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Vaccines

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Immunologic Factors

All patients will receive the full TVI-Brain-1 treatment.

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.

TVI-Brain-1

Gary Wood, Ph.D.

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.

The TVI-Brain-1 treatment involves several steps. First, the patient's cancer will be surgically removed to provide cells for the vaccine. Second, the patient will be vaccinated with the vaccine formulation. Third, the patient's blood will be filtered for killer T cell precursors which will then be cultured and stimulated to reach a higher (killer) activity level. Fourth, the activated cells will be infused into the patient's bloodstream so that they will be able to attack the cancer.

Study To Test the Safety and Efficacy of TVI-Brain-1 As A Treatment for Recurrent Grade IV Glioma

Phase 2 Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma

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.

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

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.

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

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

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

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

TVAX Biomedical

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.

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

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Recruitment was stopped to allow a change in protocol design. Some positive clinical effects were observed but this study design treated Subjects whose cancers have progressed following surgery, radiotherapy, and temozolomide chemotherapy and therefore have immune systems that are too compromised to allow maximal benefit from the use of TVI-Brain-1. Study #008 is changed to treat newly diagnosed Subjects with healthy immune systems and minimal residual disease.

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

Progression of Disease

Overall Survival

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.

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

Time to Progression of Tumor Per MRI

Objective Response Rate

Delayed-type Hypersensitivity (DTH) Skin Testing

Quality of Life as Measured by FACT-Br Tool Score

Overall Study

Anaplastic Astrocytoma

Cancer vaccine plus immune adjuvant Biological/vaccine Other

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.

Cancer vaccine plus immune adjuvant

Michael Salacz, M.D.

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.

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

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.

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.

Systematic assessments by questionnaires and completion of CRF at each scheduled visit

Biological/Vaccine: Cancer vaccine plus immune adjuvant, plus activated white blood cells

Age, Continuous

United States

Latvia

Region of Enrollment

Gary Wood PhD

Number of participants that completed treatment protocol

Number of Participants Experiencing the Incidence of Grade One or Higher Adverse Events

Cancer vaccine plus immune adjuvant Biological/vaccine Other

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study To Test the Safety and Efficacy of TVI-Brain-1 As A Treatment for Recurrent Grade IV Glioma	NCT01290692	Grade IV Glioma Grade IV Astroc... Glioblastoma Mu...	TVI-Brain-1	18 Years -	TVAX Biomedical
Study To Test the Safety and Efficacy of TVI-Brain-1 As A Treatment for Recurrent Grade IV Glioma	NCT01290692	Grade IV Glioma Grade IV Astroc... Glioblastoma Mu...	TVI-Brain-1	18 Years -	TVAX Biomedical
Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma	NCT01081223	Glioma High Grade Astr... Glioblastoma Mu...	Cancer vaccine ...	18 Years -	TVAX Biomedical

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