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
1 other identifier
interventional
19
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2005
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 12, 2005
CompletedFirst Submitted
Initial submission to the registry
January 29, 2005
CompletedFirst Posted
Study publicly available on registry
January 31, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2008
CompletedResults Posted
Study results publicly available
August 1, 2017
CompletedAugust 1, 2017
July 1, 2017
3.1 years
January 29, 2005
July 5, 2017
July 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
4 to 48 weeks
Study Arms (2)
Cisplatin liposomal 24 mg/m2
EXPERIMENTALInhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.
Cisplatin liposomal 36 mg/m2
EXPERIMENTALThe 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
The Albert Einstein College of Medicine Montefiore Medical Center
New York, New York, 10467, United States
Related Publications (1)
Chou 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: 23255417RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Margaret Galluzzi
- Organization
- Insmed
Study Officials
- STUDY CHAIR
Renu Gupta, MD
Transave Inc.
- PRINCIPAL INVESTIGATOR
Richard Gorlick, MD
The Albert Einstein College of Medicine Montefiore Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2005
First Posted
January 31, 2005
Study Start
January 12, 2005
Primary Completion
March 1, 2008
Study Completion
March 17, 2008
Last Updated
August 1, 2017
Results First Posted
August 1, 2017
Record last verified: 2017-07