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
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630 W 168th St
New York, New York
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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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
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1600 7th Avenue
Birmingham, Alabama 35233
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Children's Hospital of Alabama Children
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1720 2nd Ave S
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
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1 South Prospect Street
Burlington, Vermont 05401
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1000 Blythe Blvd
Charlotte, North Carolina 28203
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
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Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
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2500 N State St
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South 34th Street
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60 Crittenden Blvd # 70
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1600 Rockland Road
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1005 Joe DiMaggio Drive
Hollywood, Florida 33021
954-265-JDCH (5324)
Memorial Healthcare System - Joe DiMaggio Children's Hospital Since its inception in 1953, Memorial Healthcare...
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Honolulu, Hawaii 96813
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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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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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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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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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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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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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2801 Atlantic Ave
Long Beach, California 90806
(562) 933-5437
Miller Children's Hospital Miller Children
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