Glioblastoma MultiformePhase 1NCT04327011
A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511
A Phase 1 study testing Toca 511 vector and Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine in people with Glioblastoma Multiforme and Astrocytoma, run by Tocagen Inc. at 11 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme, Astrocytoma, Gliomas, Malignant
- What is being tested?
- Toca 511 vector and Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 11 sitesUnited States
- Study dates
- Feb 2011to Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent Form
- Subject received Toca 511 in prior study.
- Subject is willing to abide by protocol
Who cannot join
- Subject has history of allergy or intolerance to flucytosine
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
Henry Ford Health System
Detroit, Michigan, 48202
JFK Medical Center Neuroscience Institute
Edison, New Jersey, 08820
Hackensack University Medical Center
Hackensack, New Jersey, 07601
John Theurer Cancer Center at Hackensack University
Hackensack, New Jersey, 07601
University of California, Los Angeles
Los Angeles, California, 90095
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
UCSD
San Diego, California, 92093
UCSF
San Francisco, California, 94143
Swedish Neuroscience Institute
Seattle, Washington, 98122
About this study
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.
Read more
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
- Glioblastoma Multiforme, Astrocytoma, Gliomas, Malignant
- Being tested
- Toca 511 vector, Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine
- Keywords
- glioma, glioblastoma, glioblastoma multiforme, Grade IV astrocytoma, brain cancer, recurrent glioblastoma, GBM, AA, AOD, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, high grade glioma
- Medical subject headings
- Glioblastoma, Astrocytoma, Glioma, Brain Neoplasms, Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toca 511 vectorBiological
Also called vocimagene amiretrorepvec, RRV, retroviral replicating virus
Toca 511 consists of a purified retroviral replicating vector encoding a modified yeast cytosine deaminase (CD) gene. The CD gene converts the antifungal 5-flurocytosine (5FC) to the anticancer drug 5-FU in cells that have been infected by the Toca 511 vector
Toca FC • Flucytosine • 5-FC • 5-FluorocytosineDrug
Also called Extended Release 5-FC, 5-FC, 5-Fluorocytosine
Toca FC is an extended-release formulation of flucytosine.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Single arm Toca 511 vector/5-FC prodrug Receives: Biological: Toca 511 vector; Drug: Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term safety follow up
This will be based on treatment emergent adverse events, clinical laboratory values and viral testing.
Measured: From study entry up to 15 years
Secondary outcomes (1)
Overall survival in days from the initial Toca 511 administration on parent study to the date of death.
Measured: From initial Toca 511 administration to death of last patient alive for up to 15 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study startFeb 2011
- Primary completionDec 2019
- Study completionDec 2019
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tocagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Asha Das, MD, Study director, Tocagen Inc.Michael Vogelbaum, MD, PhD, NS, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327011
- Sponsor's protocol ID
- Tg 511-09-01
- Status last verified
- Mar 2020
- First submitted
- 21 Dec 2016
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511
- ClinicalTrials.gov ID
- NCT04327011
- Acronym / sponsor ID
- Tg 511-09-01
- Conditions
- Glioblastoma Multiforme, Astrocytoma, Gliomas, Malignant
- Keywords
- glioma, glioblastoma, glioblastoma multiforme, Grade IV astrocytoma, brain cancer, recurrent glioblastoma, GBM, AA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Tocagen Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2011 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Biological: Toca 511 vector, Drug: Toca FC • Flucytosine • 5-FC • 5-FluorocytosineSingle arm Toca 511 vector/5-FC prodrug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed Consent Form
- Subject received Toca 511 in prior study.
- Subject is willing to abide by protocol
Key exclusion criteria (1 listed)
- Subject has history of allergy or intolerance to flucytosine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toca 511 vectorAlso: vocimagene amiretrorepvec, RRV, retroviral replicating virusToca 511 consists of a purified retroviral replicating vector encoding a modified yeast cytosine deaminase (CD) gene. The CD gene converts the antifungal 5-flurocytosine (5FC) to the anticancer drug 5-FU in cells that have been infected by the Toca 511 vector | Biological | Experimental |
| Toca FC • Flucytosine • 5-FC • 5-FluorocytosineAlso: Extended Release 5-FC, 5-FC, 5-FluorocytosineToca FC is an extended-release formulation of flucytosine. | Drug | Experimental |
Primary outcome
Long term safety follow up
Time frame: From study entry up to 15 years
This will be based on treatment emergent adverse events, clinical laboratory values and viral testing.
1 secondary outcome
Overall survival in days from the initial Toca 511 administration on parent study to the date of death.
Time frame: From initial Toca 511 administration to death of last patient alive for up to 15 years.
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asha Das, MD study director
Tocagen Inc.
Michael Vogelbaum, MD, PhD, NS principal investigator
The Cleveland Clinic
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Toca 511 vector and Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine in people with Glioblastoma Multiforme and Astrocytoma, run by Tocagen Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term safety follow up (time frame: From study entry up to 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.