Clinical trial NCT01290692: Study To Test the Safety and Efficacy of TVI-Brain-1 As A Treatment for Recurrent Grade IV Glioma
Official title: Phase 2 Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Grade IV Glioma
Grade IV Astrocytoma
Glioblastoma Multiforme
Keywords: 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
Lead sponsor: TVAX Biomedical
Sponsor class: INDUSTRY
First posted: 2011-02-07
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression of Disease
timeFrame: 6-months
Secondary outcomes:
measure: Overall Survival
timeFrame: 32 months
measure: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
timeFrame: 12 weeks
measure: Time to Progression of Tumor Per MRI
timeFrame: 32-months
measure: Objective Response Rate
timeFrame: 32-months
measure: Delayed-type Hypersensitivity (DTH) Skin Testing
timeFrame: 48 hours
measure: Quality of Life as Measured by FACT-Br Tool Score
timeFrame: 32 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
Study officials:
affiliation: Sponsor GmbH
name: Gary Wood, Ph.D.
role: STUDY_CHAIR
References:
citation: 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.