Open-label, Dose Confirmation Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Glioblastoma Multiforme (GBM) at First Relapse

Inclusion Criteria:

- Histologically confirmed GBM

- Clinical Target Volume between 5 and 60 cc (inclusive)

- 18 to 75 years old (inclusive)

- Karnofsky Performance Status ≥ 70 percent

- If on steroids dose (± 4mg/day) must be stable for at least two weeks prior to
screening/baseline visit. If not on steroids for two weeks prior to
screening/baseline visit are allowed

- Adequate hematology

- Adequate renal function

- Adequate liver function

Exclusion Criteria:

- Infratentorial tumor(s), tumor(s) that communicate with the ventricles or
intraventricular disease

- Bilateral non-contiguous gadolinium enhancing tumor

- Diffuse disease (i.e., any satellite lesions less than 1.5 cm from anticipated
location of any catheter tip or less than two satellite lesions)

- Known or suspected allergy to study medication or iodine

- Surgical procedure within four weeks of baseline

- More than one prior chemotherapy regime or chemotherapy within four weeks
(nitrosourea-based within six weeks) of baseline

- Radiation therapy within four weeks of baseline

- Investigational agent within last 30 days

- Previous treatment with any chimeric monoclonal antibody

- HIV positive

- Evidence of active hepatitis