Trial · NCT00098865
Thalidomide and Temozolomide in Relapsed or Progressive CNS Disease or Neuroblastoma
NCT00098865, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2014-09-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Thalidomide and Temozolomide in Relapsed or Progressive CNS Disease or Neuroblastoma. Trials, record NCT00098865. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00098865
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Thalidomide and Temozolomide in Relapsed or Progressive CNS Disease or Neuroblastoma
- NCT number
- NCT00098865
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Central Nervous System Tumor, Pediatric, Neuroblastoma
- Interventions
- temozolomide, thalidomide
- First posted
- 2004-12-09
- Last updated
- 2014-10-07
- Results first posted
- 2014-09-25
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Therapy Completion Rate | 6 months | Feasibility in this study was defined as completion of 6 months of thalidomide with temozolomide therapy. The corresponding therapy completion rate is defined as the proportion of patients who completed 6 months of therapy. |
| Secondary | Overall Response | Assessed every 8 weeks while on treatment and every 3 months for one year off-study | Overall response is the best response during 6 months of therapy measured by radiographic response. Complete Response (CR): Disappearance of all detectable tumors by imaging, if initially positive, as well as 2 consecutively negative CSF cytologic examinations (if the initial cytology was positive). Partial Response (PR): \> 50% reduction in the sum of the products of the maximum perpendicular diameter of all measurable lesions; or 2 consecutively negative CSF cytologies and a \< 50% reduction in tumor size. Stable Disease (SD): \< 50% reduction in the sum of the products of the maximum perpendicular diameters of all measurable lesions, and persistently negative or positive CSF cytology Progressive Disease (PD): \> 25% increase in the size of any measurable lesion, the appearance of a new radiographically demonstrable lesion, or the conversion of negative CSF cytology to positive, as confirmed by at least one repeat CSF cytology |
| Secondary | Overall Survival | Assessed after treatment discontinued every 3 months up to 2 years. | Time from registration to death. Patients alive at last follow-up were censored. |
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 | Therapy Completion Rate | 6 months | The analysis dataset is comprised of all treated patients. | proportion of participants | NUMBER |
| SECONDARY | Overall Response | Assessed every 8 weeks while on treatment and every 3 months for one year off-study | participants | NUMBER | |
| SECONDARY | Overall Survival | Assessed after treatment discontinued every 3 months up to 2 years. | The analysis dataset is comprised of all treated patients. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Therapy Completion Rate | Thalidomide and Temozolomide | .40 | 90% Confidence Interval .19 to .64 | proportion of participants | |
| Overall Response | Thalidomide and Temozolomide | Partial Response | 1 | participants | |
| Overall Response | Thalidomide and Temozolomide | Stable Disease | 9 | participants | |
| Overall Response | Thalidomide and Temozolomide | Progressive Disease | 4 | participants | |
| Overall Response | Thalidomide and Temozolomide | Unevaluable | 1 | participants | |
| Overall Survival | Thalidomide and Temozolomide | 12.8 | 95% Confidence Interval 6.7 to 41.2 | 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 | Thalidomide and Temozolomide | 15 | |
| Overall Study | COMPLETED | Thalidomide and Temozolomide | 6 | |
| Overall Study | NOT COMPLETED | Thalidomide and Temozolomide | 9 |
Source ClinicalTrials.gov
Adverse events62
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 | Hemoglobin | Blood and lymphatic system disorders | Thalidomide and Temzolomide | 8 | 15 | |
| other | Cardiac-other | Cardiac disorders | Thalidomide and Temzolomide | 2 | 15 | |
| other | Hearing-other | Ear and labyrinth disorders | Thalidomide and Temzolomide | 1 | 15 | |
| other | Constipation | Gastrointestinal disorders | Thalidomide and Temzolomide | 6 | 15 | |
| other | Diarrhea w/o prior colostomy | Gastrointestinal disorders | Thalidomide and Temzolomide | 1 | 15 | |
| other | Nausea | Gastrointestinal disorders | Thalidomide and Temzolomide | 2 | 15 | |
| other | Vomiting | Gastrointestinal disorders | Thalidomide and Temzolomide | 5 | 15 | |
| other | Abdomen, pain | Gastrointestinal disorders | Thalidomide and Temzolomide | 1 | 15 | |
| other | Fatigue | General disorders | Thalidomide and Temzolomide | 8 | 15 | |
| other | Fever w/o neutropenia | General disorders | Thalidomide and Temzolomide | 3 | 15 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Thalidomide and Temzolomide | ||
| Total, other adverse events | Thalidomide and Temzolomide | 14 | 15 |
| Total, serious adverse events | Thalidomide and Temzolomide | 9 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA006516 | Dana-Farber/Harvard Cancer Center | EBERT, BENJAMIN LEVINE | DANA-FARBER CANCER INST | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT00098865
GET https://conductscience.org/api/trials/v1/NCT00098865/events?page=2