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NCT01088035 · ClinicalTrials.gov registry record · Phase 2
Carboplatin as a Radiosensitizer in Treating Childhood Ependymoma
A Phase 2 study, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- Terminated
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
NCT01088035 is a Phase 2 study that was terminated before completion, run by Ann & Robert H Lurie Children's Hospital of Chicago. The registered enrollment target is 75 participants.
The verdict
NCT01088035, a Phase 2 study, was terminated before completion, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
Study Summary
This is a phase II study evaluating the feasibility of concurrent carboplatin given with focal radiation therapy in children age 12 months to \< 21 years with newly diagnosed localized ependymoma who have no or minimal residual disease post-operatively (\< 0.5 cm). The hypothesis is that utilizing carboplatin as a radiosensitizer is feasible and tolerable and may improve event-free survival (EFS) and minimize local recurrences as compared to historic controls. Following a neurosurgical resection and staging, patients who meet the eligibility criteria will receive standard fractionated radiation therapy at doses of 54 to 59.4 Gy to the primary site depending upon age. All patients will receive 35 mg/m²/day of carboplatin prior to each fraction of radiotherapy. Although significant neutropenia is not anticipated, G-CSF will be administered per study guidelines during radiation if neutropenia occurs. All patients will be followed for toxicity, response (resolution of residual disease) and event-free survival (EFS). Patients' tumor sample, blood and cerebro-spinal fluid (CSF) will also be prospectively evaluated to quantify the level of Survivin, a known inhibitor of apoptosis, via immunohistochemistry, Western Blot Analysis (in tumor tissue) and ELISA (in blood and CSF). The feasibility of obtaining these levels prospectively and in real time will be evaluated.
Interventions
- DRUG Carboplatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2010-04 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01088035
The ClinicalTrials.gov registry entry for NCT01088035 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Carboplatin is the first listed.
NCT01088035 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01088035 about?
NCT01088035 is a clinical study titled "Carboplatin as a Radiosensitizer in Treating Childhood Ependymoma". This is a phase II study evaluating the feasibility of concurrent carboplatin given with focal radiation therapy in children age 12 months to \< 21 years with newly diagnosed localized ependymoma who have no or minimal residual disease post-operatively (\< 0.5 cm). The hypothesis is that utilizing c...
What is the current status of trial NCT01088035?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2010-04. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01088035?
The interventions under investigation include: Carboplatin (DRUG).
Who is sponsoring clinical trial NCT01088035?
This trial is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total clinical trials registered on ClinicalTrials.gov.
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