A Study of a Retroviral Replicating Vector Combined With a Prodrug Administered to Patients With Recurrent Malignant Glioma
| Status: | Completed |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/23/2018 |
| Start Date: | July 2010 |
| End Date: | August 18, 2016 |
A Phase 1 Ascending Dose Trial of the Safety and Tolerability of Toca 511 in Patients With Recurrent High Grade Glioma
This is a multicenter, open-label, ascending-dose trial of the safety and tolerability of
increasing doses of Toca 511, a Retroviral Replicating Vector (RRV), administered to patients
with recurrent high grade glioma (rHGG) who have undergone surgery followed by adjuvant
radiation therapy and chemotherapy. Patients will receive Toca 511 either via stereotactic,
transcranial injection into their tumor or as an intravenous injection given daily for 3 & 5
days, depending on cohort. Approximately 3-4 weeks following injection of the RRV, treatment
with Toca FC, an antifungal agent, will commence and will be repeated approximately every 6
weeks until study completion. After completion of this study, all patients will be eligible
for enrollment and encouraged to enter 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.
increasing doses of Toca 511, a Retroviral Replicating Vector (RRV), administered to patients
with recurrent high grade glioma (rHGG) who have undergone surgery followed by adjuvant
radiation therapy and chemotherapy. Patients will receive Toca 511 either via stereotactic,
transcranial injection into their tumor or as an intravenous injection given daily for 3 & 5
days, depending on cohort. Approximately 3-4 weeks following injection of the RRV, treatment
with Toca FC, an antifungal agent, will commence and will be repeated approximately every 6
weeks until study completion. After completion of this study, all patients will be eligible
for enrollment and encouraged to enter 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.
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
system
- 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.
We found this trial at
10
sites
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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