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Satraplatin in Children and Young Adults With Refractory Solid Tumors Including Brain Tumors
NCT01259479 · View on ClinicalTrials.gov ↗
Study Summary
Background: * Cisplatin and carboplatin are standard cancer treatment drugs used for various childhood cancers, including brain tumors. Both drugs frequently have severe side effects that may reduce their effectiveness, particularly in children, and new treatments are needed that may be similarly effective but less toxic for cancer patients. * Satraplatin is an experimental drug, similar to cisplatin and carboplatin, that has not yet been approved by the Food and Drug Administration. Satraplatin has been shown to treat cancer by interfering with genetic material (DNA) in cancer cells. Some adults with cancer who have received satraplatin had slowing of the growth or shrinkage of their tumor. Researchers are interested in determining whether satraplatin can be effective for cancers that occur in children. Objectives: * To evaluate the safety and effectiveness of satraplatin as a treatment for children and young adults who have solid tumors that have not responded to standard treatment. * To study the effects of satraplatin on the body in terms of side effects and blood chemistry. * To examine the effect that genetic variations may have on the effectiveness of satraplatin. Eligibility: \- Children, adolescents, and young adults between 3 and 21 years of age who have solid tumors (including brain tumors) that have not responded to standard treatment. Design: * Participants will be screened with a full physical examination and medical history, blood tests, and tumor imaging studies. * Participants will receive satraplatin pills to be taken every day in the morning for 5 consecutive days, with no food for 2 hours before or 1 hour after the dose. Participants will then have 23 days without the drug to complete a 28-day cycle of treatment. Participants will also receive medication to prevent nausea and vomiting 30 minutes before the first dose of satraplatin. Following the first dose of satraplatin, medication for nausea will be given if needed. * Satraplatin doses
Conditions Studied
Interventions
- DRUG Satraplatin
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2010-12-03 |
| Est. Completion | 2015-05-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01259479
The ClinicalTrials.gov registry entry for NCT01259479 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Solid Tumors appearing as the primary indexed condition, and to 1 intervention — of which Satraplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01259479 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01259479 about?
NCT01259479 is a clinical study titled "Satraplatin in Children and Young Adults With Refractory Solid Tumors Including Brain Tumors". Background: * Cisplatin and carboplatin are standard cancer treatment drugs used for various childhood cancers, including brain tumors. Both drugs frequently have severe side effects that may reduce their effectiveness, particularly in children, and new treatments are needed that may be similarly e...
What is the current status of trial NCT01259479?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2010-12-03. Estimated completion is 2015-05-29.
What conditions does trial NCT01259479 study?
This clinical trial studies the following conditions: Solid Tumors, Brain Metastases, Brain Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01259479?
The interventions under investigation include: Satraplatin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01259479?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01259479 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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