Status:
COMPLETED
Phase 2 Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Head and Neck Carcinoma
Lead Sponsor:
Oncolytics Biotech
Conditions:
Carcinoma, Squamous Cell of the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this Phase 2 study is to investigate whether intravenous administration of REOLYSIN® therapeutic reovirus in combination with Paclitaxel and Carboplatin is effective and safe in the tre...
Detailed Description
Squamous cell carcinoma of the head and neck is the sixth most common cancer in the world. More than 50% of patients diagnosed with advanced regional disease will relapse locally or at distant sites. ...
Eligibility Criteria
Inclusion
- have platinum-refractory metastatic and/or recurrent histologically confirmed stage III/IV squamous cell carcinoma of the head and neck (oral cavity, larynx or pharynx) with no secondary cancers
- have evidence of measurable disease
- have documented progressive disease (PD) on or within 190 days following the completion of treatment of cisplatin-based or carboplatin-based chemotherapy in a recurrent or metastatic setting and if treatment with cetuximab was considered indicated for the patient, documented PD(on or within 190 days of treatment)
- have no continuing acute toxic effect of any prior radiotherapy, chemotherapy or surgical procedures
- have received no chemotherapy, radiotherapy, immunotherapy or hormonotherapy within 28 days
- have ECOG performance score of ≤2
- have life expectancy of at least 3 months
- absolute neutrophils ≥ 1.5 x10\^9/L; platelets ≥100 x10\^9; hemoglobin ≥9.0 g/dL; serum creatinine ≤1.5 xULN; bilirubin ≤1.5 x ULN; AST/ALT ≤2.5xULN
- negative pregnancy test for females of childbearing potential
Exclusion
- have known brain metastasis
- have known bone metastasis
- be on immunosuppressive therapy; have known HIV infection or active hepatitis B or C
- be a pregnant or breast-feeding woman
- have clinically significant cardiac disease
- have dementia or altered mental status that would prohibit informed consent
- have any other severe, acute or 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00753038
Start Date
August 1 2008
End Date
May 1 2013
Last Update
November 4 2014
Active Locations (2)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10467
2
Cancer Therapy and Research Center at UTHSCSA
San Antonio, Texas, United States, 78229