Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00503295
Status:
COMPLETED
Last Update Posted:
2014-10-02
First Post:
2007-07-16
Brief Title:
Safety and Efficacy Study of REOLYSIN in the Treatment of Bone and Soft Tissue Sarcomas Metastatic to the Lung
Sponsor:
Oncolytics Biotech
Organization:
Oncolytics Biotech
Study Overview
Official Title:
A Phase 2 Study of Intravenous REOLYSIN Wild-Type Reovirus in the Treatment of Patients With Bone and Soft Tissue Sarcomas Metastatic to the Lung
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this Phase 2 study is to investigate whether intravenous administration of REOLYSIN therapeutic reovirus is safe and effective in the treatment of patients with bone and soft tissue sarcomas metastatic to the lung
Detailed Description:
Sarcomas are uncommon mesenchymal malignancies that encompass a variety of tumors of soft tissue or bone Included in this study are patients with osteosarcoma Ewing sarcoma family tumors malignant fibrous histiocytoma synovial sarcoma leiomyosarcoma and fibrosarcoma Patients with these lesions presenting with metastatic disease remain largely incurable In all sarcomas the lungs are by far the most frequent site of metastases
There is a need for new therapies that have activity against these types of sarcomas REOLYSIN is an unmodified oncolytic reovirus which replicates selectively in ras transformed cells causing cell lysis Activating mutations in ras or mutations in oncogenes signaling through the ras pathway may occur in as many as 80 of human tumors Such mutations have been described in many of the common sarcomas of childhood and adults REOLYSIN demonstrated excellent anti-tumor activity in vitro and in vivo in childhood sarcoma cell lines
Further supporting the development of REOLYSIN in the context of sarcomas as detailed in this study is the fact that sarcomas resistant or refractory to conventional chemotherapy may remain clinically responsive to viral therapy Sarcoma patients with pulmonary metastases may be especially suitable for studies with REOLYSIN due to rapid selective uptake of the virus by the lungs
This Phase 2 study is designed to characterize the efficacy and safety of REOLYSIN given intravenously over 5 days every 4 weeks in patients with bone and soft tissue sarcomas metastatic to the lung Safety data including laboratory parameters and adverse events will be collected for all patients in order to determine the toxicity and reversibility of toxicity of REOLYSIN therapy Response will be assessed using radiographic imaging every 2 cycles of therapy
OBJECTIVES
1 To measure tumor responses and duration of response and describe any evidence of antitumor activity of intravenous multiple dose REOLYSIN in patients with bone and soft tissue sarcomas metastatic to the lung
2 To evaluate safety of intravenous multiple dose REOLYSIN
There is a need for new therapies that have activity against these types of sarcomas REOLYSIN is an unmodified oncolytic reovirus which replicates selectively in ras transformed cells causing cell lysis Activating mutations in ras or mutations in oncogenes signaling through the ras pathway may occur in as many as 80 of human tumors Such mutations have been described in many of the common sarcomas of childhood and adults REOLYSIN demonstrated excellent anti-tumor activity in vitro and in vivo in childhood sarcoma cell lines
Further supporting the development of REOLYSIN in the context of sarcomas as detailed in this study is the fact that sarcomas resistant or refractory to conventional chemotherapy may remain clinically responsive to viral therapy Sarcoma patients with pulmonary metastases may be especially suitable for studies with REOLYSIN due to rapid selective uptake of the virus by the lungs
This Phase 2 study is designed to characterize the efficacy and safety of REOLYSIN given intravenously over 5 days every 4 weeks in patients with bone and soft tissue sarcomas metastatic to the lung Safety data including laboratory parameters and adverse events will be collected for all patients in order to determine the toxicity and reversibility of toxicity of REOLYSIN therapy Response will be assessed using radiographic imaging every 2 cycles of therapy
OBJECTIVES
1 To measure tumor responses and duration of response and describe any evidence of antitumor activity of intravenous multiple dose REOLYSIN in patients with bone and soft tissue sarcomas metastatic to the lung
2 To evaluate safety of intravenous multiple dose REOLYSIN
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None