Tabectedin to Treat Children and Adolescents With Cancer
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|ClinicalTrials.gov Identifier: NCT01453283|
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : July 2, 2017
- 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.
- 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.
-Children between 4 year and 17 years of age with tumors that recur or no longer respond to standard treatment.
- 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 drawn to look for genetic factors that may influence how the body handles trabectedin.
- Patients have periodic physical examinations and blood tests. MRI or CT scans are done before starting therapy and after every two treatment cycles to evaluate the tumor.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: Trabectedin (ecteinascidin-743, ET-743, YONDELIS [R])||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Official Title:||A Phase I Trial and Pharmacokinetic Study of Trabectedin (YONDELIS [R], ET-743) in Children and Adolescents With Relapsed or Refractory Solid Tumors|
|Study Start Date :||December 20, 2006|
|Actual Primary Completion Date :||October 11, 2011|
|Actual Study Completion Date :||October 11, 2011|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01453283
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Howard A Fine, M.D.||National Cancer Institute (NCI)|