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


Phase 1
18 Years
N/A
Not Enrolling
Both
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

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

3 weeks

Safety Issue:

Yes

Principal Investigator

David Gustin

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02723

NCT ID:

NCT00081211

Start Date:

April 2004

Completion Date:

Related Keywords:

  • 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
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Laryngeal Diseases
  • Salivary Gland Neoplasms
  • Hypopharyngeal Neoplasms
  • Laryngeal Neoplasms
  • Paranasal Sinus Neoplasms
  • Head and Neck Neoplasms
  • Oropharyngeal Neoplasms
  • Nasopharyngeal Neoplasms

Name

Location
University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470