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A PHASE II CLINICAL TRIAL FOR THE EVALUATION OF THE EFFICACY OF DISULFIRAM AS AN ADJUNCTIVE AND CONCURRENT CHEMOTHERAPY IN THE TREATMENT OF NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORM


Phase 2
18 Years
N/A
Not Enrolling
Both
Glioblastoma Multiform

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Trial Information

A PHASE II CLINICAL TRIAL FOR THE EVALUATION OF THE EFFICACY OF DISULFIRAM AS AN ADJUNCTIVE AND CONCURRENT CHEMOTHERAPY IN THE TREATMENT OF NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORM


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

6 months

Safety Issue:

No

Authority:

Greece:Ministry of Health and Social Solidarity/National Organization for Medicines (EOF)

Study ID:

PK-18081973

NCT ID:

NCT01777919

Start Date:

September 2013

Completion Date:

Related Keywords:

  • Glioblastoma Multiform
  • Glioblastoma

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