Trial · NCT00528437
Temozolomide,Thiotepa and Carboplatin With Autologous Stem Cell Rescue Followed by 13-cis-retinoic Acid in Patients With Recurrent/Refractory Malignant Brain Tumors
NCT00528437, Phase 2, Completed, NYU Langone Health; results first posted 2021-07-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Temozolomide,Thiotepa and Carboplatin With Autologous Stem Cell Rescue Followed by 13-cis-retinoic Acid in Patients With Recurrent/Refractory Malignant Brain Tumors. Trials, record NCT00528437. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00528437
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Temozolomide,Thiotepa and Carboplatin With Autologous Stem Cell Rescue Followed by 13-cis-retinoic Acid in Patients With Recurrent/Refractory Malignant Brain Tumors
- NCT number
- NCT00528437
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- NYU Langone Health
- Conditions
- Brain Tumors
- Interventions
- temozolomide, thiotepa, carboplatin, 13-cis-retinoic acid
- First posted
- 2007-09-12
- Last updated
- 2021-07-08
- Results first posted
- 2021-07-08
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival (EFS) | Day +42 | EFS will be reported in patients with recurrent or refractory medulloblastoma/ primitive neuroectodermal tumors. EFS is defined as the length of time after primary treatment for a cancer ends that the patient remains free of certain complications or events that the treatment was intended to prevent or delay. |
| Primary | Overall Survival (OS) | Day +77 | OS will be reported in patients with recurrent or refractory medulloblastoma/ primitive neuroectodermal tumors. OS is defined as the length of time from the start of treatment that patients diagnosed with disease are still alive. |
| Secondary | Toxicity of of 13-cis-retinoic Acid | One year | To report the toxicity of of 13-cis-retinoic acid following high dose temozolomide, thiotepa and carboplatin with ASCR. |
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 | Event-free Survival (EFS) | Day +42 | Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available | ||
| PRIMARY | Overall Survival (OS) | Day +77 | Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available | ||
| SECONDARY | Toxicity of of 13-cis-retinoic Acid | One year | Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Myeloablative Chemo-Temozolomide, Thiotepa, and Carboplatin. | 46 | |
| Overall Study | COMPLETED | Myeloablative Chemo-Temozolomide, Thiotepa, and Carboplatin. | 46 | |
| Overall Study | NOT COMPLETED | Myeloablative Chemo-Temozolomide, Thiotepa, and Carboplatin. | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Myeloablative Chemo-Temozolomide, Thiotepa, and Carboplatin. | 0 | 0 |
| Total, other adverse events | Myeloablative Chemo-Temozolomide, Thiotepa, and Carboplatin. | 0 | 0 |
| Total, serious adverse events | Myeloablative Chemo-Temozolomide, Thiotepa, and Carboplatin. | 0 | 0 |
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 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/NCT00528437
GET https://conductscience.org/api/trials/v1/NCT00528437/registered