Chemotherapy Followed by Surgery and Radiation Therapy With or Without Stem Cell Transplant in Treating Patients With Relapsed or Refractory Wilms' Tumor or Clear Cell Sarcoma of the Kidney
NCT ID: NCT00025103
Last Updated: 2013-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
75 participants
INTERVENTIONAL
2001-05-31
Brief Summary
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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.
Detailed Description
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* Determine survival rates of patients with relapsed or refractory Wilms' tumor or clear cell sarcoma of the kidney treated with chemotherapy followed by surgical resection and adjuvant radiotherapy with or without autologous stem cell rescue.
* Determine the efficacy and toxicity of these regimens in these patients.
* Determine prognostic variables in patients treated with these regimens.
OUTLINE: Patients are assigned to one of three treatment regimens.
* Regimen A (patients with initial stage I tumors previously treated with vincristine with or without dactinomycin with relapse at least 6 months after diagnosis): Patients receive vincristine IV once weekly on weeks 1-10 and then every 3 weeks during weeks 11-52, dactinomycin IV every 3 weeks during weeks 1-52, and doxorubicin IV over 6 hours every 3 weeks during weeks 1-34 (weeks 1-28 if pulmonary radiotherapy is planned). Patients undergo surgical resection and radiotherapy after 6 weeks of therapy.
* Regimen B (patients with initial stage II tumors previously treated with vincristine and dactinomycin with relapse at least 6 months after diagnosis): Patients receive cyclophosphamide IV twice daily on days 1-2 and 22-23, etoposide IV over 1 hour on days 1-3, and doxorubicin IV over 6 hours on days 22 and 23. Treatment repeats every 42 days for a total of 4 courses. Patients undergo surgical resection and radiotherapy after 2 courses of chemotherapy. Patients not achieving complete response after 4 courses of chemotherapy undergo autologous bone marrow transplantation as in regimen C.
* Regimen C (all other patients in first relapses OR with progression on first-line therapy OR in second or subsequent relapse previously treated on regimens A and B): Patients receive carboplatin IV over 1 hour on day 1, etoposide IV over 2 hours on days 1-3 and 22-24, and cyclophosphamide IV twice daily on days 22 and 23. Treatment repeats every 42 days for a total of 3 courses. Patients may undergo surgical resection prior to stem cell rescue. Beginning within 6 weeks after completion of chemotherapy, patients receive melphalan IV on day -1. 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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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dactinomycin
carboplatin
cyclophosphamide
doxorubicin hydrochloride
etoposide
melphalan
vincristine sulfate
autologous bone marrow transplantation
conventional surgery
peripheral blood stem cell transplantation
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Wilms' tumor or clear cell sarcoma of the kidney, meeting 1 of the following criteria:
* First relapse
* Refractory (progression during first-line therapy)
* Patients in second and subsequent relapses allowed if previously treated with vincristine, dactinomycin, and doxorubicin combination chemotherapy (VCR/DACT/DOX)
* Metachronous tumors in the contralateral kidney allowed if previously treated with VCR/DACT/DOX
* No rhabdoid tumor of the kidney
* Previously treated on UK Wilms' tumor study
PATIENT CHARACTERISTICS:
Age:
* Under 18
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* See Disease Characteristics
17 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Juliet Hale, MD
Role: STUDY_CHAIR
Newcastle-upon-Tyne Hospitals NHS Trust
Locations
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Our Lady's Hospital for Sick Children Crumlin
Dublin, , Ireland
Birmingham Children's Hospital
Birmingham, England, United Kingdom
Bristol Royal Hospital for Children
Bristol, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
Great Ormond Street Hospital for Children
London, England, United Kingdom
University College of London Hospitals
London, England, United Kingdom
Royal Manchester Children's Hospital
Manchester, England, United Kingdom
Newcastle Upon Tyne Hospitals NHS Trust
Newcastle upon Tyne, England, United Kingdom
Queen's Medical Centre
Nottingham, England, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Children's Hospital - Sheffield
Sheffield, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Countries
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Other Identifiers
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CDR0000068913
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20127
Identifier Type: -
Identifier Source: secondary_id
CCLG-UKWR
Identifier Type: -
Identifier Source: org_study_id