Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors

NCT00335556 | Completed Phase 2 Results DMC

• 5 other identifiers: AREN0321NCI-2009-00414COG-AREN0321CDR0000472893U10CA098543
• Study Type: interventional
• Target: 291
• Locations: 5 countries
• Sites: 187

Brief Summary

This phase II trial is studying how well combination chemotherapy, radiation therapy, and/or surgery work in treating patients with high-risk kidney tumors. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Conditions

Childhood Renal Cell Carcinoma; Clear Cell Renal Cell Carcinoma; Clear Cell Sarcoma of the Kidney; Papillary Renal Cell Carcinoma; Rhabdoid Tumor of the Kidney; Stage I Renal Cell Cancer; Stage I Renal Wilms Tumor; Stage II Renal Cell Cancer; Stage II Renal Wilms Tumor; Stage III Renal Cell Cancer; Stage III Renal Wilms Tumor; Stage IV Renal Cell Cancer; Stage IV Renal Wilms Tumor

Outcome Measures

Primary Outcomes (5)

• Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT)

  Compare the outcome of patients treated with alternating CyCE/VDCy chemotherapy (with or without vincristine/irinotecan cycles) to a fixed outcome based on that seen for similar patients treated with NWTS-5 (NCT00002610).

  4 years

• Long-term Survival of Patients With Stage I-IV Malignant Rhabdoid Tumors

  The outcome of these patients will be compared with a fixed outcome based on that seen for similar patients treated with NWTS-5 regimen (NCT00002610).

  4 years

• Response Rate

  Criteria for response assessed by three-dimensional measurement: Complete Response (CR), Disappearance of all index lesions and non-index lesions. No new lesions; Partial Response (PR), At least a 65% decrease in the sum of the volumes of the index lesions. No new lesions; Response rate (RR) = CR+PR of patients who received window therapy.

  Up to 2 months

• Event Free Survival Probability

  Event-free survival will be informally compared to that seem for similar patients treated on NWTS-5 (NCT00002610).

  4 years

• Toxicity Rate

  Percentage of participants with Grade 4 cardiac toxicities, Grade 4 Sinusoidal Obstruction Syndrome (SOS), and treatment-related deaths determined using CTCAE v4.

  Up to 4 years

Secondary Outcomes (2)

• Number of Patients With INI1 Mutations in Renal and Extrarenal Malignant Rhabdoid Tumor by Fluorescent in Situ Hybridization

  At baseline

• Frequency of TP53 Mutations

  At baseline

Study Arms (6)

Surgery

EXPERIMENTAL

Patients with completely resectable stage I-IV RCC undergo surgical resection. Patients with incompletely resectable stage III-IV RCC undergo treatment as per physician's choice.

Procedure: Conventional Surgery

Treatment (UH-1)

EXPERIMENTAL

Patients receive combination chemotherapy comprising vincristine, doxorubicin hydrochloride, cyclophosphamide, etoposide, and carboplatin. Patients whose primary tumors were initially resected undergo radiotherapy once daily 5 days a week for 4-5½ weeks beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13. Patients with unresectable clear cell sarcoma of the kidney (CCSK) receive no further study therapy.

Drug: Doxorubicin Hydrochloride; Procedure: Conventional Surgery; Drug: Cyclophosphamide; Drug: Etoposide; Drug: Carboplatin; Drug: Vincristine Sulfate; Radiation: Radiation Therapy; Other: Laboratory Biomarker Analysis

Treatment (window/UH-1)

EXPERIMENTAL

Patients receive vincristine IV on days 1 and 8 and irinotecan hydrochloride IV over 30 minutes on days 1-5 and 8-12 (course 1). Patients with progressive disease (PD) are treated with regimen UH-1. Patients with stable disease (SD), partial response (PR), or complete response (CR) receive another course of irinotecan hydrochloride/vincristine window therapy beginning on day 22. After the second course, patients with SD or PD are treated with regimen UH-1 and patients with PR or CR are treated with regimen UH-2.

Drug: Doxorubicin Hydrochloride; Drug: Irinotecan Hydrochloride; Procedure: Conventional Surgery; Drug: Cyclophosphamide; Drug: Etoposide; Drug: Carboplatin; Drug: Vincristine Sulfate; Radiation: Radiation Therapy; Other: Laboratory Biomarker Analysis

Treatment (UH-2)

EXPERIMENTAL

Patients receive combination chemotherapy comprising vincristine, doxorubicin hydrochloride, cyclophosphamide, etoposide, carboplatin, and irinotecan hydrochloride. Patients whose primary tumors were initially resected undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 7. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 7.

Drug: Doxorubicin Hydrochloride; Drug: Irinotecan Hydrochloride; Procedure: Conventional Surgery; Drug: Etoposide; Drug: Carboplatin; Drug: Vincristine Sulfate; Radiation: Radiation Therapy; Other: Laboratory Biomarker Analysis

Treatment (regimen I)

EXPERIMENTAL

Patients receive vincristine, doxorubicin hydrochloride, cyclophosphamide, and etoposide. Patients whose primary tumors were initially resected (except those with stage I CCSK) undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13.

Drug: Doxorubicin Hydrochloride; Procedure: Conventional Surgery; Drug: Cyclophosphamide; Drug: Etoposide; Drug: Vincristine Sulfate; Radiation: Radiation Therapy; Other: Laboratory Biomarker Analysis

Treatment (regimen DD-4A)

EXPERIMENTAL

Patients receive dactinomycin, vincristine, and doxorubicin hydrochloride. Patients whose primary tumors were initially resected undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13.

Drug: Doxorubicin Hydrochloride; Procedure: Conventional Surgery; Biological: Dactinomycin; Drug: Vincristine Sulfate; Radiation: Radiation Therapy; Other: Laboratory Biomarker Analysis

Interventions

Doxorubicin Hydrochloride DRUG

Given IV

Treatment (UH-1); Treatment (UH-2); Treatment (regimen DD-4A); Treatment (regimen I); Treatment (window/UH-1)

Irinotecan Hydrochloride DRUG

Given IV

Treatment (UH-2); Treatment (window/UH-1)

Conventional Surgery PROCEDURE

Patients undergo resection

Also known as: surgery, conventional

Surgery; Treatment (UH-1); Treatment (UH-2); Treatment (regimen DD-4A); Treatment (regimen I); Treatment (window/UH-1)

Cyclophosphamide DRUG

Given IV

Treatment (UH-1); Treatment (regimen I); Treatment (window/UH-1)

Etoposide DRUG

Given IV

Also known as: Lastet

Treatment (UH-1); Treatment (UH-2); Treatment (regimen I); Treatment (window/UH-1)

Carboplatin DRUG

Given IV

Treatment (UH-1); Treatment (UH-2); Treatment (window/UH-1)

Dactinomycin BIOLOGICAL

Given IV

Also known as: Lyovac Cosmegen

Treatment (regimen DD-4A)

Vincristine Sulfate DRUG

Given IV

Also known as: Kyocristine, Oncovin, VCR, Vincasar

Treatment (UH-1); Treatment (UH-2); Treatment (regimen DD-4A); Treatment (regimen I); Treatment (window/UH-1)

Radiation Therapy RADIATION

Undergo radiotherapy

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, RT

Treatment (UH-1); Treatment (UH-2); Treatment (regimen DD-4A); Treatment (regimen I); Treatment (window/UH-1)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (UH-1); Treatment (UH-2); Treatment (regimen DD-4A); Treatment (regimen I); Treatment (window/UH-1)

Eligibility Criteria

• Age: Up to 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Newly diagnosed disease of 1 of the following histologic types:
• Focal anaplastic Wilms' tumor
• Diffuse anaplastic Wilms' tumor
• Clear cell sarcoma of the kidney
• Malignant rhabdoid tumor (renal or extrarenal)
• Renal cell carcinoma
• Clear cell
• Papillary
• Renal medullary
• Oncocytoid
• Sarcomatoid
• Chromophobe
• Translocation
• Collecting duct
• Carcinoma associated with neuroblastoma

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (187)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of South Alabama

Mobile, Alabama, 36604, United States

Location

Phoenix Childrens Hospital

Phoenix, Arizona, 85016, United States

Location

University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591, United States

Location

Southern California Permanente Medical Group

Downey, California, 90242, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Miller Children's Hospital

Long Beach, California, 90806, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Hospital Central California

Madera, California, 93636-8762, United States

Location

Children's Hospital and Research Center at Oakland

Oakland, California, 94609-1809, United States

Location

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

Location

Childrens Hospital of Orange County

Orange, California, 92868, United States

Location

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, 94304, United States

Location

Rady Children's Hospital - San Diego

San Diego, California, 92123, United States

Location

University of California San Francisco Medical Center-Parnassus

San Francisco, California, 94143, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Denver, Colorado, 80218, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Lombardi Comprehensive Cancer Center at Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908, United States

Location

Memorial Healthcare System - Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States

Location

Nemours Children's Clinic-Jacksonville South

Jacksonville, Florida, 32207, United States

Location

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

Location

Miami Children's Hospital

Miami, Florida, 33155, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

Florida Hospital Orlando

Orlando, Florida, 32803, United States

Location

UF Cancer Center at Orlando Health

Orlando, Florida, 32806, United States

Location

Nemours Children's Clinic - Pensacola

Pensacola, Florida, 32504, United States

Location

All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Saint Joseph Children's Hospital of Tampa

Tampa, Florida, 33607, United States

Location

Saint Mary's Hospital

West Palm Beach, Florida, 33407, United States

Location

Children's Healthcare of Atlanta - Egleston

Atlanta, Georgia, 30322, United States

Location

Memorial University Medical Center

Savannah, Georgia, 31404, United States

Location

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Location

Tripler Army Medical Center

Honolulu, Hawaii, 96859, United States

Location

Saint Luke's Mountain States Tumor Institute

Boise, Idaho, 83712, United States

Location

Lurie Children's Hospital-Chicago

Chicago, Illinois, 60611, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Advocate Children's Hospital-Oak Lawn

Oak Lawn, Illinois, 60453, United States

Location

Advocate Lutheran General Hospital.

Park Ridge, Illinois, 60068, United States

Location

Saint Jude Midwest Affiliate

Peoria, Illinois, 61602, United States

Location

Southern Illinois University

Springfield, Illinois, 62702, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Saint Vincent Hospital and Health Services

Indianapolis, Indiana, 46260, United States

Location

Blank Children's Hospital

Des Moines, Iowa, 50309, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Children's Hospital New Orleans

New Orleans, Louisiana, 70118, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Maine Children's Cancer Program

Scarborough, Maine, 04074, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Saint John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Michigan State University Clinical Center

East Lansing, Michigan, 48824-7016, United States

Location

Hurley Medical Center

Flint, Michigan, 48502, United States

Location

Helen DeVos Children's Hospital at Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

Kalamazoo Center for Medical Studies

Kalamazoo, Michigan, 49008, United States

Location

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

The Childrens Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Cardinal Glennon Children's Medical Center

St Louis, Missouri, 63104, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Saint John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, 68114, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Nevada Cancer Research Foundation CCOP

Las Vegas, Nevada, 89106, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

UMDNJ - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Saint Joseph's Regional Medical Center

Paterson, New Jersey, 07503, United States

Location

Overlook Hospital

Summit, New Jersey, 07902, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

The Steven and Alexandra Cohen Children's Medical Center of New York

New Hyde Park, New York, 11040, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Weill Medical College of Cornell University

New York, New York, 10065, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

Location

Mission Hospital-Memorial Campus

Asheville, North Carolina, 28801, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

East Carolina University

Greenville, North Carolina, 27858, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Dayton Children's Hospital

Dayton, Ohio, 45404, United States

Location

The Toledo Hospital/Toledo Children's Hospital

Toledo, Ohio, 43606, United States

Location

Mercy Children's Hospital

Toledo, Ohio, 43608, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Natalie Warren Bryant Cancer Center at Saint Francis

Tulsa, Oklahoma, 74136, United States

Location

Legacy Emanuel Children's Hospital

Portland, Oregon, 97227, United States

Location

Legacy Emanuel Hospital and Health Center

Portland, Oregon, 97227, United States

Location

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Penn State Hershey Children's Hospital

Hershey, Pennsylvania, 17033, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Palmetto Health Richland

Columbia, South Carolina, 29203, United States

Location

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605, United States

Location

Greenville Cancer Treatment Center

Greenville, South Carolina, 29605, United States

Location

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

Location

T C Thompson Children's Hospital

Chattanooga, Tennessee, 37403, United States

Location

East Tennessee Childrens Hospital

Knoxville, Tennessee, 37916, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Texas Tech University Health Science Center-Amarillo

Amarillo, Texas, 79106, United States

Location

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

Location

Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Covenant Children's Hospital

Lubbock, Texas, 79410, United States

Location

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Scott and White Memorial Hospital

Temple, Texas, 76508, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

University of Vermont College of Medicine

Burlington, Vermont, 05405, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Childrens Hospital-King's Daughters

Norfolk, Virginia, 23507, United States

Location

Naval Medical Center - Portsmouth

Portsmouth, Virginia, 23708-2197, United States

Location

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

Carilion Clinic Children's Hospital

Roanoke, Virginia, 24014, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204, United States

Location

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, 98405, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

West Virginia University Charleston

Charleston, West Virginia, 25304, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Marshfield Clinic

Marshfield, Wisconsin, 54449, United States

Location

Midwest Children's Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

John Hunter Children's Hospital

Hunter Regional Mail Centre, New South Wales, 2310, Australia

Location

Sydney Children's Hospital

Randwick, New South Wales, 2031, Australia

Location

The Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Royal Children's Hospital-Brisbane

Herston, Queensland, 4029, Australia

Location

Women's and Children's Hospital-Adelaide

North Adelaide, South Australia, 5006, Australia

Location

Royal Children's Hospital

Parkville, Victoria, 3052, Australia

Location

Princess Margaret Hospital for Children

Perth, Western Australia, 6008, Australia

Location

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Janeway Child Health Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3J 3G9, Canada

Location

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

Chedoke-McMaster Hospitals

Hamilton, Ontario, L8S 4L8, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, K7L 5P9, Canada

Location

Children's Hospital

London, Ontario, N6A 5W9, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

The Montreal Children's Hospital of the MUHC

Montreal, Quebec, H3H 1P3, Canada

Location

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Centre Hospitalier Universitaire de Quebec

Ste-Foy, Quebec, G1V 4G2, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Starship Children's Hospital

Grafton, Auckland, 1145, New Zealand

Location

San Jorge Children's Hospital

San Juan, 00912, Puerto Rico

Location

Related Publications (1)

• Benedetti DJ, Renfro LA, Tfirn I, Daw NC, Kalapurakal JA, Ehrlich PF, Khanna G, Perlman E, Warwick A, Gow KW, Paulino AC, Seibel NL, Grundy P, Fernandez CV, Geller JI, Mullen EA, Dome JS. Treatment and outcomes of clear cell sarcoma of the kidney: A report from the Children's Oncology Group studies AREN0321 and AREN03B2. Cancer. 2024 Jul 1;130(13):2361-2371. doi: 10.1002/cncr.35266. Epub 2024 Feb 23.

  PMID: 38396300 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell; Wilms Tumor

Interventions

Doxorubicin; Irinotecan; Surgical Procedures, Operative; Congresses as Topic; Cyclophosphamide; Etoposide; Carboplatin; Dactinomycin; Vincristine; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplasms, Complex and Mixed; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Camptothecin; Alkaloids; Heterocyclic Compounds; Organizations; Health Care Economics and Organizations; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Coordination Complexes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Peptides, Cyclic; Macrocyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Indolizidines; Indolizines; Therapeutics; Physical Phenomena

Results Point of Contact

• Title: Results Reporting Coordinator
• Organization: Children's Oncology Group

resultsreportingcoordinator@childrensoncologygroup.org

626-447-0064

Study Officials

• Jeffrey Dome, MD

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2006
• First Posted: June 12, 2006
• Study Start: June 1, 2006
• Primary Completion: December 1, 2015
• Last Updated: July 21, 2017
• Results First Posted: June 14, 2017

Record last verified: 2016-04

Locations

CA (16); PR (1); AU (8); US (161); NZ (1)