Clear Cell Renal Cell Carcinoma Clinical Trial
Official title:
Treatment of High Risk Renal Tumors: A Groupwide Phase II Study
Verified date | April 2016 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 294 |
Est. completion date | |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 29 Years |
Eligibility |
Inclusion Criteria: - 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 - Renal cell carcinoma unclassified - Specimens/materials must be submitted for central review by Day 7 - Patients must begin protocol therapy on AREN0321 by Day 14 after surgery or biopsy (surgery/biopsy is Day 0), unless medically contraindicated - Karnofsky performance status (PS) must be >= 50 for patients > 16 years if age and Lansky PS must be >= 50 for patients =< 16 years of age - Patients must not have received systemic chemotherapy or radiation therapy prior to treatment on this study UNLESS they were enrolled on the AREN0532 or AREN0533 studies and received prenephrectomy chemotherapy for what was originally presumed to be favorable histology Wilms tumor; additionally, patients with pediatric RCC who previously received chemotherapy for another type of malignancy (not the RCC) or non-malignant condition may enroll on the study - Total bilirubin =< 1.5 times upper limit of normal (ULN) for age - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST] or serum glutamic pyruvate transaminase (SGPT) (alanine aminotransferase [ ALT]) < 2.5 times ULN for age - Shortening fraction of >= 27% by echocardiogram OR ejection fraction of >= 50% by radionuclide angiogram - Female patients of childbearing age must have a negative pregnancy test - Female patients who are lactating must agree to stop breast-feeding - Sexually active patients of childbearing potential must agree to use effective contraception - All patients and/or their parents or legal guardians must sign a written informed consent - All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Royal Brisbane and Women's Hospital | Herston | Queensland |
Australia | Royal Children's Hospital-Brisbane | Herston | Queensland |
Australia | John Hunter Children's Hospital | Hunter Regional Mail Centre | New South Wales |
Australia | Women's and Children's Hospital-Adelaide | North Adelaide | South Australia |
Australia | Royal Children's Hospital | Parkville | Victoria |
Australia | Princess Margaret Hospital for Children | Perth | Western Australia |
Australia | Sydney Children's Hospital | Randwick | New South Wales |
Australia | The Children's Hospital at Westmead | Westmead | New South Wales |
Canada | Alberta Children's Hospital | Calgary | Alberta |
Canada | University of Alberta Hospital | Edmonton | Alberta |
Canada | IWK Health Centre | Halifax | Nova Scotia |
Canada | Chedoke-McMaster Hospitals | Hamilton | Ontario |
Canada | McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario |
Canada | Cancer Centre of Southeastern Ontario at Kingston General Hospital | Kingston | Ontario |
Canada | Children's Hospital | London | Ontario |
Canada | Centre Hospitalier Universitaire Sainte-Justine | Montreal | Quebec |
Canada | The Montreal Children's Hospital of the MUHC | Montreal | Quebec |
Canada | Children's Hospital of Eastern Ontario | Ottawa | Ontario |
Canada | Janeway Child Health Centre | Saint John's | Newfoundland and Labrador |
Canada | Saskatoon Cancer Centre | Saskatoon | Saskatchewan |
Canada | Centre Hospitalier Universitaire de Quebec | Ste-Foy | Quebec |
Canada | Hospital for Sick Children | Toronto | Ontario |
Canada | British Columbia Children's Hospital | Vancouver | British Columbia |
Canada | CancerCare Manitoba | Winnipeg | Manitoba |
New Zealand | Starship Children's Hospital | Grafton | Auckland |
Puerto Rico | San Jorge Children's Hospital | San Juan | |
United States | Children's Hospital Medical Center of Akron | Akron | Ohio |
United States | University of New Mexico | Albuquerque | New Mexico |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | Texas Tech University Health Science Center-Amarillo | Amarillo | Texas |
United States | C S Mott Children's Hospital | Ann Arbor | Michigan |
United States | Mission Hospital-Memorial Campus | Asheville | North Carolina |
United States | Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia |
United States | Children's Hospital Colorado | Aurora | Colorado |
United States | Dell Children's Medical Center of Central Texas | Austin | Texas |
United States | Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland |
United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
United States | Eastern Maine Medical Center | Bangor | Maine |
United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
United States | Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania |
United States | Children's Hospital of Alabama | Birmingham | Alabama |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Saint Luke's Mountain States Tumor Institute | Boise | Idaho |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital Cancer Center | Boston | Massachusetts |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | University of Vermont College of Medicine | Burlington | Vermont |
United States | University of North Carolina | Chapel Hill | North Carolina |
United States | West Virginia University Charleston | Charleston | West Virginia |
United States | Carolinas Medical Center | Charlotte | North Carolina |
United States | Novant Health Presbyterian Medical Center | Charlotte | North Carolina |
United States | T C Thompson Children's Hospital | Chattanooga | Tennessee |
United States | Lurie Children's Hospital-Chicago | Chicago | Illinois |
United States | University of Chicago Comprehensive Cancer Center | Chicago | Illinois |
United States | University of Illinois | Chicago | Illinois |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Rainbow Babies and Childrens Hospital | Cleveland | Ohio |
United States | Palmetto Health Richland | Columbia | South Carolina |
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | Driscoll Children's Hospital | Corpus Christi | Texas |
United States | Medical City Dallas Hospital | Dallas | Texas |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Dayton Children's Hospital | Dayton | Ohio |
United States | Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver | Colorado |
United States | Blank Children's Hospital | Des Moines | Iowa |
United States | Saint John Hospital and Medical Center | Detroit | Michigan |
United States | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan |
United States | Southern California Permanente Medical Group | Downey | California |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Michigan State University Clinical Center | East Lansing | Michigan |
United States | Inova Fairfax Hospital | Falls Church | Virginia |
United States | Hurley Medical Center | Flint | Michigan |
United States | Broward Health Medical Center | Fort Lauderdale | Florida |
United States | Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida |
United States | Cook Children's Medical Center | Fort Worth | Texas |
United States | Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids | Michigan |
United States | BI-LO Charities Children's Cancer Center | Greenville | South Carolina |
United States | East Carolina University | Greenville | North Carolina |
United States | Greenville Cancer Treatment Center | Greenville | South Carolina |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Connecticut Children's Medical Center | Hartford | Connecticut |
United States | Penn State Hershey Children's Hospital | Hershey | Pennsylvania |
United States | Memorial Healthcare System - Joe DiMaggio Children's Hospital | Hollywood | Florida |
United States | Tripler Army Medical Center | Honolulu | Hawaii |
United States | University of Hawaii Cancer Center | Honolulu | Hawaii |
United States | Baylor College of Medicine | Houston | Texas |
United States | Riley Hospital for Children | Indianapolis | Indiana |
United States | Saint Vincent Hospital and Health Services | Indianapolis | Indiana |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Nemours Children's Clinic-Jacksonville South | Jacksonville | Florida |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | Kalamazoo Center for Medical Studies | Kalamazoo | Michigan |
United States | The Childrens Mercy Hospital | Kansas City | Missouri |
United States | East Tennessee Childrens Hospital | Knoxville | Tennessee |
United States | Nevada Cancer Research Foundation CCOP | Las Vegas | Nevada |
United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
United States | University of Kentucky/Markey Cancer Center | Lexington | Kentucky |
United States | Arkansas Children's Hospital | Little Rock | Arkansas |
United States | Loma Linda University Medical Center | Loma Linda | California |
United States | Miller Children's Hospital | Long Beach | California |
United States | Children's Hospital Los Angeles | Los Angeles | California |
United States | Kosair Children's Hospital | Louisville | Kentucky |
United States | Covenant Children's Hospital | Lubbock | Texas |
United States | Children's Hospital Central California | Madera | California |
United States | University of Wisconsin Hospital and Clinics | Madison | Wisconsin |
United States | Marshfield Clinic | Marshfield | Wisconsin |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
United States | Baptist Hospital of Miami | Miami | Florida |
United States | Miami Children's Hospital | Miami | Florida |
United States | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida |
United States | Midwest Children's Cancer Center | Milwaukee | Wisconsin |
United States | Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota |
United States | University of South Alabama | Mobile | Alabama |
United States | Morristown Memorial Hospital | Morristown | New Jersey |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | UMDNJ - Robert Wood Johnson University Hospital | New Brunswick | New Jersey |
United States | The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York |
United States | Children's Hospital New Orleans | New Orleans | Louisiana |
United States | Tulane University Health Sciences Center | New Orleans | Louisiana |
United States | Columbia University Medical Center | New York | New York |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | New York University Langone Medical Center | New York | New York |
United States | Weill Medical College of Cornell University | New York | New York |
United States | Newark Beth Israel Medical Center | Newark | New Jersey |
United States | Childrens Hospital-King's Daughters | Norfolk | Virginia |
United States | Advocate Children's Hospital-Oak Lawn | Oak Lawn | Illinois |
United States | Children's Hospital and Research Center at Oakland | Oakland | California |
United States | Kaiser Permanente-Oakland | Oakland | California |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Children's Hospital and Medical Center of Omaha | Omaha | Nebraska |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Childrens Hospital of Orange County | Orange | California |
United States | Florida Hospital Orlando | Orlando | Florida |
United States | UF Cancer Center at Orlando Health | Orlando | Florida |
United States | Lucile Packard Children's Hospital Stanford University | Palo Alto | California |
United States | Advocate Lutheran General Hospital. | Park Ridge | Illinois |
United States | Saint Joseph's Regional Medical Center | Paterson | New Jersey |
United States | Nemours Children's Clinic - Pensacola | Pensacola | Florida |
United States | Saint Jude Midwest Affiliate | Peoria | Illinois |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Saint Christopher's Hospital for Children | Philadelphia | Pennsylvania |
United States | Phoenix Childrens Hospital | Phoenix | Arizona |
United States | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania |
United States | Legacy Emanuel Children's Hospital | Portland | Oregon |
United States | Legacy Emanuel Hospital and Health Center | Portland | Oregon |
United States | Naval Medical Center - Portsmouth | Portsmouth | Virginia |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia |
United States | Carilion Clinic Children's Hospital | Roanoke | Virginia |
United States | Mayo Clinic | Rochester | Minnesota |
United States | University of Rochester | Rochester | New York |
United States | Cardinal Glennon Children's Medical Center | Saint Louis | Missouri |
United States | Saint John's Mercy Medical Center | Saint Louis | Missouri |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | All Children's Hospital | Saint Petersburg | Florida |
United States | Primary Children's Hospital | Salt Lake City | Utah |
United States | Methodist Children's Hospital of South Texas | San Antonio | Texas |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Rady Children's Hospital - San Diego | San Diego | California |
United States | University of California San Francisco Medical Center-Parnassus | San Francisco | California |
United States | Memorial University Medical Center | Savannah | Georgia |
United States | Maine Children's Cancer Program | Scarborough | Maine |
United States | Seattle Children's Hospital | Seattle | Washington |
United States | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota |
United States | Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington |
United States | Southern Illinois University | Springfield | Illinois |
United States | Stony Brook University Medical Center | Stony Brook | New York |
United States | Overlook Hospital | Summit | New Jersey |
United States | State University of New York Upstate Medical University | Syracuse | New York |
United States | Madigan Army Medical Center | Tacoma | Washington |
United States | Mary Bridge Children's Hospital and Health Center | Tacoma | Washington |
United States | Saint Joseph Children's Hospital of Tampa | Tampa | Florida |
United States | Scott and White Memorial Hospital | Temple | Texas |
United States | Mercy Children's Hospital | Toledo | Ohio |
United States | The Toledo Hospital/Toledo Children's Hospital | Toledo | Ohio |
United States | University of Arizona Health Sciences Center | Tucson | Arizona |
United States | Natalie Warren Bryant Cancer Center at Saint Francis | Tulsa | Oklahoma |
United States | Children's National Medical Center | Washington | District of Columbia |
United States | Lombardi Comprehensive Cancer Center at Georgetown University | Washington | District of Columbia |
United States | Saint Mary's Hospital | West Palm Beach | Florida |
United States | Alfred I duPont Hospital for Children | Wilmington | Delaware |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
United States | University of Massachusetts Medical School | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States, Australia, Canada, New Zealand, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event-free survival of patients with diffuse anaplastic Wilms' tumor (DAWT) treated with HU-1 | An analysis plan based on the method of Woolson will be used to monitor outcome for these patients. O'Brien-Fleming boundary (truncated at 3 standard deviations) will be used. | Up to 4 years | No |
Primary | 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 I. An analysis plan will be based on the method of Woolson and an O'Brien-Fleming boundary (truncated at 3 standard deviations). | Up to 5 years | No |
Primary | Efficacy of vincristine/irinotecan when delivered in an 6-week window | Design based on work by Bryant and Day (Biometrics 51:1372-83, 1995), with parameters. | Up to 5 years | No |
Primary | Event-free survival | Event-free survival will be informally compared to that seem for similar patients treated on NWTS-5. | Up to 5 years | No |
Primary | Toxicity as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | Unacceptable toxicity will be defined as treatment-related mortality and Grade 3 or 4 non-hematological toxicity, with the specific exceptions of the following Grade 3 toxicities: anorexia, weight loss, nausea, fatigue, mucositis, diarrhea, fever, electrolyte/metabolic abnormalities, and infection. Each of these adverse events will be monitored separately. A true rate of 1% for the entire treatment period is considered acceptable, whereas a rate of 5.5% would not be. | Up to 35years | Yes |
Secondary | Frequency of INI1 mutations in renal and extrarenal malignant rhabdoid tumor by fluorescent in situ hybridization | The biology studies will be hypothesis-generating and descriptive; they do not have a statistical design. | At baseline | No |
Secondary | Frequency of TP53 mutations in patients with anaplastic Wilms' tumor by immunohistochemistry | The biology studies will be hypothesis-generating and descriptive; they do not have a statistical design. | At baseline | No |
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