Clinical Trial Details
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NCT00075387 : Combination Chemotherapy With or Without Sodium Thiosulfate in Preventing Low Platelet Count While Treating Patients With Malignant Brain Tumors
PhasePhase 2
AgesMin: 18 Years Max: 75 Years
Inclusion Criteria:

- Subjects with histologically confirmed high-grade glioma are eligible; diagnosis of
high-grade glioma will be made on the basis of needle biopsy, open biopsy, or surgical

- Subjects may have had prior focal or systemic radiation or chemotherapy; at least 14
days must have elapsed since radiation treatment and 28 days since prior chemotherapy

- Performance status (Eastern Cooperative Oncology Group [ECOG]) must be less than or
equal to 2 (Karnofsky greater than or equal to 50)

- White blood cell count >= 2.5 x 10^3/mm^3

- Absolute granulocyte count >= 1.2 x 10^3/mm^3

- Platelets >= 100 x 10^3/mm^3

- Creatinine < 1.8

- Bilirubin < 2.0

- Baseline aspartate aminotransferase (AST)/alanine aminotransferase (ALT) serum
glutamic oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT)
must be < 2.5 x institutional upper limits of normal

- Subject (or legal guardian) must sign a written informed consent in accordance with
institutional guidelines

- Sexually active women of child-bearing potential and men must agree to use adequate
contraception (hormonal or barrier method of birth control; or abstinence) prior to
study treatment and for the duration of study treatment; should a female become
pregnant or suspect she is pregnant while participating in this study, she should
inform the investigator

Exclusion Criteria:

- Subjects with rapidly progressing central nervous system (CNS) disease with associated
neurological deterioration

- Subjects with uncontrolled (over the last 30 days) clinically significant confounding
medical conditions such as congestive heart failure

- Subjects who are pregnant, have a positive serum human chorionic gonadotropin (hCG) or
are lactating

- Subjects who have contraindications to carboplatin, cyclophosphamide, etoposide
phosphate, or sodium thiosulfate
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