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Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma

NCT01650090 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-08-07

No results posted yet for this study

Summary

To establish whether treatment with Inhaled Lipid Cisplatin (ILC) is effective in delaying/preventing pulmonary relapse in osteosarcoma patients in complete surgical remission following one or two prior pulmonary relapses.

Conditions

  • Pulmonary Relapse of Osteosarcoma

Interventions

DRUG

Inhaled Lipid Cisplatin (ILC)

ILC is provided as cisplatin in a lipid complex suspended in a saline solution. Every two weeks, the patient will receive 36 mg/m2 (measured as concentration of cisplatin) of ILC via nebulization. Treatment may continue for up to 1 year.

Sponsors & Collaborators

  • Eleison Pharmaceuticals LLC.

    lead INDUSTRY

Principal Investigators

  • Richard Gorlick, MD · The Children's Hospital at Montefiore

  • Forrest H Anthony, MD, PhD · Eleison Pharmaceuticals

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2018-11-30
Completion
2018-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01650090 on ClinicalTrials.gov