Head and Neck CancerPhase 4NCT00198263
Study Using the Medpulser Electroporation System With Bleomycin to Treat Head and Neck Cancer
A Phase 4 study testing Medpulser Electroporation with Bleomycin in people with Head and Neck Cancer, run by Inovio Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Medpulser Electroporation with Bleomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Sep 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Inovio Biomedical Corporation
San Diego, California, 92121
About this study
Official title: An Open-Label Study Using the Medpulser® Electroporation System to Treat Head and Neck Cancer
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- Medpulser Electroporation with Bleomycin
- Keywords
- head and neck cancer, cancer, bleomycin, medpulser, electroporation, primary oral cavity, primary pharyngeal, primary laryngeal, salivary gland, limited recurrent and second primary tumors
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medpulser Electroporation with BleomycinCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Bleomycin | Experimental | Bleomycin 4 USP Units/mL; intratumorally at dose of 0.25mL/cm^3 Receives: Combination Product: Medpulser Electroporation with Bleomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize local tumor recurrence through 8 months post-EPT/bleomycin treatment
Measured: 8 Months
Secondary outcomes (4)
To measure pharmacoeconomic factors (hospital costs, extent of medical interventions, medication use) in subjects treated by EPT/bleomycin
Measured: 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
Measured: 4 and 8 Months
To document the performance of the MedPulser® System during EPT/bleomycin treatment
Measured: 8 Nonths
To monitor local and systemic adverse events through the Month 4 follow-up study visit
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Medpulser electroporation with Bleomycin
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inovio Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Goldfarb, MD, Study chair, Inovio Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198263
- Sponsor's protocol ID
- EU-HNBE-2003
- Status last verified
- Sep 2017
- First submitted
- 12 Sep 2005
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study Using the Medpulser® Electroporation System to Treat Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00198263
- Acronym / sponsor ID
- EU-HNBE-2003
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Inovio PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Medpulser electroporation with Bleomycin
| Arm | Type | Receives |
|---|---|---|
| Bleomycin | Experimental | Combination Product: Medpulser Electroporation with BleomycinBleomycin 4 USP Units/mL; intratumorally at dose of 0.25mL/cm^3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medpulser Electroporation with BleomycinThe 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. | Combination product | Bleomycin |
Primary outcome
To characterize local tumor recurrence through 8 months post-EPT/bleomycin treatment
Time frame: 8 Months
4 secondary outcomes
To measure pharmacoeconomic factors (hospital costs, extent of medical interventions, medication use) in subjects treated by EPT/bleomycin
Time frame: 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
Time frame: 4 and 8 Months
To document the performance of the MedPulser® System during EPT/bleomycin treatment
Time frame: 8 Nonths
To monitor local and systemic adverse events through the Month 4 follow-up study visit
Time frame: 4 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Goldfarb, MD study chair
Inovio Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Medpulser Electroporation with Bleomycin in people with Head and Neck Cancer, run by Inovio Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize local tumor recurrence through 8 months post-EPT/bleomycin treatment (time frame: 8 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2017; AzTrials last refreshed its copy on 4 Nov 2026.