search
Back to results

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

Primary Purpose

Recurrent Salivary Gland Cancer, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PV701
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Salivary Gland Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (PV701)

Arm Description

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.

Outcomes

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

Secondary Outcome Measures

Toxicity as assessed by NCI CTCAE version 3.0
Response (complete and partial) rate according to Response Evaluation Criteria in Solid Tumors (RECIST) Committee
Descriptive statistics will be generated for each group.
Time to progression according to RECIST

Full Information

First Posted
April 7, 2004
Last Updated
January 23, 2013
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00081211
Brief Title
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

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Administratively complete.
Study Start Date
April 2004 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (PV701)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
PV701
Intervention Description
Given intratumorally
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Toxicity as assessed by NCI CTCAE version 3.0
Time Frame
Up to 12 weeks
Title
Response (complete and partial) rate according to Response Evaluation Criteria in Solid Tumors (RECIST) Committee
Description
Descriptive statistics will be generated for each group.
Time Frame
Up to 12 weeks
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Gustin
Organizational Affiliation
University of Chicago Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs