Trial Outcomes & Findings for Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma (NCT NCT01081223)

Last Updated: 2023-06-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

8 weeks

Results posted on

2023-06-01

Participant Flow

Participant milestones

Participant milestones
Measure	TVI-Brain-1 Biological/Vaccine: Cancer vaccine plus immune adjuvant, plus activated white blood cells
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TVI-Brain-1 n=12 Participants Biological/Vaccine: Cancer vaccine plus immune adjuvant, plus activated white blood cells
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	60 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants
Region of Enrollment Latvia	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Number of participants that completed treatment protocol

Outcome measures

Outcome measures
Measure	TVI-Brain-1 n=12 Participants Biological/Vaccine: Cancer vaccine plus immune adjuvant, plus activated white blood cells
Number of Participants Experiencing the Incidence of Grade One or Higher Adverse Events	12 participants

PRIMARY outcome

Timeframe: 48 hours

Population: Ten patients developed an immunological response to their tumor as indicated by the delayed type hypersensitivity immune test.

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.

Outcome measures

Outcome measures
Measure	TVI-Brain-1 n=12 Participants Biological/Vaccine: Cancer vaccine plus immune adjuvant, plus activated white blood cells
Immunogenicity as Measured by Delayed Type Hypersensitivity Reactions	10 Participants

SECONDARY outcome

Timeframe: 12 months

Evaluate overall survival of patients

Outcome measures

Outcome measures
Measure	TVI-Brain-1 n=12 Participants Biological/Vaccine: Cancer vaccine plus immune adjuvant, plus activated white blood cells
Overall Survival	6.3 months Interval 1.8 to 12.6

Adverse Events

TVI-Brain-1

Serious events: 12 serious events

Other events: 12 other events

Deaths: 12 deaths

Serious adverse events

Serious adverse events
Measure	TVI-Brain-1 n=12 participants at risk Biological/Vaccine: Cancer vaccine plus immune adjuvant, plus activated white blood cells
Blood and lymphatic system disorders coagulopathy	8.3% 1/12 • Number of events 1 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Psychiatric disorders psychosis postoperative	16.7% 2/12 • Number of events 2 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Gastrointestinal disorders dehydration	8.3% 1/12 • Number of events 1 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Nervous system disorders asthenia	16.7% 2/12 • Number of events 2 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Blood and lymphatic system disorders haemorrhage intracranial	8.3% 1/12 • Number of events 1 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Injury, poisoning and procedural complications vasogenic cerebral oedema	8.3% 1/12 • Number of events 1 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Neoplasms benign, malignant and unspecified (incl cysts and polyps) glioblastoma progression	100.0% 12/12 • Number of events 12 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Investigations weight loss	8.3% 1/12 • Number of events 1 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Investigations hypocalcemia	25.0% 3/12 • Number of events 3 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Investigations hypokalemia	25.0% 3/12 • Number of events 3 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Psychiatric disorders anxiety	8.3% 1/12 • Number of events 1 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Neoplasms benign, malignant and unspecified (incl cysts and polyps) cyst	8.3% 1/12 • Number of events 1 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit

Other adverse events

Other adverse events
Measure	TVI-Brain-1 n=12 participants at risk Biological/Vaccine: Cancer vaccine plus immune adjuvant, plus activated white blood cells
Gastrointestinal disorders constipation	16.7% 2/12 • Number of events 2 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Gastrointestinal disorders diarrhea	8.3% 1/12 • Number of events 1 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Gastrointestinal disorders nausea	33.3% 4/12 • Number of events 4 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Nervous system disorders asthenia	8.3% 1/12 • Number of events 1 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Skin and subcutaneous tissue disorders catheter site inflammation	8.3% 1/12 • Number of events 1 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Nervous system disorders fatigue	8.3% 1/12 • Number of events 1 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Nervous system disorders gait disturbance	8.3% 1/12 • Number of events 1 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Immune system disorders pyrexia	8.3% 1/12 • Number of events 1 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Respiratory, thoracic and mediastinal disorders sinusitis	16.7% 2/12 • Number of events 2 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	8.3% 1/12 • Number of events 1 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Metabolism and nutrition disorders gout	8.3% 1/12 • Number of events 1 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Renal and urinary disorders Oliguria	8.3% 1/12 • Number of events 1 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Gastrointestinal disorders anorexia	8.3% 1/12 • Number of events 1 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Metabolism and nutrition disorders hyperglycemia	75.0% 9/12 • Number of events 9 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Nervous system disorders headache	33.3% 4/12 • Number of events 4 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Nervous system disorders hemiparesis	8.3% 1/12 • Number of events 1 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Nervous system disorders hemisensory neglect	8.3% 1/12 • Number of events 1 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Nervous system disorders somnolence	8.3% 1/12 • Number of events 1 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Nervous system disorders vasogenic cerebral edema	8.3% 1/12 • Number of events 1 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Psychiatric disorders anxiety	41.7% 5/12 • Number of events 5 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Psychiatric disorders depression	25.0% 3/12 • Number of events 3 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit
Psychiatric disorders insomnia	25.0% 3/12 • Number of events 3 • 12 months Systematic assessments by questionnaires and completion of CRF at each scheduled visit

Additional Information

Gary Wood PhD

TVAX Biomedical, Inc.

Phone: 913-961-1327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place