||Phase 3|
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, he/she must be diagnosed with glioblastoma multiforme which has been confirmed histologically and have undergone conventional treatment, including surgery (biopsy or debulking) and/or radiation therapy and/or chemotherapy, have a recurrent and/or progressive tumor ≥1.0 cm and ≤4.0 cm in diameter.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||323 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Multicenter Study of Intratumoral/Interstitial Therapy With TransMID™ Compared to Best Standard of Care in Patients With Progressive and/or Recurrent, Non-Resectable Glioblastoma Multiforme|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||March 2006|
|Estimated Study Completion Date :||June 2007|
- Overall survival time i.e. to to death
- 12 month survival rate
- Tumor Response
- Duration of Response
- Time to Progression
- 6 and 12 month progression rates
- Progression Free Survival
- 6 and 12 progression free survival rate
- Quality of Life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00083447