Symptoms and General Pathology

All Conditions

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Recurrence

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Glioma

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Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

All Drugs and Chemicals

Vaccines

Immunomodulating Agents

Adjuvants, Immunologic

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

Oligodendroglioma

Disease Attributes

Antineoplastic Agents

Niraparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Patients will be treated with individualized starting dose of Niraparib.

The starting dose will be 300 mg niraparib (or modified according patient weight and platelet count), taken orally once a day for each cycle of 28 days.

James Battiste, MD

The purpose of this study is to determine what effects (good and bad) niraparib has on patients with recurrent brain cancer.

Patients will have tests and exams to see if they are eligible for the clinical trial. If found eligible, the patient will receive treatment with niraparib in the form of capsules taken every day for the first 28 days. If this dose is tolerated well, the patients will continue to take the capsules and more patients will be enrolled on the study.

Patients will continue treatment with niraparib while on the study unless there is evidence of tumor growth or they experience unacceptable side effects.

Patients will be monitored during treatment with tests and exams and after treatment completion for up to four years from the time they enrolled on the study.

PARP Inhibition for Gliomas (PI-4G or π4g)

Phase II Trial of Niraparib in Patients With Recurrent Glioma

Number of patients who experience toxicities with individualized starting dose (ISD) of niraparib using CTCAE v5.0

Percentage of patients who respond to niraparib monitored by disease control rate (stable disease and better) using RANO from start of treatment for up to 12 months.

Proportion of patients who have progression-free survival from date of study entry until the first documented date of progression or date of death, whichever comes first.

Proportion of patients with overall survival on the study defined as time from date of study entry to death by any cause.

Duration of response in patients treated with niraparib defined as time from date of first response (stable disease or better) to the first date of non-response post treatment on the study.

GlaxoSmithKline

University of Oklahoma

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
PARP Inhibition for Gliomas (PI-4G or π4g)	NCT05297864	Recurrent Gliob... Recurrent Astro... Recurrent Oligo... Recurrent Gliom...	Niraparib	18 Years -	University of Oklahoma
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
PARP Inhibition for Gliomas (PI-4G or π4g)	NCT05297864	Recurrent Gliob... Recurrent Astro... Recurrent Oligo... Recurrent Gliom...	Niraparib	18 Years -	University of Oklahoma

Spots Global Cancer Trial Database for recurrent astrocytoma