A Phase 1/2 interventional study of Cancer vaccine plus immune adjuvant in Glioma, High Grade Astrocytoma and Glioblastoma Multiforme, sponsored by TVAX Biomedical. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-01.
Sponsored by TVAX Biomedical · Phase 1/2, Interventional, and Treatment
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.
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.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 12 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →TVAX Biomedical is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cancer vaccine plus immune adjuvant Biological/vaccine Other
Biological: Cancer vaccine plus immune adjuvant
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.
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.
Time frame: 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.
Time frame: 48 hours
Overall Survival
Evaluate overall survival of patients
Time frame: 12 months
| Milestone | TVI-Brain-1 |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
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.
| participants | TVI-Brain-1 |
|---|---|
| Number of Participants Experiencing the Incidence of Grade One or Higher Adverse Events | 12 |
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.
| Participants | TVI-Brain-1 |
|---|---|
| Immunogenicity as Measured by Delayed Type Hypersensitivity Reactions | 10 |
Evaluate overall survival of patients
| months | TVI-Brain-1 |
|---|---|
| Overall Survival | 6.3 (1.8 to 12.6) |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TVI-Brain-1 | 12/12 (100%) | 12/12 (100%) | 12/12 (100%) |
| Event | TVI-Brain-1 |
|---|---|
| glioblastoma progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 12/12 |
| hypocalcemiaInvestigations | 3/12 |
| hypokalemiaInvestigations | 3/12 |
| psychosis postoperativePsychiatric disorders | 2/12 |
| astheniaNervous system disorders | 2/12 |
| coagulopathyBlood and lymphatic system disorders | 1/12 |
| dehydrationGastrointestinal disorders | 1/12 |
| haemorrhage intracranialBlood and lymphatic system disorders | 1/12 |
| vasogenic cerebral oedemaInjury, poisoning and procedural complications | 1/12 |
| weight lossInvestigations | 1/12 |
| Event | TVI-Brain-1 |
|---|---|
| hyperglycemiaMetabolism and nutrition disorders | 9/12 |
| anxietyPsychiatric disorders | 5/12 |
| nauseaGastrointestinal disorders | 4/12 |
| headacheNervous system disorders | 4/12 |
| depressionPsychiatric disorders | 3/12 |
| insomniaPsychiatric disorders | 3/12 |
| constipationGastrointestinal disorders | 2/12 |
| sinusitisRespiratory, thoracic and mediastinal disorders | 2/12 |
| diarrheaGastrointestinal disorders | 1/12 |
| astheniaNervous system disorders | 1/12 |
| Age, Categorical(Participants) | TVI-Brain-1 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 2 |
| Age, Continuous(years) | TVI-Brain-1 |
|---|---|
| Mean | 60 ± 10 |
| Sex: Female, Male(Participants) | TVI-Brain-1 |
|---|---|
| Female | 5 |
| Male | 7 |
| Region of Enrollment(participants) | TVI-Brain-1 |
|---|---|
| United States | 11 |
| Latvia | 1 |
Plan to share: No
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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TVAX Biomedical