Chemotherapy With or Without Surgery, Radiation Therapy, or Stem Cell Transplantation in Treating Young Patients With Kidney Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002610
First received: November 1, 1999
Last updated: August 16, 2012
Last verified: April 2003
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which therapy regimen is most effective for treating patients with kidney tumors.

PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy, surgery, and/or peripheral stem cell or bone marrow transplantation in treating young patients with kidney tumors.


Condition Intervention Phase
Kidney Cancer
Biological: dactinomycin
Biological: filgrastim
Drug: carboplatin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: vincristine sulfate
Procedure: conventional surgery
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: NATIONAL WILMS TUMOR STUDY-5 -- TREATMENT OF RELAPSED PATIENTS

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2002
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of Wilms' tumor

    • Eligible subtypes:

      • Favorable histologies
      • Anaplastic histologies
      • Clear cell sarcoma of the kidney
      • Rhabdoid tumor of the kidney
  • Relapsed disease after entry on protocol NWTS-5 (NWTS-Q9401)

PATIENT CHARACTERISTICS:

Age:

  • 21 and under at original diagnosis

Performance status:

  • Not specified

Life expectancy:

  • At least 4 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times normal
  • SGOT or SGPT less than 2.5 times normal

Renal:

  • Creatinine no greater than 1.5 times normal OR
  • Creatinine clearance or GFR at least 70 mL/min

Cardiovascular:

  • Shortening fraction at least 27% by echocardiogram OR
  • Ejection fraction greater than 50% by echocardiogram or MUGA scan

Other:

  • Not pregnant
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 2 weeks since prior chemotherapy and recovered

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No prior therapy for relapsed Wilms' tumor
  • Recovered from the toxic effects of any other prior therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002610

  Show 235 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Daniel M. Green, MD Roswell Park Cancer Institute
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00002610     History of Changes
Other Study ID Numbers: CDR0000063900, COG-Q9402, NWTS-Q9402, CCG-4942, POG-9444, INT-0152, NWTS-5/R
Study First Received: November 1, 1999
Last Updated: August 16, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent Wilms tumor and other childhood kidney tumors
clear cell sarcoma of the kidney
rhabdoid tumor of the kidney

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Dactinomycin
Doxorubicin
Cyclophosphamide
Etoposide
Vincristine
Carboplatin
Lenograstim
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Immunosuppressive Agents

ClinicalTrials.gov processed this record on April 15, 2014