The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Zoledronic Acid and Combination Chemotherapy in Treating Patients With Newly Diagnosed Metastatic Osteosarcoma
Official Title: Feasibility and Dose Discovery Analysis of Zoledronic Acid With Concurrent Chemotherapy in the Treatment of Newly Diagnosed Metastatic Osteosarcoma
Study ID: NCT00742924
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This clinical trial is studying the side effects and best dose of zoledronic acid when given together with combination chemotherapy in treating patients with newly diagnosed metastatic osteosarcoma.
Detailed Description: OBJECTIVES: Primary: * To assess the feasibility and safety of zoledronic acid when administered in combination with standard chemotherapy in patients with newly diagnosed metastatic osteosarcoma. * To determine the maximum tolerated dose of zoledronic acid when administered in combination with standard chemotherapy in these patients. Secondary: - To compare the histologic response and event-free survival of patients treated with this regimen versus patients treated on INT-0133 or CCG-7943. OUTLINE: This is a multicenter, dose-escalation study of zoledronic acid. * Induction therapy (weeks 1-11): Patients receive dexrazoxane hydrochloride IV slowly over 5-15 minutes, doxorubicin hydrochloride IV over 15 minutes, and cisplatin IV over 1 hour on days 1 and 2 of weeks 1 and 6; zoledronic acid IV at the assigned dose level over 30 minutes on day 4 of weeks 1 and 6; high-dose methotrexate IV over 4 hours on day 1 of weeks 4, 5, 9, and 10; leucovorin calcium IV or orally every 6 hours starting on day 2 and continuing until clearance of methotrexate of weeks 4, 5, 9, and 10; and filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 3 of weeks 1 and 6 and continuing until blood counts recover. * Surgery (week 12): Patients undergo definitive surgery (limb-salvage surgery or amputation) of the primary tumor in week 12. * Maintenance therapy course 1 (weeks 13-25): Patients receive etoposide IV over 1 hour and ifosfamide IV over 4 hours on days 1-5 of weeks 13 and 21; zoledronic acid IV over 30 minutes on day 4 of week 17 and on day 7 of weeks 13 and 21; high-dose methotrexate IV over 4 hours on day 1 of weeks 16, 20, and 24; leucovorin calcium IV or orally every 6 hours starting on day 2 and continuing until clearance of methotrexate of weeks 16, 20, and 24; dexrazoxane hydrochloride IV slowly over 5-15 minutes, doxorubicin hydrochloride IV over 15 minutes, and cisplatin IV over 1 hour on days 1 and 2 of week 17; and G-CSF SC once daily beginning on day 6 of weeks 13, 17, and 21 and continuing until blood counts recover. * Surgery (week 26): Patients may undergo surgical resection of primary metastases in week 26. * Maintenance therapy course 2 (weeks 27-36): Patients receive dexrazoxane hydrochloride IV slowly over 5-15 minutes and doxorubicin hydrochloride IV over 15 minutes on days 1 and 2 of weeks 27 and 31; cisplatin IV over 1 hour on days 1 and 2 of week 27; zoledronic acid IV over 30 minutes on day 4 of week 27 and on day 7 of weeks 31 and 36; high-dose methotrexate IV over 4 hours on day 1 of weeks 30, 34, and 35; leucovorin calcium IV or orally every 6 hours starting on day 2 and continuing until clearance of methotrexate of weeks 30, 34, and 35; etoposide IV over 1 hour on days 1-5 of week 36; ifosfamide (1.8 gm/m2 ) IV over 1 hour on days 1-5 of week 31;ifosfamide (2.8 gm/m2)IV over 4 hours on days 1-5 of week 36; and G-CSF SC once daily beginning on day 3 of weeks 27, 31, and 36 and continuing until blood counts recover. Mensa is a supportive care medicine used to prevent hemorrhagic cystitis caused by ifosfamide. It is always given when ifosfamide is given. It was used in all arms. After completion of study treatment, patients are followed periodically for up to 5 years.
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
UAB Comprehensive Cancer Center, Birmingham, Alabama, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Southern California Permanente Medical Group, Downey, California, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital, Long Beach, California, United States
Childrens Hospital Los Angeles, Los Angeles, California, United States
Children's Hospital Central California, Madera, California, United States
Children's Hospital and Research Center Oakland, Oakland, California, United States
Children's Hospital of Orange County, Orange, California, United States
Lucile Packard Children's Hospital Stanford University, Palo Alto, California, United States
Rady Children's Hospital - San Diego, San Diego, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, Farmington, Connecticut, United States
Alfred I. duPont Hospital for Children, Wilmington, Delaware, United States
Children's National Medical Center, Washington, District of Columbia, United States
Nemours Children's Clinic, Jacksonville, Florida, United States
Nemours Children's Clinic - Orlando, Orlando, Florida, United States
Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola, Florida, United States
All Children's Hospital, Saint Petersburg, Florida, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital, Tampa, Florida, United States
Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach, Florida, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus, Atlanta, Georgia, United States
Cancer Research Center of Hawaii, Honolulu, Hawaii, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center, Boise, Idaho, United States
Children's Memorial Hospital - Chicago, Chicago, Illinois, United States
Keyser Family Cancer Center at Advocate Hope Children's Hospital, Oak Lawn, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, United States
Lucille P. Markey Cancer Center at University of Kentucky, Lexington, Kentucky, United States
Kosair Children's Hospital, Louisville, Kentucky, United States
Maine Children's Cancer Program at Barbara Bush Children's Hospital, Scarborough, Maine, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute, Boston, Massachusetts, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Butterworth Hospital at Spectrum Health, Grand Rapids, Michigan, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
Breslin Cancer Center at Ingham Regional Medical Center, Lansing, Michigan, United States
Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
University of Mississippi Cancer Clinic, Jackson, Mississippi, United States
Children's Mercy Hospital, Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, St. Louis, Missouri, United States
Hackensack University Medical Center Cancer Center, Hackensack, New Jersey, United States
Overlook Hospital, Morristown, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
NYU Cancer Institute at New York University Medical Center, New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York, United States
SUNY Upstate Medical University Hospital, Syracuse, New York, United States
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Akron Children's Hospital, Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Dayton Children's - Dayton, Dayton, Ohio, United States
Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, United States
Knight Cancer Institute at Oregon Health and Science University, Portland, Oregon, United States
Penn State Children's Hospital, Hershey, Pennsylvania, United States
Palmetto Health South Carolina Cancer Center, Columbia, South Carolina, United States
T.C. Thompson Children's Hospital, Chattanooga, Tennessee, United States
East Tennessee Children's Hospital, Knoxville, Tennessee, United States
Driscoll Children's Hospital, Corpus Christi, Texas, United States
Medical City Dallas Hospital, Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Methodist Children's Hospital of South Texas, San Antonio, Texas, United States
Primary Children's Medical Center, Salt Lake City, Utah, United States
Children's Hospital of The King's Daughters, Norfolk, Virginia, United States
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States
Providence Cancer Center at Sacred Heart Medical Center, Spokane, Washington, United States
West Virginia University Health Sciences Center - Charleston, Charleston, West Virginia, United States
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, United States
Princess Margaret Hospital for Children, Perth, Western Australia, Australia
Alberta Children's Hospital, Calgary, Alberta, Canada
Children's & Women's Hospital of British Columbia, Vancouver, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Janeway Children's Health and Rehabilitation Centre, St. John's, Newfoundland and Labrador, Canada
IWK Health Centre, Halifax, Nova Scotia, Canada
McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, Canada
Hospital for Sick Children, Toronto, Ontario, Canada
Hopital Sainte Justine, Montreal, Quebec, Canada
Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon, Saskatchewan, Canada
San Jorge Children's Hospital, Santurce, , Puerto Rico
Name: Robert Goldsby, MD
Affiliation: University of California, San Francisco
Role: STUDY_CHAIR