Irinotecan in Treating Patients With Newly Diagnosed Ewing's Sarcoma

• ClinicalTrials.gov Identifier: NCT00276692
• Recruitment Status: Completed
• First Posted: January 13, 2006
• Last Update Posted: June 26, 2013
• Sponsor: Children's Cancer and Leukaemia Group
• Information provided by: National Cancer Institute (NCI)

Tracking Information

• First Submitted Date: January 12, 2006
• First Posted Date: January 13, 2006
• Last Update Posted Date: June 26, 2013
• Study Start Date: August 2003
• Actual Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 8, 2006): Response as measured by MRI following course 2
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Irinotecan in Treating Patients With Newly Diagnosed Ewing's Sarcoma
• Official Title: Phase II Study of Irinotecan (CPT-11) in Children and Adolescents With High Risk Ewing's Sarcoma

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well irinotecan works in treating patients with newly diagnosed Ewing's sarcoma.

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Sarcoma
• Intervention: Drug: irinotecan hydrochloride
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: November 8, 2006): 35
• Original Enrollment: Not Provided
• Actual Study Completion Date: July 2009
• Actual Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 19 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Ireland, United Kingdom

Administrative Information

• NCT Number: NCT00276692
• Other Study ID Numbers: CCLG-ET-2003-04; CDR0000454550 ( Registry Identifier: PDQ (Physician Data Query) ); EU-20582
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Children's Cancer and Leukaemia Group
• Collaborators: Not Provided

Investigators

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

• PRS Account: National Cancer Institute (NCI)
• Verification Date: June 2009