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

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01290692
• Other study ID #: TVI-AST-005
• Status: Completed
• Phase: Phase 2
• Start date: June 2011
• Est. completion date: February 2014

Study information

• Verified date: June 2023
• Source: TVAX Biomedical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18

• Informed consent

• Diagnosis of grade IV glioma with progression following standard treatment.

• Must be able to tolerate surgery to provide tumor tissue for vaccine.

• Must be able to produce viable vaccine from tumor tissue.

• Karnofsky Performance Status must be 70 or greater.

• Negative HIV test.

• Negative for hepatitis B and C virus.

• Respiratory reserve must be reasonable.

• Sufficient renal function.

• Satisfactory blood counts.

• Negative pregnancy test for women of childbearing potential.

Exclusion Criteria:

• Surgically removed cancer reveals that it is not grade IV glioma.

• Concomitant life-threatening disease.

• Active autoimmune disease.

• Currently receiving chemotherapy or biological therapy for the treatment of cancer.

• Currently receiving immunosuppressive drugs for any reason.

• Prior treatment with Avastin or other anti-angiogenesis treatment within 6 months.

• Prior treatment with Gliadel wafers.

• Corticosteroids beyond peri-operative period.

• Psychological, familial, sociological or geographical conditions that do not permit adequate medical follow-up and compliance with the study protocol.

Related Conditions & MeSH terms

• Astrocytoma
• Glioblastoma
• Glioblastoma Multiforme
• Glioma
• Grade IV Astrocytoma
• Grade IV Glioma

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas
United States	Aurora BayCare Medical Center	Green Bay	Wisconsin
United States	Saint Luke's Hospital	Kansas City	Missouri
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
TVAX Biomedical

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of Disease	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.	6-months
Secondary	Overall Survival	All patients will be followed until death or the end of the study to measure overall survival.	32 months
Secondary	Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	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.	12 weeks
Secondary	Time to Progression of Tumor Per MRI	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	32-months
Secondary	Objective Response Rate	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	32-months
Secondary	Delayed-type Hypersensitivity (DTH) Skin Testing	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	48 hours
Secondary	Quality of Life as Measured by FACT-Br Tool Score	Quality of life data using the FACT-Br score tabulation from responses on validated tool	32 months

External Links

•   Sponsor website