Clinical trial · Interventional
A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision
Summary
Brief summary (as posted)
This is a multicenter, open-label, continuation study to allow subjects who have previously received Toca 511 to continue to receive Toca FC and to allow for extended safety observations. Subjects will be seen on an every six week basis for 1 year or longer. Subjects who continue to receive Toca FC will receive the dose described in the "parent" protocol. If the Toca FC dose is adjusted for any reason, the serum concentration will be monitored. Gadolinium (Gd)-enhanced magnetic resonance imaging (MRI) scans will be performed as per standard of care. If the subject has recurred/progressed, repeat intracranial injection of Toca 511 followed by Toca FC treatment may be offered to consenting patients. Subjects who enter the study to continue Toca FC and subsequently discontinue Toca FC, and subjects who are only willing or able to perform limited testing will have viral testing alone, at the appropriate intervals. After the first year, subjects will be seen twice yearly for the next 4 years and then contacted yearly for the next 10 years. All subjects will be followed on study for at least 5 years regardless of whether they are taking Toca FC.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytoma | Astrocytoma | CURATED_BROADER | 0.80 |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
| Gliomas, Malignant | Glioma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Toca 511 vector | Biological | — | UNRESOLVED |
| Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Single arm Toca 511 vector/5-FC prodrug
- interventionNames
- Biological: Toca 511 vector
- Drug: Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine
Primary outcomes (1)
- measure
- Long term safety follow up
- timeFrame
- From study entry up to 15 years
- description
- This will be based on treatment emergent adverse events, clinical laboratory values and viral testing.
Secondary outcomes (1)
- measure
- Overall survival in days from the initial Toca 511 administration on parent study to the date of death.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Informed Consent Form * Subject received Toca 511 in prior study. * Subject is willing to abide by protocol Exclusion Criteria: * Subject has history of allergy or intolerance to flucytosine
References
Publications (0)
Data not yet available