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A Phase 1 Ascending Dose Trial of the Safety and Tolerability of Toca 511 in Patients with Recurrent Glioblastoma Multiforme
- To identify the highest, safe and well tolerated dose of Toca 511 administered intratumorally via stereotactic, transcranial injection
- Has the subject given written informed consent?
- Is the subject at least 18 years old?
- Does the subject have a single, supratentorial, histologically confirmed HGG (WHO grade III or IV glioma) measuring ≤ 9 cm^2 in its greatest cross sectional area?
- Has the subject undergone at least one prior surgical gross-total or subtotal tumor resection and a course of postoperative radiation therapy with concurrent temozolomide?
- Has the subject received at least 2, cycles of maintenance temozolomide?
- Has the subject elected not to undergo treatment with the Gliadel® wafer?
- Does the subject have unequivocal evidence of tumor progression as defined by the following:
- Subject must be at least 12 weeks post RT
- Baseline post-radiation scan performed at least 2 weeks following RT
- ≥ 25% increase in bidirectional measurement of the lesion compared to baseline, post-RT scan
- If the subject is being considered for part 2 of this protocol, does the subject have evaluable disease on Gd-MRI?
- If receiving corticosteroids, has the subject been on a stable or decreasing dose of steroids for the past 7 days?
- If age is 18-75, does the subject have a Karnofsky performance status ≥ 60; if > 75 year old, does the subject have a Karnofsky performance status ≥ 70?
- Does the subject have an absolute neutrophil count (ANC) ≥ 1500/mm3?
- Does the subject have an absolute lymphocyte count ≥ 800/mm3 (normal or grade 1 lymphopenia)?
- Does the subject have a platelet count ≥ 100,000/mm3?
- Does the subject have a Hgb ≥ 10 g/dL?
- Does the subject have a normal PT/PTT?
- Does the subject have an estimated glomerular filtration rate of at least 70 mL/min (inclusive) by the Cockcroft-Gault formula?
- Does the subject have an ALT/AST < 3 times the upper limit of the laboratory reference range and total bilirubin < 1.5 mg/dL?
- Does the subject have a life expectancy of at least 3 months?
- If the subject is a female of childbearing potential, has she had a negative serum pregnancy test within the past 21 days?
- If the subject is a fertile female, is she willing to use effective contraception while participating in this study? If the subject is a male, is he willing to use condoms for contraception while participating in this study?
- Is the subject willing and able to abide by the protocol?
- Has the subject received cytotoxic chemotherapy within the past 4 weeks (6 weeks for nitrosoureas)?
- Does the subject have a Gliadel® wafer or wafers implanted within the past 8 weeks?
- Is the subject taking more than 8 mg of dexamethasone per day?
- Would injection of one rim of the tumor require violation of the ventricular system?
- Does the subject have evidence of increased intracranial pressure or clinical deterioration that would require acute intervention prior to the projected start of flucytosine at the beginning of Week 4?
- Does the subject have, or has the subject had, within the past 4 weeks any infection requiring antibiotic, antifungal or antiviral therapy?
- Does the subject have any bleeding diathesis, or must the subject take any anticoagulants, or antiplatelet agents, including NSAIDs that cannot be stopped for surgery?
- Does the subject have poorly controlled seizures?
- Does the subject have a history of allergy or intolerance to flucytosine?
- Is the subject HIV positive?
- Does the subject have any gastrointestinal disease that would prevent him or her from being able to ingest or absorb flucytosine?
- Has the subject received any investigational treatment within the past 30 days?
- Is the subject breast feeding?
- Has the subject received Avastin® (bevacizumab) within 6 weeks of the projected Day 1 (injection)?
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