Irinotecan in Treating Patients With Newly Diagnosed Ewing's Sarcoma
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Drug: irinotecan hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Irinotecan (CPT-11) in Children and Adolescents With High Risk Ewing's Sarcoma |
- Response as measured by MRI following course 2 [ Designated as safety issue: No ]
| Estimated Enrollment: | 35 |
| Study Start Date: | August 2003 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | up to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Ireland | |
| Our Lady's Hospital for Sick Children Crumlin | |
| Dublin, Ireland, 12 | |
| United Kingdom | |
| Birmingham Children's Hospital | |
| Birmingham, England, United Kingdom, B4 6NH | |
| Institute of Child Health at University of Bristol | |
| Bristol, England, United Kingdom, BS2 8AE | |
| Addenbrooke's Hospital | |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Leeds Cancer Centre at St. James's University Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| Leicester Royal Infirmary | |
| Leicester, England, United Kingdom, LE1 5WW | |
| Royal Liverpool Children's Hospital, Alder Hey | |
| Liverpool, England, United Kingdom, L12 2AP | |
| Great Ormond Street Hospital for Children | |
| London, England, United Kingdom, WC1N 3JH | |
| Royal London Hospital | |
| London, England, United Kingdom, E1 1BB | |
| Royal Manchester Children's Hospital | |
| Manchester, England, United Kingdom, M27 4HA | |
| Sir James Spence Institute of Child Health at Royal Victoria Infirmary | |
| Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP | |
| Queen's Medical Centre | |
| Nottingham, England, United Kingdom, NG7 2UH | |
| Oxford Radcliffe Hospital | |
| Oxford, England, United Kingdom, 0X3 9DU | |
| Children's Hospital - Sheffield | |
| Sheffield, England, United Kingdom, S10 2TH | |
| Southampton General Hospital | |
| Southampton, England, United Kingdom, SO16 6YD | |
| Royal Marsden - Surrey | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Royal Belfast Hospital for Sick Children | |
| Belfast, Northern Ireland, United Kingdom, BT12 6BE | |
| Royal Aberdeen Children's Hospital | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZG | |
| Royal Hospital for Sick Children | |
| Edinburgh, Scotland, United Kingdom, EH9 1LF | |
| Royal Hospital for Sick Children | |
| Glasgow, Scotland, United Kingdom, G3 8SJ | |
| Childrens Hospital for Wales | |
| Cardiff, Wales, United Kingdom, CF14 4XW | |
| Study Chair: | Bruce Morland, MD | Birmingham Children's Hospital |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00276692 History of Changes |
| Other Study ID Numbers: | CDR0000454550, CCLG-ET-2003-04, EU-20582 |
| Study First Received: | January 12, 2006 |
| Last Updated: | July 1, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor |
Additional relevant MeSH terms:
|
Sarcoma, Ewing's Neuroectodermal Tumors, Primitive, Peripheral Sarcoma Osteosarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Irinotecan Camptothecin Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013