131-I-TM-601 Study in Adults With Recurrent High-Grade Glioma
- Conditions
- Malignant GliomaGlioblastoma MultiformeGBMAnaplastic AstrocytomaOligo-AstrocytomaGliosarcoma
- Interventions
- Drug: 131I-TM601
- Registration Number
- NCT00114309
- Lead Sponsor
- TransMolecular
- Brief Summary
This drug is being developed to treat a type of brain cancer, glioma. This study was developed to evaluate the safety, time to disease progression and survival rates after treatment.
- Detailed Description
This phase II trial was designed in two sequences. The first sequence, which is now complete to accrual was an open-label, dose escalation, multi-dose study and treated 12 evaluable patients with high-grade glioma.
The second sequence is currently open and accruing eligible subjects with high-grade glioma. The trial is an open-label, randomized study and will accrue a total of 54 evaluable patients. Eligible subjects will be randomized to receive either 3 or 6 injections of 131-I labeled TM-601 (131-I-TM-601), in weekly intervals at the dose determined in the first sequence of the trial. Patients will undergo debulking surgery and placement of a ventricular access device into the tumor cavity for administration of 131I-TM-601. Patients who participated in the first sequence are not eligible to participate in the second sequence of the study.
High-grade gliomas include; glioblastoma multiforme, anaplastic astrocytoma, oligoastrocytoma or gliosarcoma.
Patients will undergo follow-up clinical examinations and magnetic resonance imaging (MRI) assessments, at defined intervals, until 12 months after the first study dose.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 66
- Patient must have a histologically confirmed unilateral, supratentorial malignant glioma (grade 3 or 4, anaplastic astrocytoma, gliosarcoma, glioblastoma multiforme or malignant oligoastrocytoma)
- Patient must have glioma progression or recurrence following radiotherapy that was no less than 50 Gy (+/- chemotherapy; +/- surgery)
- Patient must be a candidate for resection of the recurrent tumor (surgical requirements are detailed in the study protocol)
- Imaging must show recurrent, unilateral, supratentorial tumor(s)
- There is no diffuse leptomeningeal disease
- For patients with previous radiosurgery or enhanced radiotherapy, based on neurosurgeon's judgment, the area of enhancement can be removed during the surgery
- Patient must have recovered from toxicity of prior therapy
- Patient must be > 18 years of age.
- Patient has a Karnofsky Performance Status greater than or equal to 60%
- Patient must have a life expectancy of at least 3 months
- Patient has no uncontrolled seizures or other neurological conditions which would interfere with evaluation
- Patient is not currently receiving, or is not anticipated to receive, concomitant anticancer agent(s) during the course of this study
- Patient must have given informed consent
- Patient with concurrent malignancy (except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of cervix and/or breast) or patients with prior malignancies that have not been disease-free for five years
- Patient has presence of non-contiguous satellite lesions
- Patient with known allergy to iodine, iodine containing drugs or contrast agent
- Patient with the potential for pregnancy or impregnating their partner and who do not agree to follow an acceptable birth control method to avoid conception
- Pregnant or breast feeding females
- Patient is not maintained on a stable corticosteroid regimen
- New onset of conditions not present prior to surgery (as detailed in Study Protocol) which would make patient an inappropriate study candidate, or as determined by Investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 131-I-TM-601 3 Dose Regimen 2 131I-TM601 6 Dose Regimen
- Primary Outcome Measures
Name Time Method Determine Maximum Tolerated Dose (MTD) of 131-I-TM-601 administered intracavitary to patients with recurrent high-grade glioma 28 days post last dose Determine the toxicity of a three (3) and six (6) dose cycle of 131-I-TM-601 administrations into the tumor resection site of patients with recurrent high-grade glioma 28 days post last dose and then at 3 month intervals from first dose, until disease progression Evaluate the 6 and 12-month rate of progression and survival of patients with recurrent high-grade glioma treated with a three (3) or six (6) dose cycle of 131-I-TM-601 at 3 month intervals from first dose administration, until disease progression Evaluate the overall time to progression and death of patients with recurrent high-grade glioma treated with either a three (3) or six (6) dose cycle of 131-I-TM-601 at 3 month intervals until disease progression
- Secondary Outcome Measures
Name Time Method Evaluate if either a three (3) or six (6) dose cycle of 131-I-TM-601 affects Quality of Life 3 month intervals until disease progression
Trial Locations
- Locations (19)
Emory University
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Johns Hopkins Medical Center
🇺🇸Baltimore, Maryland, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Washington University Medical Center
🇺🇸St. Louis, Missouri, United States
Mary Crowley Medical Research Center
🇺🇸Dallas, Texas, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Tufts-New England Medical Center
🇺🇸Boston, Massachusetts, United States
Lacks Cancer Center at St. Mary's Health Care
🇺🇸Grand Rapids, Michigan, United States
St. Louis Hospital
🇺🇸St. Louis, Missouri, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Carolina Neurosurgery and Spine
🇺🇸Charlotte, North Carolina, United States
University of Washington
🇺🇸Seattle, Washington, United States
City of Hope
🇺🇸Duarte, California, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States