Study of a Retroviral Replicating Vector to Treat Patients Undergoing Surgery for a Recurrent Malignant Brain Tumor
This trial is active, not recruiting.
|Conditions||glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma|
|Start date||January 2012|
|End date||May 2016|
|Trial size||58 participants|
|Trial identifier||NCT01470794, Tg 511-11-01|
This is a multicenter study evaluating the safety and tolerability of increasing doses of Toca 511, a retroviral replicating vector, injected into the resection cavity of subjects with Grade III or Grade IV Gliomas who have elected to undergo surgical removal of their tumor. Approximately 6 weeks after injection of Toca 511, subjects will take an oral course of 5-FC, an antifungal antibiotic. These one week courses of 5-FC will be repeated during the 31 week study. In some subjects, Toca 511 and Toca FC will also be evaluated with either of the following standard treatments for glioma: lomustine, a drug approved by the FDA to treat brain tumors or bevacizumab, an alternative drug approved by the FDA to treat brain tumors. After completion of this study, all subjects will be eligible for enrollment and encouraged to be in a long-term continuation protocol that enables additional Toca FC treatment cycles to be given, as well as permits the collection of long-term safety and survival data.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Los Angeles, CA||UCLA||no longer recruiting|
|San Diego, CA||University of California at San Diego||no longer recruiting|
|Detroit, MI||Henry Ford Hospital||no longer recruiting|
|Edison, NJ||JFK Medical Center||no longer recruiting|
|Cleveland, OH||Cleveland Clinic Foundation||no longer recruiting|
|Columbus, OH||Ohio State University||no longer recruiting|
|Seattle, WA||Swedish Neuroscience Institute||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Dose Limiting Toxicities
time frame: 2 months
Overall Survival of Subjects
time frame: Overall survival, Overall survival at 6 months (OS6), 9 months (OS9), and 12 months (OS12)
Progression Free Survival (PFS) of Subjects
time frame: PFS of subjects at 6 months (PFS-6)
Male or female participants from 18 years up to 80 years old.
Inclusion Criteria (must all be answered "Yes"): - 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 GBM 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 subject have a single, HGG tumor recurrence/progression that is ≤ 5 cm in its greatest dimension? - 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 normal PT/PTT? (subnormal PT/PTT acceptable) - 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? Exclusion Criteria (must all be answered "No"): - Has the subject received cytotoxic chemotherapy within the past 3 weeks (6 weeks for nitrosoureas) of the planned surgery date? - 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 had a surgical procedure in the last 28 days or a surgical wound that is not healed? - 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 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) for this recurrence/progression, or within the past 5 weeks? - 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?
|Official title||A P1 Ascending Dose Trial of Safety and Tolerability of Toca 511, a Retroviral Replicating Vector, Administered to Subjects at the Time of Resection for Recurrent High Grade Glioma & Followed by Treatment With Toca FC, Extended-Release 5-FC|
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