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



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

For Condition: metastatic osteosarcoma,recurrent osteosarcoma,lung metastases
Status: Not yet recruiting
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: 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: Phase II trial to study the effectiveness of inhaled sargramostim in treating patients who are undergoing surgery for the first recurrence of osteosarcoma that has spread to the lung.
Details: 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 disease-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. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 1.6-2 years.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /39 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed osteosarcoma - First pulmonary recurrence (unilateral or bilateral) by chest CT scan - 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) - Measurable disease - No prior complete resection of all lesions - No pleural effusion 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 2 months 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 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 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
CarolaArndt,  Study Chair,  Mayo Clinic Cancer Center


Additional Information:
Study ID Numbers:  CDR0000315540;  COG-AOST0221
Study Start Date: 
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066365

Other Lung Metastases Studies:
1. Neoadjuvant and Adjuvant Pamidronate With Induction and Maintenance Chemotherapy in Treating Patients With Osteosarcoma

2. Interferon alfa and Thalidomide in Treating Patients With Soft Tissue Sarcoma or Bone Sarcoma

3. Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer

4. Bortezomib in Treating Patients With Advanced or Metastatic Sarcoma

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

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