Status:
TERMINATED
Intratumoral PV701 in Treating Patients With Advanced or Recurrent Unresectable Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Salivary Gland Cancer
Recurrent Squamous Cell Carcinoma of the Hypopharynx
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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. Va...
Detailed Description
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 hea...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00081211
Start Date
April 1 2004
Last Update
January 24 2013
Active Locations (1)
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1
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470