Trial · NCT00424554
Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed)
NCT00424554, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2011-06-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed). Trials, record NCT00424554. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00424554
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed)
- NCT number
- NCT00424554
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Glioma
- Interventions
- temozolomide
- First posted
- 2007-01-19
- Last updated
- 2017-06-07
- Results first posted
- 2011-06-29
- Limitations and caveats
- The assay developed to measure MGMT activity had high variability.~The TMZ assay was unable to detect the low levels of the drug due to the relatively low dose and short half life of TMZ.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MethylGuanine-DNA MethylTransferase [MGMT] Activity Measured From the Tumor Tissue During Surgery | 14 days | An experimental assay was developed to measure MGMT levels. |
| Secondary | Safety: Number of Participants Who Experienced Grade 3 or 4 Toxicities | 12 months | Grade 3 was defined as severe per Common Terminology Criteria for Adverse Events (CTCAE). Grade 4 was defined as life-threatening per CTCAE. |
| Secondary | Tolerability: Number of Participants Discontinuing Treatment Due to Adverse Events (AE) | 12 months | An AE was defined as any event which was adverse, including what were commonly described as adverse or undesirable experiences, adverse events, adverse reactions, side effects, or death due to any cause associated with, or observed in conjunction with the use of a drug, biological product, or device in humans, whether or not considered related to the use of that product. Additionally, any event which was associated with, or observed in conjunction with product overdose whether accidental or intentional, or product abuse and/or withdrawal was also considered an AE. |
| Secondary | Concentrations of Temozolomide in the Serum, Cerebrospinal Fluid, and Brain Tumor | 14 days | No data available: at the time of tumor collection, the temozolomide levels were below the detection limits of the assay. |
| Secondary | MGMT Activity in the Brain Tumor Tissues by Temozolomide Levels | 14 days | No data available: at the time of tumor collection, the temozolomide levels were below the detection limits of the assay. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | MethylGuanine-DNA MethylTransferase [MGMT] Activity Measured From the Tumor Tissue During Surgery | 14 days | All participants for which a MGMT activity assay could be~performed | fmol/mg of proteins | MEAN |
| SECONDARY | Safety: Number of Participants Who Experienced Grade 3 or 4 Toxicities | 12 months | participants | NUMBER | |
| SECONDARY | Tolerability: Number of Participants Discontinuing Treatment Due to Adverse Events (AE) | 12 months | participants | NUMBER | |
| SECONDARY | Concentrations of Temozolomide in the Serum, Cerebrospinal Fluid, and Brain Tumor | 14 days | |||
| SECONDARY | MGMT Activity in the Brain Tumor Tissues by Temozolomide Levels | 14 days |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| MethylGuanine-DNA MethylTransferase [MGMT] Activity Measured From the Tumor Tissue During Surgery | Temozolomide (TMZ) | 333.7 | Standard Deviation 288.5 | fmol/mg of proteins | |
| MethylGuanine-DNA MethylTransferase [MGMT] Activity Measured From the Tumor Tissue During Surgery | No Intervention | 105.1 | Standard Deviation 155 | fmol/mg of proteins | |
| Safety: Number of Participants Who Experienced Grade 3 or 4 Toxicities | Temozolomide (TMZ) | Grade 3 | 4 | participants | |
| Safety: Number of Participants Who Experienced Grade 3 or 4 Toxicities | No Intervention | Grade 3 | 0 | participants | |
| Safety: Number of Participants Who Experienced Grade 3 or 4 Toxicities | Temozolomide (TMZ) | Grade 4 | 0 | participants | |
| Safety: Number of Participants Who Experienced Grade 3 or 4 Toxicities | No Intervention | Grade 4 | 0 | participants | |
| Tolerability: Number of Participants Discontinuing Treatment Due to Adverse Events (AE) | Temozolomide (TMZ) | 0 | participants | ||
| Tolerability: Number of Participants Discontinuing Treatment Due to Adverse Events (AE) | No Intervention | 0 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Temozolomide (TMZ) | 34 | |
| Overall Study | STARTED | No Intervention | 6 | |
| Overall Study | COMPLETED | Temozolomide (TMZ) | 34 | |
| Overall Study | COMPLETED | No Intervention | 6 | |
| Overall Study | NOT COMPLETED | Temozolomide (TMZ) | 0 | |
| Overall Study | NOT COMPLETED | No Intervention | 0 |
Source ClinicalTrials.gov
Adverse events40
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 | LYMPHOPENIA | Blood and lymphatic system disorders | Temozolomide | 2 | 34 | 2 |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | No Intervention | 0 | 6 | 0 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Temozolomide | 0 | 34 | 0 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | No Intervention | 1 | 6 | 1 |
| other | DIARRHOEA | Gastrointestinal disorders | Temozolomide | 0 | 34 | 0 |
| other | DIARRHOEA | Gastrointestinal disorders | No Intervention | 1 | 6 | 1 |
| other | PAIN | General disorders | Temozolomide | 0 | 34 | 0 |
| other | PAIN | General disorders | No Intervention | 1 | 6 | 1 |
| other | URINARY TRACT INFECTION | Infections and infestations | Temozolomide | 2 | 34 | 2 |
| other | URINARY TRACT INFECTION | Infections and infestations | No Intervention | 1 | 6 | 1 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Temozolomide | ||
| Total, all-cause mortality | No Intervention | ||
| Total, other adverse events | Temozolomide | 13 | 34 |
| Total, other adverse events | No Intervention | 5 | 6 |
| Total, serious adverse events | Temozolomide | 0 | 34 |
| Total, serious adverse events | No Intervention | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|
| Temozolomide (TMZ) vs No Intervention: Tolerability: Number of Participants Discontinuing Treatment Due to Adverse Events (AE) | Trial comparisons |
| Temozolomide vs No Intervention: 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/NCT00424554
GET https://conductscience.org/api/trials/v1/NCT00424554/events?page=2