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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 or maximum feasible safe, and well tolerated dose of Toca 511 administered intratumorally via stereotactic, transcranial injection
- To evaluate the safety and tolerability of repeated treatment with flucytosine (Toca FC) at various doses and schedules following administration of Toca 511
- To evaluate preliminary efficacy of Toca 511 by intratumoral injection followed by Toca FC by assessing:
- Overall survival
- Overall survival at 6 months (OS6), 9 months (OS9), and 12 months (OS12)
- Progression-free survival (PFS) based on independent radiology review (IRR) of MRI data in addition to clinical data
- PFS at 6 months based on IRR of MRI data in addition to clinical data (PFS-6)
- Objective response rates using an IRR of MRI data in addition to clinical data
- To image the vector injection at selected centers
- To evaluate preliminary efficacy of Toca 511 intratumoral/Toca FC by assessing the percentage of subjects who have not progressed or died at 9 months (PFS9)
- To evaluate preliminary efficacy of Toca 511 intratumoral/Toca FC by assessing the percentage of subjects who have not progressed or died at 12 months (PFS-12)
- To develop a predictive diagnostic based on RNA expression profiling and to begin assessment of its clinical utility
- To evaluate immunotherapeutic response to Toca 511
- To evaluate patterns of gadolinium/Toca 511 distribution in subjects treated by intratumoral injection by immediate postoperative MRI
- To evaluate the preliminary efficacy of Toca 511 by intravenous injection followed by Toca FC by assessing objective response rates using an IRR of MRI data in addition to clinical data
All of the following questions must be answered "Yes" in order for the subject to participate in the study.
- Has the subject given written informed consent?
- Is the subject at least 18 years old?
- For Cohort 8 only, does the subject have a supratentorial, histologically confirmed HGG (WHO grade III or IV glioma) accessible by a technically feasible stereotactic trajectory?
- Does the subject have technically unresectable HGG?
- Has the subject undergone initial definitive therapy(s) such as surgery with or without adjuvant radiation therapy and/or chemotherapy (confirmed by diagnostic biopsy or contrast-enhanced MRI and evaluable by Macdonald criteria)? Note, if first recurrence of HGG is documented by MRI, an interval of at least 12 weeks after the end of prior radiation therapy is required unless there is either: i) histopathologic confirmation of recurrent tumor, or ii) new enhancement on MRI outside of the radiotherapy treatment field.
- Has the subject elected not to undergo treatment with the Gliadel® wafer?
- If receiving corticosteroids, has the subject been on a stable or decreasing dose of dexamethasone for the past 7 days?
- Does the subject have a Karnofsky performance status (KPS) ≥ 70?
- Does the subject have an absolute neutrophil count (ANC) ≥ 1500/mm3?
- Does the subject have an absolute lymphocyte count ≥ 500/mm3?
- Does the subject have a platelet count ≥ 100,000/mm3?
- Does the subject have a Hgb ≥ 10 g/dL?
- For Cohort 8 only, does the subject have a coagulation profile that would allow for the safe performance of surgery under general anesthesia?
- Does the subject have an estimated glomerular filtration rate of at least 50 mL/min (inclusive) by the Cockcroft-Gault formula?
- Does the subject have an ALT < 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?
- Is the subject willing to use condoms for contraception for 6 months after receiving Toca 511 or until there is no evidence of the virus in his/her blood, whichever is longer. If the subject is a fertile female, is she willing to use effective contraception for at least 12 months?
- Is the subject willing and able to abide by the protocol?
All of the following questions must be answered "No" in order for the subject to participate in the study.
- Has the subject received cytotoxic chemotherapy within the past 4 weeks (6 weeks for nitrosoureas)?
- Has the subject has more than 2 recurrences including the present recurrence?
- 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?
- For Cohort 8 only, would injection of the tumor require violation of the ventricular system?
- Does the subject have, or has the subject had, within the past 4 weeks any infection requiring antibiotic, antifungal or antiviral therapy?
- For Cohort 8 only, 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 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 swallow or absorb flucytosine?
- Has the subject received any investigational treatment within the past 30 days?
- Is the subject breastfeeding?
- Has the subject received Avastin® (bevacizumab)?
- Does the patient have a history of prior malignancy, excluding basal or squamous cell carcinoma of the skin, with an expected survival of less than five years?
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