Medpedia

• Sarcoma

DISEASE CHARACTERISTICS:
-  Histologically confirmed Ewing's tumor
-  Ewing's sarcoma or peripheral primitive neuroectodermal tumor of bone or soft
tissue
-  High-risk disease (R3), defined as metastases at extrapulmonary/pleural sites
-  Newly diagnosed disease
-  Measurable primary and/or metastatic disease
-  At least one bidimensionally measurable lesion
-  Concurrent enrollment on EURO-Ewing99 clinical trial required
PATIENT CHARACTERISTICS:
-  No abnormal cardiac function, including any of the following:
-  Fractional shortening < 29%
-  Ejection fraction < 40%
-  Glomerular filtration rate ≥ 60mL/min
-  Not pregnant
-  Negative pregnancy test
-  Fertile patients must use effective contraception during and for 3 months after
completion of study treatment
-  No prior or current history of chronic diarrhea, bowel obstruction, sub obstruction,
Crohn's disease, or ulcerative colitis
-  No other medical, psychiatric, or social condition incompatible with the study
treatment
PRIOR CONCURRENT THERAPY:
-  No prior chemotherapy
-  No more than 45 days since prior definitive biopsy

OBJECTIVES:

Primary

-  Assess the responsiveness of single-agent irinotecan hydrochloride in a patient
population with newly diagnosed high-risk Ewing's sarcoma.

OUTLINE: This is an open-label, multicenter study.

Patients receive irinotecan hydrochloride IV over 1 hour on day 1. Treatment repeats every
21 days for 2 courses. After completion of 2 courses of therapy, patients may receive
additional treatment at the discretion of the treating physician.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

• Drug: irinotecan hydrochloride

• Response as measured by MRI following course 2
  Safety Issue: No

• Bruce Morland, MD
  Study Chair, Birmingham Children's Hospital

• Childrens Hospital for Wales
  Cardiff, Wales, CF14 4XW, United Kingdom
  Completed
• Royal Hospital for Sick Children
  Glasgow, Scotland, G3 8SJ, United Kingdom
  Completed
• Royal Hospital for Sick Children
  Edinburgh, Scotland, EH9 1LF, United Kingdom
  Completed
• Royal Aberdeen Children's Hospital
  Aberdeen, Scotland, AB25 2ZG, United Kingdom
  Completed
• Royal Belfast Hospital for Sick Children
  Belfast, Northern Ireland, BT12 6BE, United Kingdom
  Completed
• Royal Marsden - Surrey
  Sutton, England, SM2 5PT, United Kingdom
  Completed
• Southampton General Hospital
  Southampton, England, SO16 6YD, United Kingdom
  Completed
• Children's Hospital - Sheffield
  Sheffield, England, S10 2TH, United Kingdom
  Completed
• Oxford Radcliffe Hospital
  Oxford, England, 0X3 9DU, United Kingdom
  Completed
• Queen's Medical Centre
  Nottingham, England, NG7 2UH, United Kingdom
  Completed
• Sir James Spence Institute of Child Health at Royal Victoria Infirmary
  Newcastle-Upon-Tyne, England, NE1 4LP, United Kingdom
  Completed
• Royal Manchester Children's Hospital
  Manchester, England, M27 4HA, United Kingdom
  Completed

• Children's Cancer and Leukaemia Group
  Lead Sponsor
• United States: Federal Government

• Clinical trial summary from the National Cancer Institute's PDQ® database
  http://cancer.gov/clinicaltrials/CCLG-ET-2003-04