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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00066365
Registration number
NCT00066365
Ethics application status
Date submitted
6/08/2003
Date registered
7/08/2003
Date last updated
30/03/2015
Titles & IDs
Public title
Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma
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Scientific title
A Phase II Study of Aerosolized GM-CSF (NSC# 613795, IND# 11042) in Patients With First Pulmonary Recurrence of Osteosarcoma
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Secondary ID [1]
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CDR0000315540
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Secondary ID [2]
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AOST0221
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Cancer
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Sarcoma
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Condition category
Condition code
Cancer
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Bone
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Cancer
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Sarcoma (also see 'Bone') - soft tissue
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Cancer
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Children's - Other
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - sargramostim
Treatment: Surgery - conventional surgery
Experimental: Group 1 (unilateral recurrence) - Sargramostim and thoractomy - 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.
Experimental: Group 2 (bilateral recurrence) - Sargramostim and thoractomy - 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.
Treatment: Other: sargramostim
given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
Treatment: Surgery: conventional surgery
thoracotomy
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Status of FAS Ligand in Pre-chemotherapy Sample
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Assessment method [1]
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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.
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Timepoint [1]
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29 days after start of protocol therapy
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Primary outcome [2]
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Presence of FAS in Pre-chemotherapy Sample
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Assessment method [2]
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FAS/APO-1 is a transmembrane receptor. The presence is measured in Immunohistochemistry (IHC) categories.
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Timepoint [2]
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29 days after start of protocol therapy
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Primary outcome [3]
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FAS Ligand in Post Chemotherapy Sample
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Assessment method [3]
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FAS ligand or FASL is a homotrimeric type II transmembrane protein expressed on cytotoxic T lymphocytes. The presence is measured in Immunohistochemistry (IHC) categories.
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Timepoint [3]
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29 days after start of protocol therapy
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Primary outcome [4]
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FAS Status in Post Chemotherapy Sample
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Assessment method [4]
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FAS/APO-1 is a transmembrane receptor. The presence is measured in Immunohistochemistry (IHC) categories.
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Timepoint [4]
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29 days after start of protocol therapy
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Primary outcome [5]
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CD1a Status in Pre Chemotherapy Sample
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Assessment method [5]
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CD1a (Cluster of Differentiation 1a) is a human protein encoded by the CD1A gene, presence is measured by positivity.
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Timepoint [5]
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29 days after start of protocol therapy
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Primary outcome [6]
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CD1a Status in Post Chemotherapy Sample
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Assessment method [6]
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CD1a (Cluster of Differentiation 1a) is a human protein encoded by the CD1A gene, presence is measured by positivity.
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Timepoint [6]
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29 days after start of protocol therapy
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Primary outcome [7]
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S100 Status in Pre Chemotherapy Sample
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Assessment method [7]
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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.
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Timepoint [7]
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29 days after start of protocol therapy
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Primary outcome [8]
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S100 Status in Post Chemotherapy Sample
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Assessment method [8]
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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.
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Timepoint [8]
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29 days after start of protocol therapy
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Primary outcome [9]
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Clusterin Status in Pre Chemotherapy Sample
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Assessment method [9]
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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.
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Timepoint [9]
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29 days after start of protocol therapy
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Primary outcome [10]
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Clusterin Status in Post Chemotherapy Sample
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Assessment method [10]
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Timepoint [10]
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29 days after start of protocol therapy
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Primary outcome [11]
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Event Free Survival (EFS)
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Assessment method [11]
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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.
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Timepoint [11]
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Time of enrollment to Event or 5 years from enrollment, whichever occurs first
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Primary outcome [12]
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Feasibility Success
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Assessment method [12]
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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.
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Timepoint [12]
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Enrollment through 21 days of protocol therapy
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Eligibility
Key inclusion 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
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Minimum age
No limit
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Maximum age
39
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2013
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Sample size
Target
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Accrual to date
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Final
49
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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Westmead Institute for Cancer Research at Westmead Hospital - Westmead
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Recruitment hospital [2]
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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6001 - Perth
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Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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Arizona
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Arkansas
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California
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Delaware
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District of Columbia
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Florida
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Georgia
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Idaho
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Illinois
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Indiana
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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National Cancer Institute (NCI)
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00066365
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
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Carola A. Arndt, MD
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Address
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Mayo Clinic
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Arndt CA, Koshkina NV, Inwards CY, Hawkins DS, Kra...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT00066365
Download to PDF