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Sponsored by: |
Peregrine Pharmaceuticals |
---|---|
Information provided by: | Peregrine Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00509301 |
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.
Condition | Intervention | Phase |
---|---|---|
Recurrent Glioblastoma Multiforme |
Drug: 131-I-chTNT-1/B MAB |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Open-Label Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Recurrent Glioblastoma Multiforme |
Estimated Enrollment: | 12 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
1.5 mCi/cc
|
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.
|
2: Experimental
2.0 mCi/cc
|
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.
|
3: Experimental
2.5 mCi/cc
|
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.
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jennifer Lai, MBA, CCRA | 714-508-6097 | jlai@peregrineinc.com |
Contact: Dianne Uphoff, RN, CCRA | 714-508-6031 | duphoff@peregrineinc.com |
United States, Arizona | |
Barrow Neurological Institute | Recruiting |
Phoenix, Arizona, United States, 85013 | |
Contact: Andrea Ralph, RN OCN 602-406-6262 | |
Principal Investigator: William R Shapiro, MD | |
United States, Ohio | |
University Hospitals Case Medical Center | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Dawn M Diorio, R.N., B.S.N., B.A. 216-983-5167 Dawn.Diorio@UHHospitals.org | |
Principal Investigator: Andrew E Sloan, MD, FACS | |
United States, Pennsylvania | |
University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Joanna Lopinto, BSN, RN 215-615-4590 JLopinto@uphs.upenn.edu | |
Principal Investigator: Kevin Judy, MD | |
United States, South Carolina | |
Medical University of South Carolina | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Bonnie Muntz-Pope 843-792-8967 muntzpob@musc.edu | |
Principal Investigator: Sunil J Patel, MD | |
Principal Investigator: Kenneth Spicer, MD |
Principal Investigator: | Sunil J Patel, MD | Medical University of South Carolina |
Principal Investigator: | Kenneth M Spicer, MD PhD | Medical University of South Carolina |
Principal Investigator: | Kevin D Judy, MD | University of Pennsylvania |
Principal Investigator: | William R Shapiro, MD | Barrow Neurological Institute |
Principal Investigator: | Andrew E Sloan, MD, FACS | University Hospitals Case Medical Center |
Responsible Party: | Peregrine Pharmaceuticals ( Jennifer Lai, MBA, CCRA ) |
Study ID Numbers: | PPHM 0602 |
Study First Received: | July 27, 2007 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00509301 |
Health Authority: | United States: Food and Drug Administration |
brain cancer Cotara radioactive isotope monoclonal antibody radiation distribution |
Glioblastoma Astrocytoma Recurrence Antibodies, Monoclonal Brain Neoplasms Neuroectodermal Tumors Antibodies |
Glioblastoma multiforme Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Neoplasms, Glandular and Epithelial Immunoglobulins |
Disease Attributes Neoplasms Pathologic Processes |
Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |