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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00075582 |
Purpose
RATIONALE: 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.
PURPOSE: This phase III trial is studying how well combination chemotherapy and radiation therapy work in treating patients with newly diagnosed low-risk rhabdomyosarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Biological: dactinomycin Drug: cyclophosphamide Drug: vincristine sulfate Procedure: conventional surgery Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Vincristine, Dactinomycin, And Lower Doses Of Cyclophosphamide With or Without Radiation Therapy For Patients With Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma |
| Estimated Enrollment: | 360 |
| Study Start Date: | September 2004 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Regimen I (subset 1 patients): Experimental
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 (dactinomycin is omitted during radiotherapy); and radiotherapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiotherapy; some start it at week 24.
|
Biological: dactinomycin
Given IV
Drug: cyclophosphamide
Given IV
Drug: vincristine sulfate
Given IV
Procedure: conventional surgery
Some patients may undergo second-look surgery
Radiation: radiation therapy
Some patients undergo radiotherapy
|
|
Regimen II (subset 2 patients): Experimental
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 (dactinomycin is omitted during radiotherapy). Some patients do not receive radiotherapy; some start it at week 24.
|
Biological: dactinomycin
Given IV
Drug: cyclophosphamide
Given IV
Drug: vincristine sulfate
Given IV
Procedure: conventional surgery
Some patients may undergo second-look surgery
Radiation: radiation therapy
Some patients undergo radiotherapy
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 2 treatment regimens according to disease stage and clinical group.
Patients with clinical group III disease may undergo second-look surgery at week 13 followed by response-adjusted radiotherapy, administered as in regimen I, and continued VA* chemotherapy as in regimen I or II.
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 every 3 months for 1 year, every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 360 patients (260 for regimen I [subset 1] and 100 for regimen II [subset 2]) will be accrued for this study within 6 years.
Eligibility| Ages Eligible for Study: | up to 49 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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:
Subset 2, defined by meeting 1 of the following criteria:
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)
None of the following diagnoses:
PATIENT CHARACTERISTICS:
Age
Under 50
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Creatinine* based on age/gender as follows:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| UAB Comprehensive Cancer Center | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Clinical Trials Office - UAB Comprehensive Cancer Center 205-934-0309 | |
| United States, Arizona | |
| Arizona Cancer Center at University of Arizona Health Sciences Center | Recruiting |
| Tucson, Arizona, United States, 85724-5024 | |
| Contact: Clinical Trials Office - Arizona Cancer Center at University o 520-626-9008 | |
| Phoenix Children's Hospital | Recruiting |
| Phoenix, Arizona, United States, 85016-7710 | |
| Contact: Jessica L. Boklan 602-546-0920 | |
| United States, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Clinical Trial Office - Arkansas Cancer Research Center at Uni 501-686-8274 | |
| United States, California | |
| Children's Hospital and Research Center Oakland | Recruiting |
| Oakland, California, United States, 94609 | |
| Contact: Clinical Trial Office - Children's Hospital and Research Cente 510-450-7600 | |
| Kaiser Permanente Medical Center - Oakland | Recruiting |
| Sacramento, California, United States, 95825 | |
| Contact: Vincent Kiley 916-474-2326 | |
| Childrens Hospital Los Angeles | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Leo Mascarenhas 323-361-2529 | |
| Children's Hospital of Orange County | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Violet Shen 714-532-8636 | |
| Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Recruiting |
| Long Beach, California, United States, 90801 | |
| Contact: Jerry Z. Finklestein 562-492-1062 | |
| Jonsson Comprehensive Cancer Center at UCLA | Recruiting |
| Los Angeles, California, United States, 90095-1781 | |
| Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a 888-798-0719 | |
| Children's Hospital Central California | Recruiting |
| Madera, California, United States, 93638-8762 | |
| Contact: Vonda L. Crouse 559-353-5480 | |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | Recruiting |
| Loma Linda, California, United States, 92354 | |
| Contact: Clinical Trials Office - Loma Linda University Cancer Institut 909-558-3375 | |
| Rady Children's Hospital - San Diego | Recruiting |
| San Diego, California, United States, 92123-4282 | |
| Contact: Clinical Trials Office - Rady Children's Hospital - San Diego 858-966-5934 | |
| Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Recruiting |
| Los Angeles, California, United States, 90048-1865 | |
| Contact: Carole H. Hurvitz 310-423-4423 | |
| Southern California Permanente Medical Group | Recruiting |
| Downey, California, United States, 90027 | |
| Contact: Robert M. Cooper 323-783-5307 | |
| Stanford Cancer Center | Recruiting |
| Stanford, California, United States, 94305-5824 | |
| Contact: Clinical Trials Office - Stanford Cancer Center 650-498-7061 cctoffice@stanford.edu | |
| Sutter Cancer Center | Recruiting |
| Sacramento, California, United States, 95816 | |
| Contact: Clinical Trial Office - Sutter Cancer Center 916-454-6595 | |
| UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |
| University of California Davis Cancer Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 | |
| United States, Colorado | |
| Children's Hospital Center for Cancer and Blood Disorders | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Kelly Maloney 720-777-6673 | |
| Presbyterian - St. Luke's Medical Center | Recruiting |
| Denver, Colorado, United States, 80218 | |
| Contact: Clinical Trials Office - Presbyterian - St. Luke's Medical Cen 303-839-6000 | |
| United States, Connecticut | |
| Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Recruiting |
| Farmington, Connecticut, United States, 06360-2875 | |
| Contact: Clinical Trials Office - Carole and Ray Neag Comprehensive Can 800-579-7822 | |
| United States, Delaware | |
| Alfred I. duPont Hospital for Children | Recruiting |
| Wilmington, Delaware, United States, 19803 | |
| Contact: Clinical Trials Office - Alfred I. duPont Hospital for Childre 302-651-5755 | |
| United States, District of Columbia | |
| Children's National Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20010-2970 | |
| Contact: Clinical Trials Office - Children's National Medical Center 202-884-2549 | |
| United States, Florida | |
| All Children's Hospital | Recruiting |
| St. Petersburg, Florida, United States, 33701 | |
| Contact: Gregory Hale 727-767-4176 | |
| Baptist-South Miami Regional Cancer Program | Recruiting |
| Miami, Florida, United States, 33176 | |
| Contact: Doured Daghistani 305-274-1662 | |
| Broward General Medical Center Cancer Center | Recruiting |
| Fort Lauderdale, Florida, United States, 33316 | |
| Contact: Clinical Trials Office - Broward General Medical Center Cancer 954-355-5346 | |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | Recruiting |
| Orlando, Florida, United States, 32803-1273 | |
| Contact: Clinical Trials Office - Florida Hospital Cancer Institute 407-303-5623 | |
| Kaplan Cancer Center at St. Mary's Medical Center | Recruiting |
| West Palm Beach, Florida, United States, 33407 | |
| Contact: Narayana Gowda 561-844-6363 | |
| Sacred Heart Cancer Center at Sacred Heart Hospital | Recruiting |
| Pensacola, Florida, United States, 32504 | |
| Contact: Clinical Trials Office - Sacred Heart Cancer Center 850-416-4611 | |
| Memorial Cancer Institute at Memorial Regional Hospital | Recruiting |
| Hollywood, Florida, United States, 33021 | |
| Contact: Clinical Trials Office - Memorial Cancer Institute 954-985-3443 | |
| Miami Children's Hospital | Recruiting |
| Miami, Florida, United States, 33155 | |
| Contact: Enrique Escalon 305-662-8360x4960 | |
| Nemours Children's Clinic - Orlando | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Paul R. Gordon 407-650-7330 | |
| Nemours Children's Clinic | Recruiting |
| Jacksonville, Florida, United States, 32207 | |
| Contact: Eric S. Sandler 904-697-3793 | |
| Lee Cancer Care of Lee Memorial Health System | Recruiting |
| Fort Myers, Florida, United States, 33901 | |
| Contact: Clinical Trials Office - Lee Cancer Care of Lee Memorial Healt 877-680-0008 | |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | Recruiting |
| Tampa, Florida, United States, 33607 | |
| Contact: Clinical Trials Office - St. Joseph's Cancer Institute 800-882-4123 | |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: University of Miami Sylvester Comprehensive Cancer Center Clin 866-574-5124 Sylvester@emergingmed.com | |
| United States, Georgia | |
| Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Recruiting |
| Savannah, Georgia, United States, 31403-3089 | |
| Contact: Clinical Trials Office - Curtis and Elizabeth Anderson Cancer 912-350-8568 | |
| MBCCOP - Medical College of Georgia Cancer Center | Recruiting |
| Augusta, Georgia, United States, 30912-3730 | |
| Contact: Colleen H. McDonough 706-721-3626 | |
| Winship Cancer Institute of Emory University | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Howard M. Katzenstein 404-785-0853 | |
| United States, Idaho | |
| Mountain States Tumor Institute at St. Luke's Regional Medical Center | Recruiting |
| Boise, Idaho, United States, 83712-6297 | |
| Contact: Eugenia Chang 208-381-2731 | |
| United States, Illinois | |
| Saint Jude Midwest Affiliate | Recruiting |
| Peoria, Illinois, United States, 61637 | |
| Contact: Stephen D. Smith 309-624-4945 | |
| Advocate Lutheran General Cancer Care Center | Recruiting |
| Park Ridge, Illinois, United States, 60068-1174 | |
| Contact: Clinical Trials Office - Advocate Lutheran General Cancer Care 847-384-3621 | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center 708-226-4357 | |
| Children's Memorial Hospital - Chicago | Recruiting |
| Chicago, Illinois, United States, 60614 | |
| Contact: Stewart Goldman 773-880-3270 | |
| Advocate Christ Medical Center | Recruiting |
| Oak Lawn, Illinois, United States, 60453 | |
| Contact: Sharad Salvi 708-684-4094 | |
| Simmons Cooper Cancer Institute | Recruiting |
| Springfield, Illinois, United States, 62794-9677 | |
| Contact: Clinical Trials Office - Simmons Cooper Cancer Institute 217-545-7929 | |
| University of Chicago Cancer Research Center | Recruiting |
| Chicago, Illinois, United States, 60637-1470 | |
| Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
| University of Illinois Cancer Center | Recruiting |
| Chicago, Illinois, United States, 60612-7243 | |
| Contact: Clinical Trial Office - University of Illinois Cancer Center 312-355-3046 | |
| United States, Indiana | |
| Indiana University Melvin and Bren Simon Cancer Center | Recruiting |
| Indianapolis, Indiana, United States, 46202-5289 | |
| Contact: Clinical Trials Office - Indiana University Cancer Center 317-274-2552 | |
| St. Vincent Indianapolis Hospital | Recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| Contact: Clinical Trials Office - St. Vincent Indianapolis Hospital 317-338-2194 | |
| United States, Iowa | |
| Blank Children's Hospital | Recruiting |
| Des Moines, Iowa, United States, 50309 | |
| Contact: Clinical Trials Office - Blank Children's Hospital 515-241-6729 | |
| Holden Comprehensive Cancer Center at University of Iowa | Recruiting |
| Iowa City, Iowa, United States, 52242-1002 | |
| Contact: Cancer Information Service 800-237-1225 | |
| United States, Kansas | |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Recruiting |
| Kansas City, Kansas, United States, 66160-7357 | |
| Contact: Clinical Trials Office - Kansas Masonic Cancer Research Instit 913-588-4709 | |
| United States, Kentucky | |
| Kosair Children's Hospital | Recruiting |
| Louisville, Kentucky, United States, 40232 | |
| Contact: Clinical Trials Office - Kosair Children's Hospital 502-629-5500 CancerResource@nortonhealthcare.org | |
| Lucille P. Markey Cancer Center at University of Kentucky | Recruiting |
| Lexington, Kentucky, United States, 40536-0093 | |
| Contact: Clinical Trials Office - Markey Cancer Center at University of 859-257-3379 | |
| United States, Louisiana | |
| Tulane Cancer Center Office of Clinical Research | Recruiting |
| Alexandria, Louisiana, United States, 71315-3198 | |
| Contact: Clinical Trials Office - Tulane Cancer Center 504-988-6121 | |
| United States, Maine | |
| Maine Children's Cancer Program at Barbara Bush Children's Hospital | Recruiting |
| Scarborough, Maine, United States, 04074-9308 | |
| Contact: Eric C. Larsen 207-885-7565 | |
| United States, Maryland | |
| Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Recruiting |
| Baltimore, Maryland, United States, 21215 | |
| Contact: Joseph M. Wiley 410-601-5864 | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
| Baltimore, Maryland, United States, 21231-2410 | |
| Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Suzanne Shusterman 617-632-4901 | |
| Floating Hospital for Children at Tufts - New England Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Contact: Cynthia S. Kretschmar 617-636-5535 | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | Recruiting |
| Detroit, Michigan, United States, 48201-1379 | |
| Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363 | |
| Hurley Medical Center | Recruiting |
| Flint, Michigan, United States, 48503 | |
| Contact: Clinical Trials Office - Hurley Medical Center 810-762-8057 | |
| Butterworth Hospital at Spectrum Health | Recruiting |
| Grand Rapids, Michigan, United States, 49503-2560 | |
| Contact: David S. Dickens 616-391-2086 | |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | Recruiting |
| Ann Arbor, Michigan, United States, 48109-0286 | |
| Contact: Clinical Trials Office - C.S. Mott Children's Hospital 800-865-1125 | |
| CCOP - Kalamazoo | Recruiting |
| Kalamazoo, Michigan, United States, 49007-5381 | |
| Contact: Jeffrey S. Lobel 269-341-6350 | |
| Breslin Cancer Center at Ingham Regional Medical Center | Recruiting |
| Lansing, Michigan, United States, 48910 | |
| Contact: Clinical Trials Office - Breslin Cancer Center at Ingham Regio 517-334-2765 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Recruiting |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| Contact: Clincial Trials Office - Van Elslander Cancer Center at St. Jo 313-343-3166 | |
| William Beaumont Hospital - Royal Oak Campus | Recruiting |
| Royal Oak, Michigan, United States, 48073 | |
| Contact: Clinical Trials Office - William Beaumont Hospital - Royal Oak 248-551-7695 | |
| United States, Minnesota | |
| Masonic Cancer Center at University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 | |
| Mayo Clinic Cancer Center | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, Mississippi | |
| University of Mississippi Cancer Clinic | Recruiting |
| Jackson, Mississippi, United States, 39216-4505 | |
| Contact: Gail C. Megason 601-984-5220 | |
| United States, Missouri | |
| Cardinal Glennon Children's Hospital | Recruiting |
| St. Louis, Missouri, United States, 63104 | |
| Contact: William S. Ferguson 314-577-5638 | |
| Children's Mercy Hospital | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: Maxine Hetherington 816-234-3265 | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Recruiting |
| Columbia, Missouri, United States, 65203 | |
| Contact: Clinical Trial Office - Ellis Fischel Cancer Center 573-882-7440 | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Robert J. Hayashi 314-454-4118 | |
| United States, Nebraska | |
| Children's Hospital | Recruiting |
| Omaha, Nebraska, United States, 68114-4113 | |
| Contact: Minnie Abromowitch 402-955-3950 | |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68198-6805 | |
| Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ 800-999-5465 | |
| United States, Nevada | |
| CCOP - Nevada Cancer Research Foundation | Recruiting |
| Las Vegas, Nevada, United States, 89109-2306 | |
| Contact: Jonathan Bernstein 702-732-0971 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Recruiting |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| Contact: Clinical Trials Office - Norris Cotton Cancer Center 603-650-7609 cancerhelp@dartmouth.edu | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675 | |
| Hackensack University Medical Center Cancer Center | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Contact: Clinical Trials Office - Hackensack University Medical Center 201-996-2879 | |
| Newark Beth Israel Medical Center | Recruiting |
| Newark, New Jersey, United States, 07112 | |
| Contact: Clinical Trials Office - Newark Beth Israel Medical Center 973-926-3136 | |
| Overlook Hospital | Recruiting |
| Morristown, New Jersey, United States, 07962 | |
| Contact: Hazem Mahmoud 973-971-6720 | |
| St. Joseph's Hospital and Medical Center | Recruiting |
| Paterson, New Jersey, United States, 07503 | |
| Contact: Mary A. Bonilla 973-754-3349 | |
| United States, New Mexico | |
| University of New Mexico Cancer Center | Recruiting |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| Contact: Clinical Trials Office - University of New Mexico Cancer Cente 505-272-6972 | |
| United States, New York | |
| Albany Medical Center Hospital | Recruiting |
| Albany, New York, United States, 12208-3419 | |
| Contact: Vikramjit S. Kanwar 518-262-5513x25265 | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | Recruiting |
| Bronx, New York, United States, 10461 | |
| Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe 718-904-2730 aecc@aecom.yu.edu | |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C 212-305-8615 | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Barbara L. Asselin 585-275-2981 | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Peter G. Steinherz 212-639-7951 | |
| Mount Sinai Medical Center | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Birte Wistinghausen 212-241-7022 | |
| New York Medical College | Recruiting |
| Valhalla, New York, United States, 10595 | |
| Contact: Fevzi Ozkaynak 914-493-7997 | |
| NYU Cancer Institute at New York University Medical Center | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Elizabeth Raetz 212-263-8400 | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263-0001 | |
| Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724 | |
| Schneider Children's Hospital | Recruiting |
| New Hyde Park, New York, United States, 11040 | |
| Contact: Arlene S. Redner 718-470-3460 | |
| SUNY Upstate Medical University Hospital | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi 315-464-5476 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | Recruiting |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas 704-355-2884 | |
| Duke Comprehensive Cancer Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Clinical Trials Office - Duke Comprehensive Cancer Center 888-275-3853 | |
| Leo W. Jenkins Cancer Center at ECU Medical School | Recruiting |
| Greenville, North Carolina, United States, 27834 | |
| Contact: Clinical Trials Office - Leo W. Jenkins Cancer Center at ECU M 252-744-2391 | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432 | |
| Mission Hospitals - Memorial Campus | Recruiting |
| Asheville, North Carolina, United States, 28801 | |
| Contact: Clinical Trials Office - Mission Hospitals - Memorial Campus 828-213-4150 | |
| Presbyterian Cancer Center at Presbyterian Hospital | Recruiting |
| Charlotte, North Carolina, United States, 28233-3549 | |
| Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt 704-384-5369 | |
| Wake Forest University Comprehensive Cancer Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 | |
| United States, North Dakota | |
| CCOP - MeritCare Hospital | Recruiting |
| Fargo, North Dakota, United States, 58122 | |
| Contact: Nathan Kobrinsky 701-234-7544 | |
| United States, Ohio | |
| Akron Children's Hospital | Recruiting |
| Akron, Ohio, United States, 44308-1062 | |
| Contact: Clinical Trials Office - Akron Children's Hospital 330-543-3193 | |
| Children's Medical Center - Dayton | Recruiting |
| Dayton, Ohio, United States, 45404-1815 | |
| Contact: Emmett Broxson 937-641-3111 | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica 513-636-2799 | |
| Cleveland Clinic Taussig Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100 | |
| Medical University of Ohio Cancer Center | Recruiting |
| Toledo, Ohio, United States, 43614 | |
| Contact: Clinical Trials Office - Medical University of Ohio Cancer Cen 419-383-6583 | |
| Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205-2696 | |
| Contact: Amanda M. Termuhlen 614-722-3552 | |
| Rainbow Babies and Children's Hospital | Recruiting |
| Cleveland, Ohio, United States, 44106-5000 | |
| Contact: Yousif (Joe) H. Matloub 216-844-3345 | |
| Toledo Hospital | Recruiting |
| Toledo, Ohio, United States, 43606 | |
| Contact: Clinical Trials Office - Toledo Hospital 419-824-1842 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Rene Y. McNall-Knapp 405-271-5311 | |
| United States, Oregon | |
| Knight Cancer Institute at Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239-3098 | |
| Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea 503-494-1080 trials@ohsu.edu | |
| Legacy Emanuel Hospital and Health Center and Children's Hospital | Recruiting |
| Portland, Oregon, United States, 97227 | |
| Contact: Clinical Trials Office - Legacy Emanuel Hospital and Health Ce 503-413-8199 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104-9786 | |
| Contact: Richard Aplenc 267-426-7252 | |
| Children's Hospital of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Clinical Trials Office - Children's Hospital of Pittsburgh 412-692-5573 | |
| Geisinger Cancer Institute at Geisinger Health | Recruiting |
| Danville, Pennsylvania, United States, 17822-0001 | |
| Contact: Clinical Trials Office - Geisinger Cancer Institute 570-271-5251 | |
| Lehigh Valley Hospital - Muhlenberg | Recruiting |
| Bethlehem, Pennsylvania, United States, 18017 | |
| Contact: Philip M. Monteleone 484-884-3333 | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Contact: Clinical Trials Office - Penn State Cancer Institute at Milton 717-531-3779 CTO@hmc.psu.edu | |
| St. Christopher's Hospital for Children | Recruiting |
| Philadelphia, Pennsylvania, United States, 19134-1095 | |
| Contact: Clinical Trials Office - St. Christopher's Hospital for Childr 215-427-8991 | |
| United States, Rhode Island | |
| Rhode Island Hospital Comprehensive Cancer Center | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Contact: Clinical Trials Office - Rhode Island Hospital Comprehensive C 401-444-1488 | |
| United States, South Carolina | |
| Greenville Hospital Cancer Center | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| Contact: Clinical Trials Office - Greenville Hospital Cancer Center 864-241-6251 | |
| Palmetto Health South Carolina Cancer Center | Recruiting |
| Columbia, South Carolina, United States, 29203 | |
| Contact: Clinical Trials Office - Palmetto Health South Carolina Cancer 803-434-3680 | |
| United States, South Dakota | |
| Sanford Cancer Center at Sanford USD Medical Center | Recruiting |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| Contact: Clinical Trials Office - Sanford Cancer Center 605-328-1367 | |
| United States, Tennessee | |
| East Tennessee Children's Hospital | Recruiting |
| Knoxville, Tennessee, United States, 37901 | |
| Contact: Ray C. Pais 865-541-8266 | |
| St. Jude Children's Research Hospital | Recruiting |
| Memphis, Tennessee, United States, 38105 | |
| Contact: Clinical Trials Office - St. Jude Children's Research Hospital 901-595-4644 | |
| T.C. Thompson Children's Hospital | Recruiting |
| Chattanooga, Tennessee, United States, 37403 | |
| Contact: Manoo G. Bhakta 423-778-7289 | |
| Vanderbilt-Ingram Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37232-6838 | |
| Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 | |
| United States, Texas | |
| Baylor University Medical Center - Houston | Recruiting |
| Houston, Texas, United States, 77030-2399 | |
| Contact: Patrick A. Thompson 832-824-4029 | |
| CCOP - Scott and White Hospital | Recruiting |
| Temple, Texas, United States, 76508 | |
| Contact: Arlynn F. Mulne 254-724-2006 | |
| M. D. Anderson Cancer Center at University of Texas | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 | |
| Covenant Children's Hospital | Recruiting |
| Lubbock, Texas, United States, 79410 | |
| Contact: Latha Prasannan 806-725-4840 | |
| Dell Children's Medical Center of Central Texas | Recruiting |
| Austin, Texas, United States, 78723 | |
| Contact: Clinical Trials Office - Dell Children's Medical Center of Cen 512-324-8022 | |
| Driscoll Children's Hospital | Recruiting |
| Corpus Christi, Texas, United States, 78411 | |
| Contact: Clinical Trials Office - Driscoll Children's Hospital 361-694-5311 | |
| Cook Children's Medical Center - Fort Worth | Recruiting |
| Fort Worth, Texas, United States, 76104 | |
| Contact: Clinical Trials Office - Cook's Children's Medical Center 682-885-2103 | |
| Medical City Dallas Hospital | Recruiting |
| Dallas, Texas, United States, 75230 | |
| Contact: Carl Lenarsky 972-566-6647x4439 | |
| Methodist Children's Hospital of South Texas | Recruiting |
| San Antonio, Texas, United States, 78229-3993 | |
| Contact: Michael S. Grimley 210-575-7268 | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097 | |
| Texas Tech University Health Sciences Center School of Medicine - Amarillo | Recruiting |
| Amarillo, Texas, United States, 79106 | |
| Contact: Curtis W. Turner 806-354-5434X264 | |
| University of Texas Health Science Center at San Antonio | Recruiting |
| San Antonio, Texas, United States, 78207 | |
| Contact: Paul Thomas 210-704-2187 | |
| United States, Utah | |
| Primary Children's Medical Center | Recruiting |
| Salt Lake City, Utah, United States, 84113-1100 | |
| Contact: Phillip E. Barnette 801-662-4700 | |
| United States, Vermont | |
| Fletcher Allen Health Care - University Health Center Campus | Recruiting |
| Burlington, Vermont, United States, 05401 | |
| Contact: Clinical Trials Office - Fletcher Allen Health Care 802-656-8990 | |
| United States, Virginia | |
| Carilion Medical Center for Children at Roanoke Community Hospital | Recruiting |
| Roanoke, Virginia, United States, 24014 | |
| Contact: Mandy M. Atkinson 540-981-7376 | |
| Children's Hospital of The King's Daughters | Recruiting |
| Norfolk, Virginia, United States, 23507-1971 | |
| Contact: Eric J. Lowe 757-668-7243 | |
| Inova Fairfax Hospital | Recruiting |
| Falls Church, Virginia, United States, 22042-3300 | |
| Contact: Clinical Trials Office - Inova Fairfax Hospital 703-208-6650 | |
| University of Virginia Cancer Center | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Kimberly P. Dunsmore 434-924-5105 | |
| Virginia Commonwealth University Massey Cancer Center | Recruiting |
| Richmond, Virginia, United States, 23298-0037 | |
| Contact: Clinical Trials Office -Virginia Commonwealth University Masse 804-628-1939 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | Recruiting |
| Seattle, Washington, United States, 98105 | |
| Contact: Julie R. Park 206-987-2106 | |
| Providence Cancer Center at Sacred Heart Medical Center | Recruiting |
| Spokane, Washington, United States, 99220-2555 | |
| Contact: Judy L. Felgenhauer 509-474-2777 | |
| United States, West Virginia | |
| West Virginia University Health Sciences Center - Charleston | Recruiting |
| Charleston, West Virginia, United States, 25302 | |
| Contact: Allen R. Chauvenet 304-388-1552 | |
| United States, Wisconsin | |
| Marshfield Clinic - Marshfield Center | Recruiting |
| Marshfield, Wisconsin, United States, 54449 | |
| Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center 800-782-1581 ext. 94457 | |
| Midwest Children's Cancer Center at Children's Hospital of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Michael E. Kelly 414-456-4170 | |
| St. Vincent Hospital Regional Cancer Center | Recruiting |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer 920-433-8889 | |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Recruiting |
| Madison, Wisconsin, United States, 53792-6164 | |
| Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo 608-262-5223 | |
| Australia, New South Wales | |
| Westmead Institute for Cancer Research at Westmead Hospital | Recruiting |
| Westmead, New South Wales, Australia, 2145 | |
| Contact: Geoffrey B. McCowage 61298452122 | |
| Australia, Queensland | |
| Royal Children's Hospital | Recruiting |
| Brisbane, Queensland, Australia, 4029 | |
| Contact: Helen Irving 617-3636-8671 | |
| Australia, South Australia | |
| Women's and Children's Hospital | Recruiting |
| North Adelaide, South Australia, Australia, 5006 | |
| Contact: Maria L. Kirby 61881617411 | |
| Australia, Victoria | |
| Royal Children's Hospital | Recruiting |
| Parkville, Victoria, Australia, 3052 | |
| Contact: David Ashley 61393455652 | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | Recruiting |
| Perth, Western Australia, Australia, 6001 | |
| Contact: Catherine Cole 011-6189340-8238 | |
| Canada | |
| Centre Hospitalier Universitaire de Quebec | Recruiting |
| Quebec, Canada, G1V 4G2 | |
| Contact: Bruno Michon 418-656-4141X47191 | |
| Canada, Alberta | |
| Alberta Children's Hospital | Recruiting |
| Calgary, Alberta, Canada, T3B 6A8 | |
| Contact: Douglas R. Strother 403-955-7272 | |
| University of Alberta Hospital | Recruiting |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Contact: Sunil Jayantilal` S. Desai 780-407-8829 | |
| Canada, British Columbia | |
| Children's & Women's Hospital of British Columbia | Recruiting |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Contact: Mason C. Bond 604-875-2322 | |
| Canada, Manitoba | |
| CancerCare Manitoba | Recruiting |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Contact: Rochelle Yanofsky 204-787-4163 | |
| Canada, Newfoundland and Labrador | |
| Janeway Children's Health and Rehabilitation Centre | Recruiting |
| St. John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Contact: John (Jack) P. Hand 709-777-4799 | |
| Canada, Nova Scotia | |
| IWK Health Centre | Recruiting |
| Halifax, Nova Scotia, Canada, B3K 6R8 | |
| Contact: Margaret C. Yhap 902-470-8778 | |
| Canada, Ontario | |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | Recruiting |
| Kingston, Ontario, Canada, K7L 2V7 | |
| Contact: Mariana P. Silva 613-5496666x3833 | |
| Children's Hospital of Eastern Ontario | Recruiting |
| Ottawa, Ontario, Canada, K1H 8L1 | |
| Contact: Jacqueline Halton 613-737-7600x2370 | |
| Children's Hospital of Western Ontario | Recruiting |
| London, Ontario, Canada, N6A 5W9 | |
| Contact: A. E.L. Cairney 519-685-8494 | |
| Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Contact: Sylvain Baruchel 416-813-7795 | |
| McMaster Children's Hospital at Hamilton Health Sciences | Recruiting |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Contact: Carol A. Portwine 905-521-2100x73464 | |
| Canada, Quebec | |
| Hopital Sainte Justine | Recruiting |
| Montreal, Quebec, Canada, H3T 1C5 | |
| Contact: Yvan Samson 418-656-4141x47191 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre at Pasqua Hospital | Recruiting |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Contact: Mansoor M. Haq 306-766-2498 | |
| Saskatoon Cancer Centre at the University of Saskatchewan | Recruiting |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Contact: Kaiser Ali 306-655-2744 | |
| Netherlands | |
| Universitair Medisch Centrum St. Radboud - Nijmegen | Recruiting |
| Nijmegen, Netherlands, 6500 HB | |
| Contact: Jacqueline J. Groot-Loonen 31243616928 | |
| New Zealand | |
| Christchurch Hospital | Recruiting |
| Christchurch, New Zealand, 8140 | |
| Contact: Robin P. Corbett 643364-0740 | |
| Starship Children's Health | Recruiting |
| Auckland, New Zealand, 1 | |
| Contact: Lochie Teague 64930749496368 | |
| Puerto Rico | |
| San Jorge Children's Hospital | Recruiting |
| Santurce, Puerto Rico, 00912 | |
| Contact: Luis A. Clavell 787-728-1575 | |
| Switzerland | |
| Swiss Pediatric Oncology Group Bern | Recruiting |
| Bern, Switzerland, 3010 | |
| Contact: Roland A. Ammann 41316329372 | |
| Swiss Pediatric Oncology Group Geneva | Recruiting |
| Geneva, Switzerland, 1205 | |
| Contact: Hulya A. Ozsahin 0041223824712 | |
| Swiss Pediatric Oncology Group Lausanne | Recruiting |
| Lausanne, Switzerland, 1011 | |
| Contact: Maja Beck Popovic 41213141111x3567 | |
| Study Chair: | David O. Walterhouse, MD | Children's Memorial Hospital |
| Investigator: | Alberto S. Pappo, MD | Texas Children's Cancer Center |
More Information
| Responsible Party: | Children's Oncology Group - Group Chair Office ( Gregory H. Reaman ) |
| Study ID Numbers: | CDR0000347078, COG-ARST0331 |
| Study First Received: | January 9, 2004 |
| Last Updated: | November 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00075582 History of Changes |
| Health Authority: | Unspecified |
|
previously untreated childhood rhabdomyosarcoma embryonal childhood rhabdomyosarcoma embryonal-botryoid childhood rhabdomyosarcoma adult rhabdomyosarcoma |
stage II adult soft tissue sarcoma stage III adult soft tissue sarcoma stage I adult soft tissue sarcoma |
|
Neoplasms, Muscle Tissue Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Neoplasms, Connective and Soft Tissue Anti-Bacterial Agents Dactinomycin Therapeutic Uses Alkylating Agents Nucleic Acid Synthesis Inhibitors Rhabdomyosarcoma |
Neoplasms by Histologic Type Myosarcoma Mitosis Modulators Vincristine Enzyme Inhibitors Antimitotic Agents Immunosuppressive Agents Pharmacologic Actions Protein Synthesis Inhibitors Neoplasms Tubulin Modulators Myeloablative Agonists Sarcoma Antineoplastic Agents, Alkylating Antirheumatic Agents |