Clinical trial NCT00102531: Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung
Official title: Phase Ib/IIa Study of SLIT Cisplatin by Inhalation in the Treatment of Patients Wtih Relapsed/Progressive Osteosarcoma Metastatic to the Lung
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Osteosarcoma Metastatic
Keywords: Osteosarcoma
relapsed
progressive
metastatic
lung
Lead sponsor: Insmed Incorporated
Sponsor class: INDUSTRY
First posted: 2005-01-31
Enrollment: 19
Sex: ALL
Minimum age (years): 13
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 4 to 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: The Albert Einstein College of Medicine Montefiore Medical Center
state: New York
Study officials:
affiliation: Transave Inc.
name: Renu Gupta, MD
role: STUDY_CHAIR
affiliation: The Albert Einstein College of Medicine Montefiore Medical Center
name: Richard Gorlick, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.