Study To Test the Safety and Efficacy of TVI-Brain-1 As A Treatment for Recurrent Grade IV Glioma

NCT01290692 | Completed Phase 2 Results

• 1 other identifier: TVI-AST-005
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (1)

• Progression of Disease

  To assess the efficacy of TVI-Brain-1 on patients to evaluate progression free survival. MRI data is used to evaluate tumor progression; success is defined if a patient is still alive and has \< 25 % increase in Tumor volume in MRI collected at 6 month timepoint.

  6-months

Secondary Outcomes (6)

• Overall Survival

  32 months

• Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

  12 weeks

• Time to Progression of Tumor Per MRI

  32-months

• Objective Response Rate

  32-months

• Delayed-type Hypersensitivity (DTH) Skin Testing

  48 hours

Study Arms (1)

TVI-Brain-1

EXPERIMENTAL

All patients will receive the full TVI-Brain-1 treatment.

Biological: TVI-Brain-1

Interventions

TVI-Brain-1 BIOLOGICAL

Following surgery, tumor tissue is used to generate a cancer vaccine. Patients are vaccinated with neutralized cells to initiate an immune response. Following vaccinations, the patient's white blood cells are collected, the white blood cells are stimulated and expanded, and are then reinfused into the patient's blood.

Also known as: Cancer vaccine plus immune adjuvant plus activated WBC

TVI-Brain-1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TVAX Biomedical: lead

Study Sites (4)

Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311, United States

Location

Related 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.

  PMID: 16817692 BACKGROUND

Related Links

• Sponsor website

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms; Central Nervous System Neoplasms; Brain Diseases; Neoplasms; Nervous System Neoplasms; Astrocytoma; Nervous System Diseases; Central Nervous System Diseases; Glioma

Interventions

Cancer Vaccines; Adjuvants, Immunologic

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Vaccines; Biological Products; Complex Mixtures; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Limitations and Caveats

Recruitment was stopped to allow a change in protocol design. Some positive clinical effects were observed but this study design treated Subjects whose cancers have progressed following surgery, radiotherapy, and temozolomide chemotherapy and therefore have immune systems that are too compromised to allow maximal benefit from the use of TVI-Brain-1. Study #008 is changed to treat newly diagnosed Subjects with healthy immune systems and minimal residual disease.

Results Point of Contact

• Title: Michael E. Salacz,MD and David Tran,MD, PH.D
• Organization: Saint Lukes Hospital KC, Missouri and Washington University School of Medicine, St.Louis Missouri

gwood@tvaxbiomedical.com

9134922221

Study Officials

• Gary Wood, Ph.D.

  Sponsor GmbH

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 7, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: July 3, 2023
• Results First Posted: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)