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Intratumoral PV701 in Treating Patients With Advanced or Recurrent Unresectable Squamous Cell Carcinoma of the Head and Neck
This study has been completed.
First Received: April 7, 2004   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00081211
  Purpose

RATIONALE: 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.

PURPOSE: 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.


Condition Intervention Phase
Head and Neck Cancer
Biological: PV701
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Study Of PV701 In Patients With Head And Neck Squamous Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Detailed Description:

OBJECTIVES:

  • 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.
  • Determine the toxicity of intratumoral PV701 in these patients.
  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months

Hematopoietic

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

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. FEV_1 < 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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00081211

Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: David M. Gustin, MD University of Chicago
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000360664, UCCRC-12157B, NCI-1614
Study First Received: April 7, 2004
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00081211     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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
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 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
recurrent salivary gland cancer
stage III salivary gland cancer
stage IV salivary gland cancer
salivary gland squamous cell carcinoma

Study placed in the following topic categories:
Nasopharyngeal Carcinoma
Laryngeal Carcinoma
Carcinoma, Squamous Cell of Head and Neck
Squamous Cell Carcinoma
Recurrence
Carcinoma
Hypopharyngeal Cancer
Head and Neck Neoplasms
Epidermoid Carcinoma
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Salivary Gland Diseases
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Head and Neck Neoplasms
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on July 02, 2009