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



Status:Completed
Conditions:Colorectal Cancer, Cancer, Cancer, Kidney Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 29
Updated:4/21/2016
Start Date:June 2006

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Treatment of High Risk Renal Tumors: A Groupwide Phase II Study

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.

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.

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
We found this trial at
162
sites
1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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4900 Mueller Boulevard
Austin, Texas 78723
(512) 324-0000
Dell Children's Medical Center of Central Texas Welcome to Dell Children
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2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
(484) 884-2200
Lehigh Valley Hospital - Muhlenberg At Lehigh Valley Health Network, we continually go the extra...
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1600 7th Avenue
Birmingham, Alabama 35233
(205) 638-9100
Children's Hospital of Alabama Children
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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3533 South Alameda Street
Corpus Christi, Texas 78411
(361) 694-5000
Driscoll Children's Hospital Driscoll Children's Hospital was built because Clara Driscoll's will requested that a...
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7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
Medical City Dallas Hospital If you have concerns for your health, that of a family...
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1200 Pleasant Street
Des Moines, Iowa 50309
(515) 241-KIDS
Blank Children's Hospital Blank Children's Hospital is completely dedicated to meeting the unique health care...
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3300 Gallows Road
Falls Church, Virginia 22042
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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100 Michigan Street Northeast
Grand Rapids, Michigan 49503
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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231 E Chestnut St
Louisville, Kentucky 40202
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4015 22nd Place
Lubbock, Texas 79410
806-725-0000
Covenant Children's Hospital Every child is different. And when they're sick or injured, they deserve...
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9300 Valley Children's Pl
Madera, California 93720
(559) 353-3000
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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3100 SW 62nd Ave
Miami, Florida 33155
(305) 666-6511
Miami Children's Hospital Welcome to Miami Children
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2220 Pierce Ave
Nashville, Tennessee 37232
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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747 52nd St
Oakland, California 94609
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Children's Hospital and Research Center Oakland For nearly 100 years, Children's Hospital & Research Center...
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1201 W La Veta Ave
Orange, California 92868
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Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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5153 North 9th Avenue
Pensacola, Florida 32504
(850) 505-4700
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530 Northeast Glen Oak Avenue
Peoria, Illinois 61603
(309) 624-4945
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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620 John Paul Jones Cir
Portsmouth, Virginia 23708
(757) 953-5008
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
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401 College Street
Richmond, Virginia 23298
(804) 828-0450
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
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7700 Floyd Curl Dr
San Antonio, Texas 78229
(210) 575-7000
Methodist Children's Hospital of South Texas Methodist Children
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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Albuquerque, New Mexico 87131
(505) 277-0111
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1540 East Hospital Drive
Ann Arbor, Michigan 48109
(877) 475-6688
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Asheville, North Carolina 28801
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13123 E 16th Ave
Aurora, Colorado 80045
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2401 W Belvedere Ave
Baltimore, Maryland 21215
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489 State St
Bangor, Maine 04401
(207) 973-7000
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
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100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
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Chapel Hill, North Carolina 27599
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Charleston, West Virginia 25304
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Chattanooga, Tennessee 37403
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Chicago, Illinois 60614
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1200 West Harrison Stree
Chicago, Illinois 60607
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
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2049 E 100th St
Cleveland, Ohio 44106
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5 Richland Medical Park Dr
Columbia, South Carolina 29203
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1801 Inwood Rd
Dallas, Texas 75390
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100 North Academy Avenue
Danville, Pennsylvania 17822
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4160 John R St #2122
Detroit, Michigan 48201
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22101 Moross Rd
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Downey, California 90027
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2301 Erwin Rd
Durham, North Carolina 27710
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East Lansing, Michigan 48824
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1600 S Andrews Ave
Fort Lauderdale, Florida 33316
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801 7th Avenue
Fort Worth, Texas 76104
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Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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1001 E 5th St
Greenville, North Carolina 27858
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900 West Faris Rd.
Greenville, South Carolina 29605
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Greenville, South Carolina 29605
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30 Prospect Ave
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500 University Dr
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1005 Joe DiMaggio Drive
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Hollywood, FL
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Honolulu, Hawaii 96813
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Honolulu, HI
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1 Jarrett White Rd
Honolulu, Hawaii 96859
(808) 433-6661
Tripler Army Medical Center The attack of Pearl Harbor led to the construction of Tripler...
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Honolulu, HI
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Hunter Regional Mail Centre, New South Wales
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Hunter Regional Mail Centre,
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Indianapolis, IN
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2001 W 86th St
Indianapolis, Indiana 46260
(317) 338-2345
Saint Vincent Hospital and Health Services At St.Vincent Indianapolis, everything we do begins with a...
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Indianapolis, IN
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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Jacksonville, Florida 32207
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Jacksonville, FL
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Kalamazoo, Michigan 49008
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Kalamazoo, MI
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2018 W Clinch Ave
Knoxville, Tennessee 37916
(865) 541-8000
East Tennessee Children's Hospital East Tennessee Children's Hospital is a not-for-profit, private, independent pediatric medical...
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Knoxville, TN
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601 South Rancho Drive Suite C-26
Las Vegas, Nevada 89106
(702) 384-0013
Nevada Cancer Research Foundation CCOP The Nevada Cancer Research Foundation Community Clinical Oncology Program (NCRF-CCOP)...
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Las Vegas, NV
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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Lexington, KY
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Little Rock, AR
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Loma Linda, CA
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2801 Atlantic Ave
Long Beach, California 90806
(562) 933-5437
Miller Children's Hospital Miller Children
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Long Beach, CA
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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Madison, WI
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