131-I-TM-601 Study in Adults With Recurrent High-Grade Glioma

Status unconfirmed · Phase 2

Conditions studied: Malignant Glioma, Glioblastoma Multiforme, GBM, Anaplastic Astrocytoma, Oligo-Astrocytoma, Gliosarcoma

In brief

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.

Key facts

Study ID

NCT00114309

Run by

TransMolecular

People needed

66

Starts

2004-11-01

Expected to finish

2009-08-01

Last updated by the study team

2009-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• City of Hope — Duarte, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• 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
• Tufts-New England Medical Center — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Lacks Cancer Center at St. Mary's Health Care — Grand Rapids, Michigan, United States
• St. Louis Hospital — St Louis, Missouri, United States
• Washington University Medical Center — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Carolina Neurosurgery and Spine — Charlotte, North Carolina, United States
• Mary Crowley Medical Research Center — Dallas, Texas, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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