Melphalan, Carboplatin, Mannitol, and Sodium Thiosulfate in Treating Patients With Recurrent or Progressive CNS Embryonal or Germ Cell Tumors
Public ClinicalTrials.gov record NCT00983398. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase I/II Study of Intra-Arterial Melphalan Given With Intra-Arterial Carboplatin, Osmotic Blood-Brain Barrier Disruption and Delayed Otoprotective Sodium Thiosulfate for Patients With Recurrent or Progressive CNS Embryonal or Germ Cell Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase I/II trial studies the side effects and best dose of melphalan when given together with carboplatin, mannitol, and sodium thiosulfate, and to see how well they work in treating patients with central nervous system (CNS) embryonal or germ cell tumors that is growing, spreading, or getting worse (progressive) or has come back (recurrent). Drugs used in chemotherapy, such as melphalan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Osmotic blood-brain barrier disruption (BBBD) uses mannitol to open the blood vessels around the brain and allow cancer-killing substances to be carried directly to the brain. Sodium thiosulfate may help lessen or prevent hearing loss and toxicities in patients undergoing chemotherapy with carboplatin and BBBD. Giving melphalan together with carboplatin, mannitol, and sodium thiosulfate may be an effective treatment for recurrent or progressive CNS embryonal or germ cell tumors.
Study identification
- NCT ID
- NCT00983398
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 17 participants
Conditions and interventions
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 Drug
- Mannitol Drug
- Melphalan Drug
- Quality-of-Life Assessment Other
- Questionnaire Administration Other
- Sodium Thiosulfate Drug
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 8, 2009
- Primary completion
- Dec 30, 2021
- Completion
- Dec 30, 2022
- Last update posted
- Oct 25, 2021
2009 – 2022
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | — |
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00983398, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 25, 2021 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00983398 live on ClinicalTrials.gov.