Spots Global Cancer Trial Database for Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma
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Trial Identification
Brief Title: Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma
Official Title: A Phase II Study of Aerosolized GM-CSF (NSC# 613795, IND# 11042) in Patients With First Pulmonary Recurrence of Osteosarcoma
Study ID: NCT00066365
Study Description
Brief Summary: RATIONALE: Inhaling aerosolized sargramostim before and after surgery may interfere with the growth of tumor cells and shrink the tumor so that it can be removed during surgery. Sargramostim may then kill any tumor cells remaining after surgery. This may be an effective treatment for osteosarcoma that has spread to the lung. PURPOSE: This phase II trial is studying how well inhaled sargramostim works in treating patients who are undergoing surgery for the first recurrence of osteosarcoma that has spread to the lung.
Detailed Description: OBJECTIVES: Primary * Assess the histological findings from patients with first pulmonary recurrence of osteosarcoma who undergo resection of pulmonary metastases after treatment with 2 courses of aerosolized sargramostim (GM-CSF). * Determine the event-free survival of patients treated with this drug. * Determine whether the maximum tolerated dose in the trial of inhaled GM-CSF in adult patients with melanoma is tolerable in pediatric patients. Secondary * Determine the effect of specific thoracic surgical management on outcome in patients treated with this drug. OUTLINE: This is a multicenter, dose escalation study. Patients are assigned to 1 of 2 groups according to the extent of pulmonary recurrence (unilateral or bilateral). * Group I (unilateral recurrence): * Initial inhalation therapy: Patients receive inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. * Thoracotomy: Patients undergo thoracotomy on day 22. * Post-thoracotomy inhalation therapy: Beginning on day 29, or as soon as possible thereafter, patients resume inhalation therapy as above for up to 12 additional courses. * Group II (bilateral recurrence): Patients may be enrolled on study either before or after the first thoracotomy. * First thoracotomy: Patients undergo unilateral thoracotomy. * Initial inhalation therapy: Patients receive inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. * Contralateral thoracotomy: Patients undergo contralateral thoracotomy on day 22. * Post-thoracotomy inhalation therapy: Beginning on day 29, or as soon as possible, patients resume inhalation therapy as above for up to 12 additional courses. Treatment in both groups continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 1.6-2 years.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham, Birmingham, Alabama, United States
Phoenix Children's Hospital, Phoenix, Arizona, United States
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, 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
Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital, Long Beach, California, United States
Children's Hospital and Research Center Oakland, Oakland, California, United States
University of California Davis Cancer Center, Sacramento, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Stanford Cancer Center, Stanford, California, United States
Alfred I. duPont Hospital for Children, Wilmington, Delaware, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, United States
Children's National Medical Center, Washington, District of Columbia, United States
Lee Cancer Care of Lee Memorial Health System, Fort Myers, Florida, United States
University of Florida Shands Cancer Center, Gainesville, Florida, United States
Nemours Children's Clinic, Jacksonville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida, United States
Miami Children's Hospital, Miami, Florida, United States
Baptist-South Miami Regional Cancer Program, Miami, 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, St. 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
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, 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
Simmons Cooper Cancer Institute, Springfield, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, 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
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Butterworth Hospital at Spectrum Health, Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
Breslin Cancer Center at Ingham Regional Medical Center, Lansing, Michigan, 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
Hackensack University Medical Center Cancer Center, Hackensack, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center, Newark, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, 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
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Akron Children's Hospital, Akron, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Children's Medical Center - Dayton, Dayton, Ohio, United States
Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, United States
Legacy Emanuel Hospital and Health Center and Children's Hospital, Portland, Oregon, United States
Oregon Health and Science University Cancer Institute, Portland, Oregon, United States
Lehigh Valley Hospital - Muhlenberg, Bethlehem, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
Palmetto Health South Carolina Cancer Center, Columbia, South Carolina, United States
Greenville Hospital Cancer Center, Greenville, South Carolina, United States
East Tennessee Children's Hospital, Knoxville, Tennessee, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, United States
M. D. Anderson Cancer Center at University of Texas, Houston, Texas, United States
Covenant Children's Hospital, Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, 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
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, United States
Midwest Children's Cancer Center at Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States
Westmead Institute for Cancer Research at Westmead Hospital, Westmead, New South Wales, Australia
Princess Margaret Hospital for Children, Perth, Western Australia, Australia
CancerCare Manitoba, Winnipeg, Manitoba, Canada
IWK Health Centre, Halifax, Nova Scotia, Canada
McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, Canada
Montreal Children's Hospital at McGill University Health Center, Montreal, Quebec, Canada
Hopital Sainte Justine, Montreal, Quebec, Canada
Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon, Saskatchewan, Canada
Centre Hospitalier Universitaire de Quebec, Quebec, , Canada
San Jorge Children's Hospital, Santurce, , Puerto Rico
Contact Details
Name: Carola A. Arndt, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR
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