Trial · NCT01081223
Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma
NCT01081223, Phase 1, Phase 2, Completed, TVAX Biomedical; results first posted 2023-06-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma. Trials, record NCT01081223. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01081223
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma
- NCT number
- NCT01081223
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- TVAX Biomedical
- Conditions
- Glioma, High Grade Astrocytoma, Glioblastoma Multiforme
- Interventions
- Cancer vaccine plus immune adjuvant
- First posted
- 2010-03-05
- Last updated
- 2023-06-01
- Results first posted
- 2023-06-01
- Limitations and caveats
- small number of participants in study
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing the Incidence of Grade One or Higher Adverse Events | 8 weeks | 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. |
| Primary | Immunogenicity as Measured by Delayed Type Hypersensitivity Reactions | 48 hours | 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 | Overall Survival | 12 months | Evaluate overall survival of patients |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Experiencing the Incidence of Grade One or Higher Adverse Events | 8 weeks | Number of participants that completed treatment protocol | participants | NUMBER |
| PRIMARY | Immunogenicity as Measured by Delayed Type Hypersensitivity Reactions | 48 hours | Ten patients developed an immunological response to their tumor as indicated by the delayed type hypersensitivity immune test. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | 12 months | months | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Experiencing the Incidence of Grade One or Higher Adverse Events | TVI-Brain-1 | 12 | participants | ||
| Immunogenicity as Measured by Delayed Type Hypersensitivity Reactions | TVI-Brain-1 | 10 | Participants | ||
| Overall Survival | TVI-Brain-1 | 6.3 | Full Range 1.8 to 12.6 | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TVI-Brain-1 | 12 | |
| Overall Study | COMPLETED | TVI-Brain-1 | 12 | |
| Overall Study | NOT COMPLETED | TVI-Brain-1 | 0 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | constipation | Gastrointestinal disorders | TVI-Brain-1 | 2 | 12 | 2 |
| other | diarrhea | Gastrointestinal disorders | TVI-Brain-1 | 1 | 12 | 1 |
| other | nausea | Gastrointestinal disorders | TVI-Brain-1 | 4 | 12 | 4 |
| other | asthenia | Nervous system disorders | TVI-Brain-1 | 1 | 12 | 1 |
| other | catheter site inflammation | Skin and subcutaneous tissue disorders | TVI-Brain-1 | 1 | 12 | 1 |
| other | fatigue | Nervous system disorders | TVI-Brain-1 | 1 | 12 | 1 |
| other | gait disturbance | Nervous system disorders | TVI-Brain-1 | 1 | 12 | 1 |
| other | pyrexia | Immune system disorders | TVI-Brain-1 | 1 | 12 | 1 |
| other | sinusitis | Respiratory, thoracic and mediastinal disorders | TVI-Brain-1 | 2 | 12 | 2 |
| other | Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | TVI-Brain-1 | 1 | 12 | 1 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TVI-Brain-1 | 12 | 12 |
| Total, other adverse events | TVI-Brain-1 | 12 | 12 |
| Total, serious adverse events | TVI-Brain-1 | 12 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 16817692 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01081223
GET https://conductscience.org/api/trials/v1/NCT01081223/events?page=2