Trial · NCT01105702
Temodar (Temozolomide), Bevacizumab, Lithium and Radiation for High Grade Glioma
NCT01105702, Phase 2, Terminated, NYU Langone Health; results first posted 2015-11-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Temodar (Temozolomide), Bevacizumab, Lithium and Radiation for High Grade Glioma. Trials, record NCT01105702. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01105702
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Temodar (Temozolomide), Bevacizumab, Lithium and Radiation for High Grade Glioma
- NCT number
- NCT01105702
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- NYU Langone Health
- Conditions
- Brain Cancer
- Interventions
- Temozolomide, Bevacizumab, Lithium Carbonate, Radiation
- First posted
- 2010-04-16
- Last updated
- 2016-08-04
- Results first posted
- 2015-11-06
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Progression-Free Survival (PFS) | Up to 50 months | PFS defined as time from date of diagnosis to most recent follow up, disease progression, or death. Disease progress defined as either clinical deterioration or radiographic progressive disease on magnetic resonance imaging (MRI) per updated response assessment in neuro-oncology criteria (Wen, et al). |
| Secondary | Median Overall Survival (OS) | Up to 50 months | OS defined as time from diagnosis to most recent follow up or death. |
| Secondary | Number of Patients With Grade 3 or 4 Adverse Events | The whole time while on treatment and 30 days after the treatment | Adverse events evaluated per CTCAE 3 |
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 | Median Progression-Free Survival (PFS) | Up to 50 months | Intent-to-treat population | months | MEDIAN |
| SECONDARY | Median Overall Survival (OS) | Up to 50 months | intent-to-treat population | months | MEDIAN |
| SECONDARY | Number of Patients With Grade 3 or 4 Adverse Events | The whole time while on treatment and 30 days after the treatment | all the patients with treatment | participants | NUMBER |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Progression-Free Survival (PFS) | TBL/RT | 9.4 | 95% Confidence Interval 6.1 to 12.4 | months | |
| Median Overall Survival (OS) | TBL/RT | 18.5 | 95% Confidence Interval 14.7 to 20.8 | months | |
| Number of Patients With Grade 3 or 4 Adverse Events | Grade 3 | Dermatitis | 1 | participants | |
| Number of Patients With Grade 3 or 4 Adverse Events | Grade 4 | Dermatitis | 0 | participants | |
| Number of Patients With Grade 3 or 4 Adverse Events | Grade 3 | DVT | 1 | participants | |
| Number of Patients With Grade 3 or 4 Adverse Events | Grade 4 | DVT | 0 | participants | |
| Number of Patients With Grade 3 or 4 Adverse Events | Grade 3 | Neurologic | 3 | participants | |
| Number of Patients With Grade 3 or 4 Adverse Events | Grade 4 | Neurologic | 0 | participants | |
| Number of Patients With Grade 3 or 4 Adverse Events | Grade 3 | Pneumonia | 1 | participants | |
| Number of Patients With Grade 3 or 4 Adverse Events | Grade 4 | Pneumonia | 0 | participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TBL/RT | 28 | |
| Overall Study | COMPLETED | TBL/RT | 10 | |
| Overall Study | NOT COMPLETED | TBL/RT | 18 |
Source ClinicalTrials.gov
Adverse events84
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 | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip): | Respiratory, thoracic and mediastinal disorders | TBL/RT | 1 | 28 | |
| other | Anorexia | Gastrointestinal disorders | TBL/RT | 9 | 28 | |
| other | Ataxia (incoordination) | Nervous system disorders | TBL/RT | 1 | 28 | |
| other | Auditory/Ear - Other (Specify, __): flud in right ear | Ear and labyrinth disorders | TBL/RT | 1 | 28 | |
| other | Calcium, serum-high (hypercalcemia) | Metabolism and nutrition disorders | TBL/RT | 1 | 28 | |
| other | Cholesterol, serum-high (hypercholestremia) | Metabolism and nutrition disorders | TBL/RT | 1 | 28 | |
| other | Confusion | Nervous system disorders | TBL/RT | 1 | 28 | |
| other | Constipation | Gastrointestinal disorders | TBL/RT | 9 | 28 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | TBL/RT | 3 | 28 | |
| other | Dental: periodontal disease | Gastrointestinal disorders | TBL/RT | 1 | 28 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TBL/RT | ||
| Total, other adverse events | TBL/RT | 26 | 28 |
| Total, serious adverse events | TBL/RT | 7 | 28 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20231676 | 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/NCT01105702
GET https://conductscience.org/api/trials/v1/NCT01105702/results?page=2