Clinical Trial Details
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NCT00303849 : Carboplatin, Melphalan, Etoposide Phosphate, Mannitol, and Sodium Thiosulfate in Treating Patients With Previously Treated Brain Tumors
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: 75 Years
Inclusion Criteria:

- Subjects with pathologic evidence of an anaplastic oligodendroglioma or mixed glioma
(i.e. oligoastrocytoma) are eligible; histopathologic diagnosis will be made using
World Health Organization classification criteria; to qualify as a mixed tumor there
must be a minimum of 25% oligodendroglial element

- Surgical procedure may have been complete resection, partial resection, or biopsy

- Subjects must have had prior treatment with temozolomide; at least 28 days must have
elapsed since completion of temozolomide or other chemotherapy

- If subject has not undergone radiation therapy, then subject must have undergone prior
consultation with a radiation oncologist (who is not an investigator on this study);
if the subject has undergone radiation therapy, then at least 14 days must have
elapsed since completion of radiation

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

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

- Absolute granulocyte count > 1.5 x 10^3/mm3

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

- Serum creatinine < 1.5 x upper limit of normal

- Bilirubin < 1.5 x upper limit of normal

- Subjects baseline serum glutamic oxaloacetic transaminase (SGOT)/serum glutamate
pyruvate transaminase (SGPT) must be < 2.5 x institutional upper limit of normal

- Subjects must sign a written informed consent in accordance with institutional

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

Exclusion Criteria:

- Subjects with radiographic signs of excessive intracranial mass effect with associated
rapid neurologic deterioration, and/or spinal cord block

- Subjects at significant risk for general anesthesia

- Subjects with uncontrolled (over the last 30 days) clinically significant confounding
medical conditions

- Subject is pregnant, has a positive serum human chorionic gonadotropin (hCG) or is

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