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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00335556
Other study ID # AREN0321
Secondary ID NCI-2009-00414CO
Status Completed
Phase Phase 2
First received June 8, 2006
Last updated April 14, 2016
Start date June 2006

Study information

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

Clinical Trial 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.


Description:

PRIMARY OBJECTIVES:

I. Evaluate whether a treatment regimen containing cyclophosphamide, carboplatin, and etoposide alternating with vincristine, doxorubicin hydrochloride, and cyclophosphamide (regimen UH-1) improves the event-free and overall survival of patients with diffuse anaplastic Wilms' tumor (DAWT) as compared to historical controls.

II. Evaluate, in a phase II "window" study, the antitumor activity of a combination of vincristine and protracted-schedule irinotecan hydrochloride in patients with metastatic DAWT.

III. Evaluate whether regimen UH-1 improves the event-free and overall survival of patients with malignant rhabdoid tumor (MRT) as compared to historical controls.

IV. Maintain the excellent event-free survival of patients with stage I clear cell sarcoma of the kidney (CCSK) without the use of abdominal irradiation.

SECONDARY OBJECTIVES:

I. Describe the outcomes of patients with stage I DAWT or stages I-III focal anaplastic Wilms' tumor (FAWT) treated with vincristine, dactinomycin, doxorubicin hydrochloride, and flank radiation.

II. Describe the outcomes of patients with stage IV FAWT or stage IV CCSK treated with regimen UH-1.

III. Describe event-free and overall survival of children and adolescents with localized renal cell carcinoma (RCC) (including patients with local lymph node involvement) treated with surgical resection without adjuvant therapy.

IV. Describe response rate, event-free survival, and overall survival of patients with unresectable or distantly metastatic RCC treated according to institutional preference.

V. Correlate histologic and molecular cytogenetic findings with outcome in pediatric RCC.

VI. Evaluate the frequency of germline and inherited INI1 mutations in renal and extrarenal MRT and correlate the presence of detectable INI1 mutation with clinical outcome.

VII. Determine the frequency of TP53 mutations in anaplastic Wilms' tumor and correlate the presence of detectable TP53 mutation with clinical outcome.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 6 treatment regimens according to tumor histology, stage of disease, and response to treatment.

SURGERY (renal cell carcinoma [RCC]): 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.

REGIMEN UH-1 (stage II-III or stage IV [with no measurable disease] diffuse anaplastic Wilms' tumor [DAWT], stage I-IV malignant rhabdoid tumor [MRT], stage IV focal anaplastic Wilms' tumor [FAWT], or stage IV clear cell sarcoma of the kidney [CCSK]): Patients receive vincristine IV on day 1 in weeks 1-3, 10-12, 13-15, 22-24, and 28-30; doxorubicin hydrochloride IV over 15 minutes on day 1 and cyclophosphamide (CPM2) IV over 15-30 minutes on day 1 in weeks 1, 10, 13, 22, and 28; and cyclophosphamide (at lower doses [CPM1]) IV over 1 hour and etoposide IV over 1 hour on days 1-4 and carboplatin IV over 1 hour on day 1 in weeks 4, 7, 16, 19, and 25. 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 CCSK receive no further study therapy.

IRINOTECAN/VINCRISTINE WINDOW THERAPY* (stage IV DAWT with measurable disease at diagnosis): Patients receive vincristine IV on day 1 and irinotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 2. 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.

NOTE: *Patients who are eligible for but who are unwilling to receive window therapy, receive therapy on regimen UH-1.

REGIMEN UH-2 (DAWT with CR/PR to irinotecan hydrochloride/vincristine window therapy): Patients receive vincristine on day 1 in weeks 1-3, 10, 11, 16-21, 25, 26, 28-30, and 34-36 and doxorubicin hydrochloride and CPM2 as in regimen UH-1 in weeks 1, 16, 19, 28, and 34. Patients also receive CPM1, etoposide, and carboplatin as in regimen UH-1 in weeks 4, 7, 13, 22, and 31 and irinotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 10, 11, 25, and 26. 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.

REGIMEN I (stage I-III CCSK): Patients receive vincristine IV on day 1 in weeks 1-3, 5-9, 8-9, 11-14, 19, and 25; doxorubicin hydrochloride IV over 15 minutes on day 1 and cyclophosphamide IV over 1 hour on days 1-3 in weeks 1, 7, 13, 19, and 25; and cyclophosphamide IV and etoposide IV on days 1-5 in weeks 4, 10, 16, and 22. 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.

REGIMEN DD-4A (stage I DAWT or stages I-III FAWT): Patients receive dactinomycin IV over 1-5 minutes on day 1 in weeks 1, 7, 13, 19, and 25; vincristine IV on day 1 in weeks 1-10, 13, 16, 19, 22, and 25; and doxorubicin hydrochloride IV over 15 minutes on day 1 in weeks 4,10, 16, and 22. 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. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for at least 3 years.


Recruitment information / eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Doxorubicin Hydrochloride
Given IV
Irinotecan Hydrochloride
Given IV
Procedure:
Conventional Surgery
Patients undergo resection
Drug:
Cyclophosphamide
Given IV
Etoposide
Given IV
Carboplatin
Given IV
Biological:
Dactinomycin
Given IV
Drug:
Vincristine Sulfate
Given IV
Radiation:
Radiation Therapy
Undergo radiotherapy
Other:
Laboratory Biomarker Analysis
Correlative studies

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  New Zealand,  Puerto Rico, 

Outcome

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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