Phase 2
Completed N=14
Study To Test the Safety and Efficacy of TVI-Brain-1 As A Treatment for Recurrent Grade IV Glioma
Brain Cancer · Grade IV Astrocytoma · Glioblastoma multiforme
Source: ClinicalTrials.gov NCT01290692 ↗
Enrolled (actual)
14
Serious AEs
64.3%
Results posted
Jun 2023
Primary outcomePrimary: Progression of Disease — 14 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression of Disease |
14 | — |
| SECONDARY Overall Survival |
— | — |
| SECONDARY Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 |
14 | — |
| SECONDARY Time to Progression of Tumor Per MRI |
— | — |
| SECONDARY Objective Response Rate |
— | — |
| SECONDARY Delayed-type Hypersensitivity (DTH) Skin Testing |
14 | — |
| SECONDARY Quality of Life as Measured by FACT-Br Tool Score |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT01290692). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.