Clinical trial NCT00081211: Intratumoral PV701 in Treating Patients With Advanced or Recurrent Unresectable Squamous Cell Carcinoma of the Head and Neck
Official title: A Phase I Study Of PV701 In Patients With Head And Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

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 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

Primary outcomes:
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
timeFrame: 3 weeks
Secondary outcomes:
measure: Toxicity as assessed by NCI CTCAE version 3.0
timeFrame: Up to 12 weeks
measure: Response (complete and partial) rate according to Response Evaluation Criteria in Solid Tumors (RECIST) Committee
timeFrame: Up to 12 weeks
measure: Time to progression according to RECIST
timeFrame: From the time of study entry until tumor growth is determined by physical exam or by radiographic imaging, assessed up to 12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Comprehensive Cancer Center
state: Illinois
Study officials:
affiliation: University of Chicago Comprehensive Cancer Center
name: David Gustin
role: PRINCIPAL_INVESTIGATOR
References: