Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 49
Updated:4/21/2016
Start Date:September 2004

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Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients With Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma

This phase III trial is studying how well combination chemotherapy and radiation therapy
work in treating patients with newly diagnosed low-risk rhabdomyosarcoma. Drugs used in
chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in different
ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses
high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may
kill more tumor cells. It is not yet known which treatment regimen is more effective in
treating low-risk rhabdomyosarcoma.

PRIMARY OBJECTIVES:

I. Determine the failure-free survival of patients with newly diagnosed low-risk
rhabdomyosarcoma treated with vincristine (V), dactinomycin (A), cyclophosphamide (C), and
radiotherapy.

SECONDARY OBJECTIVES:

I. Determine local control rates in patients treated with this regimen. II. Determine the
rate of second-look surgery in patients with bulk residual tumor at diagnosis (clinical
group III) and the proportion of second-look surgeries that render patients treated with
this regimen tumor-free or with microscopic tumor only and evaluate the pathologic
significance of that residual tumor.

III. Determine the local control rates in patients with clinical group III disease treated
with response-adjusted radiotherapy doses after second-look surgical resection.

OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 2
treatment regimens according to disease stage and clinical group.

REGIMEN I (subset 1 patients) [closed to accrual as of 08/13/2010: Patients receive VAC
chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-9 and dactinomycin
IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA
chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 13-21 and
dactinomycin* IV over 1 minute on day 1 of weeks 13, 16, 19, and 22; and radiotherapy**, 5
days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed
dose.

REGIMEN II (subset 2 patients)[closed to accrual as of 9/23/2011]: Patients receive VAC
chemotherapy and radiotherapy** as in regimen I and VA chemotherapy comprising vincristine
IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin* IV over 1
minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46. Patients with
clinical group III disease may undergo second-look surgery at week 13 followed by
response-adjusted radiotherapy, and continued VA* chemotherapy. In both regimens, treatment
continues in the absence of disease progression or unacceptable toxicity.

NOTE: *For both regimens, dactinomycin is omitted during radiotherapy.

NOTE: **Clinical Group I tumors and those with Clinical Group III uterine/cervix primary
disease with negative nodes who have undergone a complete resection (i.e. hysterectomy) at
Week 13 do not receive radiotherapy at Week 13

Patients are followed up every 3 months for 1 year, every 4 months for 2 years, every 6
months for 1 year, and then annually thereafter.

Inclusion Criteria:

- Histologically confirmed newly diagnosed embryonal rhabdomyosarcoma (RMS), botryoid
or spindle cell variants of embryonal RMS, or embryonal ectomesenchymoma, meeting
criteria for 1 of the following subsets:

- Subset 1, defined by meeting 1 of the following criteria (closed to accrual as
of 08/13/2010):

- Stage 1 and clinical group I (completely resected) or II (microscopic
residual disease and/or regional lymph node involvement) disease

- Stage 1 and clinical group III (gross residual disease) disease arising in
the orbit

- Stage 2 and clinical group I or II disease

- Subset 2, defined by meeting 1 of the following criteria (closed to accrual as
of 09/23/2011):

- Stage 1 and clinical group III disease arising in a non-orbit site

- Stage 3 and clinical group I or II disease

- Prior staging ipsilateral retroperitoneal lymph node dissection required for all
patients age 10 and over with paratesticular tumors and patients under 10 years of
age with clinically or radiographically involved lymph nodes (except when extensive
lymph node involvement is identified by imaging studies)

- If there is extensive gross node involvement only confirmatory node biopsy is
recommended and the patient is classified as Clinical Group III

- Prior regional lymph node sampling required for patients with extremity tumors

- None of the following diagnoses:

- Intermediate-risk embryonal RMS

- Metastatic embryonal RMS

- Alveolar RMS

- Undifferentiated sarcoma

- RMS not otherwise specified (NOS)

- Other soft tissue sarcoma, including sarcoma NOS

- Prior enrollment on clinical trial COG-D9902

- Performance status - ECOG 0-2

- Performance status - Karnofsky 50-100% (≥ 16 years old)

- Performance status - Lansky 50-100% (< 16 years old)

- Absolute neutrophil count at least 750/mm^3

- Platelet count at least 75,000/mm^3 (transfusion independent)

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)*

- Creatinine* based on age/gender as follows:

- No greater than 0.8 mg/dL for patients age 5 and under

- No greater than 1.0 mg/dL for patients age 6 to 9

- No greater than 1.2 mg/dL for patients age 10 to 12

- No greater than 1.4 mg/dL for female patients age 13 and over

- No greater than 1.5 mg/dL for male patients age 13 to 15

- No greater than 1.7 mg/dL for male patients age 16 and over

- Creatinine clearance* or radioisotope glomerular filtration rate at least 70
mL/min/1.73 m^2

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No uncontrolled infection

- No prior chemotherapy (except for patients treated on the related intermediate-risk
study)

- Prior steroids allowed

- No prior radiotherapy
We found this trial at
139
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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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
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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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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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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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85 S Prospect St
Burlington, Vermont 5405
(802) 656-3131
University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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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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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
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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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Helen DeVos Children's Hospital at Spectrum Health Helen DeVos Children's Hospital, located in Grand Rapids,...
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282 Washington St
Hartford, Connecticut 06106
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2500 Campus Rd
Honolulu, Hawaii 96822
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1200 Moursund Street
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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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8700 Beverly Blvd # 8211
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231 E Chestnut St
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262 Danny Thomas Pl
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2220 Pierce Ave
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1 Gustave L Levy Pl # 271
New York, New York 10029
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601 Children's Lane
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Orange, California 92868
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5153 North 9th Avenue
Pensacola, Florida 32504
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530 Northeast Glen Oak Avenue
Peoria, Illinois 61603
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South 34th Street
Philadelphia, Pennsylvania 19104
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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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60 Crittenden Blvd # 70
Rochester, New York 14642
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100 N Mario Capecchi Dr
Salt Lake City, Utah 84132
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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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40 Sunshine Cottage Road
Valhalla, New York 10595
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Albany, New York 12208
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1540 East Hospital Drive
Ann Arbor, Michigan 48109
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440 E Huntington Dr
Arcadia, California 91006
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509 Biltmore Ave
Asheville, North Carolina 28801
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13123 E 16th Ave
Aurora, Colorado 80045
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22 South Greene Street
Baltimore, Maryland 21201
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489 State St
Bangor, Maine 04401
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100 E Idaho St
Boise, Idaho 83712
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55 Fruit St
Boston, Massachusetts 02114
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450 Brookline Ave
Boston, Massachusetts 2215
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121 Dekalb Ave
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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Charleston, West Virginia 25304
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200 Hawthorne Ln
Charlotte, North Carolina 28204
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Charlottesville, Virginia 22903
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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
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2049 E 100th St
Cleveland, Ohio 44106
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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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4760 Sunset Blvd
Downey, California 90027
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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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835 S Van Buren St
Green Bay, Wisconsin 54301
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Greenville, South Carolina 29605
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30 Prospect Ave
Hackensack, New Jersey 07601
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500 University Dr
Hershey, Pennsylvania 17033
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1005 Joe DiMaggio Drive
Hollywood, Florida 33021
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1 Jarrett White Rd
Honolulu, Hawaii 96859
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Houston, Texas 77030
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545 Barnhill Dr
Indianapolis, Indiana 46201
(317) 274-8157
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200 Hawkins Dr,
Iowa City, Iowa 52242
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Jacksonville, Florida 32207
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2018 W Clinch Ave
Knoxville, Tennessee 37916
(865) 541-8000
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401 West Greenlawn Avenue
Lansing, Michigan 48910
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601 South Rancho Drive Suite C-26
Las Vegas, Nevada 89106
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1 Medical Center Dr
Lebanon, New Hampshire 03756
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Lexington, Kentucky
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11234 Anderson St
Loma Linda, California 92354
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Long Beach, California 90806
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600 Highland Ave
Madison, Wisconsin 53792
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Miami, Florida 33176
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Baptist Hospital of Miami Since 1960, Baptist Hospital of Miami has been one of the...
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Miami, FL
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Milwaukee, Wisconsin 53226
Midwest Children's Cancer Center The Medical College of Wisconsin Cancer Center is dedicated to providing...
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Milwaukee, WI
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2525 Chicago Ave
Minneapolis, Minnesota 55404
(612) 813-6000
Children's Hospitals and Clinics of Minnesota - Minneapolis Children's Hospitals and Clinics of Minnesota is...
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Minneapolis, MN
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2450 Riverside Ave
Minneapolis, Minnesota 55454
(612) 273-3000
University of Minnesota Medical Center, Fairview Improving patients' lives drives the innovation that makes University...
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Minneapolis, MN
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One Robert Wood Johnson Place
New Brunswick, New Jersey 08901
(732) 828-3000
UMDNJ-Robert Wood Johnson University Hospital Robert Wood Johnson University Hospital is a 965-bed hospital with...
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New Brunswick, NJ
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