Trial Outcomes & Findings for Study To Test the Safety and Efficacy of TVI-Brain-1 As A Treatment for Recurrent Grade IV Glioma (NCT NCT01290692)

Last Updated: 2023-07-03

Results Overview

To assess the efficacy of TVI-Brain-1 on patients to evaluate progression free survival. MRI data is used to evaluate tumor progression; success is defined if a patient is still alive and has \< 25 % increase in Tumor volume in MRI collected at 6 month timepoint.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

6-months

Results posted on

2023-07-03

Participant Flow

The recruitment was prematurely closed to allow a change in protocol design based on clinical findings from the small study. The data justified change in protocol design (study #008) to treat subjects with minimal residual disease and healthy immune system.

Participant milestones

Participant milestones
Measure	TVI-Brain-1 All patients will receive the full TVI-Brain-1 treatment. TVI-Brain-1: Following surgery, tumor tissue is used to generate a cancer vaccine. Patients are vaccinated with neutralized cells to initiate an immune response. Following vaccinations, the patient's white blood cells are collected, the white blood cells are stimulated and expanded, and are then reinfused into the patient's blood.
Overall Study STARTED	14
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	TVI-Brain-1 All patients will receive the full TVI-Brain-1 treatment. TVI-Brain-1: Following surgery, tumor tissue is used to generate a cancer vaccine. Patients are vaccinated with neutralized cells to initiate an immune response. Following vaccinations, the patient's white blood cells are collected, the white blood cells are stimulated and expanded, and are then reinfused into the patient's blood.
Overall Study Lack of sufficient efficacy as patients were immunocompromised	7

Baseline Characteristics

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=14 Participants All patients will receive the full TVI-Brain-1 treatment. TVI-Brain-1: Following surgery, tumor tissue is used to generate a cancer vaccine. Patients are vaccinated with neutralized cells to initiate an immune response. Following vaccinations, the patient's white blood cells are collected, the white blood cells are stimulated and expanded, and are then reinfused into the patient's blood.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=99 Participants
Age, Categorical >=65 years	4 Participants n=99 Participants
Sex: Female, Male Female	6 Participants n=99 Participants
Sex: Female, Male Male	8 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	13 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: 6-months

Outcome measures

Outcome measures
Measure	TVI-Brain-1 n=14 Participants All patients will receive the full TVI-Brain-1 treatment. TVI-Brain-1: Following surgery, tumor tissue is used to generate a cancer vaccine. Patients are vaccinated with neutralized cells to initiate an immune response. Following vaccinations, the patient's white blood cells are collected, the white blood cells are stimulated and expanded, and are then reinfused into the patient's blood.
Progression of Disease	14 Participants

SECONDARY outcome

Timeframe: 32 months

All patients will be followed until death or the end of the study to measure overall survival.

Outcome measures

Outcome measures
Measure	TVI-Brain-1 n=14 Participants All patients will receive the full TVI-Brain-1 treatment. TVI-Brain-1: Following surgery, tumor tissue is used to generate a cancer vaccine. Patients are vaccinated with neutralized cells to initiate an immune response. Following vaccinations, the patient's white blood cells are collected, the white blood cells are stimulated and expanded, and are then reinfused into the patient's blood.
Overall Survival	0 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Toxicity was assessed throughout the study by recording clinical symptoms, physical examinations, vital signs, clinical laboratory tests, including blood counts and differentials, blood chemistries and autoimmune profiles. Patients were monitored for toxicities during the study and for one month following removal from the study for any reason.

Toxicity will be assessed throughout the study by recording clinical symptoms, performing physical examinations, measuring vital signs and performing clinical laboratory tests, including complete blood counts and differentials, blood chemistries and autoimmune profiles.

Outcome measures

Outcome measures
Measure	TVI-Brain-1 n=14 Participants All patients will receive the full TVI-Brain-1 treatment. TVI-Brain-1: Following surgery, tumor tissue is used to generate a cancer vaccine. Patients are vaccinated with neutralized cells to initiate an immune response. Following vaccinations, the patient's white blood cells are collected, the white blood cells are stimulated and expanded, and are then reinfused into the patient's blood.
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	14 Participants

SECONDARY outcome

Timeframe: 32-months

Population: MRI data not collected

Time to progression is defined date of evidence of increase in tumor volume as evaluated by review and analysis of imaging, using MacDonald Criteria in review of serial MRI's taken at specific timepoints

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 32-months

Population: MRI data not collected nor analyzed

Time to progression is defined as assessed by neurologists and radiologists evaluation of time to worsening of patient's neurological status and/or increase in tumor volume measurements as evaluated by review and analysis of serial physical exams and MRI's taken at specific timepoints

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 hours

Skin Test using attenuated autologous cancer cells will be performed to assess the immunogenicity of the Subject's cancer. Evidence of a Resulting wheal or flare reaction from sub-cutanous injection of test will be evaluated in each patient

Outcome measures

Outcome measures
Measure	TVI-Brain-1 n=14 Participants All patients will receive the full TVI-Brain-1 treatment. TVI-Brain-1: Following surgery, tumor tissue is used to generate a cancer vaccine. Patients are vaccinated with neutralized cells to initiate an immune response. Following vaccinations, the patient's white blood cells are collected, the white blood cells are stimulated and expanded, and are then reinfused into the patient's blood.
Delayed-type Hypersensitivity (DTH) Skin Testing	14 Participants

SECONDARY outcome

Timeframe: 32 months

Population: QOL tool data was not collected

Quality of life data using the FACT-Br score tabulation from responses on validated tool

Outcome measures

Outcome data not reported

Adverse Events

TVI-Brain-1

Serious events: 9 serious events

Other events: 5 other events

Deaths: 14 deaths

Serious adverse events

Serious adverse events
Measure	TVI-Brain-1 n=14 participants at risk All patients will receive the full TVI-Brain-1 treatment. TVI-Brain-1: Following surgery, tumor tissue is used to generate a cancer vaccine. Patients are vaccinated with neutralized cells to initiate an immune response. Following vaccinations, the patient's white blood cells are collected, the white blood cells are stimulated and expanded, and are then reinfused into the patient's blood.
Immune system disorders Fever and Chills	21.4% 3/14 • Number of events 3 • 32 months Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.
Renal and urinary disorders Urinary Tract Infection	7.1% 1/14 • Number of events 1 • 32 months Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.
Metabolism and nutrition disorders Hypokalemia	7.1% 1/14 • Number of events 1 • 32 months Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.
Musculoskeletal and connective tissue disorders Hemiparesis	7.1% 1/14 • Number of events 1 • 32 months Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.
Nervous system disorders Hemisensory Neglect	7.1% 1/14 • Number of events 1 • 32 months Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.
Nervous system disorders Paresthesia	7.1% 1/14 • Number of events 1 • 32 months Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.
Nervous system disorders Seizures	21.4% 3/14 • Number of events 3 • 32 months Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.
Nervous system disorders disorientation	7.1% 1/14 • Number of events 1 • 32 months Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.
Cardiac disorders Pulmonary Edema	7.1% 1/14 • Number of events 1 • 32 months Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.

Other adverse events

Other adverse events
Measure	TVI-Brain-1 n=14 participants at risk All patients will receive the full TVI-Brain-1 treatment. TVI-Brain-1: Following surgery, tumor tissue is used to generate a cancer vaccine. Patients are vaccinated with neutralized cells to initiate an immune response. Following vaccinations, the patient's white blood cells are collected, the white blood cells are stimulated and expanded, and are then reinfused into the patient's blood.
Cardiac disorders Tachycardia	7.1% 1/14 • Number of events 1 • 32 months Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.
Gastrointestinal disorders Nausea	7.1% 1/14 • Number of events 2 • 32 months Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.
General disorders Chills	14.3% 2/14 • Number of events 2 • 32 months Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.
General disorders Redness at injection sites	7.1% 1/14 • Number of events 1 • 32 months Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.
General disorders Fever	14.3% 2/14 • Number of events 5 • 32 months Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.
General disorders Generalized Aching	7.1% 1/14 • Number of events 1 • 32 months Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.
General disorders Infusion Site irritation/pain	7.1% 1/14 • Number of events 1 • 32 months Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.
General disorders Rigors	7.1% 1/14 • Number of events 1 • 32 months Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.
Investigations Calcium Low	7.1% 1/14 • Number of events 1 • 32 months Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.
Metabolism and nutrition disorders Hypocalcemia	7.1% 1/14 • Number of events 1 • 32 months Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.
Metabolism and nutrition disorders Hypokalemia	7.1% 1/14 • Number of events 2 • 32 months Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.
Metabolism and nutrition disorders Hypomagnesae	7.1% 1/14 • Number of events 2 • 32 months Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.
Gastrointestinal disorders Vomiting	7.1% 1/14 • Number of events 1 • 32 months Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.

Additional Information

Michael E. Salacz,MD and David Tran,MD, PH.D

Saint Lukes Hospital KC, Missouri and Washington University School of Medicine, St.Louis Missouri

Phone: 9134922221

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place