Study Using the Medpulser Electroporation System With Bleomycin to Treat Head and Neck Cancer - Full Text View

Sponsor:	Inovio Biomedical Corporation
Information provided by:	Inovio Biomedical Corporation
ClinicalTrials.gov Identifier:	NCT00198263

Purpose

The purpose of the trial is to study the safety and efficacy of the Medpulser Electroporation System with bleomycin in the treatment of head and neck cancer.

Condition	Intervention	Phase
Head and Neck Cancer	Device: Medpulser Electroporation with Bleomycin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Study Using the Medpulser® Electroporation System to Treat Head and Neck Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Bleomycin Bleomycin sulfate

U.S. FDA Resources

Further study details as provided by Inovio Biomedical Corporation:

Primary Outcome Measures:

To characterize local tumor recurrence through 8 months post-EPT/bleomycin treatment [ Time Frame: 8 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To measure pharmacoeconomic factors (hospital costs, extent of medical interventions, medication use) in subjects treated by EPT/bleomycin [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
To evaluate organ function and appearance using the Performance Status Scale (PSS) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck (EORTC QLQ - H&N 35) at 4 and 8 months following treatment [ Time Frame: 4 and 8 Months ] [ Designated as safety issue: No ]
To document the performance of the MedPulser® System during EPT/bleomycin treatment [ Time Frame: 8 Nonths ] [ Designated as safety issue: Yes ]
To monitor local and systemic adverse events through the Month 4 follow-up study visit [ Time Frame: 4 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	January 2004
Estimated Study Completion Date:	September 2008

Intervention Details:

The MedPulser device will be used in conjunction with injection of Bleomycin Sulfate at a concentration of 1 U/ml per cm3 of tumor treatment area.

Detailed Description:

Electroporation therapy is a tumor-specific ablative treatment modality with the potential to manage local tumors without the potentially undesirable side effects of systemic chemotherapy agents or radiotherapy. Surgical resection of solid tumors often leaves subjects with significant organ dysfunction and/or permanent disfigurement requiring reconstructive surgery. In contrast, electroporation therapy may offer equivalent disease control to conventional surgery with lessened need for reconstructive surgery. Electroporation therapy may also provide economic benefits over conventional surgical and or radiation procedures through reduced operating theatre costs, hospital stays and post treatment interventions. The ability to shrink or eliminate local tumors with the MedPulser® System when used in conjunction with intralesional Bleomycin is an important new possible treatment for the conservative local management of SCCHN and provides a possible alternative treatment option to surgical excision in the management of cancer.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The presence of primary oral cavity, primary pharyngeal, primary laryngeal, salivary gland, limited recurrent and second primary tumors must be confirmed by histological examination of a tissue sample (e.g., biopsy) obtained within 2 months of the subject receiving the study treatment.
The length of the longest diameter of the study lesion must be < 5 cm and the calculated treatment volume (tumor volume plus a 0.5 cm margin around the tumor) for the study lesion [where treatment volume = 0.5 (a+1) (b+1)2 and where a = length of the longest diameter (cm), b = the next longest diameter perpendicular to "a" (cm)] must be < 60.0 cm3.
Age: 18 years or older.
Male or female.
Men and women of childbearing potential must be using Investigator prescribed contraceptive methods while undergoing protocol related therapy.
Baseline performance status: ECOG 0-2:
- Grade 0: Fully active, able to carry on all pre-disease performance without restriction.
- Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- Grade 2: Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
Life expectancy of at least 6 months.
Subjects must sign a written Informed Consent prior to receiving any study procedures or treatments.

Exclusion Criteria:

Subjects with tumors suspected of involving a 50% or greater encasement of a blood vessel as measured by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
Subjects with tumors having bone invasion.
Subjects with hypersensitivity to bleomycin.
Subjects who have received or will exceed a total lifetime dose of bleomycin greater than 400 units.
Subjects deemed unsuitable for general anesthesia.
Subjects with a significant history of emphysema or pulmonary fibrosis.
Subjects with indwelling cardiac pacemakers who cannot tolerate a period with pacemaker turned off.
Subjects with a history of uncontrolled cardiac arrhythmia.
Women who are pregnant, or are nursing. Women must have a negative pregnancy test (urine pregnancy tests are acceptable) within 7 days of study treatment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198263

Locations

United States, California
Inovio Biomedical Corporation
San Diego, California, United States, 92121

Sponsors and Collaborators

Inovio Biomedical Corporation

Investigators

Study Chair:

Paul Goldfarb, MD

Inovio Biomedical Corporation

More Information

No publications provided

Responsible Party:	Inovio Biomedical Corporation ( Larry Young, Executive Director of Clinical Affairs )
Study ID Numbers:	EU-HNBE-2003
Study First Received:	September 12, 2005
Last Updated:	December 4, 2007
ClinicalTrials.gov Identifier:	NCT00198263 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Paul-Ehrlich-Institut; Sweden: Medical Products Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Austria: Secretariat of Health

Keywords provided by Inovio Biomedical Corporation:

head and neck cancer
cancer
bleomycin

medpulser
electroporation
primary oral cavity, primary pharyngeal, primary laryngeal, salivary gland, limited recurrent and second primary tumors

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses

Head and Neck Neoplasms
Antibiotics, Antineoplastic
Bleomycin
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 05, 2009