Clinical trial NCT01081223: Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma
Official title: Phase I/II 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: PHASE1
PHASE2
Conditions: Glioma
High Grade 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
Low dose IL-2
Activated lymphocytes
Lead sponsor: TVAX Biomedical
Sponsor class: INDUSTRY
First posted: 2010-03-05
Enrollment: 12
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: 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.

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.
* 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.

Primary outcomes:
measure: Number of Participants Experiencing the Incidence of Grade One or Higher Adverse Events
timeFrame: 8 weeks
measure: Immunogenicity as Measured by Delayed Type Hypersensitivity Reactions
timeFrame: 48 hours
Secondary outcomes:
measure: Overall Survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Missouri
Study officials:
affiliation: St. Luke's Hospital
name: Michael Salacz, M.D.
role: PRINCIPAL_INVESTIGATOR
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.