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| Tracking Information | |||||||||||||||||||||
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| First Received Date ICMJE | July 27, 2007 | ||||||||||||||||||||
| Last Updated Date | December 2, 2009 | ||||||||||||||||||||
| Start Date ICMJE | November 2006 | ||||||||||||||||||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
To confirm dose limit and maximum tolerated dose and to characterize radiation distribution [ Time Frame: unknown ] [ Designated as safety issue: Yes ] | ||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00509301 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | Safety & Radiation Distribution Study of Cotara® in Patients With Recurrent Glioblastoma Multiforme | ||||||||||||||||||||
| Official Title ICMJE | Open-label Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Recurrent Glioblastoma Multiforme | ||||||||||||||||||||
| Brief Summary | RATIONALE: Cotara® is an experimental new treatment that links a radioactive isotope (iodine 131) to a targeted monoclonal antibody. This monoclonal antibody is designed to bind tumor cells and deliver radiation directly to the center of the tumor mass while minimizing effects on normal tissues. Cotara® thus literally destroys the tumor "from the inside out." This may be an effective treatment for glioblastoma multiforme, a malignant type of brain cancer. PURPOSE: This trial is studying the safety and radiation distribution of Cotara® in patients with recurrent glioblastoma multiforme. |
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| Detailed Description | OBJECTIVES: Primary
OUTLINE: This is an open-label, dose escalation study of Cotara®. All patients will receive 3 mCi of Cotara® for biodistribution and radiation dosimetry purposes. In addition, patients will receive escalating therapeutic dose levels of Cotara® for confirmation of the maximum tolerated dose (MTD). After completion of study treatment, patients are followed for a minimum of 12 weeks and until disease progression. |
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| Study Phase | Phase I | ||||||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||||||
| Study Design ICMJE | Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Recurrent Glioblastoma Multiforme | ||||||||||||||||||||
| Intervention ICMJE | Drug: 131-I-chTNT-1/B MAB
The study drug is given interstitially for approximately 25 hours at a dose of 1.5, 2.0, or 2.5 mCi/cc.
Other Name: Cotara |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||||||||
| Estimated Enrollment ICMJE | 12 | ||||||||||||||||||||
| Estimated Completion Date | March 2010 | ||||||||||||||||||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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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 | United States | ||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT ID ICMJE | NCT00509301 | ||||||||||||||||||||
| Responsible Party | Jennifer Lai, MBA, CCRA, Peregrine Pharmaceuticals | ||||||||||||||||||||
| Study ID Numbers ICMJE | PPHM 0602 | ||||||||||||||||||||
| Study Sponsor ICMJE | Peregrine Pharmaceuticals | ||||||||||||||||||||
| Collaborators ICMJE | |||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Peregrine Pharmaceuticals | ||||||||||||||||||||
| Verification Date | December 2009 | ||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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