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

Glioma Clinical Trial

Official title:

Phase I/II 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: NCT01081223
• Other study ID #: TVI-AST-002
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2010
• Est. completion date: March 2011

Study information

• Verified date: April 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• 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.

• 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.

Related Conditions & MeSH terms

• Astrocytoma
• Glioblastoma
• Glioblastoma Multiforme
• Glioma
• High Grade Astrocytoma

Intervention

Biological:
• Cancer vaccine plus immune adjuvant
Tumor tissue is used for cancer vaccine. Following vaccinations, white blood cells are collected, stimulated and expanded, and are then reinfused. The infusion is followed by a course of low-dose IL-2.

Locations

Country	Name	City	State
United States	Saint Luke's Hospital	Kansas City	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	Number of Participants Experiencing the Incidence of Grade One or Higher Adverse Events	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.	8 weeks
Primary	Immunogenicity as Measured by Delayed Type Hypersensitivity Reactions	The potency of the modified vaccination regimen will be assessed by measuring immune responses following each vaccination. The study is designed to determine whether vaccinating recurrent grade IV glioma subjects four times with attenuated cancer cells stimulates more powerful immune responses than vaccinating subjects twice. Clinical effects also will be measured to determine whether the treatment causes the cancer to regress.	48 hours
Secondary	Overall Survival	Evaluate overall survival of patients	12 months

External Links

•   Sponsor website