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

August 1, 2013 updated by: Children's Cancer and Leukaemia Group

Protocol For The Treatment Of Relapsed And Refractory Wilms Tumour And Clear Cell Sarcoma Of The Kidney (CCSK)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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.

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, 12
        • Our Lady's Hospital for Sick Children Crumlin
  • United Kingdom
    • England
      • Birmingham, England, United Kingdom, B4 6NH
        • Birmingham Children's Hospital
      • Bristol, England, United Kingdom, BS2 8BJ
        • Bristol Royal Hospital for Children
      • Cambridge, England, United Kingdom, CB2 2QQ
        • Addenbrooke's Hospital
      • Leeds, England, United Kingdom, LS9 7TF
        • Leeds Cancer Centre at St. James's University Hospital
      • Leicester, England, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • Liverpool, England, United Kingdom, L12 2AP
        • Royal Liverpool Children's Hospital, Alder Hey
      • London, England, United Kingdom, EC1A 7BE
        • Saint Bartholomew's Hospital
      • London, England, United Kingdom, WC1N 3JH
        • Great Ormond Street Hospital for Children
      • London, England, United Kingdom, WIT 3AA
        • University College of London Hospitals
      • Manchester, England, United Kingdom, M27 4HA
        • Royal Manchester Children's Hospital
      • Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN
        • Newcastle Upon Tyne Hospitals NHS Trust
      • Nottingham, England, United Kingdom, NG7 2UH
        • Queen's Medical Centre
      • Oxford, England, United Kingdom, 0X3 9DU
        • Oxford Radcliffe Hospital
      • Sheffield, England, United Kingdom, S10 2TH
        • Children's Hospital - Sheffield
      • Southampton, England, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden - Surrey
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT12 6BE
        • Royal Belfast Hospital for Sick Children
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
      • Edinburgh, Scotland, United Kingdom, EH9 1LF
        • Royal Hospital for Sick Children
      • Glasgow, Scotland, United Kingdom, G3 8SJ
        • Royal Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Unified treatment strategy
Improvement of current survival rates
Efficacy and toxicity
Prognostic variables

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Cancer and Leukaemia Group

Investigators

  • Study Chair: Juliet Hale, MD, Newcastle-upon-Tyne Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2001

Primary Completion (ANTICIPATED)

November 1, 2008

Study Registration Dates

First Submitted

October 11, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

August 2, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCLG-UKWR
  • CDR0000068913 (REGISTRY: PDQ (Physician Data Query))
  • EU-20127

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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