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

Stage IV Squamous Cell Carcinoma of the Hypopharynx Clinical Trial

Official title:

A Phase I Study Of PV701 In Patients With Head And Neck Squamous Cell Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00081211
• Other study ID #: NCI-2012-02723
• Secondary ID: 12157BN01CM17102
• Status: Terminated
• Phase: Phase 1
• First received: April 7, 2004
• Last updated: January 23, 2013
• Start date: April 2004

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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. 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Laryngeal Diseases
• Laryngeal Neoplasms
• Nasopharyngeal Neoplasms
• Oropharyngeal Neoplasms
• Paranasal Sinus Neoplasms
• Recurrent Salivary Gland Cancer
• Recurrent Squamous Cell Carcinoma of the Hypopharynx
• Recurrent Squamous Cell Carcinoma of the Larynx
• Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
• Recurrent Squamous Cell Carcinoma of the Nasopharynx
• Recurrent Squamous Cell Carcinoma of the Oropharynx
• Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
• Salivary Gland Neoplasms
• Salivary Gland Squamous Cell Carcinoma
• Stage III Salivary Gland Cancer
• Stage III Squamous Cell Carcinoma of the Hypopharynx
• Stage III Squamous Cell Carcinoma of the Larynx
• Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage III Squamous Cell Carcinoma of the Nasopharynx
• Stage III Squamous Cell Carcinoma of the Oropharynx
• Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
• Stage IV Salivary Gland Cancer
• Stage IV Squamous Cell Carcinoma of the Hypopharynx
• Stage IV Squamous Cell Carcinoma of the Larynx
• Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage IV Squamous Cell Carcinoma of the Nasopharynx
• Stage IV Squamous Cell Carcinoma of the Oropharynx
• Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity

Intervention

Biological:
• PV701
Given intratumorally

Locations

Country	Name	City	State
United States	University of Chicago Comprehensive Cancer Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum-tolerated dose (MTD) of PV701 based on the incidence of dose-limiting toxicity (DLT) as assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0		3 weeks	Yes
Secondary	Toxicity as assessed by NCI CTCAE version 3.0		Up to 12 weeks	Yes
Secondary	Response (complete and partial) rate according to Response Evaluation Criteria in Solid Tumors (RECIST) Committee	Descriptive statistics will be generated for each group.	Up to 12 weeks	No
Secondary	Time to progression according to RECIST		From the time of study entry until tumor growth is determined by physical exam or by radiographic imaging, assessed up to 12 weeks	No