Safety and Efficacy Study of REOLYSIN® in the Treatment of Bone and Soft Tissue Sarcomas Metastatic to the Lung

NCT00503295 | Completed Phase 2

• 1 other identifier: REO 014
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 4

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.

Conditions

Osteosarcoma; Ewing Sarcoma Family Tumors; Malignant Fibrous Histiocytoma; Sarcoma, Synovial; Fibrosarcoma; Leiomyosarcoma

Keywords

reovirus; oncolytic virus; sarcoma; REOLYSIN; Oncolytics Biotech

Outcome Measures

Primary Outcomes (1)

• Complete response (CR) and partial response (PR) as well as prolonged stabilization of disease (SD) will be considered indicative of response. RECIST criteria will be utilized to assess radiographic response.

  For PR or CR, changes in tumor measurements must be confirmed 4 weeks after the criteria for response are first met. For SD, follow-up measurements must have met the SD criteria at least once after trial entry at a minimum interval of 12 weeks.

Secondary Outcomes (1)

• Safety data, including laboratory parameters and adverse events, will be collected for all patients in order to determine the qualitative and quantitative toxicity, and reversibility of toxicity, of REOLYSIN®.

  within 30 days of the last dose of REOLYSIN®

Interventions

REOLYSIN® BIOLOGICAL

REOLYSIN® is given intravenously at a dose of 3x10E10 TCID50 over 60 minutes on Days 1-5 of a 28 day cycle.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• have a bone or soft tissue sarcoma metastatic to the lung deemed by a physician to be unresponsive to, or untreatable by, standard therapies. Acceptable histologies include only osteosarcoma, Ewing sarcoma family tumors, malignant fibrous histiocytoma, synovial sarcoma, fibrosarcoma and leiomyosarcoma
• have ≥ 2 measurable lesions in the lungs detectable on CT scan
• all residual adverse effects related to any prior anti-cancer therapy including, but not limited to, chemotherapy, biologic therapy, radiotherapy or surgical procedures must have resolved to Grade 1 or lower (as defined by the Common Terminology Criteria for Adverse Events, Version 3.0) before study therapy is initiated
• have received NO chemotherapy, radiotherapy, immunotherapy, hormonotherapy or surgery (except skin surgeries and minor biopsies) within 28 days prior to receiving REOLYSIN®
• have ECOG Performance Score of ≤ 2
• have life expectancy of at least 3 months
• Absolute neutrophils ≥ 1.5 x10\^9/L; hemoglobin ≥ 9.0g/dL; platelets ≥ 100 x 10\^9/L
• SGOT/SGPT (AST/ALT) ≤ 2.5 x ULN; bilirubin ≤ 1.5 x ULN
• Serum creatinine ≤ 1.5 x ULN
• negative pregnancy test for females of childbearing potential

You may not qualify if:

• have inadequate pulmonary function defined as a forced expiratory volume in 1 second (FEV1) less than 50% of predicted
• be on immunosuppressive therapy; have known HIV infection or active hepatitis B or C
• have clinically significant pulmonary or cardiac disease
• have dementia or altered mental status that would prohibit informed consent
• have any other severe or acute chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgement of the Principal Investigator, would make the patient inappropriate for this study

Sponsors & Collaborators

• Oncolytics Biotech: lead

Study Sites (4)

University of Michigan Medical School

Ann Arbor, Michigan, 48106, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Montefiore Medical Center/Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Institute of Drug Development, Cancer Therapy Research Center

San Antonio, Texas, 78229, United States

Location

Related Links

• Click here for more information about this study: Clinical Trials - Phase II Sarcomas Trial - United States

MeSH Terms

Conditions

Osteosarcoma; Histiocytoma, Malignant Fibrous; Sarcoma, Synovial; Fibrosarcoma; Leiomyosarcoma; Sarcoma

Interventions

reolysin

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Histiocytoma; Neoplasms, Fibrous Tissue; Neoplasms, Muscle Tissue

Study Officials

• Karl Mettinger, MD, PhD

  Oncolytics Biotech

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2007
• First Posted: July 18, 2007
• Study Start: June 1, 2007
• Primary Completion: February 1, 2011
• Study Completion: April 1, 2011
• Last Updated: October 2, 2014

Record last verified: 2012-05

Locations

US (4)