GliomaPhase 1/2NCT01081223
Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma
A Phase 1/2 study testing Cancer vaccine plus immune adjuvant in people with Glioma and High Grade Astrocytoma, run by TVAX Biomedical at 1 site in United States.
Trial summary
TVI-Brain-1 is an experimental treatment that takes advantage of the fact that your body can produce immune cells, called 'killer' white blood cells that have the ability to kill large numbers of the cancer cells that are present in your body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, High Grade Astrocytoma, Glioblastoma Multiforme
- What is being tested?
- Cancer vaccine plus immune adjuvant
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Mar 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age > 18
- Informed consent
- Diagnosis of grade IV glioma with progression following standard treatment.
- Must be able to tolerate surgery to provide tumor tissue for vaccine.
- Must be able to produce viable vaccine from tumor tissue.
- Eastern Cooperative Oncology Group (ECOG) performance status must be < 2 or Karnofsky Performance Status must be 70 or greater.
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- Negative HIV test.
- Negative for hepatitis B and C virus.
- Respiratory reserve must be reasonable.
- Sufficient renal function.
- Satisfactory blood counts.
- Negative pregnancy test for women of childbearing potential.
Who cannot join
- Surgically removed cancer reveals that it is not grade IV glioma.
- Concomitant life-threatening disease.
- Active autoimmune disease.
- Currently receiving chemotherapy or biological therapy for the treatment of cancer.
- Currently receiving immunosuppressive drugs for any reason.
- Prior treatment with Avastin or other anti-angiogenesis treatment within 6 months.
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- Prior treatment with Gliadel wafers.
- Corticosteroids beyond peri-operative period.
- Psychological, familial, sociological or geographical conditions that do not permit adequate medical follow-up and compliance with the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
TVI-Brain-1 is an experimental treatment that takes advantage of the fact that your body can produce immune cells, called 'killer' white blood cells that have the ability to kill large numbers of the cancer cells that are present in your body. TVI-Brain-1 is designed to generate large numbers of those 'killer' white blood cells and to deliver those cells into your body so that they can kill your cancer cells.
Read the detailed description
TVI-Brain-1 involves several steps. First, the patient's cancer will be surgically removed to provide cells for the vaccine. Second, the patient will be vaccinated twice with those cells and GM-CSF. Third, the patient's blood will be filtered for white cells which will then be cultured and stimulated to reach a higher (killer) activity level. Fourth, the activated white blood cells will be infused into the patient's bloodstream so that they will be able to attack the cancer. Finally, the entire process starting with vaccination will be repeated, for a total of two rounds of therapy.
- Conditions
- Glioma, High Grade Astrocytoma, Glioblastoma Multiforme
- Being tested
- Cancer vaccine plus immune adjuvant
- Keywords
- Brain Neoplasms, Central Nervous System Neoplasms, Brain Diseases, Neoplasms, Nervous System Neoplasms, Glioblastoma, Astrocytoma, Nervous System Diseases, Central Nervous System Diseases, Glioma, Recurrent astrocytoma, Recurrent glioma, Cancer vaccine, Immunotherapy, Killer T cells, Activated T cells, GM-CSF, Low dose IL-2, Activated lymphocytes
- Medical subject headings
- Glioma, Astrocytoma, Glioblastoma, Brain Neoplasms, Central Nervous System Neoplasms, Brain Diseases, Neoplasms, Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer vaccine plus immune adjuvantBiological
Tumor tissue is used for cancer vaccine. Following vaccinations, white blood cells are collected, stimulated and expanded, and are then reinfused. The infusion is followed by a course of low-dose IL-2.
| Study group | Role | What they receive |
|---|---|---|
| TVI-Brain-1 | Experimental | Cancer vaccine plus immune adjuvant Biological/vaccine Other Receives: Biological: Cancer vaccine plus immune adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing the Incidence of Grade One or Higher Adverse Events
To determine the relative toxicity (safety) of vaccinating recurrent grade IV glioma patients four times with live, attenuated cancer cells combined with granulocyte-macrophage colony-stimulating factor (GM-CSF). Toxicity will be assessed following delivery of each treatment component.
Measured: 8 weeks
Immunogenicity as Measured by Delayed Type Hypersensitivity Reactions
The potency of the modified vaccination regimen will be assessed by measuring immune responses following each vaccination. The study is designed to determine whether vaccinating recurrent grade IV glioma subjects four times with attenuated cancer cells stimulates more powerful immune responses than vaccinating subjects twice. Clinical effects also will be measured to determine whether the treatment causes the cancer to regress.
Measured: 48 hours
Secondary outcomes (1)
Overall Survival
Evaluate overall survival of patients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- TVAX Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Salacz, M.D., Principal investigator, St. Luke's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081223
- Sponsor's protocol ID
- TVI-AST-002
- Status last verified
- Apr 2023
- First submitted
- 3 Mar 2010
- Last updated
- 1 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sloan AE, Dansey R, Zamorano L, Barger G, Hamm C, Diaz F, Baynes R, Wood G. Adoptive immunotherapy in patients with recurrent malignant glioma: preliminary results of using autologous whole-tumor vaccine plus granulocyte-macrophage colony-stimulating factor and adoptive transfer of anti-CD3-activated lymphocytes. Neurosurg Focus. 2000 Dec 15;9(6):e9. doi: 10.3171/foc.2000.9.6.10.
PubMed 16817692
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma
- ClinicalTrials.gov ID
- NCT01081223
- Acronym / sponsor ID
- TVI-AST-002
- Conditions
- Glioma, High Grade Astrocytoma, Glioblastoma Multiforme
- Keywords
- Brain Neoplasms, Central Nervous System Neoplasms, Brain Diseases, Neoplasms, Nervous System Neoplasms, Glioblastoma, Astrocytoma, Nervous System Diseases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- TVAX BiomedicalIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 5 Mar 2010 (estimated)
- Results
- Posted 1 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TVI-Brain-1 is an experimental treatment that takes advantage of the fact that your body can produce immune cells, called 'killer' white blood cells that have the ability to kill large numbers of the cancer cells that are present in your body. TVI-Brain-1 is designed to generate large numbers of those 'killer' white blood cells and to deliver those cells into your body so that they can kill your cancer cells.
Detailed description
TVI-Brain-1 involves several steps. First, the patient's cancer will be surgically removed to provide cells for the vaccine. Second, the patient will be vaccinated twice with those cells and GM-CSF. Third, the patient's blood will be filtered for white cells which will then be cultured and stimulated to reach a higher (killer) activity level. Fourth, the activated white blood cells will be infused into the patient's bloodstream so that they will be able to attack the cancer. Finally, the entire process starting with vaccination will be repeated, for a total of two rounds of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TVI-Brain-1 | Experimental | Biological: Cancer vaccine plus immune adjuvantCancer vaccine plus immune adjuvant Biological/vaccine Other |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age > 18
- Informed consent
- Diagnosis of grade IV glioma with progression following standard treatment.
- Must be able to tolerate surgery to provide tumor tissue for vaccine.
- Must be able to produce viable vaccine from tumor tissue.
Key exclusion criteria (9 listed)
- Surgically removed cancer reveals that it is not grade IV glioma.
- Concomitant life-threatening disease.
- Active autoimmune disease.
- Currently receiving chemotherapy or biological therapy for the treatment of cancer.
- Currently receiving immunosuppressive drugs for any reason.
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 |
|---|---|---|
| Cancer vaccine plus immune adjuvantTumor tissue is used for cancer vaccine. Following vaccinations, white blood cells are collected, stimulated and expanded, and are then reinfused. The infusion is followed by a course of low-dose IL-2. | Biological | TVI-Brain-1 |
Primary outcome
Number of Participants Experiencing the Incidence of Grade One or Higher Adverse Events
Time frame: 8 weeks
To determine the relative toxicity (safety) of vaccinating recurrent grade IV glioma patients four times with live, attenuated cancer cells combined with granulocyte-macrophage colony-stimulating factor (GM-CSF). Toxicity will be assessed following delivery of each treatment component.
Immunogenicity as Measured by Delayed Type Hypersensitivity Reactions
Time frame: 48 hours
The potency of the modified vaccination regimen will be assessed by measuring immune responses following each vaccination. The study is designed to determine whether vaccinating recurrent grade IV glioma subjects four times with attenuated cancer cells stimulates more powerful immune responses than vaccinating subjects twice. Clinical effects also will be measured to determine whether the treatment causes the cancer to regress.
1 secondary outcome
Overall Survival
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16817692Sloan AE, Dansey R, Zamorano L, Barger G, Hamm C, Diaz F, Baynes R, Wood G. Adoptive immunotherapy in patients with recurrent malignant glioma: preliminary results of using autologous whole-tumor vaccine plus granulocyte-macrophage colony-stimulating factor and adoptive transfer of anti-CD3-activated lymphocytes. Neurosurg Focus. 2000 Dec 15;9(6):e9. doi: 10.3171/foc.2000.9.6.10.
- Sponsor websiteLink provided by the sponsor.
- 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.
Michael Salacz, M.D. principal investigator
St. Luke's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cancer vaccine plus immune adjuvant in people with Glioma and High Grade Astrocytoma, run by TVAX Biomedical at 1 site 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 12 inclusion and 9 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: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Experiencing the Incidence of Grade One or Higher Adverse Events (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01081223, which also lists 1 linked publication.
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 1 Jun 2023.