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.
Full Title of Study: “Phase II Study of Irinotecan (CPT-11) in Children and Adolescents With High Risk Ewing’s Sarcoma”
- Study Type: Interventional
- Study Design
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: September 2008
- 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
Clinical Trial Outcome Measures
- Response as measured by MRI following course 2
Participating in This Clinical Trial
- 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
- 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
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: 19 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Children’s Cancer and Leukaemia Group
- Overall Official(s)
- Bruce Morland, MD, Study Chair, Birmingham Children’s Hospital
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