Head Neck CancerPhase 3NCT00198328
Medpulser Electroporation With Bleomycin Study to Treat Posterior Head and Neck Squamous Cell Carcinoma
A Phase 3 study testing Medpulser Electroporation with Bleomycin and Surgical Excision in people with Head Neck Cancer, run by Inovio Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of the study is to evaluate Medpulser electroporation (EPT) with bleomycin with regard to local tumor recurrence, disease-free survival, and overall survival rates versus surgery in recurrent or secondary primary squamous cell carcinoma (SCC) of the base of the tongue, posterior lateral pharyngeal wall… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head Neck Cancer
- What is being tested?
- Medpulser Electroporation with Bleomycin and Surgical Excision
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Jun 2007
- Phase
- Phase 3
- 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 SCC of the base of the tongue, posterior lateral pharyngeal wall, hypopharynx, or larynx must be confirmed by histological examination of a tissue sample (e.g., biopsy) obtained within 1 month of the patient receiving the study treatment.
- Recurrent or second primary disease in patients where surgical resection is seen as an option for disease control.
- The length of the longest diameter of the study lesion must be < 5 cm and the calculated treatment volume must be < 60.0 cm3 (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)].
- Tumor burden must be completely encompassed by surgery or bleomycin-EPT.
- Age: 18 years or older.
- Men and women of childbearing potential must use physician approved contraceptive methods for 7 days following bleomycin-EPT.
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- Hematopoietic status:
- Absolute neutrophil count (ANC) > 1000/uL
- Platelets > 75,000/mm3
- Prothrombin time: international normalized ratio (PT: INR) 1.5 (correctable with vitamin K injection)
- Blood chemistry status:
- Transaminases < 3 times upper limit of normal
- Total bilirubin < 2.5 mg/dL
- Creatinine < 2.5mg/dL
- A written Informed Consent form must be signed prior to the patient receiving any study procedures or treatments.
Who cannot join
- Patients 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.
- Patients with tumors having bone invasion.
- Patients with any metallic implants in the treatment field.
- Patients with hypersensitivity to bleomycin.
- Patients who have received or will exceed a total lifetime dose of bleomycin greater than 400 units.
- Patients deemed unsuitable for general anesthesia.
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- Patients with a significant history of emphysema or pulmonary fibrosis.
- Patients with indwelling cardiac pacemakers who cannot tolerate a period with pacemaker turned off.
- Patients with a history of uncontrolled cardiac arrhythmia.
- Women who are pregnant, or are nursing. Women of childbearing potential must have a negative beta human chorionic gonadotropin (beta hCG) test within 7 days of study treatment.
- Radiation therapy to the treatment area within 8 weeks of study treatment.
- Chemotherapy or other cancer therapy (e.g., surgery, cryotherapy, etc.) to the treatment area within 4 weeks of study treatment.
- Patients participating in a clinical study for an investigational drug or device within 4 weeks prior to the study treatment.
- Patients previously randomized to this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Inovio Biomedical Corporation
San Diego, California, 92121
About this study
Official title: A Randomized Trial Comparing Preservation of Function Status After Either Medpulser Electroporation With Intratumoral Bleomycin Therapy or Surgery in Patients With Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Base of the Tongue, Posterior Lateral Pharyngeal Wall, Hypopharynx, or Larynx That Have Failed Primary Curative Therapy
The purpose of the study is to evaluate Medpulser electroporation (EPT) with bleomycin with regard to local tumor recurrence, disease-free survival, and overall survival rates versus surgery in recurrent or secondary primary squamous cell carcinoma (SCC) of the base of the tongue, posterior lateral pharyngeal wall, hypopharynx or larynx.
Read the detailed description
Recurrent tumors in head and neck squamous cell carcinoma usually have a poor prognosis. In patients suitable for salvage surgery of their recurrent disease, the success rate for local control has been reported to be 40-50%. The surgical treatment of H\&N SCC frequently results in significant loss of organ function (e.g., inability to swallow, speak, etc.) and/or permanent disfigurement. There is a compelling and unmet medical need for a local therapy that destroys tumors while preserving function status and appearance in patients with primary, recurrent, or metastatic H\&N SCC.
Comparison: To compare function status at 4 months after treatment with bleomycin-EPT or surgery in patients with locally recurrent or second primary SCC of the base of the tongue, posterior lateral pharyngeal wall, hypopharynx or larynx that have failed primary curative therapy and in whom surgical resection is seen as an option for disease control.
- Conditions
- Head Neck Cancer
- Being tested
- Medpulser Electroporation with Bleomycin, Surgical Excision
- Keywords
- Squamous Cell Carcinoma, carcinoma, head and neck cancer, larynx, electroporation, medpulser, bleomycin, cancer, Locally recurrent or second primary squamous cell carcinoma of the base of the tongue, posterior lateral pharyngeal wall, hypopharynx, or larynx
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell, Carcinoma, Laryngeal Diseases, 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
Also called MedPulser EPT
Patients receive injections of Bleomycin Sulfate at a concentration of 1 U/ml per cm3 of tumor treatment area followed by electroporation.
Surgical ExcisionProcedure or surgery
Patients have their tumor surgically removed.
| Study group | Role | What they receive |
|---|---|---|
| Surgery Control | Active comparator | Patients receive surgical excision of their tumor. Receives: Procedure: Surgical Excision |
| MedPulser EPT | Experimental | Patients receive electroporation with injection of Bleomycin Sulfate. Receives: Combination Product: Medpulser Electroporation with Bleomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function status at 4 months using the performance status scale for head and neck cancer (PSSHN) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck (EORTC-QLC-H&N35)
Measured: 4 Months
Secondary outcomes (5)
Local tumor recurrence, disease free survival and overall survival rates through 2 years after bleomycin-EPT or surgery treatment
Measured: 4 Months
Safety through 6 months after the study treatment
Measured: 6 Months
Durability of function status outcomes at 8 months after bleomycin-EPT or surgery treatment
Measured: 8 Months
Pharmacoeconomic parameters through 8 months after bleomycin-EPT or surgery treatment
Measured: 8 Months
Bleomycin systemic absorption and plasma pharmacokinetics following intratumoral (IT) bleomycin-EPT administration
Measured: 96 Hours
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 startNov 2004
- Primary completionJun 2007
- Study completionJun 2007
Why it stopped: Enrollment was stopped based on the Data Monitoring Committee's recommendation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 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
- NCT00198328
- Sponsor's protocol ID
- HNBE-03-02
- Status last verified
- Mar 2022
- First submitted
- 12 Sep 2005
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Preservation of Function Status After Either Medpulser Electroporation With Intratumoral Bleomycin Therapy or Surgery in Patients With Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Base of the Tongue, Posterior Lateral Pharyngeal Wall, Hypopharynx, or Larynx That Have Failed Primary Curative Therapy
- ClinicalTrials.gov ID
- NCT00198328
- Acronym / sponsor ID
- HNBE-03-02
- Conditions
- Head Neck Cancer
- Keywords
- Squamous Cell Carcinoma, carcinoma, head and neck cancer, larynx, electroporation, medpulser, bleomycin, cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment was stopped based on the Data Monitoring Committee's recommendation.
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Inovio PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2004 (actual)
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (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 study is to evaluate Medpulser electroporation (EPT) with bleomycin with regard to local tumor recurrence, disease-free survival, and overall survival rates versus surgery in recurrent or secondary primary squamous cell carcinoma (SCC) of the base of the tongue, posterior lateral pharyngeal wall, hypopharynx or larynx.
Detailed description
Recurrent tumors in head and neck squamous cell carcinoma usually have a poor prognosis. In patients suitable for salvage surgery of their recurrent disease, the success rate for local control has been reported to be 40-50%. The surgical treatment of H\&N SCC frequently results in significant loss of organ function (e.g., inability to swallow, speak, etc.) and/or permanent disfigurement. There is a compelling and unmet medical need for a local therapy that destroys tumors while preserving function status and appearance in patients with primary, recurrent, or metastatic H\&N SCC.
Comparison: To compare function status at 4 months after treatment with bleomycin-EPT or surgery in patients with locally recurrent or second primary SCC of the base of the tongue, posterior lateral pharyngeal wall, hypopharynx or larynx that have failed primary curative therapy and in whom surgical resection is seen as an option for disease control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery Control | Active comparator | Procedure: Surgical ExcisionPatients receive surgical excision of their tumor. |
| MedPulser EPT | Experimental | Combination Product: Medpulser Electroporation with BleomycinPatients receive electroporation with injection of Bleomycin Sulfate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The presence of SCC of the base of the tongue, posterior lateral pharyngeal wall, hypopharynx, or larynx must be confirmed by histological examination of a tissue sample (e.g., biopsy) obtained within 1 month of the patient receiving the study treatment.
- Recurrent or second primary disease in patients where surgical resection is seen as an option for disease control.
- The length of the longest diameter of the study lesion must be < 5 cm and the calculated treatment volume must be < 60.0 cm3 (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)].
- Tumor burden must be completely encompassed by surgery or bleomycin-EPT.
- Age: 18 years or older.
Key exclusion criteria (14 listed)
- Patients 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.
- Patients with tumors having bone invasion.
- Patients with any metallic implants in the treatment field.
- Patients with hypersensitivity to bleomycin.
- Patients who have received or will exceed a total lifetime dose of bleomycin greater than 400 units.
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 BleomycinAlso: MedPulser EPTPatients receive injections of Bleomycin Sulfate at a concentration of 1 U/ml per cm3 of tumor treatment area followed by electroporation. | Combination product | MedPulser EPT |
| Surgical ExcisionPatients have their tumor surgically removed. | Procedure or surgery | Surgery Control |
Primary outcome
Function status at 4 months using the performance status scale for head and neck cancer (PSSHN) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck (EORTC-QLC-H&N35)
Time frame: 4 Months
5 secondary outcomes
Local tumor recurrence, disease free survival and overall survival rates through 2 years after bleomycin-EPT or surgery treatment
Time frame: 4 Months
Safety through 6 months after the study treatment
Time frame: 6 Months
Durability of function status outcomes at 8 months after bleomycin-EPT or surgery treatment
Time frame: 8 Months
Pharmacoeconomic parameters through 8 months after bleomycin-EPT or surgery treatment
Time frame: 8 Months
Bleomycin systemic absorption and plasma pharmacokinetics following intratumoral (IT) bleomycin-EPT administration
Time frame: 96 Hours
Results and safety
The study was stopped early (reason given: Enrollment was stopped based on the Data Monitoring Committee's recommendation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
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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 3 study testing Medpulser Electroporation with Bleomycin and Surgical Excision in people with Head 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 15 inclusion and 14 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: stopped early, as of the sponsor's last update on 4 Mar 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Enrollment was stopped based on the Data Monitoring Committee's recommendation.). Results are not available in the source record.
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?
Function status at 4 months using the performance status scale for head and neck cancer (PSSHN) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck (EORTC-QLC-H&N35) (time frame: 4 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 4 Mar 2022.