Status:
COMPLETED
A Study of a Retroviral Replicating Vector Combined With a Prodrug Administered to Patients With Recurrent Malignant Glioma
Lead Sponsor:
Tocagen Inc.
Conditions:
Glioblastoma
Anaplastic Astrocytoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 h...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2016
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01156584
Start Date
July 1 2010
End Date
August 18 2016
Last Update
May 21 2018
Active Locations (10)
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1
City of Hope
Duarte, California, United States, 91010
2
UCLA
Los Angeles, California, United States, 90095
3
UCSD
San Diego, California, United States, 92093
4
UCSF
San Francisco, California, United States, 94143