Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma



Status:Active, not recruiting
Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 49
Updated:4/21/2016
Start Date:December 2006

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Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine and Irinotecan (VI) for Patients With Intermediate-Risk Rhabdomyosarcoma (RMS)

This randomized phase III trial is studying two different combination chemotherapy regimens
to compare how well they work when given together with radiation therapy in treating
patients with newly diagnosed rhabdomyosarcoma. Drugs used in chemotherapy, such as
vincristine sulfate, dactinomycin, cyclophosphamide, and irinotecan hydrochloride, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving
combination chemotherapy together with radiation therapy may kill more tumor cells. It is
not yet known which combination chemotherapy regimen is more effective when given together
with radiation therapy in treating patients with rhabdomyosarcoma.

PRIMARY OBJECTIVES:

I. To compare the early response rates, failure-free survival (FFS), and survival of
patients with intermediate-risk rhabdomyosarcoma (RMS) treated with surgery, radiotherapy,
and vincristine (vincristine sulfate), dactinomycin and cyclophosphamide (VAC) or VAC
alternating with vincristine, irinotecan (irinotecan hydrochloride) (VI).

SECONDARY OBJECTIVES:

I. To compare FFS, local control, and survival of patients with intermediate-risk RMS
treated with VAC and early (week 4) radiotherapy vs delayed (week 10) radiotherapy, using
data from Intergroup Rhabdomyosarcoma Study (IRS)-IV for historic comparison.

II. To compare the acute and late effects of VAC to VAC alternating with VI, including the
toxicity associated with concurrent VI and radiotherapy.

III. To compare the acute and late effects of VAC as delivered on this study to D9803 VAC.

IV. To correlate change in fludeoxyglucose F-18 positron emission tomography (FDG-PET)
maximum standard uptake value (SUVmax) from week 1 to week 4 and 15 with FFS.

V. For VI treated patients, to correlate patient UDP glucuronosyltransferase 1 family,
polypeptide A1 (UGT1A1) genotype with VI toxicity. VI. To correlate cytochrome P450, family
2, subfamily B, polypeptide 6 (CYP2B6), cytochrome P450, family 2, subfamily C, polypeptide
9 (CYP2C9), and glutathione S-transferase alpha 1 (GSTA1) genotypes with VAC toxicity.

VII. To prospectively evaluate and validate gene expression values with the intent to define
the best diagnostic predictors and more powerful prognostic classifiers.

VIII. To assess the frequency of bladder dysfunction in patients with bladder, prostate, and
pelvic sites of RMS 3-6 years after study enrollment.

OUTLINE: Patients are randomized to 1 of 2 treatment arms within 42 days of initial surgery
or biopsy.

ARM I (VAC): Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1
minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5
minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40; and
cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31,
34, 37, and 40.

ARM II (VAC/VI): Patients receive VAC chemotherapy alternating with VI chemotherapy
comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-13,16, 17, 19, 20,
22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1,13,
22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34,
and 40; and irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 7, 16, 19,
25, 31, and 37.

In both arms, treatment continues in the absence of disease progression or unacceptable
toxicity. Patients* in both arms also undergo radiotherapy 5 days a week for 4-6 weeks
beginning in week 4 (except patients with alveolar RMS rendered group I by amputation OR
patients needing week 1 emergency radiotherapy for symptomatic spinal cord compression).

NOTE: *Individualized local control plan that deviates from protocol-mandated radiotherapy
allowed for patients =< 24 months of age.

After completion of study treatment, patients are followed up every 2-4 months for 4 years
and then annually for 5-10 years.

Inclusion Criteria:

- Patients with newly diagnosed embryonal RMS, botryoid or spindle cell variants of
embryonal RMS, ectomesenchymoma, or alveolar RMS are eligible for this study

- Enrollment on COG-D9902 to confirm local histologic diagnosis with central pathology
review is required for all patients

- Patients may be enrolled on ARST0531 and start protocol treatment prior to receipt of
central pathology review results

- Patient must have Intermediate-risk RMS defined as:

- Embryonal, botryoid, or spindle cell RMS, or ectomesenchymoma: stage 2 or 3 and
group III OR

- Alveolar RMS: stage 1-3 and group I-III

- Staging ipsilateral retroperitoneal lymph node dissection (SIRLND) is required for
all patients >= 10 years of age with paratesticular tumors and for patients < 10
years with clinically or radiographically involved lymph nodes (except when extensive
lymph node involvement, defined as two or more lymph nodes > 2 cm in dimension, is
identified by imaging studies)

- Regional lymph node sampling or sentinel lymph node procedure is required for
histologic evaluation in patients with extremity tumors

- Clinically or radiographically enlarged nodes should be sampled for histologic
evaluation

- Detection of metastasis by optional FDG PET (not required for study enrollment); FDG
PET may detect abnormalities suggestive of metastasis not identified by bone scan,
computed tomography (CT), or bone marrow aspiration/biopsy; the prognostic
significance of FDG PET-detected abnormalities is not clear; FDG PET-detected
abnormalities MUST be confirmed to be metastases by an additional imaging modality
(such as magnetic resonance imaging [MRI] or CT) OR pathologic confirmation; unless
FDG PET abnormalities are confirmed by another imaging modality or biopsy, FDG PET
abnormalities will NOT be considered evidence of metastasis

- Patients must have a performance status of 0, 1, or 2; the Lansky performance score
should be used for patients < 16 years and the Karnofsky performance score for
patients >= 16 years

- Patients who have received prior chemotherapy (excluding steroids) or radiation
therapy, except for patients transferring from ARST0331 (low-risk study), are not
eligible

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows:

- 1 month to < 6 months: 0.4 mg/dL

- 6 months to < 1 year: 0.5 mg/dL

- 1 to < 2 years: 0.6 mg/dL

- 2 to < 6 years: 0.8 mgt/dL

- 6 to < 10 years: 1 mg/dL

- 10 to < 13 years: 1.2 mg/dL

- 13 to < 16 years: 1.5 mg/dL (males) or 1.4 mg/dL (females)

- >= 16 years: 1.7 mg/dL (males) or 1.4 mg/dL (females)

- Patients with urinary tract obstruction by tumor must meet the renal function
criteria AND must have unimpeded urinary flow established via decompression of the
obstructed portion of the urinary tract

- Total bilirubin =< 1.5 x upper limit of normal for age

- Peripheral absolute neutrophil count (ANC) >= 750/uL

- Platelet count >= 75,000/uL (transfusion independent)

- No evidence of uncontrolled infection

- Patients must be able to undergo radiation therapy, if necessary, as specified in the
protocol

- Female patients of childbearing potential must have a negative pregnancy test

- Female patients who are breast feeding must agree to stop breast feeding

- Sexually active patients of childbearing potential must be willing to use effective
contraception during therapy and for at least 1 month after treatment is completed

- 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
186
sites
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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Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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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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9981 S Healthpark Dr # 465
Fort Myers, Florida 33908
239-343-5000
Lee Memorial Health System Our origins can be traced to the Fall of 1916 when...
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Gainesville, Florida 32610
(352) 392-3261
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100 Michigan Street Northeast
Grand Rapids, Michigan 49503
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282 Washington St
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
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2500 N State St
Jackson, Mississippi 39216
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524 South Park Street
Kalamazoo, Michigan 49007
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2401 Gillham Rd
Kansas City, Missouri 64108
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Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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529 West Markham Street
Little Rock, Arkansas 72205
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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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8700 Beverly Blvd # 8211
Los Angeles, California 90048
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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231 E Chestnut St
Louisville, Kentucky 40202
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Kosair Children's Hospital For more than a century, Kosair Children's Hospital and its predecessor hospitals...
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4015 22nd Place
Lubbock, Texas 79410
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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
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262 Danny Thomas Pl
Memphis, Tennessee 38105
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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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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
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747 52nd St
Oakland, California 94609
(510) 428-3000
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1201 W La Veta Ave
Orange, California 92868
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1717 South Orange Avenue # 100
Orlando, Florida 32806
(407) 650-7000
Nemours Children's Clinic - Orlando Located near downtown Orlando, Nemours Children’s Clinic, Orlando is a...
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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
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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593 Eddy Street
Providence, Rhode Island 02903
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401 College Street
Richmond, Virginia 23298
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60 Crittenden Blvd # 70
Rochester, New York 14642
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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
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3020 Childrens way
San Diego, California 92123
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Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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40 Sunshine Cottage Road
Valhalla, New York 10595
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1600 Rockland Road
Wilmington, Delaware 19803
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Albany, New York 12208
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Albuquerque, New Mexico 87131
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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
(720) 777-1234
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
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2401 W Belvedere Ave
Baltimore, Maryland 21215
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489 State St
Bangor, Maine 04401
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8901 Rockville Pike
Bethesda, Maryland 20889
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100 E Idaho St
Boise, Idaho 83712
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Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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55 Fruit St
Boston, Massachusetts 02114
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450 Brookline Ave
Boston, Massachusetts 2215
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Brooklyn, New York 11205
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Chapel Hill, North Carolina 27599
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171 Ashley Avenue
Charleston, South Carolina 29425
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Charlotte, North Carolina 28204
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Charlottesville, Virginia 22903
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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
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2049 E 100th St
Cleveland, Ohio 44106
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1 Hospital Dr
Columbia, Missouri 65212
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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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Detroit, Michigan 48236
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Downey, California 90027
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Duarte, California 91010
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Durham, North Carolina 27710
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East Lansing, Michigan 48824
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East Lansing, MI
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801 Broadway
Fargo, North Dakota 58102
(701) 234-6175
Sanford Medical Center-Fargo Sanford Medical Center Fargo is a major medical center that provides comprehensive,...
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1600 S Andrews Ave
Fort Lauderdale, Florida 33316
(954) 355-4400
Broward Health Medical Center Broward Health, providing service for more than 75 years, is a...
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Fort Myers, FL
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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835 S Van Buren St
Green Bay, Wisconsin 54301
(920) 433-0111
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Green Bay, WI
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900 West Faris Rd.
Greenville, South Carolina 29605
(864)455-8898
BI-LO Charities Children's Cancer Center The BI-LO Charities Children
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Greenville, SC
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Greenville, South Carolina 29605
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Greenville, SC
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-8521
Penn State Hershey Children's Hospital Penn State Milton S. Hershey Medical Center, Penn State College...
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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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Hollywood, FL
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