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Sponsored by: |
TransMolecular |
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Information provided by: | TransMolecular |
ClinicalTrials.gov Identifier: | NCT00683761 |
The purpose of this study is to evaluate the safety and effectiveness of 131I-TM601 in the treatment of adult patients with progressive or recurrent malignant gliomas.
Condition | Intervention | Phase |
---|---|---|
Malignant Glioma Glioblastoma Multiforme GBM Astrocytoma Oligodendroglioma |
Drug: 131I-TM601 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1/2 Multi-Center, Safety and Efficacy Study Evaluating Intravenously Administered 131I-TM601 in Patients With Progressive and/or Recurrent Malignant Glioma |
Estimated Enrollment: | 64 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: 131I-TM601
In the first study phase (Dose Escalation), patients will be assigned to treatment to between 2-5 doses of 131I-TM601 treatment at a treatment dose of 1.2 mCi/kg of lean body mass (in scaled dosing, this will amount to 0.024 mg TM601 peptide/kg of lean body mass), once weekly (for between 2-5 weeks, depending upon dose cohort). The maximum amount of administered radioactivity per infusion is 100 mCi.
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This is a multi-center, open label, non-randomized, Phase 1/2 study evaluating the use of multiple intravenous doses of 131I-TM601 in patients with progressive and/or recurrent malignant glioma.
The study will be conducted in two phases. Prior to initiating treatment as part of this study, patients will be administered a single imaging dose of 131I-TM601, IV, to demonstrate tumor uptake. Only patients demonstrating tumor uptake will remain on the study. During the first, Dose Escalation Phase of the study, eligible patients will be assigned in groups of 3-6 (depending upon the treatment response seen at each dose) to dose cohorts of between 2-5 weekly IV doses of 131I-TM601, with escalation to the next highest dose dependent upon demonstrated tolerance in the previous dosing group. Patients enrolled in the second phase will be assigned to a dose determined by the experience in the first phase.
Patients in both study phases will have safety parameters evaluated continuously throughout the study. Clinical response to 131I-TM601 will be assessed in each study patient at 28 days following the final study dose, and then at quarterly intervals scheduled at 3 month intervals following the first study dose, until disease progression.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must:
Have bi-dimensional measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 2 planes on post-contrast MRI.
Note - a CT scan will be acceptable in place of an MRI only in patients who are unable to undergo an MRI.
Exclusion Criteria:
Patients may not:
Contact: Judy Burns | 617-995-3050 ext 318 | burns@transmolecular.com |
United States, Illinois | |
University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: MaryAnn Schroder 773-702-2856 mschroder@radonc.uchicago.edu | |
Principal Investigator: Steven Chmura, MD | |
United States, Maryland | |
Johns Hopkins University | Not yet recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: , MD | |
Principal Investigator: Heather Jacene, MD | |
Sub-Investigator: Richard Wahl, MD | |
United States, Michigan | |
St. Mary's Health Care | Recruiting |
Grand Rapids, Michigan, United States, 49503 | |
Contact: Pam Bartlett, BS 616-685-5252 bartletp@trinity-health.org | |
Principal Investigator: Thomas Gribbin, MD | |
United States, Virginia | |
University of Virginia | Recruiting |
Charlottesville, Virginia, United States, 22908-0394 | |
Contact: Gospova (Goga) Radkovic, MD, CCRC 434-243-5750 GR2P@hscmail.mcc.virginia.edu | |
Principal Investigator: David Schiff, MD |
Principal Investigator: | Karen Fink, MD | Baylor University |
Principal Investigator: | Adam Mamelak, MD | Cedars-Sinai Medical Center |
Principal Investigator: | Steven Rosenfeld, MD | Columbia University |
Principal Investigator: | Jan Drappatz, MD | Dana-Farber Cancer Institute |
Principal Investigator: | Patrick Wen, MD | Dana-Farber Cancer Institute |
Principal Investigator: | Jeffrey Olson, MD | Emory University |
Principal Investigator: | Richard Wahl, MD | Johns Hopkins University |
Principal Investigator: | Heather Jacene, MD | Johns Hopkins University |
Principal Investigator: | Antonio Omuro, MD | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Edward Pan, MD | Moffitt Cancer Center |
Principal Investigator: | Sean Grimm, MD | Northwestern University |
Principal Investigator: | Jeffrey Raizer, MD | Northwestern University |
Principal Investigator: | Nimish Mobile, MD | University of Rochester |
Principal Investigator: | Marc Chamberlain, MD | University of Washington |
Principal Investigator: | Jay-Jiguang Zhu, MD | Tufts Medical Center |
Principal Investigator: | John Fiveash, MD | University of Alabama at Birmingham |
Principal Investigator: | David Schiff, MD | University of Virginia |
Principal Investigator: | Michael Edgeworth, MD | Vanderbilt University |
Principal Investigator: | Mark Malkin, MD | Medical College of Wisconsin |
Principal Investigator: | Maciej Mrugala, MD | University of Washington |
Principal Investigator: | Steven Chmura, MD | University of Chicago |
Principal Investigator: | Thomas Gribbin, MD | St. Mary's Health Care |
Responsible Party: | TransMolecular ( Susan Stewart, Vice President, Regulatory Affairs ) |
Study ID Numbers: | TM601-008 |
Study First Received: | May 21, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00683761 |
Health Authority: | United States: Food and Drug Administration |
High grade recurrent glioma Phase 2 Phase 1 Multi-center Open label Multiple dose Brain Cancer Brain Tumor |
GBM glioma glioblastoma astrocytoma oligodendroglioma 131I-TM601 TM601 |
Neuroectodermal Tumors Brain Neoplasms Glioblastoma Glioblastoma multiforme Astrocytoma Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Oligodendroglioma Glioma Recurrence Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |