A Phase II Open-Label, Multiple-Dose Study of Intracavitary Administered 131-I-TM-601 in Adult Patients With Recurrent High-Grade Glioma

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