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Testing Trabectedin in Pediatric Patients
Untitled Document
Name of the Trial
Phase I Study of Trabectedin in Pediatric Patients With Relapsed or Refractory
Solid Tumors (NCI-07-C-0054). See the protocol
summary.
Principal Investigators
Dr. Elizabeth Fox and Dr. Meredith Chuk (Lead Associate Investigator), NCI
Center for Cancer Research
Why This Trial Is Important
New chemotherapy treatments for childhood cancers are often based on drugs
developed to treat adult cancers. However, adults and children may not always
react the same way to the same drugs. Because children's bodies are undergoing rapid
growth and development, pediatric patients may be adversely affected in ways
not seen in adult patients. It is critically important, therefore, to conduct
early-phase clinical trials to find the best dose of a new drug for children
with cancer and to determine any side effects in these young patients.
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| Trabectedin was originally derived from the Mangrove tunicate, a species of sea squirt. (Photo courtesy of Kathy Hill, Smithsonian Marine Station at Fort Pierce)
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A new drug called trabectedin (Yondelis, ET-743), which was originally obtained from marine creatures known as sea squirts, is being developed for the treatment of adult patients with
soft
tissue sarcoma, ovarian cancer, and other solid
tumors. This drug is now made in the laboratory and appears to kill
cells by damaging their DNA
and by interfering with DNA repair. In laboratory and animal testing, trabectedin was shown to be effective in killing cancer cells from several different types of solid tumors that occur in children, leading researchers to pursue its development for use against these pediatric cancers.
In this trial, children with solid tumors that have either recurred or have
not responded to previous treatment will be treated with trabectedin. The patients
will receive trabectedin by intravenous infusion over a 24-hour period once
every 21 days. The doses will be increased in consecutive groups of patients
until the maximum tolerated dose is reached. The side effects of trabectedin
will also be determined.
"Although this drug has undergone limited testing in pediatric patients
previously, using a shorter infusion schedule, we need to establish the maximum
tolerated dose with this new 24-hour infusion schedule, which is the recommended
schedule for adults," said Dr. Fox. "In addition, most research on
trabectedin use in children focuses primarily on patients with sarcoma. We hope
to also recruit patients with non-sarcoma cancers, so we can explore the drug's
potential in a broader range of childhood cancers."
For More Information
See the lists of entry
criteria and trial
contact information or call the NCI Clinical Trials Referral Office at 1-888-NCI-1937.
The call is toll free and confidential.
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