Disulfiram/Copper Combination In The Treatment of Newly Diagnosed Glioblastoma Multiform (GLIODIS)

This is an interventional treatment trial for Glioblastoma Multiforme Read More

Inclusion Criteria:

1. Histopathologically confirmed diagnosis of glioblastoma (World Health Organization [WHO] grade IV astrocytoma). Patients must be newly diagnosed with unifocal supratentorial GBM amenable to gross total resection (< 1 cm. enhancing rim) and not yet received chemoradiation.
2. Patient must have undergone a gross total surgical resection of the tumor mass with post-surgical MRI (performed within 72 hours after operation) demonstration of adequacy defined as < 1.0 cm of residual enhancement away from resection cavity perimeter.
3. Ability to start disulfiram on the 5th postoperative day
4. ≥ 18 years of age
5. Karnofsky Performance Status (KPS) ≥ 70%

6. Adequate bone marrow function, defined as:

   Absolute neutrophil count ≥ 1000 cells/mm3 Hemoglobin ≥ 10 g/dL Platelet count ≥ 100,000 cells/mm3

7. Adequate hepatic function, defined as:

   Bilirubin ≤ 2.0 mg/dL Alkaline phosphatase (ALP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 4x upper limit of normal (ULN)

8. Adequate renal function, defined blood urea nitrogen (BUN) < 30 mg/dL and creatinine < 2 mg/dL
9. Prothrombin time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6x control unless therapeutically warranted
10. Female patients of child-bearing potential must have negative serum or urine pregnancy test
11. If not surgically sterile, male and female patients of childbearing age must use double barrier contraception (hormonal; intrauterine device; barrier)
12. Patient must give written informed consent prior to any study-specific procedures being implemented.

Exclusion Criteria:

1. Recurrent disease
2. Infratentorial or multifocal tumor.
3. Placement of Gliadel wafer

4. No severe, active comorbidity, including any of the following:

   • Unstable angina and/or congestive heart failure requiring hospitalization
   • Transmural myocardial infarction within the last 6 months
   • Chronic obstructive pulmonary disease
   • Known hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
   • Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness or other serious medical illness
   • Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy
   • Known history of an autoimmune disorder
   • Presence of any other active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin)
5. Alcoholism
6. Breastfeeding
7. Prior or planned chemotherapy, immunotherapy, biologic therapy, radiation therapy, radioimmunotherapy, hormonal therapy, or experimental therapy for brain tumor
8. History of severe allergic reaction to contrast media.
9. Inability to undergo an MRI.
10. Patients treated on any other therapeutic clinical trial within 30 days prior to study entry or during participation in the study.