Irinotecan in Treating Patients With Newly Diagnosed Ewing’s Sarcoma

Overview

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

  • Study Type: Interventional
  • Study Design
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2008

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.

Interventions

  • Drug: irinotecan hydrochloride

Clinical Trial Outcome Measures

Primary Measures

  • Response as measured by MRI following course 2

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 19 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Children’s Cancer and Leukaemia Group
  • Overall Official(s)
    • Bruce Morland, MD, Study Chair, Birmingham Children’s Hospital

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