Clinical Trial Details
Braintumor Website

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NCT01985256 : Study of a Retroviral Replicating Vector Given Intravenously to Patients Undergoing Surgery for Recurrent Brain Tumor
PhasePhase 1
AgesMin: 18 Years Max: 80 Years
Inclusion Criteria:

- Has the subject given written informed consent?

- Is the subject between 18 years old and 80 years old inclusive?

- Has the subject had histologically proven HGG with recurrence or progression
following 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.

- Does the patient have either (1) a single, enhancing tumor recurrence/progression
that is ? 8 cm in greatest dimension, or (2) multiple enhancing tumor
recurrences/progressions within the same surgical field where the sum of their
greatest dimensions is ? 8 cm?

- Based on the pre-operative evaluation, is the tumor recurrence/progression a
candidate for ? 80% resection?

- Has the subject elected not to undergo treatment with the Gliadel® wafer?

- 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 ? 500/mm3?

- Does the subject have a platelet count ? 100,000/mm3?

- Does the subject have a Hgb ? 10 g/dL?

- 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?

- 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 contraception for
at least 12 months?

- Is the subject willing and able to abide by the protocol?

- Does the subject have adequate venous access?

Exclusion Criteria:

- Has the subject received cytotoxic chemotherapy within the past 3 weeks (6 weeks for
nitrosoureas) of the planned date of vector injection?

- Does the subject have, or has the subject had, within the past 4 weeks any infection
requiring antibiotic, antifungal or antiviral therapy?

- Has the subject received Avastin® (bevacizumab) for this recurrence/progression, or
within the 4 weeks prior to planned Visit 1?

- Does the subject have any bleeding diathesis, or must the subject take any
anticoagulants, or antiplatelet agents, including NSAIDs that cannot be stopped for

- 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?

- 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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