Clinical Trial Details
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NCT01156584 : A Study of a Retroviral Replicating Vector Administered to Subjects With Recurrent Malignant Glioma
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- at least 18 years of age

- for intratumoral cohorts, supratentorial HGG (WHO grade III or IV)

- technically unresectable HGG

- initial definitive therapy such as surgery with or without adjuvant radiation

- subject elected not to undergo treatment with Gliadel wafer

- if receiving corticosteroids, dose is stable or decreasing for past 7 days

- KPS: at least 70

- absolute neutrophil count > 1500/mm^3

- absolute lymphocyte count > 500/mm^3

- platelet count > 100,000/mm^3

- hemoglobin > 10 g/dL

- for intratumoral cohort, coagulation profile favorable to surgery

- estimated glomerular filtration rate > 50 mL/min

- ALT < 3 times ULN and bilirubin < 1.5 mg/dL

- negative serum pregnancy test

Exclusion Criteria:

- cytotoxic therapy within the past 4 weeks (6 weeks for BCNU/CCNU)

- more than 2 recurrences including present recurrence

- Gliadel wafer or wafers implanted within the past 8 weeks

- taking more than 8 mg of dexamethasone per day

- for intratumoral cohorts, injection of tumor would require violation of ventricular

- any infection requiring antibiotic, anticoagulant, or antiplatelet agents within the
past 4 weeks

- for intratumoral cohort, bleeding diathesis or use of anticoagulants/antiplatelet
agents that cannot be stopped

- allergy or intolerance to 5-FC

- HIV positive

- g.i. condition that would prevent ingestion or absorption of 5-FC

- any investigational treatment within the past 30 days

- pregnant or breast feeding

- received Avastin

- history of prior malignancy, excluding basal or squamous cell carcinoma of the skin,
with an expected survival of less than 5 years.
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