CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
trabectedin +1 moredrug
Likely dose
Trabectedin IV (dose not specified in interventions or arms)AI-extracted
Key inclusion· 7
  • ✓Age ≥12 months at entry and ≤21 years at initial diagnosis
  • ✓Histologically confirmed recurrent or refractory sarcoma (rhabdomyosarcoma, nonrhabdomyosarcomatous soft tissue sarcoma, or Ewing's sarcoma)
  • ✓Measurable disease by imaging (lesions assessable only by radionuclide scans do not count; previously irradiated lesions must show interim size increase)
  • ✓No significant metastatic liver disease (>25% of liver by imaging with abnormal liver function)
Key exclusion· 6
  • ✕Prior allogeneic stem cell transplantation
  • ✕Prior total body radiotherapy
  • ✕Uncompensated congestive heart failure within past 6 months
  • ✕Concurrent CYP3A4 inhibitors (grapefruit juice, erythromycin, azithromycin, clarithromycin, rifampin, fluconazole, ketoconazole, itraconazole, cimetidine, cannabinoids, leukotriene inhibitors)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00070109
NCT00070109Phase 2Completed
CompareCT.gov

A Phase II Study Of Trabectedin (ET-743, Yondelis®) in Children With Recurrent Rhabdomyosarcoma, Ewing Sarcoma, or Nonrhabdomyosarcomatous Soft Tissue Sarcomas

Children's Oncology Group·interventional·Posted Oct 7, 2003·Updated Sep 14, 2018

In Brief

A Phase 2 clinical trial evaluating trabectedin and pharmacological study for Previously Treated Childhood Rhabdomyosarcoma and 4 related conditions. Completed, enrolled 50 participants across 14 sites in 2 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreviously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Ewing Sarcoma, Peripheral Primitive Neuroectodermal Tumor
CountriesCanada, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 7, 2003
Enrollment StartJan 1, 2008
Primary CompletionOct 1, 2010
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 22.7 years ago

Interventions

trabectedindrug

Given IV

pharmacological studyother

Correlative studies