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

Sponsors and Collaborators:	Children's Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002610

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	Drug: carboplatin Drug: cyclophosphamide Drug: dactinomycin Drug: doxorubicin hydrochloride Drug: etoposide Drug: filgrastim Drug: vincristine sulfate Procedure: conventional surgery Procedure: radiation therapy	Phase III

MedlinePlus related topics: Cancer Kidney Cancer Wilms' Tumor

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Carboplatin Filgrastim Etoposide Vincristine sulfate Vincristine Etoposide phosphate Dactinomycin

U.S. FDA Resources

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

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

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

Publications of Results:

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]

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 23, 2008
ClinicalTrials.gov Identifier:	NCT00002610
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

Study placed in the following topic categories:

Rhabdoid Tumor
Malignant mesenchymal tumor
Urogenital Neoplasms
Cyclophosphamide
Urologic Neoplasms
Kidney cancer
Etoposide phosphate
Soft tissue sarcomas
Urologic Diseases
Kidney Neoplasms
Dactinomycin
Wilms Tumor
Kidney Diseases
Etoposide

Wilms' tumor
Sarcoma, Clear Cell
Vincristine
Carboplatin
Renal cancer
Recurrence
Doxorubicin
Carcinoma
Rhabdoid tumor
Carcinoma, Renal Cell
Sarcoma
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Enzyme Inhibitors
Antimitotic Agents
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

Protein Synthesis Inhibitors
Anti-Bacterial Agents
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009