Trabectedin in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors

Completed · Phase 2

Conditions studied: Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Ewing Sarcoma, Peripheral Primitive Neuroectodermal Tumor

In brief

This phase II trial is studying how well trabectedin works in treating young patients with recurrent or refractory soft tissue sarcoma or Ewing's family of tumors. Drugs used in chemotherapy such as trabectedin use different ways to stop tumor cells from dividing so they stop growing or die.

Key facts

Study ID

NCT00070109

Run by

Children's Oncology Group

People needed

50

Starts

2008-01-01

Expected to finish

2013-12-01

Last updated by the study team

2018-09-14

Who can join

Age: 1 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be greater than or equal to 12 months of age at the time of study entry and no more than 21 years of age when initially diagnosed with the malignancy to be treated on this protocol
• Histologically confirmed recurrent or refractory sarcoma tumors, including the following:
• Rhabdomyosarcoma
• Nonrhabdomyosarcomatous soft tissue sarcoma
• Ewing's sarcoma
• Measurable disease by imaging studies
• Lesions assessable only by radionuclide scans are not considered measurable
• If the only measurable lesion has been previously irradiated, then that lesion must have shown evidence of an interim increase in size
• No significant amount of metastatic liver disease, defined as the following:
• Lesions occupying more than 25% of the liver by imaging and abnormal liver function tests or abnormal synthetic liver function
• Performance status - Lansky 50-100% (10 years of age and under)
• Performance status - Karnofsky 50-100% (over 10 years of age)
• Absolute neutrophil count at least 1,000/mm\^3
• Platelet count at least 100,000/mm\^3 (transfusion independent)
• Hemoglobin at least 8.0 g/dL (transfusion allowed)
• No concurrent CYP3A4 inhibitors, including the following:
• Grapefruit juice
• Erythromycin
• Azithromycin
• Clarithromycin
• Rifampin and its analogs
• Fluconazole
• Ketoconazole
• Itraconazole
• Cimetidine

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Children's Hospital Central California — Madera, California, United States
• Childrens Memorial Hospital — Chicago, Illinois, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• New York University Langone Medical Center — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• University of Vermont — Burlington, Vermont, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Chedoke-McMaster Hospitals — Hamilton, Ontario, Canada
• Hospital for Sick Children — Toronto, Ontario, Canada
• Hospital Sainte-Justine — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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