Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	UCCRC-12157B 1614, NCI-1614, NCT00081211

Objectives

1. 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.
2. Determine the toxicity of intratumoral PV701 in these patients.
3. Determine response rate and time to progression at the injection site in patients treated with this drug.

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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 3 months

Hematopoietic

• WBC ≥ 3,000/mm³
• Hemoglobin > 10 g/dL (transfusion permitted)
• Platelet count ≥ 100,000/mm³

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. FEV₁ < 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

Expected Enrollment

A maximum of 30 patients will be accrued for this study within 6-10 months.

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.

Trial Contact Information

Trial Lead Organizations

University of Chicago Cancer Research Center

David Gustin, MD, Protocol chair(Contact information may not be current)		Ph: 773-834-8634; 888-824-0200

Registry Information
Official Title		A Phase I Study Of PV701 In Patients With Head And Neck Squamous Cell Carcinoma
Registered in ClinicalTrials.gov		NCT00081211
Date Submitted to PDQ		2004-02-27
Information Last Verified		2004-05-25
NCI Grant/Contract Number		P30-CA14599, N01-CM17102

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