Tabectedin to Treat Children and Adolescents With Cancer
Status:
Completed
Trial end date:
2011-10-11
Target enrollment:
Participant gender:
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 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.