Not Signed In -
Dactinomycin |
Actinomycin D; Cosmegen |
Clinical Trial: Combination Chemotherapy in Treating Patients With Previously Untreated Rhabdomyosarcoma
This study is currently recruiting patients.
Purpose
RATIONALE: Drugs used in chemotherapy, such as dactinomycin, cyclophosphamide, vincristine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective in treating rhabdomyosarcoma.
PURPOSE: This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well each works in treating patients with previously untreated rhabdomyosarcoma or sarcoma.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| childhood rhabdomyosarcoma childhood soft tissue sarcoma Muscle Cancer | Drug: cyclophosphamide Drug: dactinomycin Drug: filgrastim Drug: sargramostim Drug: topotecan Drug: vincristine Procedure: biological response modifier therapy Procedure: chemotherapy Procedure: colony-stimulating factor therapy Procedure: cytokine therapy Procedure: radiation therapy Procedure: surgery | Phase III |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Muscle Disorders; Soft Tissue Sarcoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Vincristine, Dactinomycin, and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine, Topotecan, and Cyclophosphamide in Patients With Intermediate-Risk, Previously Untreated Rhabdomyosarcoma
Further Study Details:
OBJECTIVES:
- Compare the early response rates, failure-free survival, and survival of patients with intermediate-risk rhabdomyosarcoma treated with surgery, radiotherapy, and vincristine, dactinomycin, and cyclophosphamide (VAC) vs VAC alternating with vincristine, topotecan, and cyclophosphamide.
- Compare the acute and late effects of these two treatment regimens in these patients.
- Determine the rate of second-look surgery in selected patients with bulk residual tumor at diagnosis (i.e., Clinical Group III) and the proportion of these that render the patient tumor free or with microscopic tumor only.
- Determine the rate of local failure in selected patients with bulk residual tumors at diagnosis (i.e., Clinical Group III) who, after second-look resection, have response-adjusted radiotherapy dose reduction.
- Determine if preoperative radiotherapy followed by second-look surgery is feasible for selected patients with bulk residual disease (i.e., Clinical Group III) who respond poorly to induction chemotherapy.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease (embryonal histology, stage II or III, Clinical Group III vs embryonal histology, Clinical Group IV, less than 10 years of age vs alveolar or undifferentiated sarcoma histology, stage I, Clinical Group I vs alveolar or undifferentiated sarcoma histology, stage II or III, Clinical Group II or III). Patients are randomized to 1 of 2 treatment arms.
- Patients receive vincristine IV over 5-10 minutes once a week on weeks 0-12, 15, 18-24, 27, 30-36, and 39. Dactinomycin IV is administered over 15-20 minutes once a week on weeks 0, 3, 6, 9, 12, 21, 24, 27, 30, 33, 36, and 39. Cyclophosphamide IV is administered over 30-60 minutes once a week on weeks 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, and 39. After the initial 12 weeks of chemotherapy, depending on tumor shrinkage, patients may undergo surgery. After recovery from surgery, patients receive radiotherapy once a day, 5 days a week, during weeks 12-18. For patients receiving radiotherapy during weeks 0-6, dactinomycin is omitted during weeks 3 and 6 and administered during weeks 15 and 18. For patients receiving radiotherapy during weeks 12-18, dactinomycin is omitted during weeks 15 and 18. Patients showing an adequate response at week 24 continue chemotherapy during weeks 24-39. Patients with Clinical Group III tumors of a parameningeal site with documented evidence of intracranial extension receive radiotherapy within the first 2 weeks of the initiation of the first course of chemotherapy (day 0).
Patients with Clinical Group II parameningeal tumors and Clinical Group III parameningeal tumors with base of skull erosion and/or cranial nerve palsy without evidence of intracranial extension receive radiotherapy on week 12 (day 84) or immediately thereafter.
Patients with Clinical Group IV parameningeal tumors with distant metastases receive radiotherapy to the primary site on week 12 (day 84). Patients with distant metastases confined to one site may receive radiotherapy to the metastatic site concurrently with therapy to the primary site if it began within 2 weeks of the initiation of chemotherapy (day 0).
- Arm II: Patients receive treatment as in arm I, except dactinomycin is replaced with topotecan IV over 15-30 minutes daily for 5 days during weeks 3, 9, 21, 27, 33, and 39. All patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning 24 hours after completion of each course of chemotherapy and continuing 1 year, until hematopoietic recovery.
Patients are followed every 1-2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 518 patients will be accrued for this study within 5 years.
Eligibility
Ages Eligible for Study: up to 49 Years, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Histologically proven disease of any of the following types:
- Nonmetastatic alveolar rhabdomyosarcoma
- Stage I, II, or III; Clinical Group I, II, or III
- Stage II or III, Clinical Group III embryonal rhabdomyosarcoma
- Botryoid
- Spindle cell
- Under 10 years, stage IV, Clinical Group IV embryonal rhabdomyosarcoma
- Botryoid
- Spindle cell
- Undifferentiated sarcoma
- Stage I, II, or III; Clinical Group I, II, or III
- Ectomesenchymoma
- Stage I, II, or III; Clinical Group I, II, or III, with alveolar features
- Under 10 years, Stage IV, Clinical Group IV, with embryonal features
- No more than 6 weeks since initial surgical procedure (e.g., biopsy) giving the definitive diagnosis
- No parameningeal rhabdomyosarcoma with positive CSF cytology or multiple intracranial metastases
PATIENT CHARACTERISTICS: Age:
- Under 50
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
Renal:
- Creatinine normal* for age NOTE: *Patients with tumor obstruction causing creatinine elevation may be enrolled
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Prior steroids allowed
Radiotherapy:
- No prior radiotherapy
Surgery:
- See Disease Characteristics
Location and Contact Information
Alabama
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, 35233, United States; Recruiting
Robert P. Castleberry, MD 205-939-9285 rcastleberry@peds.uab.edu
University of South Alabama Cancer Research Institute, Mobile, Alabama, 36604, United States; Recruiting
Felicia L. Wilson, MD 251-405-5115 fwilson@usouthal.edu
Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, 85724, United States; Recruiting
Rochelle Bagatell, MD 520-626-4851
Phoenix Children's Hospital, Phoenix, Arizona, 85016, United States; Recruiting
Dale Anne Singer, MD 602-546-0920
Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States; Recruiting
David L. Becton, MD 501-320-5650
California
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California, 92868, United States; Recruiting
Stanley Calderwood, MD 714-456-6615 scalderw@uci.edu
Children's Hospital and Health Center, San Diego, San Diego, California, 92123-4282, United States; Recruiting
Richard Kadota, MD 858-966-5811
Children's Hospital and Research Center at Oakland, Oakland, California, 94609-1809, United States; Recruiting
James H. Feusner, MD 510-428-3000 jfeusner@mail.cho.org
Children's Hospital Central California, Madera, California, 93638-8762, United States; Recruiting
Vonda Lee Crouse, MD 559-353-5480 vcrouse@childrenscentralcal.org
Children's Hospital Los Angeles, Los Angeles, California, 90027-0700, United States; Recruiting
Paul S. Gaynon, MD 323-669-2163 pgaynon@chla.usc.edu
Children's Hospital of Orange County, Orange, California, 92868, United States; Recruiting
Wei-Ping Violet Shen, MD 714-516-4348 vshen@choc.org
City of Hope Comprehensive Cancer Center, Duarte, California, 91010-3000, United States; Recruiting
Clinical Trials Office - New Patient Services 800-826-4673 becomingapatient@coh.org
General Robert Huyser Cancer Center at David Grant Medical Center, Travis Air Force Base, California, 94535, United States; Recruiting
Peter J. Chenaille, MD 707-423-7176
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital, Long Beach, California, 90801-1428, United States; Recruiting
William Mark Roberts, MD 562-933-8600 wmroberts@memorialcare.org
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-1781, United States; Recruiting
Stephen A. Feig, MD 310-825-5268
Kaiser Permanente Medical Center - Sacramento, Sacramento, California, 95825, United States; Recruiting
Vincent A. Kiley, MD 916-973-7331 vincent.kiley@kp.org
Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, 95051-5386, United States; Recruiting
Carolyn Lucille Russo, MD 408-236-5028 carolyn.l.russo@kp.org
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego, San Diego, California, 92120, United States; Recruiting
Wellington Loh, MD 619-516-6144
Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California, 92354, United States; Recruiting
Antranik Bedros, MD 909-558-8626 abedro@ahs.llumc.edu
Lucile Packard Children's Hospital at Stanford University Medical Center, Palo Alto, California, 94304, United States; Recruiting
Neyssa M. Marina, MD 650-723-5535 neyssa.marina@stanford.edu
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, 92093-0658, United States; Recruiting
Richard Kadota, MD 858-657-7020
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States; Recruiting
Moshe Arditi, MD 310-423-4471
Santa Barbara Cottage Hospital, Santa Barbara, California, 93102, United States; Recruiting
Felicity Hodder, MD 805-682-7111 fhodder@cottagehealthsystem.org
Southern California Permanente Medical Group, Downey, California, 90242, United States; Recruiting
Willye B. Powell, MD 562-803-2472
Sutter Cancer Center, Sacramento, California, 95816, United States; Recruiting
Yisheng Lee, MD, PhD, MBA 916-733-1757
UCSF Comprehensive Cancer Center, San Francisco, California, 94143, United States; Recruiting
Katherine K. Matthay, MD 415-476-3831
University of California Davis Cancer Center, Sacramento, California, 95817, United States; Recruiting
Theodore Zwerdling, MD 916-734-2781 theodore.zwerding@ucdmc.ucdavis.edu
Colorado
Children's Hospital Cancer Center, Denver, Colorado, 80218, United States; Recruiting
Lorrie F. Odom, MD 303-861-6740 odom.lorrie@tchden.org
Presbyterian - St. Luke's Medical Center, Denver, Colorado, 80218, United States; Recruiting
Stephen R. Palmer, MD 719-471-2462
Connecticut
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, Farmington, Connecticut, 06360-7106, United States; Recruiting
Arnold J. Altman, MD 860-545-9630
Yale Comprehensive Cancer Center, New Haven, Connecticut, 06520-8064, United States; Recruiting
Jack van Hoff, MD 203-785-4640 jack.vanhoff@yale.edu
Delaware
Alfred I. duPont Hospital for Children, Wilmington, Delaware, 19899, United States; Recruiting
Rita S. Meek, MD 302-651-5502 rmeek@nemours.org
District of Columbia
Children's National Medical Center, Washington, District of Columbia, 20010-2970, United States; Recruiting
Nita Louise Seibel, MD 202-884-2144 nseibel@cnmc.org
Lombardi Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, 20007, United States; Recruiting
Aziza Shad, MD 202-444-2224 shada@georgetown.edu
Florida
All Children's Hospital, St. Petersburg, Florida, 33701, United States; Recruiting
Jerry L. Barbosa, MD 727-892-4231 barbosaj@allkids.org
Baptist-South Miami Regional Cancer Program, Miami, Florida, 33176-2197, United States; Recruiting
Doured Daghistani, MD 786-596-1960
Broward General Medical Center, Fort Lauderdale, Florida, 33316, United States; Recruiting
Rudolph R. Roskos, MD 954-355-4527 rroskos@nbhd.org
Children's Hospital of Southwest Florida, Fort Myers, Florida, 33908, United States; Recruiting
Emad K. Salman, MD 239-432-3333 emad.salman@leememorial.org
Florida Hospital Cancer Institute, Orlando, Florida, 32804, United States; Recruiting
Jane Crofton, RN, BSN, OCN 407-303-2090
Jackson Memorial Hospital, Miami, Florida, 33136, United States; Recruiting
Stuart R. Toledano, MD 305-585-5635 stoledan@med.miami.edu
Joe DiMaggio Children's Hospital at Memorial, Hollywood, Florida, 33021, United States; Recruiting
Iftikhar Hanif, MD 954-986-2234 ifhanif@aol.com
Miami Children's Hospital, Miami, Florida, 33155, United States; Recruiting
Enrique A. Escalon, MD 305-666-6511
Nemours Children's Clinic, Jacksonville, Florida, 32207, United States; Recruiting
Eric Sandler, MD 904-390-3793 esandler@nemours.org
Nemours Children's Clinic-Orlando, Orlando, Florida, 32806, United States; Recruiting
Vincent F. Giusti, MD 407-650-7230
Sacred Heart Children's Hospital, Pensacola, Florida, 32504, United States; Recruiting
John F. Kelleher, MD 850-505-4798 jfkelleh@neumous.org
St. Joseph's Children's Hospital, Tampa, Florida, 33677-4227, United States; Recruiting
Cameron K. Tebbi, MD 813-870-4252 cameron.tebbi@baycare.org
St. Mary's Hospital, West Palm Beach, Florida, 33407, United States; Recruiting
Narayana Gowda, MD 561-840-6125 doctorgowda@hotmail.com
University of Florida Shands Cancer Center, Gainesville, Florida, 32610-0296, United States; Recruiting
Stephen P. Hunger, MD 352-392-5633 hungersp@peds.ufl.edu
Georgia
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus, Atlanta, Georgia, 30342, United States; Recruiting
Howard M. Katzenstein, MD 404-785-0853 howard.katzenstein@choa.org
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, 31405, United States; Recruiting
Tribhawan S. Vats, MD 912-350-8194 vatsri@memorialhealth.com
MBCCOP-Medical College of Georgia Cancer Center, Augusta, Georgia, 30912-4000, United States; Recruiting
Roger A. Vega, MD 706-721-3626
Medical Center of Central Georgia, Macon, Georgia, 31201, United States; Recruiting
Hassan Dannawi, MD 478-633-1104 dannawi.hassan@mccg.org
Hawaii
Cancer Research Center of Hawaii, Honolulu, Hawaii, 96813, United States; Recruiting
Robert Warren Wilkinson, MD 808-586-2979
MBCCOP - Hawaii, Honolulu, Hawaii, 96813, United States; Recruiting
Brian F. Issell, MD 808-586-3015 brian@crch.hawaii.edu
Tripler Army Medical Center, Honolulu, Hawaii, 96859-5000, United States; Recruiting
Braden Alan Shoupe, MD 808-433-6057
Idaho
Mountain States Tumor Institute - Boise, Boise, Idaho, 83712, United States; Recruiting
J. Martin Johnston, MD 208-381-2782 johnstom@slrmc.org
Illinois
Advocate Hope Children's Hospital, Oak Lawn, Illinois, 60453, United States; Recruiting
Sharad N. Salvi, MD 708-346-4094 sharad.salvi@advocatehealth.com
Children's Memorial Hospital - Chicago, Chicago, Illinois, 60614, United States; Recruiting
Susan Lerner Cohn, MD 773-880-4562
Lutheran General Cancer Care Center, Park Ridge, Illinois, 60068-1174, United States; Recruiting
Jong-Hyo Kwon, MD 847-723-5962 jong-hyo.kwon_md@advocatehealth.com
Rush University Medical Center, Chicago, Illinois, 60612, United States; Recruiting
Allen D. Korenblit, MD 312-942-5983 akorenbl@rush.edu
Saint Jude Midwest Affiliate, Peoria, Illinois, 61637, United States; Recruiting
John A. McCallister, MD 309-624-4945 john.mccallister@stjude.org
Southern Illinois University School of Medicine, Springfield, Illinois, 62794-9658, United States; Recruiting
Gregory Brandt, MD 217-545-5817 gbrandt@siumed.edu
University of Chicago Cancer Research Center, Chicago, Illinois, 60601, United States; Recruiting
James B. Nachman, MD 773-702-6808
University of Illinois Medical Center, Chicago, Illinois, 60612, United States; Recruiting
Mary Lou Schmidt, MD 312-996-6143 mls3@uic.edu
Indiana
Riley Children Cancer Center at Riley Hospital for Children, Indianapolis, Indiana, 46202-5225, United States; Recruiting
Robert Fallon, MD, PhD 317-274-8784 rfallon@iupui.edu
St. Vincent Hospitals and Health Care Centers, Indianapolis, Indiana, 46260, United States; Recruiting
Randy Alan Hock, MD, PhD, MMM 317-338-4673
Iowa
Blank Children's Hospital, Des Moines, Iowa, 50309, United States; Recruiting
Stephen C. Elliott, DO, PhD, FAAP 515-241-6000 elliotsc@ihs.org
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, 52242-1009, United States; Recruiting
Raymond Tannous, MD 319-356-1905
Kansas
Wesley Medical Center, Wichita, Kansas, 67214, United States; Recruiting
David Rosen, MD 316-962-2025
Kentucky
Kosair Children's Hospital, Louisville, Kentucky, 40202-3830, United States; Recruiting
Salvatore J. Bertolone, MD 502-852-8450
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, 40536-0284, United States; Recruiting
Martha F. Greenwood, MD 859-323-6771 mfgree0@pop.uky.edu
Louisiana
Children's Hospital of New Orleans, New Orleans, Louisiana, 70118, United States; Recruiting
Lolie Chua Yu, MD 504-896-9740
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, 70112, United States; Recruiting
Jill Gilbert, MD 504-568-5613 jgilbe@lsuhsc.edu
Ochsner Cancer Institute at Ochsner Clinic Foundation, New Orleans, Louisiana, 70121, United States; Recruiting
Marquis Zimri Hodes, MD, PhD 504-842-5230
Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans, Louisiana, 70112, United States; Recruiting
Marshall A. Schorin, MD 504-988-5412 mschori@tulane.edu
Maine
CancerCare of Maine at Eastern Maine Medial Center, Bangor, Maine, 04401, United States; Recruiting
Judith B. Allen, MD 207-973-7520
Maine Children's Cancer Program, Scarborough, Maine, 04074-9308, United States; Recruiting
Craig A. Hurwitz, MD 207-885-7565 hurwic@mmc.org
Maryland
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland, 21215, United States; Recruiting
Joseph Michael Wiley, MD 410-601-5864 jwiley@lifebridehealth.org
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, 21201-1595, United States; Recruiting
Neil Jeffrey Grossman, MD 410-328-2808 ngrossma@peds.umaryland.edu
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, 21231-2410, United States; Recruiting
Cindy Schwartz, MD 410-955-7385 schwac@ijhmi.edu
Walter Reed Army Medical Center, Silver Spring, Maryland, 20910, United States; Recruiting
Kip R. Hartman, MD 301-319-9116
Massachusetts
Baystate Regional Cancer Program at D'Amour Center for Cancer Care, Springfield, Massachusetts, 01107, United States; Recruiting
David A. Steele, MD 413-794-9338 david.steele@bhs.org
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States; Recruiting
Holcombe Edwin Grier, MD 617-632-3971 holcombe-grier@dfci.harvard.edu
Floating Hospital for Children, Boston, Massachusetts, 02111, United States; Recruiting
Cynthia S. Kretschmar, MD 617-636-5535 ckretschmar@tufts-nemc.org
UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts, 01655, United States; Recruiting
Ghazala Naheed Usmani, MD 508-856-4225 usmanin@ummhc.org
Michigan
Breslin Cancer Center at Ingham Regional Medical Center, Lansing, Michigan, 48910, United States; Recruiting
Renuka Gera, MD 517-334-2337
Bronson Methodist Hospital, Kalamazoo, Michigan, 49007-5364, United States; Recruiting
Leonard August Mattano, MD, PhD 616-341-6350
CCOP - Beaumont, Royal Oak, Michigan, 48073-6769, United States; Recruiting
Jeanne Archer, PhD, APN 248-551-8299 carcher@beaumon.edu
Children's Hospital of Michigan, Detroit, Michigan, 48201, United States; Recruiting
Yaddanapudi Ravindranath, MBBS 313-745-5649 ravi@med.wayne.edu
DeVos Children's Hospital, Grand Rapids, Michigan, 49503, United States; Recruiting
David Robert Freyer, DO 616-391-2086
Hurley Medical Center, Flint, Michigan, 48503, United States; Recruiting
Susumu Inoue, MD 810-762-7303 sinoue1@hurleymc.com
Josephine Ford Cancer Center at Henry Ford Health System, Detroit, Michigan, 48202, United States; Recruiting
Hassan M. Yaish, MD 313-916-3138
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109-0914, United States; Recruiting
Raymond J. Hutchinson, MD 734-936-8785
Van Elslander Cancer Center at St. John Hospital and Medical Center, Detroit, Michigan, 48236, United States; Recruiting
Hadi Sawaf, MD 313-647-3200 hadi.sawaf@stjohn.org
William Beaumont Hospital - Royal Oak, Royal Oak, Michigan, 48073-6769, United States; Recruiting
Charles A. Main, MD 248-551-0360
Minnesota
Children's Hospitals and Clinics - Minneapolis/St. Paul, Minneapolis, Minnesota, 55404, United States; Recruiting
Maura C. O'Leary, MD 612-813-5940
Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States; Recruiting
Carola A.S. Arndt, MD 507-284-2511 carndt@mayo.edu
St. Mary's - Duluth Clinic Cancer Center, Duluth, Minnesota, 55805, United States; Recruiting
Jacquelyn Dawn Wiermaa, MD 218-786-3625
Mississippi
University of Mississippi Medical Center, Jackson, Mississippi, 39216-4505, United States; Recruiting
Dale Jeanette Pullen, MD 601-984-5220
Missouri
Cardinal Glennon Children's Hospital, Saint Louis, Missouri, 63104, United States; Recruiting
William Shay Ferguson, MD 314-577-5638
Children's Mercy Hospital, Kansas City, Missouri, 64108, United States; Recruiting
Maxine L. Hetherington, MD 816-234-3265
St. Louis Children's Hospital, Saint Louis, Missouri, 63110, United States; Recruiting
Robert James Hayashi, MD 314-454-4118 hayashi_r@kids.wustl.edu
Nebraska
Children's Hospital of Omaha, Omaha, Nebraska, 68114, United States; Recruiting
Minnie Abromowitch, MD 402-955-3949 mabromo@unmc.edu
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, 68198-2168, United States; Recruiting
Peter F. Coccia, MD 402-559-7257 pcoccia@unmc.edu
Nevada
Sunrise Hospital and Medical Center, Las Vegas, Nevada, 89109, United States; Recruiting
Jonathan Bernstein, MD 702-732-0971 jonbern1@aol.com
New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756, United States; Recruiting
Eric Christian Larsen, MD 603-650-5541 eric.c.larsen@hitchcock.org
New Jersey
Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, 07601, United States; Recruiting
Michael B. Harris, MD 201-996-5437 mbharris@humed.com
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, 08903, United States; Recruiting
Richard A. Drachtman, MD 732-235-5437 drachtri@umdnj.edu
Newark Beth Israel Medical Center, Newark, New Jersey, 07112-2094, United States; Recruiting
Peri Kamalakar, MD 973-926-7161 pkamalak@sghcs.com
St. Joseph's Hospital and Medical Center, Paterson, New Jersey, 07503, United States; Recruiting
Mary Ann Bonilla, MD 973-754-3230 bonillam@sjhmc.org
Valerie Fund Children's Center at Atlantic Health, Summit, New Jersey, 07901, United States; Recruiting
Hazem Helmy Mahmoud, MD 973-971-6731
New Mexico
University of New Mexico Cancer Research and Treatment Center, Albuquerque, New Mexico, 87131, United States; Recruiting
Jami Frost, MD 505-272-4461
New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, 10461, United States; Recruiting
Eva Radel, MD 718-920-7844
Brookdale University Hospital and Medical Center, Brooklyn, New York, 11212, United States; Recruiting
Kusum Viswanathan, MD 718-240-5904
Brooklyn Hospital Center, Brooklyn, New York, 11201-5493, United States; Recruiting
Swayamprabha Sadanandan, MD 718-250-6074 sws9001@nyp.org
Cancer Center of Albany Medical Center, Albany, New York, 12208, United States; Recruiting
Jennifer M. Pearce, MD 518-262-5513 pearcej@mail.amc.edu
Comprehensive Cancer Center at Maimonides Medical Center, Brooklyn, New York, 11219, United States; Recruiting
Ludovico Guarini, MD 718-283-8173 lguarini@maimonidesmed.org
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, 10032, United States; Recruiting
Linda Granowetter, MD 212-305-8652 lg519@columbia.edu
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, 14642, United States; Recruiting
Barbara Lawrence Asselin, MD 716-275-2981
Long Island Cancer Center at Stony Brook University Hospital, Stony Brook, New York, 11794, United States; Recruiting
Robert Ingalls Parker, DSc 631-444-4000
Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting
Peter G. Steinherz, MD 212-639-7951
Mount Sinai School of Medicine, New York, New York, 10029, United States; Recruiting
Elizabeth Raetz, MD 212-241-7022
New York Medical College, Valhalla, New York, 10595, United States; Recruiting
M. Fevzi Ozkaynak, MD 914-493-7997 mehmet_ozkaynak@nymc.edu
New York Weill Cornell Cancer Center at Cornell University, New York, New York, 10021, United States; Recruiting
Patricia J.V. Giardina, MD 212-746-3400
Roswell Park Cancer Institute, Buffalo, New York, 14263-0001, United States; Recruiting
Martin L. Brecher, MD 716-845-2333 martin.brecher@roswellpark.org
Schneider Children's Hospital, New Hyde Park, New York, 11042, United States; Recruiting
Arlene Sara Redner, MD 718-470-3460
SUNY Downstate Medical Center, Brooklyn, New York, 11203, United States; Recruiting
Sreedhar P. Rao, MD 718-270-1693
SUNY Upstate Medical University Hospital, Syracuse, New York, 13210, United States; Recruiting
Ronald L. Dubowy, MD 315-464-5294 dubowyr@upstate.edu
North Carolina
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, 28232-2861, United States; Recruiting
Daniel P. McMahon, MD 704-355-1130 dmcmahon@carolinas.org
Comprehensive Cancer Center at Wake Forest University, Winston Salem, North Carolina, 27157-1081, United States; Recruiting
Thomas Williams McLean, MD 336-716-4324
Duke Comprehensive Cancer Center, Durham, North Carolina, 27710, United States; Recruiting
Philip Paul Breitfeld, MD 919-684-3377
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital, Greenville, North Carolina, 27858-4354, United States; Recruiting
Charles W. Daeschner, MD 252-744-4676 DaeschnerC@mail.ecu.edu
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, 27599, United States; Recruiting
Stuart Gold, MD 919-966-0985 stubaby@med.unc.med
Mission Hospitals, Asheville, North Carolina, 28801, United States; Recruiting
Orren Beaty, DO, PhD 823-213-5770 orren.beaty@msj.org
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, 28233, United States; Recruiting
Mark Mogul, MD 704-384-1900
North Dakota
Dakota Cancer Institute at Innovis Health - Dakota Clinic, Fargo, North Dakota, 58103-4940, United States; Recruiting
Janet K. Tillisch, MD 701-364-4964
Ohio
Children's Hospital Medical Center of Akron, Akron, Ohio, 44308-1062, United States; Recruiting
Steven J. Kuerbitz, MD 330-543-8730 skuerbitz@chmca.org
Children's Medical Center - Dayton, Dayton, Ohio, 45404, United States; Recruiting
Emmett H. Broxson, MD, FAAP 937-641-3111 broxsone@childrensdayton.org
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, 45229-3039, United States; Recruiting
John Peter Perentesis, MD 513-636-6090
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195, United States; Recruiting
Karen A. Bringelsen, MD 216-444-7923
Columbus Children's Hospital, Columbus, Ohio, 43205-2696, United States; Recruiting
Amanda Termuhlen, MD 614-722-3552
Forum Health-Tod Childrens Hospital, Youngstown, Ohio, 44501, United States; Recruiting
Ayman Saleh, MD, FAAP 330-884-3955 asaleh@neoucom.edu
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland, Ohio, 44106-5065, United States; Recruiting
Susan Wiersma, MD 216-844-3345 srw3@po.cwru.edu
St. Vincent Mercy Medical Center, Toledo, Ohio, 43608, United States; Recruiting
Rama Jasty, MD 419-251-8215 rjasty@mco.edu
Toledo Children's Hospital, Toledo, Ohio, 43601, United States; Recruiting
Richard M. Shore, MD 419-471-5437
Oklahoma
CCOP - Oklahoma, Tulsa, Oklahoma, 74136, United States; Recruiting
James B. Lockhart, MD 918-491-5878
Children's Hospital at Oklahoma University Medical Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
William H. Meyer, MD 405-271-5311 william-meyer@ouhsc.edu
Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa, Oklahoma, 74136, United States; Recruiting
Martina Christine Hum, MD 918-494-2525 pedonc@saintfrancis.com
Oregon
CCOP - Columbia River Oncology Program, Portland, Oregon, 97225, United States; Recruiting
Keith S. Lanier, MD 503-216-6260
Doernbecher Children's Hospital at Oregon Health & Science University, Portland, Oregon, 97239-3098, United States; Recruiting
H. Stacy Nicholson, MD, MPH 503-494-1543
Legacy Emanuel Hospital and Health Center & Children's Hospital, Portland, Oregon, 97227, United States; Recruiting
Janice Faye Olson, MD 503-413-2200
Pennsylvania
Children's Hospital at Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033, United States; Recruiting
John E. Neely, MD 717-531-6012 jen6@psu.edu
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States; Recruiting
Richard Berry Womer, MD 215-590-2229 rwomer@mail.med.upenn.edu
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States; Recruiting
Arthur Kim Ritchey, MD 412-692-5055 kim.ritchey@chp.edu
Geisinger Medical Center, Danville, Pennsylvania, 17822-1320, United States; Recruiting
Jeffrey Taylor, MD 570-271-6848
St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, 19134-1095, United States; Recruiting
Gregory E. Halligan, MD 215-427-5000 Gregory.Halligan@tenethealth.com
Rhode Island
Rhode Island Hospital, Providence, Rhode Island, 02903, United States; Recruiting
Sam W. Lew, MD 401-444-5171
South Carolina
Children's Hospital of Greenville Hospital System, Greenville, South Carolina, 29605, United States; Recruiting
Cary Ernest Stroud, MD 864-455-8898
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, 29425-0721, United States; Recruiting
Julio C. Barredo, MD 843-792-2957 barredjc@musc.edu
Palmetto Health South Carolina Cancer Center, Columbia, South Carolina, 29203, United States; Recruiting
Ronnie W. Neuberg, MD 803-434-3533 ronnie.neuberg@palmettohealth.org
South Dakota
Avera Cancer Institute, Sioux Falls, South Dakota, 57105-1080, United States; Recruiting
Marwan D. Hanna, MD 605-322-7595
Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls, South Dakota, 57117-5039, United States; Recruiting
Jakica Tancabelic, MD 605-333-7171 jtancabe@usd.edu
Tennessee
East Tennessee Children's Hospital, Knoxville, Tennessee, 37901, United States; Recruiting
Ray C. Pais, MD 865-541-8266 hemonc@etch.com
East Tennessee State University Cancer Center at Johnson City Medical Center, Johnson City, Tennessee, 37614-0622, United States; Recruiting
David K. Kalwinsky, MD 423-433-6200 sjcrhta@msha,cin
St. Jude Children's Research Hospital, Memphis, Tennessee, 38105-2794, United States; Recruiting
Wayne Lee Furman, MD 901-495-3300
Vanderbilt Children's Hospital, Nashville, Tennessee, 37232-6310, United States; Recruiting
James A. Whitlock, MD 615-936-1762
Texas
Baylor College of Medicine, Houston, Texas, 77030, United States; Recruiting
C. Philip Steuber, MD 713-798-6970
CCOP - Scott and White Hospital, Temple, Texas, 76508, United States; Recruiting
Lucas Wong, MD 254-724-1053 lwong@swmail.sw.org
Center for Cancer Prevention and Care at Scott and White Clinic, Temple, Texas, 76508, United States; Recruiting
Dick Suh, MD, PhD 254-724-9852 DSuh@swmail.sw.org
Children's Hospital of Austin, Austin, Texas, 78701, United States; Recruiting
Sharon K. Lockhart, MD 512-324-8480 slockhart@stcaustin.com
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, 76104, United States; Recruiting
Timothy C. Griffin, MD 682-885-4020 TGriffin@cookchildrens.org
Covenant Children's Hospital, Lubbock, Texas, 79410, United States; Recruiting
John Iacuone, MD 806-725-4840
MBCCOP - South Texas Pediatrics, San Antonio, Texas, 78229-3900, United States; Recruiting
Anne-Marie Langevin, MD 210-704-3405 langevin@uthscsa.edu
MD Anderson Cancer Center at University of Texas, Houston, Texas, 77030-4009, United States; Recruiting
Joann Ater, MD 713-792-6665 jater@mdanderson.org
Medical City Dallas Hospital, Dallas, Texas, 75230, United States; Recruiting
Carl Lenarsky, MD 972-566-6647 carl.lenarsky@usoncology.com
Methodist Cancer Center at Methodist Specialty and Transplant Hospital, San Antonio, Texas, 78229-3902, United States; Recruiting
Jaime Estrada, MD 210-575-8130
San Antonio Military Pediatric Cancer and Blood Disorders Center, Lackland Air Force Base, Texas, 78236, United States; Recruiting
Aaron Pitney, MD 210-292-5684
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, 75390-9063, United States; Recruiting
Naomi J. Winick, MD 214-648-3074 naomi.winick@utsouthwestern.edu
Texas Tech University Health Sciences Center School of Medicine, Amarillo, Texas, 79106, United States; Recruiting
Curtis Wade Turner, MD 806-354-5434 curtis.turner@ttuhsc.edu
University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78207, United States; Recruiting
Paul Jan Thomas, MD 210-704-3405 thomasp@uthscsa.edu
University of Texas Medical Branch, Galveston, Texas, 77555-0209, United States; Recruiting
Frederick Szujuei Huang, MD 409-772-2341 fshuang@utmb.edu
Utah
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, 84112, United States; Recruiting
Carol S. Bruggers, MD 801-585-0303
Vermont
Vermont Cancer Center at University of Vermont, Burlington, Vermont, 05401-3498, United States; Recruiting
Alan C. Homans, MD 802-847-2850
Virginia
Cancer Center at the University of Virginia, Charlottesville, Virginia, 22908, United States; Recruiting
Kimberly Dunsmore, MD 434-924-9333
Carilion Medical Center for Children at Roanoke Community Hospital, Roanoke, Virginia, 24029, United States; Recruiting
Joan Mistretta Fisher, MD, PhD 540-985-8055 jmfisher@carilion.com
Children's Hospital of the King's Daughters, Norfolk, Virginia, 23507, United States; Recruiting
Rebecca L. Byrd, MD 757-668-7243 byrdrl@chkd.org
INOVA Fairfax Hospital, Falls Church, Virginia, 22
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Publications
Arndt C, Hawkins D, Anderson JR, Breitfeld P, Womer R, Meyer W. Age is a risk factor for chemotherapy-induced hepatopathy with vincristine, dactinomycin, and cyclophosphamide. J Clin Oncol. 2004 May 15;22(10):1894-901. Erratum in: J Clin Oncol. 2004 Aug 15;22(16):3434. Correction of dosage error in text.
Study ID Numbers: CDR0000067157; COG-D9803; CCG-D9803; POG-D9803; IRS-D9803; NCT00003958
Record last reviewed: December 2004
Last Updated: April 4, 2005
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003958
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: December 2004
Last Updated: April 4, 2005
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003958
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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