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Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma Clinical research trials and Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma. Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma clinical trial. Human subjects frequently get the finest healthcare available for their Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma  Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma
Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma
For Condition: cardiac toxicity,localized osteosarcoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Children's Cancer Group,Pediatric Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Chemoprotective drugs such as dexrazoxane may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase III trial to study the effectiveness of three combination chemotherapy regimens plus dexrazoxane in treating patients who have newly diagnosed nonmetastatic osteosarcoma.
Details: OBJECTIVES: I. Compare the efficacy of three intensification regimens (doxorubicin vs doxorubicin plus ifosfamide vs doxorubicin plus ifosfamide and etoposide) in patients with newly diagnosed, previously untreated, nonmetastatic osteosarcoma. II. Determine the effect of postoperative dose intensification on outcome in patients with standard response to preoperative chemotherapy. III. Determine the effect of dexrazoxane cardioprotection during standard induction therapy on histologic response in these patients. IV. Evaluate biological factors that may predict outcome in these patients. V. Determine the safety of dexrazoxane administered with doxorubicin in combination with cisplatin or cisplatin and ifosfamide in these patients. VI. Determine the effect of dexrazoxane on cytotoxicity as measured by tumor necrosis at definitive surgery in these patients. VII. Assess the feasibility of administering doxorubicin with dexrazoxane cardioprotection or high dose ifosfamide with etoposide to standard risk patients who are also receiving methotrexate and cisplatin. PROTOCOL OUTLINE: This is a multicenter study. Patients are enrolled sequentially on 1 of 3 pilot intensification regimens. After surgery to completely remove the primary tumor, patients are assigned to 1 of 2 adjuvant chemotherapy groups based on percent necrosis at limb salvage. Pilot 1: (Closed to accrual as of 6/2/2000) Patients receive dexrazoxane IV followed immediately by doxorubicin IV over 20 minutes plus cisplatin IV over 4 hours on days 1 and 2 of weeks 1 and 6. Methotrexate IV over 4 hours is administered on day 1 of weeks 4, 5, 9, and 10. Patients undergo surgery on week 11. Adjuvant chemotherapy begins on day 1 of week 13. Group 1 (good response to neoadjuvant chemotherapy): Patients receive methotrexate IV over 4 hours every 3 weeks for 6 courses, beginning on week 13. Patients also receive dexrazoxane and doxorubicin every 3 weeks for 4 courses, beginning on week 14. Cisplatin is administered with the first 2 courses of dexrazoxane and doxorubicin. Group 2 (standard response to neoadjuvant chemotherapy): Patients receive methotrexate and cisplatin as in group 1 plus dexrazoxane and doxorubicin for 6 courses. Pilot 2: Patients receive preoperative therapy comprised of dexrazoxane, doxorubicin, and methotrexate as in pilot 1. Ifosfamide IV over 4 hours is also administered on days 1-5 of week 1. Patients undergo surgery on week 11, then begin adjuvant chemotherapy on week 13. Group 1: Patients receive methotrexate, dexrazoxane, and doxorubicin as in pilot 1, group 1. Ifosfamide is also administered on weeks 14 and 20. Cisplatin is administered on weeks 17, 23, and 26. Group 2: Patients receive methotrexate, dexrazoxane, and doxorubicin as in pilot 1, group 2. Ifosfamide is administered on weeks 14, 20, 26, and 31. Cisplatin is administered on weeks 17, 23, and 29. Pilot 3: (Open to accrual as of 6/2/2000) Patients receive preoperative therapy comprised of methotrexate, dexrazoxane, doxorubicin, ifosfamide, and cisplatin as in pilot 2. Patients undergo surgery on week 11, then begin adjuvant chemotherapy on week 13. Group 1: Patients receive methotrexate, dexrazoxane, doxorubicin, ifosfamide, and cisplatin as in pilot 2, group 1. Group 2: Patients receive methotrexate on weeks 13, 19, 29, 32, 35, and 36, high dose ifosfamide and etoposide IV over 4 hours on days 1-5 of weeks 14, 23, and 26, and cisplatin on weeks 20, 30, and 33. Dexrazoxane and doxorubicin are administered on weeks 17, 20, 30, and 33. Patients are followed every 3 months for 1 year, every 6 months for 4 years and then annually thereafter. PROJECTED ACCRUAL: Approximately 180 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: /30 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven newly diagnosed moderate or high grade osteosarcoma without metastases; No prior treatment, including complete resection; No parosteal or periosteal sarcoma; No osteosarcoma associated with Paget's disease - No nonresectable tumors or tumors that may result in marginal or interlesion resection - Must be enrolled on protocol POG-9851 --Prior/Concurrent Therapy-- - See Disease Characteristics - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: 30 and under - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times normal; SGOT no greater than 3 times normal - Renal: Creatinine normal; Phosphate at least 3.0 mg/dL without supplementation - Cardiovascular: Shortening fraction at least 28% by echocardiogram; If echocardiogram unsatisfactory, must have ejection fraction at least 50%; No history of pericarditis or myocarditis; No symptomatic arrhythmia or symptomatic cardiac conduction disturbances
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CindySchwartz, Study Chair, Pediatric Oncology Group
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
Carilion Roanoke Community Hospital
Roanoke, Virginia, 24029
United States
Schneider Children's Hospital
New Hyde Park, New York, 11042
United States
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Canada
Mount Sinai School of Medicine
New York City, New York, 10029
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Scott and White Clinic
Temple, Texas, 76508
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
United States
Oklahoma Memorial Hospital
Oklahoma City, Oklahoma, 73126-0307
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, 29605
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Sutter Cancer Center
Sacramento, California, 95816
United States
Walt Disney Memorial Cancer Institute
Orlando, Florida, 32803
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0209
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Clinique de Pediatrie
Geneva, , 1211
Switzerland
Inova Fairfax Hospital
Falls Church, Virginia, 22042-3300
United States
Children's Hospital and Health Center
San Diego, California, 92123-4282
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
United States
University of California Davis Medical Center
Sacramento, California, 95817
United States
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, 32610-100277
United States
Long Beach Memorial Medical Center
Long Beach, California, 90806
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Swiss Pediatric Oncology Group Bern
Bern, , CH 3010
Switzerland
Eastern Maine Medical Center
Bangor, Maine, 04401
United States
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, 74136
United States
Children's Hospital of Denver
Denver, Colorado, 80218
United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
James H. Quillen College of Medicine
Johnson City, Tennessee, 37614-0622
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
University of Rochester Cancer Center
Rochester, New York, 14642
United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
United States
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
Canada
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134-1095
United States
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
Australia
Baptist Hospital of Miami
Miami, Florida, 33176-2197
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
Texas Oncology P.A.
Dallas, Texas, 75230-2503
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Naval Medical Center, Portsmouth
Portsmouth, Virginia, 23708-2197
United States
Legacy Emanuel Hospital and Health Center
Portland, Oregon, 97227
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
All Children's Hospital
St. Petersburg, Florida, 33701
United States
Miami Children's Hospital
Miami, Florida, 33155
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Nemours Children's Clinic
Jacksonville, Florida, 32207
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
Mission Saint Joseph's Health System
Asheville, North Carolina, 28801
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
St. John's Hospital and Medical Center
Detroit, Michigan, 48236
United States
West Virginia University Hospitals
Morgantown, West Virginia, 26506-9300
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
United States
Academisch Ziekenhuis Groningen
Groningen, , 9713 EZ
Netherlands
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, 92120
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
MBCCOP - South Texas Pediatric
San Antonio, Texas, 78229-3900
United States
Saint Jude Midwest Affiliate
Peoria, Illinois, 61637
United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
United States
East Carolina University School of Medicine
Greenville, North Carolina, 27858-4354
United States
St. Mary's Hospital
West Palm Beach, Florida, 33407
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Canada
Hurley Medical Center
Flint, Michigan, 48503
United States
Cardinal Glennon Children's Hospital
St. Louis, Missouri, 63104
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
University of Missouri-Columbia Hospital and Clinics
Columbia, Missouri, 65212
United States
IWK Health Centre
Halifax, Nova Scotia, B3J 3G9
Canada
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
David Grant Medical Center
Travis Air Force Base, California, 94535
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Medical City Dallas Hospital
Dallas, Texas, 75230
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Children's Hospital
Hamilton, Ontario, L8N 3Z5
Canada
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
University of New Mexico School of Medicine
Albuquerque, New Mexico, 87131
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Children's Memorial Hospital, Chicago
Chicago, Illinois, 60614
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304
United States
Maine Children's Cancer Program
Portland, Maine, 04101
United States
Doernbecher Children's Hospital
Portland, Oregon, 97201-3098
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Royal Children's Hospital
Parkville, Victoria, 3052
Australia
CCOP - Columbia River Program
Portland, Oregon, 97213
United States
Alberta Children's Hospital
Calgary, Alberta, T2T 5C7
Canada
Presbyterian Healthcare
Charlotte, North Carolina, 28233-3549
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
West Virginia University Medical School-Charleston
Charleston, West Virginia, 25304
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Boston Floating Hospital Infants and Children
Boston, Massachusetts, 02111
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
Children's Hospital of Columbus
Columbus, Ohio, 43205-2696
United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000
United States
Centre Hospitalier de L'Universite Laval
Sainte-Foy, Quebec, GIV 4G2
Canada
Via Christi Regional Medical Center
Wichita, Kansas, 67214
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, 78236-5300
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
San Jorge Childrens Hospital
Santurce, , 00912
Puerto Rico
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Canada
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Canada
St. Vincent Hospital
Green Bay, Wisconsin, 54307-3508
United States
Hope Children's Hospital
Oak Lawn, Illinois, 60453
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051-5386
United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
United States
CCOP - Florida Pediatric
Tampa, Florida, 33682-7757
United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
Additional Information:
Study ID Numbers: CDR0000067129; POG-P9754
Study Start Date: September 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003937
Other Cardiac Toxicity Studies:
1. Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer
2. Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma
3. Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors
4. Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer
5. Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Disease
Related Studies:
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Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma
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