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Sponsored by: |
Children's Cancer and Leukaemia Group |
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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 |
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Kidney Cancer |
Biological: dactinomycin Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: melphalan Drug: vincristine sulfate Procedure: autologous bone marrow transplantation Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase II |
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 undergo surgical resection and radiotherapy after 6 weeks of therapy.
Autologous peripheral blood stem cells or bone marrow is reinfused on day 0. Patients undergo radiotherapy after transplantation. 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 | |
Dublin, Ireland, 12 | |
United Kingdom, England | |
Addenbrooke's Hospital | |
Cambridge, England, United Kingdom, CB2 2QQ | |
Birmingham Children's Hospital | |
Birmingham, England, United Kingdom, B4 6NH | |
Bristol Royal Hospital for Children | |
Bristol, England, United Kingdom, BS2 8BJ | |
Children's Hospital - Sheffield | |
Sheffield, England, United Kingdom, S10 2TH | |
Oxford Radcliffe Hospital | |
Oxford, England, United Kingdom, 0X3 9DU | |
Leeds Cancer Centre at St. James's University Hospital | |
Leeds, England, United Kingdom, LS9 7TF | |
Leicester Royal Infirmary | |
Leicester, England, United Kingdom, LE1 5WW | |
Newcastle Upon Tyne Hospitals NHS Trust | |
Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN | |
Great Ormond Street Hospital for Children | |
London, England, United Kingdom, WC1N 3JH | |
Queen's Medical Centre | |
Nottingham, England, United Kingdom, NG7 2UH | |
Royal Liverpool Children's Hospital, Alder Hey | |
Liverpool, England, United Kingdom, L12 2AP | |
Royal Manchester Children's Hospital | |
Manchester, England, United Kingdom, M27 4HA | |
Royal Marsden - Surrey | |
Sutton, England, United Kingdom, SM2 5PT | |
Saint Bartholomew's Hospital | |
London, England, United Kingdom, EC1A 7BE | |
Southampton General Hospital | |
Southampton, England, United Kingdom, SO16 6YD | |
University College of London Hospitals | |
London, England, United Kingdom, WIT 3AA | |
United Kingdom, Northern Ireland | |
Royal Belfast Hospital for Sick Children | |
Belfast, Northern Ireland, United Kingdom, BT12 6BE | |
United Kingdom, Scotland | |
Aberdeen Royal Infirmary | |
Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
Royal Hospital for Sick Children | |
Glasgow, Scotland, United Kingdom, G3 8SJ | |
Royal Hospital for Sick Children | |
Edinburgh, Scotland, United Kingdom, EH9 1LF |
Study Chair: | Juliet Hale, MD | Newcastle-upon-Tyne Hospitals NHS Trust |
Study ID Numbers: | CDR0000068913, CCLG-UKWR, EU-20127 |
Study First Received: | October 11, 2001 |
Last Updated: | July 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00025103 History of Changes |
Health Authority: | United States: Federal Government |
recurrent Wilms tumor and other childhood kidney tumors clear cell sarcoma of the kidney |
Anti-Infective Agents Melphalan Urinary Tract Neoplasm Immunologic Factors Urogenital Neoplasms Cyclophosphamide Urologic Neoplasms Etoposide phosphate Anti-Bacterial Agents Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Renal Cancer Urologic Diseases Kidney Neoplasms Dactinomycin |
Wilms' Tumor Wilms Tumor Kidney Diseases Alkylating Agents Etoposide Kidney Cancer Vincristine Sarcoma, Clear Cell Antimitotic Agents Carboplatin Immunosuppressive Agents Recurrence Doxorubicin Carcinoma Malignant Mesenchymal Tumor |
Anti-Infective Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Cyclophosphamide Antibiotics, Antineoplastic Urologic Neoplasms Anti-Bacterial Agents Neoplasms, Connective and Soft Tissue Neoplasms by Site Urologic Diseases Kidney Neoplasms Dactinomycin |
Therapeutic Uses Wilms Tumor Kidney Diseases Alkylating Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Mitosis Modulators Sarcoma, Clear Cell Vincristine Enzyme Inhibitors Antimitotic Agents Carboplatin Immunosuppressive Agents Pharmacologic Actions Doxorubicin |