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

• Status: Unknown status
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TransMolecular

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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