Tabectedin to Treat Children and Adolescents With Cancer

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

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.

Key facts

Study ID

NCT01453283

Run by

National Cancer Institute (NCI)

People needed

12

Starts

2006-12-20

Expected to finish

2011-10-11

Last updated by the study team

2017-07-02

Who can join

Age: 4 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients with severe uncontrolled infections or other unrelated systemic illnesses, which in the judgment of the Principal or Associate Investigator would compromise the patient's ability to tolerate trabectedin or are likely to interfere with the study procedures or results.
• Patients with known history of xeroderma pigmentosum or other diseases with reduced DNA repair.
• Pregnant or breast-feeding females. Sexually active patients must be willing to use an effective form of birth control.
• Patients currently receiving other investigational agents.
• Patients who have received allogeneic stem cell transplants.
• Patients who have had prior therapy with trabectedin (ET-743, Yondelis).

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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