Clinical trial · Interventional
Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma
NCT01081223CI-TRIAL-00066848completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| High Grade Astrocytoma | Anaplastic Astrocytoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cancer vaccine plus immune adjuvant | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TVI-Brain-1
- description
- Cancer vaccine plus immune adjuvant Biological/vaccine Other
- interventionNames
- Biological: Cancer vaccine plus immune adjuvant
Primary outcomes (2)
- measure
- Number of Participants Experiencing the Incidence of Grade One or Higher Adverse Events
- timeFrame
- 8 weeks
- 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.
- measure
- Immunogenicity as Measured by Delayed Type Hypersensitivity Reactions
- timeFrame
- 48 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDSloan 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