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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

Phase 2
16 Years
Not Enrolling
Osteosarcoma, Ewing Sarcoma Family Tumors, Malignant Fibrous Histiocytoma, Sarcoma, Synovial, Fibrosarcoma, Leiomyosarcoma

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Trial Information

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

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.


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®.

Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

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.

Safety Issue:


Principal Investigator

Karl Mettinger, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Oncolytics Biotech


United States: Food and Drug Administration

Study ID:

REO 014



Start Date:

June 2007

Completion Date:

April 2011

Related Keywords:

  • Osteosarcoma
  • Ewing Sarcoma Family Tumors
  • Malignant Fibrous Histiocytoma
  • Sarcoma, Synovial
  • Fibrosarcoma
  • Leiomyosarcoma
  • reovirus
  • oncolytic virus
  • sarcoma
  • Oncolytics Biotech
  • Histiocytoma
  • Fibrosarcoma
  • Leiomyosarcoma
  • Osteosarcoma
  • Sarcoma, Synovial
  • Histiocytoma, Benign Fibrous
  • Histiocytoma, Malignant Fibrous
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma



Mayo Clinic Rochester, Minnesota  55905
University of Michigan Medical School Ann Arbor, Michigan  48106
Montefiore Medical Center/Albert Einstein College of Medicine Bronx, New York  10461
Institute of Drug Development, Cancer Therapy Research Center San Antonio, Texas  78229