Trial · NCT00108069
Tamoxifen and Bortezomib to Treat Recurrent Brain Tumors
NCT00108069, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-06-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tamoxifen and Bortezomib to Treat Recurrent Brain Tumors. Trials, record NCT00108069. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00108069
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tamoxifen and Bortezomib to Treat Recurrent Brain Tumors
- NCT number
- NCT00108069
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Glioma
- Interventions
- Tamoxifen citrate, Bortezomib
- First posted
- 2005-04-13
- Last updated
- 2015-11-05
- Results first posted
- 2014-06-12
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response, Defined as Stable Disease or Objective (Partial or Complete) Response. | Patients were followed for an average of six weeks for assessment of response | Complete response (CR) is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. All measurable, evaluable and non-evaluable lesions and site must be assessed using the same techniques as baseline. Patients who respond must be on the same or decreasing doses of dexamethasone. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable disease. No new lesions. All measurable and evaluable lesions and sites must be assessed using same techniques as baseline. Responders must be on the same decreasing doses of dexamethasone. Stable disease (SD) does not qualify for CR, PR, or progression (e.g., a 25% increase in the sum of products of all measurable lesions). The designation of stable/no response requires a minimum of 6 weeks duration. All measurable and evaluable sites must be assessed using the same techniques as baseline. |
| Secondary | Number of Participants With Adverse Events | 7.5 years | Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. |
| Secondary | Adverse Event Grades | 7.5 years | The combined serious and non-serious adverse event Table describes count of patients whose highest grade adverse event for any CTC (common terminology criteria) term was related to study drugs for the GBM (Glioblastoma multiforme) and AG (Anaplastic glioma) cohorts. |
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 | Response, Defined as Stable Disease or Objective (Partial or Complete) Response. | Patients were followed for an average of six weeks for assessment of response | Two patients were not able to complete follow-up neuroimaging to assess response due to clinical progression of disease. | Participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events | 7.5 years | Participants | NUMBER | |
| SECONDARY | Adverse Event Grades | 7.5 years | Neither cohort completed planned accrual and are small in number separately. Additionally, the underlying histological grade would not affect toxicity. Therefore, these cohorts may be combined. The Table describes count of patients whose highest grade adverse event for any CTC (common terminology criteria) term was related to study drugs. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group202
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response, Defined as Stable Disease or Objective (Partial or Complete) Response. | GBM (Glioblastoma Multiforme) | Complete response | 0 | Participants | |
| Response, Defined as Stable Disease or Objective (Partial or Complete) Response. | AG (Anaplastic Glioma) | Complete response | 0 | Participants | |
| Response, Defined as Stable Disease or Objective (Partial or Complete) Response. | GBM (Glioblastoma Multiforme) | Partial response | 0 | Participants | |
| Response, Defined as Stable Disease or Objective (Partial or Complete) Response. | AG (Anaplastic Glioma) | Partial response | 0 | Participants | |
| Response, Defined as Stable Disease or Objective (Partial or Complete) Response. | GBM (Glioblastoma Multiforme) | Stable disease | 1 | Participants | |
| Response, Defined as Stable Disease or Objective (Partial or Complete) Response. | AG (Anaplastic Glioma) | Stable disease | 0 | Participants | |
| Response, Defined as Stable Disease or Objective (Partial or Complete) Response. | GBM (Glioblastoma Multiforme) | Progressive disease | 27 | Participants | |
| Response, Defined as Stable Disease or Objective (Partial or Complete) Response. | AG (Anaplastic Glioma) | Progressive disease | 12 | Participants | |
| Number of Participants With Adverse Events | GBM (Glioblastoma Multiforme) | 30 | Participants | ||
| Number of Participants With Adverse Events | AG (Anaplastic Glioma) | 12 | Participants |
1 to 10 of 202Source ClinicalTrials.gov
See all 202 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GBM (Glioblastoma Multiforme) | 30 | |
| Overall Study | STARTED | AG (Anaplastic Glioma) | 13 | |
| Overall Study | COMPLETED | GBM (Glioblastoma Multiforme) | 0 | |
| Overall Study | COMPLETED | AG (Anaplastic Glioma) | 0 | |
| Overall Study | NOT COMPLETED | GBM (Glioblastoma Multiforme) | 30 | |
| Overall Study | NOT COMPLETED | AG (Anaplastic Glioma) | 13 |
Source ClinicalTrials.gov
Adverse events152
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 | Death not associated with CTCAE term: Disease progression NOS | General disorders | GBM (Glioblastoma Multiforme) | 1 | 30 | 1 |
| other | Death not associated with CTCAE term: Disease progression NOS | General disorders | AG (Anaplastic Glioma) | 0 | 12 | 0 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | GBM (Glioblastoma Multiforme) | 7 | 30 | 7 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | AG (Anaplastic Glioma) | 3 | 12 | 3 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | GBM (Glioblastoma Multiforme) | 4 | 30 | 4 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | AG (Anaplastic Glioma) | 1 | 12 | 1 |
| other | Anorexia | Gastrointestinal disorders | GBM (Glioblastoma Multiforme) | 1 | 30 | 1 |
| other | Anorexia | Gastrointestinal disorders | AG (Anaplastic Glioma) | 0 | 12 | 0 |
| other | Ataxia | Nervous system disorders | GBM (Glioblastoma Multiforme) | 1 | 30 | 1 |
| other | Ataxia | Nervous system disorders | AG (Anaplastic Glioma) | 0 | 12 | 0 |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GBM (Glioblastoma Multiforme) | ||
| Total, all-cause mortality | AG (Anaplastic Glioma) | ||
| Total, other adverse events | GBM (Glioblastoma Multiforme) | 26 | 30 |
| Total, other adverse events | AG (Anaplastic Glioma) | 10 | 12 |
| Total, serious adverse events | GBM (Glioblastoma Multiforme) | 11 | 30 |
| Total, serious adverse events | AG (Anaplastic Glioma) | 3 | 12 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GBM (Glioblastoma Multiforme) vs AG (Anaplastic Glioma): Number of Participants With Adverse Events | Trial comparisons |
| GBM (Glioblastoma Multiforme) vs AG (Anaplastic Glioma): serious adverse events | Trial comparisons |
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/NCT00108069
GET https://conductscience.org/api/trials/v1/NCT00108069/results?page=2