Intratumoral PV701 in Treating Patients With Advanced or Recurrent Unresectable Squamous Cell Carcinoma of the Head and Neck

Stopped early · Phase 1

Conditions studied: Recurrent Salivary Gland Cancer, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Nasopharynx, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Salivary Gland Squamous Cell Carcinoma, Stage III Salivary Gland Cancer, Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Nasopharynx, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IV Salivary Gland Cancer, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Larynx, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IV Squamous Cell Carcinoma of the Oropharynx, Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity

In brief

Phase I trial to study the effectiveness of intratumoral (in the tumor) PV701 in treating patients who have advanced or recurrent unresectable squamous cell carcinoma (cancer) of the head and neck. Vaccines made from a specially-modified virus such as PV701 may make the body build an immune response to kill tumor cells while leaving normal cells undamaged. Injecting PV701 directly into the tumor may cause a stronger immune response and kill more tumor cells

Key facts

Study ID

NCT00081211

Run by

National Cancer Institute (NCI)

People needed

30

Starts

2004-04-01

Last updated by the study team

2013-01-24

Who can join

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

You may qualify if…

• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
• Locally advanced or recurrent disease
• Distant metastases in addition to locally advanced disease acceptable
• Not amenable to available standard treatment or palliative measures
• At least one target lesion accessible for intratumoral injection, less than 4 cm, and not situated near an airway or major artery
• Tumor volume(s) must be large enough to receive injection
• No known brain metastases
• Performance status - ECOG 0-2
• More than 3 months
• WBC >= 3,000/mm\^3
• Hemoglobin > 10 g/dL (transfusion permitted)
• Platelet count >= 100,000/mm\^3
• Bilirubin < 2 times upper limit of normal (ULN)
• AST/ALT =< 2.5 times ULN
• Creatinine < 2.5 mg/dL
• No uncontrolled symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• No history of significantly compromised pulmonary function (i.e. FEV_1 < 50% of predicted) or decreased oxygen saturation of < 95% on room air
• No history of allergy to eggs or egg-based or chicken embryo-based vaccines
• No frequent contact with immunocompromised individuals
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• No history of diabetes mellitus requiring oral hypoglycemic agents or insulin
• No HIV-positive patients receiving combination antiretroviral therapy

Where it is running

• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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