Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
National Cancer Institute (NCI)
OBJECTIVES:
I. Determine the maximum tolerated dose (MTD) of PV701 administered by direct intratumoral injection in patients with advanced or recurrent unresectable squamous cell carcinoma of the head and neck.
II. Determine the toxicity of intratumoral PV701 in these patients. III. Determine response rate and time to progression at the injection site in patients treated with this drug.
OUTLINE: This is a dose-escalation study. Patients receive intratumoral PV701 once weekly for 3 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of PV701 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 6 evaluable patients are treated at that dose.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 6-10 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
More than 4 weeks since prior chemotherapy and recovered
More than 4 weeks since prior radiotherapy and recovered
More than 4 weeks since prior surgery and recovered
No other concurrent investigational agents or commercial agents or therapies for treatment of malignancy
No concurrent antiviral therapy
Clareo Health | Intratumoral PV701 in Treating Patients With Advanced or Recurrent Unresectable Squamous Cell Carcinoma of the Head and Neck