Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-12

Study Completion Date

2008-03-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteosarcoma Metastatic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cisplatin liposomal 24 mg/m2

Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.

Group Type EXPERIMENTAL

Cisplatin liposomal

Intervention Type DRUG

Cisplatin liposomal 36 mg/m2

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

Group Type EXPERIMENTAL

Cisplatin liposomal

Intervention Type DRUG

Interventions

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Cisplatin liposomal

Intervention Type DRUG

Other Intervention Names

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SLIT Cisplatin

Eligibility Criteria

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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

Minimum Eligible Age

13 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No