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Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma

Primary Purpose

Metastatic Cancer, Sarcoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
sargramostim
conventional surgery
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring metastatic osteosarcoma, recurrent osteosarcoma, lung metastases

Eligibility Criteria

undefined - 39 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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 or pleural based nodules PATIENT CHARACTERISTICS: Age 39 and under Performance status Karnofsky 50-100% (patients over 16 years of age) Lansky 50-100% (patients 16 years of age and under) Life expectancy At least 8 weeks Hematopoietic Not specified Hepatic Not specified Renal Not specified Pulmonary No evidence of dyspnea at rest No exercise intolerance Pulse oximetry at least 94% Baseline Forced expiratory volume in 1 second (FEV_1) at least 80% of predicted No history of asthma No history of reactive airway disease No history of bronchospasm Other Willing and able to perform inhalation therapy No medical contraindication to surgical excision Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception 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 Radiotherapy Not specified 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

Sites / Locations

  • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
  • Phoenix Children's Hospital
  • Arizona Cancer Center at University of Arizona Health Sciences Center
  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • Southern California Permanente Medical Group
  • Loma Linda University Cancer Institute at Loma Linda University Medical Center
  • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
  • Children's Hospital and Research Center Oakland
  • University of California Davis Cancer Center
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • Stanford Cancer Center
  • Alfred I. duPont Hospital for Children
  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
  • Children's National Medical Center
  • Lee Cancer Care of Lee Memorial Health System
  • University of Florida Shands Cancer Center
  • Nemours Children's Clinic
  • University of Miami Sylvester Comprehensive Cancer Center - Miami
  • Miami Children's Hospital
  • Baptist-South Miami Regional Cancer Program
  • Nemours Children's Clinic - Orlando
  • Sacred Heart Cancer Center at Sacred Heart Hospital
  • All Children's Hospital
  • St. Joseph's Cancer Institute at St. Joseph's Hospital
  • Kaplan Cancer Center at St. Mary's Medical Center
  • Winship Cancer Institute of Emory University
  • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  • Mountain States Tumor Institute at St. Luke's Regional Medical Center
  • Children's Memorial Hospital - Chicago
  • Simmons Cooper Cancer Institute
  • Indiana University Melvin and Bren Simon Cancer Center
  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
  • Lucille P. Markey Cancer Center at University of Kentucky
  • Kosair Children's Hospital
  • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • Barbara Ann Karmanos Cancer Institute
  • Hurley Medical Center
  • Butterworth Hospital at Spectrum Health
  • Van Elslander Cancer Center at St. John Hospital and Medical Center
  • Breslin Cancer Center at Ingham Regional Medical Center
  • Mayo Clinic Cancer Center
  • University of Mississippi Cancer Clinic
  • Children's Mercy Hospital
  • Hackensack University Medical Center Cancer Center
  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
  • Newark Beth Israel Medical Center
  • University of New Mexico Cancer Center
  • Roswell Park Cancer Institute
  • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • SUNY Upstate Medical University Hospital
  • Blumenthal Cancer Center at Carolinas Medical Center
  • Duke Comprehensive Cancer Center
  • Akron Children's Hospital
  • Cleveland Clinic Taussig Cancer Center
  • Nationwide Children's Hospital
  • Children's Medical Center - Dayton
  • Oklahoma University Cancer Institute
  • Legacy Emanuel Hospital and Health Center and Children's Hospital
  • Oregon Health and Science University Cancer Institute
  • Lehigh Valley Hospital - Muhlenberg
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
  • Children's Hospital of Philadelphia
  • St. Christopher's Hospital for Children
  • Children's Hospital of Pittsburgh
  • Palmetto Health South Carolina Cancer Center
  • Greenville Hospital Cancer Center
  • East Tennessee Children's Hospital
  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
  • Cook Children's Medical Center - Fort Worth
  • M. D. Anderson Cancer Center at University of Texas
  • Covenant Children's Hospital
  • University of Texas Health Science Center at San Antonio
  • CCOP - Scott and White Hospital
  • Fletcher Allen Health Care - University Health Center Campus
  • Children's Hospital and Regional Medical Center - Seattle
  • Providence Cancer Center at Sacred Heart Medical Center
  • St. Vincent Hospital Regional Cancer Center
  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
  • Marshfield Clinic - Marshfield Center
  • Midwest Children's Cancer Center at Children's Hospital of Wisconsin
  • Westmead Institute for Cancer Research at Westmead Hospital
  • Princess Margaret Hospital for Children
  • CancerCare Manitoba
  • IWK Health Centre
  • McMaster Children's Hospital at Hamilton Health Sciences
  • Montreal Children's Hospital at McGill University Health Center
  • Hopital Sainte Justine
  • Saskatoon Cancer Centre at the University of Saskatchewan
  • Centre Hospitalier Universitaire de Quebec
  • San Jorge Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1 (unilateral recurrence) - Sargramostim and thoractomy

Group 2 (bilateral recurrence) - Sargramostim and thoractomy

Arm Description

Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment 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.

Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo surgical procedure unilateral thoracotomy. Patients receive initial inhalation therapy 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. Patients undergo surgical procedure contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment 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.

Outcomes

Primary Outcome Measures

Status of FAS Ligand in Pre-chemotherapy Sample
FAS ligand (FASL) is a homotrimeric type II transmembrane protein expressed on cytotoxic T lymphocytes. The Cluster of Differentiation 1a (CD1a) status is measured in Immunohistochemistry (IHC) categories.
Presence of FAS in Pre-chemotherapy Sample
FAS/APO-1 is a transmembrane receptor. The presence is measured in Immunohistochemistry (IHC) categories.
FAS Ligand in Post Chemotherapy Sample
FAS ligand or FASL is a homotrimeric type II transmembrane protein expressed on cytotoxic T lymphocytes. The presence is measured in Immunohistochemistry (IHC) categories.
FAS Status in Post Chemotherapy Sample
FAS/APO-1 is a transmembrane receptor. The presence is measured in Immunohistochemistry (IHC) categories.
CD1a Status in Pre Chemotherapy Sample
CD1a (Cluster of Differentiation 1a) is a human protein encoded by the CD1A gene, presence is measured by positivity.
CD1a Status in Post Chemotherapy Sample
CD1a (Cluster of Differentiation 1a) is a human protein encoded by the CD1A gene, presence is measured by positivity.
S100 Status in Pre Chemotherapy Sample
The S-100 proteins are a family of low-molecular-weight proteins characterized by two calcium-binding sites that have helix-loop-helix ("EF-hand type") conformation.
S100 Status in Post Chemotherapy Sample
The S-100 proteins are a family of low-molecular-weight proteins characterized by two calcium-binding sites that have helix-loop-helix ("EF-hand type") conformation.
Clusterin Status in Pre Chemotherapy Sample
The protein encoded by this gene can under some stress conditions also be found in the cell cytosol. It has been suggested to be involved in several basic biological events such as cell death, tumor progression, and neurodegenerative disorders.
Clusterin Status in Post Chemotherapy Sample
Event Free Survival (EFS)
EFS defined as the time from enrollment on the study until disease progression, occurrence of a second malignant neoplasm (SMN), death or last contact, whichever comes first. Disease progression, occurrence of a SMN or death will be considered an analytic even. In all other cases, the patient will be considered censored at last contact.
Feasibility Success
Feasibility success defined as received 21 days of protocol therapy, did not experience grade III or grade IV toxicity according to Common Toxicity Criteria for Adverse Events (CTCAE) version 3 and rendered surgically free of disease in the lungs.

Secondary Outcome Measures

Full Information

First Posted
August 6, 2003
Last Updated
March 17, 2015
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00066365
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 Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer, Sarcoma
Keywords
metastatic osteosarcoma, recurrent osteosarcoma, lung metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (unilateral recurrence) - Sargramostim and thoractomy
Arm Type
Experimental
Arm Description
Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment 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.
Arm Title
Group 2 (bilateral recurrence) - Sargramostim and thoractomy
Arm Type
Experimental
Arm Description
Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo surgical procedure unilateral thoracotomy. Patients receive initial inhalation therapy 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. Patients undergo surgical procedure contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment 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.
Intervention Type
Biological
Intervention Name(s)
sargramostim
Other Intervention Name(s)
aerosol sargramostim, inhaled GM-CSF, Granulocyte Macrophage Colony Stimulating Factor, rhu GM-CSF, rGM-CSF, GM-CSF, Prokine®, Leukine®, Interberin®, NSC#613795
Intervention Description
given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Description
thoracotomy
Primary Outcome Measure Information:
Title
Status of FAS Ligand in Pre-chemotherapy Sample
Description
FAS ligand (FASL) is a homotrimeric type II transmembrane protein expressed on cytotoxic T lymphocytes. The Cluster of Differentiation 1a (CD1a) status is measured in Immunohistochemistry (IHC) categories.
Time Frame
29 days after start of protocol therapy
Title
Presence of FAS in Pre-chemotherapy Sample
Description
FAS/APO-1 is a transmembrane receptor. The presence is measured in Immunohistochemistry (IHC) categories.
Time Frame
29 days after start of protocol therapy
Title
FAS Ligand in Post Chemotherapy Sample
Description
FAS ligand or FASL is a homotrimeric type II transmembrane protein expressed on cytotoxic T lymphocytes. The presence is measured in Immunohistochemistry (IHC) categories.
Time Frame
29 days after start of protocol therapy
Title
FAS Status in Post Chemotherapy Sample
Description
FAS/APO-1 is a transmembrane receptor. The presence is measured in Immunohistochemistry (IHC) categories.
Time Frame
29 days after start of protocol therapy
Title
CD1a Status in Pre Chemotherapy Sample
Description
CD1a (Cluster of Differentiation 1a) is a human protein encoded by the CD1A gene, presence is measured by positivity.
Time Frame
29 days after start of protocol therapy
Title
CD1a Status in Post Chemotherapy Sample
Description
CD1a (Cluster of Differentiation 1a) is a human protein encoded by the CD1A gene, presence is measured by positivity.
Time Frame
29 days after start of protocol therapy
Title
S100 Status in Pre Chemotherapy Sample
Description
The S-100 proteins are a family of low-molecular-weight proteins characterized by two calcium-binding sites that have helix-loop-helix ("EF-hand type") conformation.
Time Frame
29 days after start of protocol therapy
Title
S100 Status in Post Chemotherapy Sample
Description
The S-100 proteins are a family of low-molecular-weight proteins characterized by two calcium-binding sites that have helix-loop-helix ("EF-hand type") conformation.
Time Frame
29 days after start of protocol therapy
Title
Clusterin Status in Pre Chemotherapy Sample
Description
The protein encoded by this gene can under some stress conditions also be found in the cell cytosol. It has been suggested to be involved in several basic biological events such as cell death, tumor progression, and neurodegenerative disorders.
Time Frame
29 days after start of protocol therapy
Title
Clusterin Status in Post Chemotherapy Sample
Time Frame
29 days after start of protocol therapy
Title
Event Free Survival (EFS)
Description
EFS defined as the time from enrollment on the study until disease progression, occurrence of a second malignant neoplasm (SMN), death or last contact, whichever comes first. Disease progression, occurrence of a SMN or death will be considered an analytic even. In all other cases, the patient will be considered censored at last contact.
Time Frame
Time of enrollment to Event or 5 years from enrollment, whichever occurs first
Title
Feasibility Success
Description
Feasibility success defined as received 21 days of protocol therapy, did not experience grade III or grade IV toxicity according to Common Toxicity Criteria for Adverse Events (CTCAE) version 3 and rendered surgically free of disease in the lungs.
Time Frame
Enrollment through 21 days of protocol therapy

10. Eligibility

Sex
All
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 or pleural based nodules PATIENT CHARACTERISTICS: Age 39 and under Performance status Karnofsky 50-100% (patients over 16 years of age) Lansky 50-100% (patients 16 years of age and under) Life expectancy At least 8 weeks Hematopoietic Not specified Hepatic Not specified Renal Not specified Pulmonary No evidence of dyspnea at rest No exercise intolerance Pulse oximetry at least 94% Baseline Forced expiratory volume in 1 second (FEV_1) at least 80% of predicted No history of asthma No history of reactive airway disease No history of bronchospasm Other Willing and able to perform inhalation therapy No medical contraindication to surgical excision Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception 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 Radiotherapy Not specified 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carola A. Arndt, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016-7710
Country
United States
Facility Name
Arizona Cancer Center at University of Arizona Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5024
Country
United States
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Southern California Permanente Medical Group
City
Downey
State/Province
California
ZIP/Postal Code
90242-2814
Country
United States
Facility Name
Loma Linda University Cancer Institute at Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
City
Long Beach
State/Province
California
ZIP/Postal Code
90801
Country
United States
Facility Name
Children's Hospital and Research Center Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5824
Country
United States
Facility Name
Alfred I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
Lee Cancer Care of Lee Memorial Health System
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
University of Florida Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0232
Country
United States
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer Center - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Miami Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Baptist-South Miami Regional Cancer Program
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Nemours Children's Clinic - Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Sacred Heart Cancer Center at Sacred Heart Hospital
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
All Children's Hospital
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
St. Joseph's Cancer Institute at St. Joseph's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Kaplan Cancer Center at St. Mary's Medical Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31403-3089
Country
United States
Facility Name
Mountain States Tumor Institute at St. Luke's Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712-6297
Country
United States
Facility Name
Children's Memorial Hospital - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Simmons Cooper Cancer Institute
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794-9677
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7357
Country
United States
Facility Name
Lucille P. Markey Cancer Center at University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0093
Country
United States
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40232
Country
United States
Facility Name
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Butterworth Hospital at Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503-2560
Country
United States
Facility Name
Van Elslander Cancer Center at St. John Hospital and Medical Center
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Breslin Cancer Center at Ingham Regional Medical Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Mississippi Cancer Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Hackensack University Medical Center Cancer Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-5636
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Blumenthal Cancer Center at Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308-1062
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205-2696
Country
United States
Facility Name
Children's Medical Center - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404-1815
Country
United States
Facility Name
Oklahoma University Cancer Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Legacy Emanuel Hospital and Health Center and Children's Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Oregon Health and Science University Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Lehigh Valley Hospital - Muhlenberg
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18107
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-9786
Country
United States
Facility Name
St. Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134-1095
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Palmetto Health South Carolina Cancer Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Greenville Hospital Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
East Tennessee Children's Hospital
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37901
Country
United States
Facility Name
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Cook Children's Medical Center - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
M. D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Covenant Children's Hospital
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Fletcher Allen Health Care - University Health Center Campus
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Children's Hospital and Regional Medical Center - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Providence Cancer Center at Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99220-2555
Country
United States
Facility Name
St. Vincent Hospital Regional Cancer Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54307-3508
Country
United States
Facility Name
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
Marshfield Clinic - Marshfield Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Midwest Children's Cancer Center at Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Westmead Institute for Cancer Research at Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
McMaster Children's Hospital at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Montreal Children's Hospital at McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
Facility Name
Hopital Sainte Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Saskatoon Cancer Centre at the University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
San Jorge Children's Hospital
City
Santurce
ZIP/Postal Code
00912
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
20576718
Citation
Arndt CA, Koshkina NV, Inwards CY, Hawkins DS, Krailo MD, Villaluna D, Anderson PM, Goorin AM, Blakely ML, Bernstein M, Bell SA, Ray K, Grendahl DC, Marina N, Kleinerman ES. Inhaled granulocyte-macrophage colony stimulating factor for first pulmonary recurrence of osteosarcoma: effects on disease-free survival and immunomodulation. a report from the Children's Oncology Group. Clin Cancer Res. 2010 Aug 1;16(15):4024-30. doi: 10.1158/1078-0432.CCR-10-0662. Epub 2010 Jun 24.
Results Reference
result

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Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma

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