Safety and Efficacy Study to Treat Recurrent Grade 4 Malignant Brain Tumors
This study has been completed.
Sponsor:
Teva Pharmaceutical Industries
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00104091
First received: February 22, 2005
Last updated: May 20, 2011
Last verified: May 2011
Tracking Information | |
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First Received Date ICMJE | February 22, 2005 |
Last Updated Date | May 20, 2011 |
Start Date ICMJE | December 2004 |
Primary Completion Date | April 2007 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE |
Evaluate TP-38 at a 100 nanograms/mL concentration for sufficient activity [ Time Frame: 26 weeks ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00104091 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE |
Efficacy parameters including time to progression, safety, and survival [ Time Frame: 26 weeks ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Safety and Efficacy Study to Treat Recurrent Grade 4 Malignant Brain Tumors |
Official Title ICMJE | A Multicenter Phase II Study of TP-38 in Those Patients With Glioblastoma Multiforme Who Have Recurred or Progressed After Previous Resection and Radiation Therapy and Are Scheduled for Gross Total Resection |
Brief Summary | Immunotoxin therapy may be effective in treating malignant glioma. Immunotoxins can locate tumor cells and kill them without harming normal cells. |
Detailed Description | |
Study Type ICMJE | Interventional |
Study Phase | Phase 2 |
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Condition ICMJE | Glioblastoma Multiforme |
Intervention ICMJE | Drug: TP-38
TP-38 is a recombinant chimeric protein composed of the epidermal growth factor (EGFR) binding ligand (TGF-α)and a genetically engineered form of the Pseudomonas exotoxin, PE-38. |
Study Arm (s) | Experimental: 1
40 mL of TP-38 at a 100 nanograms/mL concentration
Intervention: Drug: TP-38 |
Publications * | |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Completed |
Estimated Enrollment ICMJE | 56 |
Completion Date | June 2007 |
Primary Completion Date | April 2007 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria: The patients must fulfill all the following criteria:
Exclusion Criteria: Patients fulfilling any of the following criteria should not be enrolled in the study:
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Gender | Both |
Ages | 18 Years and older |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | |
Administrative Information | |
NCT Number ICMJE | NCT00104091 |
Other Study ID Numbers ICMJE | IXR-202-22-188 |
Has Data Monitoring Committee | |
Responsible Party | Rivka Kreitman, Ph.D., Vice President, Innovative Research and Development, Teva Neuroscience |
Study Sponsor ICMJE | Teva Pharmaceutical Industries |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Teva Pharmaceutical Industries |
Verification Date | May 2011 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |