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

National Cancer Institute (NCI)

Status and phase: Terminated; Phase 1

Conditions: Stage IV Squamous Cell Carcinoma of the Hypopharynx; Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IV Salivary Gland Cancer; Recurrent Squamous Cell Carcinoma of the Hypopharynx; Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IV Squamous Cell Carcinoma of the Oropharynx; Stage III Squamous Cell Carcinoma of the Nasopharynx; Recurrent Squamous Cell Carcinoma of the Larynx; Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage III Squamous Cell Carcinoma of the Larynx; Recurrent Squamous Cell Carcinoma of the Nasopharynx; Stage IV Squamous Cell Carcinoma of the Nasopharynx; Stage III Squamous Cell Carcinoma of the Oropharynx; Salivary Gland Squamous Cell Carcinoma; Stage III Salivary Gland Cancer; Stage IV Squamous Cell Carcinoma of the Larynx; Recurrent Squamous Cell Carcinoma of the Oropharynx; Stage III Squamous Cell Carcinoma of the Hypopharynx; Recurrent Salivary Gland Cancer

Treatments: Biological: PV701

Study type: Interventional

Funder types: NIH

Identifiers

NCT00081211

N01CM17102 (U.S. NIH Grant/Contract)

NCI-2012-02723

CDR0000360664 (Registry Identifier)

12157B

Details and patient eligibility

About

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. 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

Full 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 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Treatment (PV701)

Experimental group

Description:

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.

Treatment:

Biological: PV701