Clinical Trials in Osteosarcoma
Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma
Official Title: Phase II Study of Aerosolized Sargramostim (GM-CSF) in Patients With First Pulmonary Recurrence of Osteosarcoma
Purpose
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.
OBJECTIVES:
- 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 the effect of specific thoracic surgical management on outcome in patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups according to the extent of pulmonary recurrence (unilateral or bilateral).
- Initial inhalation therapy: Patients receive inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every 14 days for 2 courses.
- Thoracotomy: Patients undergo thoracotomy on day 22.
- Post-thoracotomy inhalation therapy: Beginning on day 29, patients resume inhalation therapy as above for up to 12 additional courses.
- Unilateral thoracotomy: Patients undergo unilateral thoracotomy on day 1.
- Initial inhalation therapy: Patients receive inhaled GM-CSF twice daily on days 7-14. Treatment repeats every 14 days for 2 courses.
- Contralateral thoracotomy: Patients undergo contralateral thoracotomy on day 29.
- Post-thoracotomy inhalation therapy: Beginning on day 36, 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.
Eligibility
Ages Eligible for Study: up to 39 Years
Disease Characteristics:
- Histologically confirmed osteosarcoma at primary diagnosis
- Lesions detected in at least 1 lung that are consistent with metastatic disease and approachable with thoracotomy
- No prior recurrence of osteosarcoma
- No other sites of metastases
- Resectable pulmonary nodule(s), defined as nodule(s) that are removable without performing a pneumonectomy (e.g., nodules immediately adjacent to the main stem bronchus or main pulmonary vessels)
- Prior thoracotomy allowed in patients with imaging consistent with metastatic involvement in both lungs provided the lung on which the thoracotomy was performed is disease-free
- No pleural effusion
Patient Characteristics:
- Age: 39 and under
- Pulmonary:
- No evidence of dyspnea at rest
- No exercise intolerance
- Pulse oximetry at least 94%
- Baseline FEV_1 at least 75% of normal
- Other:
- Willing and able to perform inhalation therapy
- No medical contraindication to surgical excision
Prior Concurrent Therapy:
- Biologic therapy:
- No other concurrent immunotherapy
- No other concurrent immunomodulating agents
- Chemotherapy: No concurrent anticancer chemotherapy
- Endocrine therapy: No concurrent steroids by any route
- Surgery:
- See Disease Characteristics
- No concurrent thoracoscopy or video-assisted thoracic surgery
- Other:
- No more than 1 prior treatment regimen for osteosarcoma
- No concurrent participation in another COG therapeutic study
Location and Contact Information
Arizona
Phoenix Children's Hospital, Phoenix, Arizona, 85016-7710, United States; Recruiting
Jessica L. Boklan 602-546-0920
Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States; Recruiting
David Becton 501-364-5650
California
Southern California Permanente Medical Group, Downey, California, 90242-2814, United States; Recruiting
Robert Cooper 323-783-5307
Stanford Cancer Center at Stanford University Medical Center, Stanford, California, 94305, United States; Recruiting
Clinical Trials Office - Stanford Cancer Center at Stanford Un 650-498-7061. E-mail
District of Columbia
Children's National Medical Center, Washington, District of Columbia, 20010-2970, United States; Recruiting
Clinical Trials Office - Children's National Medical Center 202-884-2549
Florida
Baptist-South Miami Regional Cancer Program, Miami, Florida, 33176, United States; Recruiting
Doured Daghistani 305-274-1662
Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach, Florida, 33407, United States; Recruiting
Narayana Gowda 561-844-6363
Lee Cancer Care of Lee Memorial Health System, Fort Myers, Florida, 33901, United States; Recruiting
Clinical Trials Office for Lee Cancer Care of Lee Memorial Hea 877-680-0008
Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola, Florida, 32504, United States; Recruiting
CTO contact for Sacred Heart Cancer Center at Sacred Heart Hos 850-416-4611
Georgia
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, 31403-3089, United States; Recruiting
Clinical Trials Office - Curtis & Elizabeth Anderson Cancer In 912-350-8568
Emory University Hospital - Atlanta, Atlanta, Georgia, 30322, United States; Recruiting
Howard M. Katzenstein 404-785-0853
Idaho
St. Luke's Mountain States Tumor Institute - Boise, Boise, Idaho, 83712-6297, United States; Recruiting
J. M. Johnston 208-381-2782
Illinois
Children's Memorial Hospital - Chicago, Chicago, Illinois, 60614, United States; Recruiting
Susan Cohn 773-880-4562
Southern Illinois University School of Medicine, Springfield, Illinois, 62794-9620, United States; Recruiting
Clinical Trials Office - Southern Illinois University School o 217-545-7929
Indiana
St. Vincent Indianapolis Hospital, Indianapolis, Indiana, 46260, United States; Recruiting
Clinical Trials Office - St. Vincent Indianapolis Hospital 317-338-2194
Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, 21231-2410, United States; Recruiting
Clinical Trials Office 410-955-8804. E-mail
Michigan
Hurley Medical Center, Flint, Michigan, 48503, United States; Recruiting
Clinical Trials Office - Hurley Medical Center 810-762-8057
Spectrum Health Cancer Care - Butterworth Campus, Grand Rapids, Michigan, 49503-2560, United States; Recruiting
David R. Freyer 616-391-2086
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, 48236, United States; Recruiting
Clincial Trials Office - Van Elslander Cancer Center 313-343-3166
Minnesota
Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States; Recruiting
Clinical Trials Office 507-538-7623
New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, 08903, United States; Recruiting
Clinical Trials Office - Cancer Institute of New Jersey at UMD 732-235-8675
New York
SUNY Upstate Medical University Hospital, Syracuse, New York, 13210, United States; Recruiting
Clinical Trials Office - SUNY Upstate Medical University Hospi 315-464-5476
Ohio
Children's Medical Center - Dayton, Dayton, Ohio, 45404-1815, United States; Recruiting
Emmett Broxson 937-641-3111
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195-5217, United States; Recruiting
Joanne M. Hilden 216-444-8407
Oklahoma
Oklahoma University Medical Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
William Meyer 405-271-5311
Oregon
Institute of Oncology at Vilnius University, Portland, Oregon, 97227, United States; Recruiting
Janice F. Olson 503-413-2560
Pennsylvania
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033-0850, United States; Recruiting
Clinical Trials Office 717-531-3779. E-mail
South Carolina
Greenville Hospital System Cancer Center, Greenville, South Carolina, 29605, United States; Recruiting
Clinical Trials Office 864-241-6251
Palmetto Health South Carolina Cancer Center, Columbia, South Carolina, 29203, United States; Recruiting
Clinical Trials Office - Palmetto Health South Carolina Cancer 803-434-3680
Tennessee
East Tennessee Children's Hospital, Knoxville, Tennessee, 37916, United States; Recruiting
Ray C. Pais 865-541-8266
Texas
CCOP - Scott and White Hospital, Temple, Texas, 76508, United States; Recruiting
Dick Y. Suh 254-724-9852
Covenant Children's Hospital, Lubbock, Texas, 79410, United States; Recruiting
John Iacuone 806-725-4840
Utah
Primary Children's Medical Center, Salt Lake City, Utah, 84113-1100, United States; Recruiting
Phillip E. Barnette 801-588-2680
Washington
Providence Cancer Center at Sacred Heart Medical Center, Spokane, Washington, 99220-2555, United States; Recruiting
Judy Felgenhauer 509-474-2777
Wisconsin
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, 54449, United States; Recruiting
Clinical Trials Office - Marshfield Clinic 800-782-1581 ext. 94457
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, 54307-3508, United States; Recruiting
Clinical Trials Office - St. Vincent Hospital Regional Cancer 920-433-8889
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, 53792-6164, United States; Recruiting
Clinical Trials Office for University of Wisconsin Comprehensi 608-262-5223
Canada, Nova Scotia
IWK Health Centre, Halifax, Nova Scotia, B3K 6R8, Canada; Recruiting
Margaret C. Yhap 902-470-8778
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, L8N 3Z5, Canada; Recruiting
Carol A. Portwine 905-521-2100x73428
Canada, Quebec
Centre Hospitalier Universitaire de Quebec, Ste Foy, Quebec, G1V 4G2, Canada; Recruiting
Yvan Samson 418-656-4141x47191
McGill Cancer Centre at McGill University, Montreal, Quebec, H3H 1P3, Canada; Recruiting
Sharon Abish 514-412-4400x22219
Study chairs or principal investigators
Carola A.S. Arndt, MD, Study Chair, Mayo Clinic
Site Design: Caroline Courtney