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Spots Global Cancer Trial Database for Zoledronic Acid and Combination Chemotherapy in Treating Patients With Newly Diagnosed Metastatic Osteosarcoma

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Trial Identification

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

Conditions

Sarcoma

Study Description

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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Robert Goldsby, MD

Affiliation: University of California, San Francisco

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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