Trial · NCT00983398
Melphalan, Carboplatin, Mannitol, and Sodium Thiosulfate in Treating Patients With Recurrent or Progressive CNS Embryonal or Germ Cell Tumors
NCT00983398, Phase 1, Phase 2, Unknown, OHSU Knight Cancer Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Melphalan, Carboplatin, Mannitol, and Sodium Thiosulfate in Treating Patients With Recurrent or Progressive CNS Embryonal or Germ Cell Tumors. Trials, record NCT00983398. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00983398
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Melphalan, Carboplatin, Mannitol, and Sodium Thiosulfate in Treating Patients With Recurrent or Progressive CNS Embryonal or Germ Cell Tumors
- NCT number
- NCT00983398
- Status
- Unknown
- Phases
- Phase 1, Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- OHSU Knight Cancer Institute
- Conditions
Central Nervous System Embryonal Neoplasm, Embryonal Tumor With Multilayered Rosettes, C19MC-Altered, Germ Cell Tumor, Medulloblastoma, Medulloepithelioma, Primitive Neuroectodermal Tumor, Recurrent Childhood Central Nervous System Embryonal Neoplasm, Recurrent Malignant Germ Cell Tumor, Recurrent Medulloblastoma, Recurrent Primitive Neuroectodermal Tumor
- Interventions
- Carboplatin, Mannitol, Melphalan, Quality-of-Life Assessment, Questionnaire Administration, Sodium Thiosulfate
- First posted
- 2009-09-24
- Last updated
- 2021-10-26
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (Phase I) | 6 weeks | Will be assessed based on the incidence of dose-limiting toxicity, graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. All toxicities will be tabulated by event and by overall. The toxicities will also be tabulated by highest grade. The recovery from toxicities (i.e. hematologic toxicities) will also be summarized. |
| Primary | Response rate (Phase II) | Up to 5 years | Descriptive statistics will be estimated. |
| Secondary | Progression free survival rate (Phase II) | Time from first study treatment to evidence of first progression, assessed at 2 years | Estimation made using Kaplan-Meier product limit estimation. A Cox proportional hazards regression model will be fit to the data to estimate the association of progression free survival and overall survival with baseline demographic and disease characteristics. |
| Secondary | Overall survival rate (Phase II) | Time from time of first study treatment until death, assessed at 2 years | Estimation made using Kaplan-Meier product limit estimation. A Cox proportional hazards regression model will be fit to the data to estimate the association of progression free survival and overall survival with baseline demographic and disease characteristics. |
| Secondary | Change in neurocognitive assessment scores (Phase II) | Baseline to 90 days after completion of study treatment | Quantitative scores, whenever possible, will be derived from each measure and converted to measure-specific Z scores using normative data. Post-treatment Z scores will be subtracted from pre-treatment Z scores to calculate absolute change in neuropsychological test performance. Significant change will be defined as change of 1 standard deviation. These data will be summarized descriptively. |
| Secondary | Proportion of patients with ototoxicity (Phase II) | Up to 30 days after completion of study treatment | Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Estimated using proportions with associated confidence intervals. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| P30CA069533 | OHSU Knight Cancer Institute | KUMMAR, SHIVAANI | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1997 to 2025 | NIH RePORTER |
| R01NS044687 | Opening of the blood-brain barrier to antitumor agents | NEUWELT, EDWARD A. | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2010 to 2014 | 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/NCT00983398
GET https://conductscience.org/api/trials/v1/NCT00983398/registered