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



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

For Condition: Head and Neck Cancer
Status: Not yet recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: 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. PURPOSE: Phase I trial to study the effectiveness of intratumoral (in the tumor) PV701 in treating patients who have advanced or recurrentunresectablesquamous cell carcinoma (cancer) of the head and neck.
Details: OBJECTIVES: - 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. - Determine the toxicity of intratumoral PV701 in these patients. - 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - 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 PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - More than 3 months Hematopoietic - WBC 3,000/mm^3 - Hemoglobin > 10 g/dL (transfusion permitted) - Platelet count 100,000/mm^3 Hepatic - Bilirubin < 2 times upper limit of normal (ULN) - AST/ALT 2.5 times ULN Renal - Creatinine < 2.5 mg/dL Cardiovascular - No uncontrolled symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Pulmonary - No history of significantly compromised pulmonary function (i.e. FEV_1 < 50% of predicted) or decreased oxygen saturation of < 95% on room air Other - 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 PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 4 weeks since prior chemotherapy and recovered Endocrine therapy - Not specified Radiotherapy - More than 4 weeks since prior radiotherapy and recovered Surgery - More than 4 weeks since prior surgery and recovered Other - No other concurrent investigational agents or commercial agents or therapies for treatment of malignancy - No concurrent antiviral therapy
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
DavidGustin,  Study Chair,  University of Chicago Cancer Research Center


Additional Information:
Study ID Numbers:  CDR0000360664;  UCCRC-12157B,NCI-1614
Study Start Date: 
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081211

Other Head And Neck Cancer Studies:
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2. Celecoxib in Treating Patients With Early-Stage Head and Neck Cancer or Non-Small Cell Lung Cancer

3. Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer

4. Study of SCH 54031 in Surgically Resectable Squamous Cell Tumors of the Head and Neck

5. Patient Evaluation for Head and Neck Surgery Branch Studies

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