Single-Patient Expanded Access Protocol - RNA-LP in a Patient With Recurrent Osteosarcoma

N/ANo Longer AvailableNCT07560709

University of Florida

Overview

Treatment of a patient with recurrent osteosarcoma with personalized pp65/tumor mRNA RNA-LP under an individual patient expanded access protocol.

The prognosis for patients with recurrent osteosarcoma and measurable disease is dismal and there are no FDA-approved therapies for this indication. A patient was enrolled on a clinical trial to develop a personalized pp65/tumor mRNA RNA-LP; however, the patient progressed following pp65 RNA-LP and had to be taken off treatment. Because the patient had not yet received personalized pp65/tumor mRNA RNA-LP, the IND sponsor treated the patient under an expanded access, individual patient protocol.

Study Type

EXPANDED_ACCESS

Conditions

Recurrent Osteosarcoma

Interventions

pp65/tumor mRNA RNA-LPBIOLOGICAL

Autologous total tumor mRNA and pp65 full length (fl) lysosomal associated membrane protein (LAMP) mRNA loaded DOTAP liposome vaccine administered intravenously (RNA loaded lipid particles, RNA-LPs)

Eligibility

Sex: MALEMin age: 15 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participated in clinical trial * Received pp65 RNA-LPs alone and had pp65/tumor mRNA RNA-LP manufactured * Progressive disease prior to treatment with pp65/tumor mRNA RNA-LP Exclusion Criteria: • Diagnosis of recurrent OSA is not histopathologically confirmed (i.e. pseudoprogression)

Locations (1)

University of Florida Health

Gainesville, Florida, United States

Data from ClinicalTrials.gov

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