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

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:

MedlinePlus related topics: Cancer Kidney Cancer Wilms' Tumor

Drug Information available for: Cyclophosphamide Dactinomycin Vincristine sulfate Doxorubicin Doxorubicin hydrochloride Etoposide Carboplatin Etoposide phosphate Filgrastim Lenograstim Granulocyte colony-stimulating factor

U.S. FDA Resources

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

Study Start Date:

May 2002

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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

National Cancer Institute (NCI)

Investigators

Study Chair:

Daniel M. Green, MD

Roswell Park Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Green DM, Cotton CA, Malogolowkin M, Breslow NE, Perlman E, Miser J, Ritchey ML, Thomas PR, Grundy PE, D'Angio GJ, Beckwith JB, Shamberger RC, Haase GM, Donaldson M, Weetman R, Coppes MJ, Shearer P, Coccia P, Kletzel M, Macklis R, Tomlinson G, Huff V, Newbury R, Weeks D. Treatment of wilms tumor relapsing after initial treatment with vincristine and actinomycin D: A report from the National Wilms Tumor Study Group. Pediatr Blood Cancer. 2006 Mar 17; [Epub ahead of print]

Kalapurakal JA, Perlman EJ, Seibel NL, Ritchey M, Dome JS, Grundy PE. Outcomes of Patients With Revised Stage I Clear Cell Sarcoma of Kidney Treated in National Wilms Tumor Studies 1-5. Int J Radiat Oncol Biol Phys. 2012 Jun 1. [Epub ahead of print]

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ehrlich PF, Anderson JR, Ritchey ML, Dome JS, Green DM, Grundy PE, Perlman EJ, Kalapurakal JA, Breslow NE, Shamberger RC. Clinicopathologic findings predictive of relapse in children with stage III favorable-histology Wilms tumor. J Clin Oncol. 2013 Mar 20;31(9):1196-201. doi: 10.1200/JCO.2011.41.1165. Epub 2013 Feb 4.

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 June 17, 2013