Phase 2 Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Head and Neck Carcinoma

Completed · Phase 2

Conditions studied: Carcinoma, Squamous Cell of the Head and Neck

In brief

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 treatment of squamous cell carcinoma of the head and neck.

Key facts

Study ID: NCT00753038
Run by: Oncolytics Biotech
People needed: 14
Starts: 2008-08-01
Expected to finish: 2013-05-01
Last updated by the study team: 2014-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Montefiore Medical Center — The Bronx, New York, United States
Cancer Therapy and Research Center at UTHSCSA — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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