Clinical trial · Interventional
Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung
Phase Ib/IIa Study of SLIT Cisplatin by Inhalation in the Treatment of Patients Wtih Relapsed/Progressive Osteosarcoma Metastatic to the Lung
NCT00102531CI-TRIAL-00028887completedPhase 1 / Phase 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)
Phase Ib/IIa open label safety and efficacy study designed to determine the maximum tolerated dose of inhaled cisplatin liposomal (SLIT cisplatin) administered every 14 days to patients with relapsed/progressive osteosarcoma metastatic to the lung.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteosarcoma Metastatic | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin liposomal | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cisplatin liposomal 24 mg/m2
- description
- Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.
- interventionNames
- Drug: Cisplatin liposomal
- type
- EXPERIMENTAL
- label
- Cisplatin liposomal 36 mg/m2
- description
- The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2
- interventionNames
- Drug: Cisplatin liposomal
Primary outcomes (1)
- measure
- The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven, Progressive or recurrent high grade osteosarcoma metastatic to the lung * Patients with histologically proven, fully malignant high-grade osteosarcoma of bone * Measureable pulmonary metastases * Less than grade 3 neuropathies, insignificant decreases in cardiac or auditory function * ECOG performance status of 0, 1 or 2 * FEV1 of 50% or greater of predicted value * FEV1/FVC ratio of 65% or greater * Serum creatinine of ≤ 1.5 mg/dl * Total bilirubin ≤ 1.5mg/dl and SGOT or SGPT \< 2.5 times upper normal limit * ANC of ≥ 1,000/mm3 and platelet count of ≥ 100,000/mm3 Exclusion Criteria: * Grade 3 or higher painful neuropathy persisting after a prior platinum containing regimen * Patients who are pregnant or are of childbearing potential and not using methods to avoid pregnancy * Concurrent systemic chemotherapy * Greater than Grade 2 pulmonary toxicity * Pulmonary atelectasis * Reactive airway disease which has resulted in hospitalization within the last year or which requires daily treatment with bronchodilator therapy * Concurrent serious infections * Unstable or serious concurrent medical condition * Recent major surgery or thoracic radiation therapy or chemotherapy * Significant pulmonary fibrosis secondary to prior radiation * Major ventilatory distribution abnormalities * Osteosarcoma secondary to radiation or premalignant conditions * History of prior malignancy * Low grade osteosarcoma, parosteal or periosteal sarcoma
References
Publications (1)
- RESULTChou AJ, Gupta R, Bell MD, Riewe KO, Meyers PA, Gorlick R. Inhaled lipid cisplatin (ILC) in the treatment of patients with relapsed/progressive osteosarcoma metastatic to the lung. Pediatr Blood Cancer. 2013 Apr;60(4):580-6. doi: 10.1002/pbc.24438. Epub 2012 Dec 19. PMID 23255417