Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TVI-Brain-1 | Experimental | Cancer vaccine plus immune adjuvant Biological/vaccine Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cancer vaccine plus immune adjuvant | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Evaluate overall survival of patients | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Salacz, M.D. | St. Luke's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16817692 | Background | 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. |
| Label | URL |
|---|---|
| Sponsor website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TVI-Brain-1 | Biological/Vaccine: Cancer vaccine plus immune adjuvant, plus activated white blood cells |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TVI-Brain-1 | Biological/Vaccine: Cancer vaccine plus immune adjuvant, plus activated white blood cells |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Number of participants that completed treatment protocol | Posted | Number | participants | 8 weeks |
|
|
12 months
Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TVI-Brain-1 | Biological/Vaccine: Cancer vaccine plus immune adjuvant, plus activated white blood cells |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| coagulopathy | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
small number of participants in study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Wood PhD | TVAX Biomedical, Inc. | 913-961-1327 | gwood@tvaxbiomedical.com |
Not provided
| ID | Term |
|---|---|
| D005910 | Glioma |
| D001254 | Astrocytoma |
| D005909 | Glioblastoma |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D009369 | Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009422 | Nervous System Diseases |
| D002493 | Central Nervous System Diseases |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D019496 | Cancer Vaccines |
| D000276 | Adjuvants, Immunologic |
| ID | Term |
|---|---|
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D007155 | Immunologic Factors |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | 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. | Ten patients developed an immunological response to their tumor as indicated by the delayed type hypersensitivity immune test. | Posted | Count of Participants | Participants | 48 hours |
|
|
|
| Secondary | Overall Survival | Evaluate overall survival of patients | Posted | Mean | Full Range | months | 12 months |
|
|
|
| 12 |
| 12 |
| 12 |
| 12 |
| 12 |
| 12 |
| psychosis postoperative | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| dehydration | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| asthenia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| haemorrhage intracranial | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| vasogenic cerebral oedema | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| glioblastoma progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| weight loss | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| hypocalcemia | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| hypokalemia | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| asthenia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| catheter site inflammation | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| fatigue | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| gait disturbance | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| pyrexia | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
|
| sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| gout | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Oliguria | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| anorexia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| hyperglycemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| hemiparesis | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| hemisensory neglect | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| somnolence | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| vasogenic cerebral edema | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| depression | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| insomnia | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
Not provided
Not provided
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D009371 | Neoplasms by Site |
| D045505 |
| Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |