Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma
Condition: Metastatic Cancer; Sarcoma
MeSH terms: Osteosarcoma; Recurrence
Intervention: sargramostim; conventional surgery
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.; thoracotomy
Intervention MeSH terms: Molgramostim; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Maximum age: 39 Years
Healthy volunteers: No
Keywords: metastatic osteosarcoma; recurrent osteosarcoma; lung metastases

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.
    

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