Intratumoral PV701 in Treating Patients With Advanced or Recurrent Unresectable Squamous Cell Carcinoma of the Head and Neck
NCT ID: NCT00081211
Last Updated: 2013-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
30 participants
INTERVENTIONAL
2004-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (PV701)
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.
PV701
Given intratumorally
Interventions
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PV701
Given intratumorally
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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David Gustin
Role: PRINCIPAL_INVESTIGATOR
University of Chicago Comprehensive Cancer Center
Locations
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University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Countries
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Other Identifiers
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12157B
Identifier Type: -
Identifier Source: secondary_id
CDR0000360664
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-02723
Identifier Type: -
Identifier Source: org_study_id
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