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

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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

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

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

National Cancer Institute (NCI)

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:

Nose Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Laryngeal Diseases
Salivary Gland Neoplasms
Hypopharyngeal Neoplasms
Laryngeal Neoplasms
Paranasal Sinus Neoplasms
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell

Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Mouth Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Respiratory Tract Neoplasms
Nose Diseases
Paranasal Sinus Diseases
Nasopharyngeal Diseases

ClinicalTrials.gov processed this record on May 22, 2013