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Phase II Study of Irinotecan (CPT-11) in Children and Adolescents With High Risk Ewing's Sarcoma


Phase 2
N/A
19 Years
Not Enrolling
Both
Sarcoma

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Trial Information

Phase II Study of Irinotecan (CPT-11) in Children and Adolescents With High Risk Ewing's Sarcoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response as measured by MRI following course 2

Safety Issue:

No

Principal Investigator

Bruce Morland, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Birmingham Children's Hospital

Authority:

United States: Federal Government

Study ID:

CCLG-ET-2003-04

NCT ID:

NCT00276692

Start Date:

August 2003

Completion Date:

July 2009

Related Keywords:

  • Sarcoma
  • metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

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