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NCT01453283 · ClinicalTrials.gov registry record · Phase 1
Tabectedin to Treat Children and Adolescents With Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01453283: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01453283 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01453283, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Background: * Trabectedin is an experimental drug that kills some cancer cells in the laboratory and in mice by interfering with genetic material (DNA) in cancer cells. * In some adult patients with cancer who received trabectedin, tumors grew slower or shrank. Objectives: * To determine a dose of trabectedin that can be given safely to children and adolescents as a 24-hour continuous infusion through a vein. * To determine the side effects of trabectedin in children and adolescents. * To study how the body handles trabectedin by measuring the amount of the drug in the bloodstream over time after a dose is given. * To measure the effect of trabectedin on DNA in white blood cells. * To determine if an individual's tumor cells have a specific proteins involved in DNA repair and if a pattern of genes can be identified in tumor samples that might help explain why trabectedin reduces tumors in some individuals and not others. * To study genetic factors that may influence the way the body handles trabectedin. * To see if trabectedin is beneficial in certain types of cancer. Eligibility: -Children between 4 year and 17 years of age with tumors that recur or no longer respond to standard treatment. Design: * Patients receive trabectedin as a 24-hour continuous infusion repeated every 21 days. The first three children entering the study receive a dose of 1.1 mg/m2. Subsequent groups of up to six patients receive higher doses (1.5 mg/m2 and 1.7 mg/m2) as long as the preceding dose is well tolerated. Patients enrolled at the lowest dose level may have their dose increased to the next level if they tolerated the lower dose well. Treatment may continue as long as the cancer does not worsen and the treatment is tolerated. * Patients have blood drawn on days 1, 2, 3, 4, 5 and 7 of the first treatment cycle to study how the body handles trabectedin. * A tumor sample obtained from a prior surgery or biopsy is examined for proteins involved in DNA repair. * A blood sample is d
Interventions
- DRUG Trabectedin (ecteinascidin-743, ET-743, YONDELIS [R])
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2006-12-20 |
| Est. Completion | 2011-10-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01453283
The ClinicalTrials.gov registry entry for NCT01453283 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 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 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Trabectedin (ecteinascidin-743, ET-743, YONDELIS [R]) is the first listed.
NCT01453283 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01453283 about?
NCT01453283 is a clinical study titled "Tabectedin to Treat Children and Adolescents With Cancer". Background: * Trabectedin is an experimental drug that kills some cancer cells in the laboratory and in mice by interfering with genetic material (DNA) in cancer cells. * In some adult patients with cancer who received trabectedin, tumors grew slower or shrank. Objectives: * To determine a dose o...
What is the current status of trial NCT01453283?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2006-12-20. Estimated completion is 2011-10-11.
What interventions are being tested in trial NCT01453283?
The interventions under investigation include: Trabectedin (ecteinascidin-743, ET-743, YONDELIS [R]) (DRUG).
Who is sponsoring clinical trial NCT01453283?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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