Radiotherapy, Cetuximab, and Injections of TNFerade™ Biol... | NCT00496236

Studies
Radiotherapy, Cetuximab, and Injections of TNFerade™ Biologic for Elderly or Frail Patients With Head and Neck Cancer

NCT00496236

Sponsor

GenVec

Status

Completed

Last Update Posted

Feb 23, 2012Estimated

Enrollment

Not provided

Phase

Phase 1Phase 2

Conditions

Head and Neck Cancer
Head and Neck Neoplasms

Interventions

TNFerade biologic

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
GV-001.010 (TNF-ELF)

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 28, 2007

First Submission Date that Met QC Criteria

Jul 2, 2007

First Posted Date

Jul 4, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2012

Last Update Posted Date

Feb 23, 2012Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
TNFerade biologic	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The maximum tolerated dose established in the Phase I (dose-finding) portion of the study will be used to assess the investigational drug's ability to enhance clinical outcome. The primary endpoint being locoregional control rate at 24 months.

Secondary Outcomes

Measure	Description	Time Frame
Locoregional control at 3,6, and 12 months, objective response rate, progression-free survival at 3,6,12, and 24 months, and the rate of distal metastases at 3,6, 12 and 24 months will also be assessed.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 70 or older with an ECOG performance status 0-2,or
Patients > 18 years of age with ECOG performance status of 2 or greater, or
Patients > 18 years of age unsuitable for concurrent chemotherapy or surgery due to:
Renal failure, or
Severe cardiopulmonary disease, or
Other end-organ dysfunction that precludes the use of chemotherapy but does not preclude the administration of TNFerade™ Biologic or cetuximab
Tumor that is unresectable or inoperable and not amenable to regular concurrent chemoradiotherapy
Patients > 18 years of age with intermediate stage disease, stages II-III (T2-T3, N0-1MO) carcinoma of the head and neck, including oral cavity, pharynx larynx, paranasal sinuses and cervical esophagus. Selected patients with stage IV disease (T4N0-1M0) will also be considered for enrollment. Therapy is given with curative intent.
Disease should be clinically accessible (measurable or evaluable) to keep injection via direct intratumoral injection
Informed consent

Exclusion Criteria:

History of malignancy in the last 2 years except carcinoma in situ of the cervix or bladder, non-melanomatous skin cancer, or localized early stage prostate cancer, with patients continually disease free, or cancers that are not felt to influence treatment for head and neck cancer and life expectancy of patient
Overt systemic metastatic disease
Previous radiation or chemotherapy for malignancy of the head and neck
Clinical evidence of active infection of any type
pregnant or lactating women
Experimental medications within the last 4 weeks prior to Day 1
Chronic treatment for greater than 6 months with steroids at doses above 10 mg/day prednisone (or equivalent)
Patients receiving hormone replacement therapy or hormonal contraceptives within 2 weeks of day 1
Patients who have undergone surgery within the last 1 month
Allergic reaction to cetuximab

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006258	Head and Neck Neoplasms
D009369	Neoplasms