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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 terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00081211
First received: April 7, 2004
Last updated: January 23, 2013
Last verified: January 2013
  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. 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


Condition Intervention Phase
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 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
Biological: PV701
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: 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):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity as assessed by NCI CTCAE version 3.0 [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]
  • Response (complete and partial) rate according to Response Evaluation Criteria in Solid Tumors (RECIST) Committee [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    Descriptive statistics will be generated for each group.

  • 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 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Illinois
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
Investigators
Principal Investigator: David Gustin University of Chicago Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00081211     History of Changes
Other Study ID Numbers: NCI-2012-02723, 12157B, N01CM17102, CDR0000360664
Study First Received: April 7, 2004
Last Updated: January 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Paranasal Sinus Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Laryngeal Diseases
Laryngeal Neoplasms
Nasopharyngeal Neoplasms
Oropharyngeal Neoplasms
Salivary Gland Neoplasms
Head and Neck Neoplasms
Mouth Diseases
Mouth Neoplasms
Nasopharyngeal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Nose Diseases
Nose Neoplasms
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Paranasal Sinus Diseases
Pharyngeal Diseases
Pharyngeal Neoplasms
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Salivary Gland Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 19, 2014