search
Back to results

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

Primary Purpose

Glioma, High Grade Astrocytoma, Glioblastoma Multiforme

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cancer vaccine plus immune adjuvant
Sponsored by
TVAX Biomedical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Saint Luke's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TVI-Brain-1

Arm Description

Cancer vaccine plus immune adjuvant Biological/vaccine Other

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Overall Survival
Evaluate overall survival of patients

Full Information

First Posted
March 3, 2010
Last Updated
May 4, 2023
Sponsor
TVAX Biomedical
search

1. Study Identification

Unique Protocol Identification Number
NCT01081223
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TVAX Biomedical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TVI-Brain-1
Arm Type
Experimental
Arm Description
Cancer vaccine plus immune adjuvant Biological/vaccine Other
Intervention Type
Biological
Intervention Name(s)
Cancer vaccine plus immune adjuvant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Experiencing the Incidence of Grade One or Higher Adverse Events
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.
Time Frame
8 weeks
Title
Immunogenicity as Measured by Delayed Type Hypersensitivity Reactions
Description
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.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Evaluate overall survival of patients
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Salacz, M.D.
Organizational Affiliation
St. Luke's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16817692
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.
Results Reference
background
Links:
URL
http://www.tvaxbiomedical.com
Description
Sponsor website

Learn more about this trial

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

We'll reach out to this number within 24 hrs