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

January 23, 2013 updated by: National Cancer Institute (NCI)

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Biological: PV701
Given intratumorally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity as assessed by NCI CTCAE version 3.0
Time Frame: Up to 12 weeks
Up to 12 weeks
Response (complete and partial) rate according to Response Evaluation Criteria in Solid Tumors (RECIST) Committee
Time Frame: Up to 12 weeks
Descriptive statistics will be generated for each group.
Up to 12 weeks
Time to progression according to RECIST
Time Frame: From the time of study entry until tumor growth is determined by physical exam or by radiographic imaging, assessed up to 12 weeks
From the time of study entry until tumor growth is determined by physical exam or by radiographic imaging, assessed up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: David Gustin, University of Chicago Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (ACTUAL)

July 1, 2004

Study Registration Dates

First Submitted

April 7, 2004

First Submitted That Met QC Criteria

April 7, 2004

First Posted (ESTIMATE)

April 8, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02723
  • N01CM17102 (U.S. NIH Grant/Contract)
  • 12157B
  • CDR0000360664 (REGISTRY: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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