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Sponsored by: |
Children's Cancer and Leukaemia Group |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00025103 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This phase II trial is studying how well chemotherapy followed by surgery and radiation therapy with or without stem cell transplant work in treating patients with relapsed or refractory Wilms' tumor or clear cell sarcoma of the kidney.
Condition | Intervention | Phase |
Kidney Cancer |
Drug: carboplatin Drug: cyclophosphamide Drug: dactinomycin Drug: doxorubicin hydrochloride Drug: etoposide Drug: melphalan Drug: vincristine sulfate Procedure: autologous bone marrow transplantation Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase II |
MedlinePlus related topics: | Bone Marrow Transplantation Cancer Kidney Cancer Soft Tissue Sarcoma Wilms' Tumor |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Protocol For The Treatment Of Relapsed And Refractory Wilms Tumour And Clear Cell Sarcoma Of The Kidney (CCSK) |
Estimated Enrollment: | 75 |
Study Start Date: | May 2001 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients are assigned to one of three treatment regimens.
Patients are followed every 8 weeks for 1 year, every 12 weeks for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 75 patients (25 for regimens A and B and 50 for regimen C) will be accrued for this study.
Ages Eligible for Study: | up to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of Wilms' tumor or clear cell sarcoma of the kidney, meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Ireland | |||||
Our Lady's Hospital for Sick Children Crumlin | Recruiting | ||||
Dublin, Ireland, 12 | |||||
Contact: Fin Breatnach, MD, FRCPE 353-1-409-6659 fin.breatnach@olhsc.ie | |||||
United Kingdom, England | |||||
Addenbrooke's Hospital | Recruiting | ||||
Cambridge, England, United Kingdom, CB2 2QQ | |||||
Contact: Denise Williams, MD 44-1223-216-878 | |||||
Birmingham Children's Hospital | Recruiting | ||||
Birmingham, England, United Kingdom, B4 6NH | |||||
Contact: Bruce Morland, MD 44-121-333-8233 bruce.morland@bch.nhs.uk | |||||
Bristol Royal Hospital for Children | Recruiting | ||||
Bristol, England, United Kingdom, BS2 8BJ | |||||
Contact: Annabel B.M. Foot 44-117-342-8520 | |||||
Children's Hospital - Sheffield | Recruiting | ||||
Sheffield, England, United Kingdom, S10 2TH | |||||
Contact: Mary P. Gerrard, BSc, MBChB, FRCP, FRCPCH 44-114-271-7366 mary.gerrard@sch.nhs.uk | |||||
Oxford Radcliffe Hospital | Recruiting | ||||
Oxford, England, United Kingdom, 0X3 9DU | |||||
Contact: Kate Wheeler, MD 44-186-522-1066 | |||||
Leeds Cancer Centre at St. James's University Hospital | Recruiting | ||||
Leeds, England, United Kingdom, LS9 7TF | |||||
Contact: Adam Glaser, MD 44-113-206-4984 adam.glaser@leedsth.nhs.uk | |||||
Leicester Royal Infirmary | Recruiting | ||||
Leicester, England, United Kingdom, LE1 5WW | |||||
Contact: Rosemary S. Shannon, MD 44-116-254-1414 | |||||
Newcastle Upon Tyne Hospitals NHS Trust | Recruiting | ||||
Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN | |||||
Contact: Andrew David J. Pearson, MD, FRCP, DCh 44-191-232-5131 ext. 24101 | |||||
Great Ormond Street Hospital for Children | Recruiting | ||||
London, England, United Kingdom, WC1N 3JH | |||||
Contact: Penelope Brock, MD, PhD 44-20-829-8832 Brockp@gosh.nhs.uk | |||||
Queen's Medical Centre | Recruiting | ||||
Nottingham, England, United Kingdom, NG7 2UH | |||||
Contact: David A. Walker 44-115-924-9924 david.walker@nottingham.ac.uk | |||||
Royal Liverpool Children's Hospital, Alder Hey | Recruiting | ||||
Liverpool, England, United Kingdom, L12 2AP | |||||
Contact: Heather P. McDowell, MD 44-151-293-3679 | |||||
Royal Manchester Children's Hospital | Recruiting | ||||
Manchester, England, United Kingdom, M27 4HA | |||||
Contact: Bernadette Brennan, MD 44-161-922-2227 bernadette.brennan@cmmc.nhs.uk | |||||
Royal Marsden - Surrey | Recruiting | ||||
Sutton, England, United Kingdom, SM2 5PT | |||||
Contact: Kathy Pritchard-Jones, MD 44-20-8661-3498 | |||||
Saint Bartholomew's Hospital | Recruiting | ||||
London, England, United Kingdom, EC1A 7BE | |||||
Contact: Judith E. Kingston, MD 44-20-7943-1339 j.e.kingston@qmul.ac.uk | |||||
Southampton General Hospital | Recruiting | ||||
Southampton, England, United Kingdom, SO16 6YD | |||||
Contact: Janice A. Kohler, MD, FRCP 44-23-8079-6942 | |||||
University College of London Hospitals | Recruiting | ||||
London, England, United Kingdom, WIT 3AA | |||||
Contact: Maria Michelagnoli, MD 44-20-7380-9950 maria.michelagnoli@uclh.org | |||||
United Kingdom, Northern Ireland | |||||
Royal Belfast Hospital for Sick Children | Recruiting | ||||
Belfast, Northern Ireland, United Kingdom, BT12 6BE | |||||
Contact: Anthony McCarthy, MD 44-289-063-3631 anthonymcarthy@royalhospital.n.i.nhs.uk | |||||
United Kingdom, Scotland | |||||
Aberdeen Royal Infirmary | Recruiting | ||||
Aberdeen, Scotland, United Kingdom, AB25 2ZN | |||||
Contact: D.J. King, MD 44-84-5456-6000 derek.king@arh.gampian.scot.nhs.uk | |||||
Royal Hospital for Sick Children | Recruiting | ||||
Glasgow, Scotland, United Kingdom, G3 8SJ | |||||
Contact: E.M. Simpson 44-141-201-0000 | |||||
Royal Hospital for Sick Children | Recruiting | ||||
Edinburgh, Scotland, United Kingdom, EH9 1LF | |||||
Contact: W. Hamish Wallace, MD 44-131-536-0426 |
Children's Cancer and Leukaemia Group |
Study Chair: | Juliet Hale, MD | Newcastle-upon-Tyne Hospitals NHS Trust |
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
Study ID Numbers: | CDR0000068913, CCLG-UKWR, EU-20127 |
First Received: | October 11, 2001 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00025103 |
Health Authority: | Unspecified |
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