Clinical trial · Interventional
Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma
A Phase II Study of Aerosolized GM-CSF (NSC# 613795, IND# 11042) in Patients With First Pulmonary Recurrence of Osteosarcoma
NCT00066365CI-TRIAL-00017316completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1 (unilateral recurrence) - Sargramostim and thoractomy
- 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.
- interventionNames
- Biological: sargramostim
- Procedure: conventional surgery
- type
- EXPERIMENTAL
- label
- Group 2 (bilateral recurrence) - Sargramostim and thoractomy
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 39 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTArndt 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. PMID 20576718