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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Glioma, High Grade Astrocytoma, Glioblastoma Multiforme

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Trial Information

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


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.


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.

- Eastern Cooperative Oncology Group (ECOG) performance status must be < 2 or 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 Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Relative toxicity

Outcome Description:

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.

Outcome Time Frame:

8 weeks

Safety Issue:

Yes

Principal Investigator

Michael Salacz, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

St Luke's Hospital

Authority:

United States: Food and Drug Administration

Study ID:

TVI-AST-002

NCT ID:

NCT01081223

Start Date:

April 2010

Completion Date:

March 2011

Related Keywords:

  • Glioma
  • High Grade 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
  • Low dose IL-2
  • Activated lymphocytes
  • Astrocytoma
  • Glioblastoma
  • Glioma

Name

Location
Saint Luke's Hospital Chesterfield, Missouri  63017