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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Grade IV Glioma, Grade IV Astrocytoma, Glioblastoma Multiforme

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Description:

To assess the efficacy of TVI-Brain-1 using progression-free survival at 6-months as a surrogate for overall survival. Determining the effect of TVI-Brain-1 on overall survival is the study's most important secondary endpoint.

Outcome Time Frame:

6-months

Safety Issue:

No

Principal Investigator

Gary Wood, Ph.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Sponsor GmbH

Authority:

United States: Food and Drug Administration

Study ID:

TVI-AST-005

NCT ID:

NCT01290692

Start Date:

June 2011

Completion Date:

February 2014

Related Keywords:

  • Grade IV Glioma
  • Grade IV Astrocytoma
  • Glioblastoma Multiforme
  • Brain Neoplasms
  • Central Nervous System Neoplasms
  • Brain Diseases
  • Neoplasms
  • Nervous System Neoplasms
  • Glioblastoma
  • Astrocytoma
  • Nervous System Diseases
  • Central Nervous System Diseases
  • Glioma
  • Recurrent astrocytoma
  • Recurrent glioma
  • Cancer vaccine
  • Immunotherapy
  • Killer T cells
  • Activated T cells
  • GM-CSF
  • Activated lymphocytes
  • Astrocytoma
  • Glioblastoma
  • Glioma

Name

Location

Baylor University Medical CenterDallas, Texas  75246
Saint Luke's HospitalChesterfield, Missouri  63017
Washington UniversitySt. Louis, Missouri  63110
Aurora BayCare Medical CenterGreen Bay, Wisconsin  54311-6519