A Study of 131I-TM601 in Adults With Recurrent Malignant Glioma

Inclusion Criteria

• •Patients must:
• •1. Have histologically proven malignant glioma (anaplastic astrocytoma, anaplastic oligodendroglioma or glioblastoma multiforme) which is progressive and/or recurrent after external beam radiation therapy (to at least 50 Gy) ± chemotherapy with or without a history of surgical resection. Patients with previous low grade glioma who progressed after radiotherapy ± chemotherapy and are biopsied and found to have a high grade glioma are eligible. Patients with prior therapy that included interstitial brachytherapy, stereotactic radiosurgery, or local radiopharmaceutical injection must have confirmation of true progressive disease rather than radiation necrosis based upon PET or Thallium scanning or pathological documentation of disease.
• •2. Have bi-dimensional measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 2 planes on post-contrast MRI.
• •Note - a CT scan will be acceptable in place of an MRI only in patients who are unable to undergo an MRI.
• •3. Be ≥18 years of age.
• •4. Have a baseline Karnofsky Performance Status (KPS) of ≥60%.
• •5. Have a Mini Mental State Exam score of ≥ 19.
• •6. Have a life expectancy, based on the Investigator's judgment, of \>3 months.
• •7. On screening ECG, have a QTc interval of \<450 ms.
• •8. If taking steroids, be on a dose that is stable for at least 5 days prior to the Imaging Dose.
• •9. Have recovered from the toxicity of all previous therapy prior to enrollment. If the patient has undergone recent major surgery, an interval of at least 3 weeks must have elapsed between the surgery and the date of the Imaging Dose.
• •10. Have adequate organ and marrow function as defined by serum chemistry evaluations (defined in study protocol).
• •11. Have a negative serum pregnancy test within 14 days of study drug administration, if female and of child bearing potential.
• •12. Agree to use an effective form of contraception to avoid pregnancy, if fertile (applicable to both male and female patients).
• •13. Agree to refrain from nursing, if female.
• •14. Have signed and dated written informed consent.
• •15. Be able to comply with treatment plan, study procedures and follow-up examinations.