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

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00025103
• Other study ID #: CCLG-UKWR
• Secondary ID: CDR0000068913EU-
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 11, 2001
• Last updated: August 1, 2013
• Start date: May 2001

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Cancer
• Sarcoma, Clear Cell
• Wilms Tumor

Intervention

Biological:
• dactinomycin

Drug:
• carboplatin

• cyclophosphamide

• doxorubicin hydrochloride

• etoposide

• melphalan

• vincristine sulfate

Procedure:
• autologous bone marrow transplantation

• conventional surgery

• peripheral blood stem cell transplantation

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Ireland	Our Lady's Hospital for Sick Children Crumlin	Dublin
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	Royal Belfast Hospital for Sick Children	Belfast	Northern Ireland
United Kingdom	Birmingham Children's Hospital	Birmingham	England
United Kingdom	Bristol Royal Hospital for Children	Bristol	England
United Kingdom	Addenbrooke's Hospital	Cambridge	England
United Kingdom	Royal Hospital for Sick Children	Edinburgh	Scotland
United Kingdom	Royal Hospital for Sick Children	Glasgow	Scotland
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	Great Ormond Street Hospital for Children	London	England
United Kingdom	Saint Bartholomew's Hospital	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

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer and Leukaemia Group

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unified treatment strategy			No
Primary	Improvement of current survival rates			No
Primary	Efficacy and toxicity			Yes
Primary	Prognostic variables			No