Study Using the Medpulser Electroporation System With Bleomycin to Treat Head and Neck Cancer

NCT00198263 | Completed Phase 4

• 1 other identifier: EU-HNBE-2003
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer

Keywords

head and neck cancer; cancer; bleomycin; medpulser; electroporation; primary oral cavity, primary pharyngeal, primary laryngeal, salivary gland, limited recurrent and second primary tumors

Outcome Measures

Primary Outcomes (1)

• To characterize local tumor recurrence through 8 months post-EPT/bleomycin treatment

  8 Months

Secondary Outcomes (4)

• To measure pharmacoeconomic factors (hospital costs, extent of medical interventions, medication use) in subjects treated by EPT/bleomycin

  24 Months

• 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

  4 and 8 Months

• To document the performance of the MedPulser® System during EPT/bleomycin treatment

  8 Nonths

• To monitor local and systemic adverse events through the Month 4 follow-up study visit

  4 Months

Study Arms (1)

Bleomycin

EXPERIMENTAL

Bleomycin 4 USP Units/mL; intratumorally at dose of 0.25mL/cm\^3

Combination Product: Medpulser Electroporation with Bleomycin

Interventions

Medpulser Electroporation with Bleomycin COMBINATION_PRODUCT

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.

Bleomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inovio Pharmaceuticals: lead

Study Sites (1)

Inovio Biomedical Corporation

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasms

Interventions

Bleomycin

Condition Hierarchy (Ancestors)

Neoplasms by Site

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Paul Goldfarb, MD

  Inovio Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Medpulser electroporation with Bleomycin

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: January 1, 2004
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: October 3, 2017

Record last verified: 2017-09

Locations

US (1)