Clinical trial NCT00025103: 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
Official title: Protocol For The Treatment Of Relapsed And Refractory Wilms Tumour And Clear Cell Sarcoma Of The Kidney (CCSK)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Kidney Cancer
Keywords: recurrent Wilms tumor and other childhood kidney tumors
clear cell sarcoma of the kidney
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 75
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Unified treatment strategy
measure: Improvement of current survival rates
measure: Efficacy and toxicity
measure: Prognostic variables
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Our Lady's Hospital for Sick Children Crumlin
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
state: England
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
state: England
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: England
city: Leeds
country: United Kingdom
facility: Leeds Cancer Centre at St. James's University Hospital
state: England
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
state: England
city: Liverpool
country: United Kingdom
facility: Royal Liverpool Children's Hospital, Alder Hey
state: England
city: London
country: United Kingdom
facility: Saint Bartholomew's Hospital
state: England
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children
state: England
city: London
country: United Kingdom
facility: University College of London Hospitals
state: England
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital
state: England
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Newcastle Upon Tyne Hospitals NHS Trust
state: England
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
state: England
city: Oxford
country: United Kingdom
facility: Oxford Radcliffe Hospital
state: England
city: Sheffield
country: United Kingdom
facility: Children's Hospital - Sheffield
state: England
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: England
city: Sutton
country: United Kingdom
facility: Royal Marsden - Surrey
state: England
city: Belfast
country: United Kingdom
facility: Royal Belfast Hospital for Sick Children
state: Northern Ireland
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Scotland
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Sick Children
state: Scotland
city: Glasgow
country: United Kingdom
facility: Royal Hospital for Sick Children
state: Scotland
Study officials:
affiliation: Newcastle-upon-Tyne Hospitals NHS Trust
name: Juliet Hale, MD
role: STUDY_CHAIR
References: