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Tabectedin to Treat Children and Adolescents With Cancer

NCT01453283 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-07-02

No results posted yet for this 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 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.

Conditions

Interventions

DRUG

Trabectedin (ecteinascidin-743, ET-743, YONDELIS [R])

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Howard A Fine, M.D. · National Cancer Institute (NCI)

Study Design

Purpose
TREATMENT

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-20
Primary Completion
2011-10-11
Completion
2011-10-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01453283 on ClinicalTrials.gov