Medpulser Electroporation With Bleomycin Study to Treat Anterior Head and Neck Squamous Cell Carcinoma - Full Text View

Sponsor:	Inovio Biomedical Corporation
Information provided by:	Inovio Biomedical Corporation
ClinicalTrials.gov Identifier:	NCT00198315

Purpose

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 anterior oral cavity, soft palate, or tonsil.

Condition	Intervention	Phase
Head and Neck Cancer	Device: Medpulser electroporation with Bleomycin Procedure: Tumor surgical excision	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy 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 Anterior Oral Cavity, Soft Palate, or Tonsil That Have Failed Primary Curative Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Surgery Tonsils and Adenoids

Drug Information available for: Bleomycin Bleomycin sulfate

U.S. FDA Resources

Further study details as provided by Inovio Biomedical Corporation:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Local tumor recurrence, disease free survival and overall survival rates through 2 years after bleomycin-EPT or surgery treatment [ Time Frame: 4 Months ] [ Designated as safety issue: Yes ]
Safety through 6 months after the study treatment [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
Durability of function status outcomes at 8 months after bleomycin-EPT or surgery treatment [ Time Frame: 8 Months ] [ Designated as safety issue: No ]
Pharmacoeconomic parameters through 8 months after bleomycin-EPT or surgery treatment [ Time Frame: 8 Months ] [ Designated as safety issue: No ]
Bleomycin systemic absorption and plasma pharmacokinetics following intratracheal (IT) bleomycin-EPT administration [ Time Frame: 96 Hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	June 2004
Estimated Study Completion Date:	February 2009

Arms	Assigned Interventions
Surgery Control: Active Comparator Patients will receive standard of care surgical removal of their tumor.	Procedure: Tumor surgical excision Patients have their tumor surgically removed.
MedPulser EPT: Experimental Patients who are eligible for surgical excision will receive MedPulser electroporation with injection of bleomycin sulfate into the tumor treatment area.	Device: Medpulser electroporation with Bleomycin Patients receive electroporation with injection of bleomycin sulfate at a concentration of 1 U/ml per cm3 of tumor treatment area.

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 anterior oral cavity, soft palate, or tonsil that have failed primary curative therapy and in whom surgical resection is seen as an option for disease control.

Eligibility

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

Criteria

Inclusion Criteria:

The presence of SCC of the anterior oral cavity, soft palate or tonsil 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.
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 < 2.5 mg/dL
A written Informed Consent form must be signed prior to the patient receiving any study procedures or treatments.

Exclusion Criteria:

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.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198315

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:	HNBE-03-01, HNBE-03-01
Study First Received:	September 12, 2005
Last Updated:	December 5, 2007
ClinicalTrials.gov Identifier:	NCT00198315 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Ireland: Irish Medicines Board; Germany: BfArM; Sweden: Medical Products Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Belgium: Pharmaceutical Inspectorate; Latvia: Ministry of Health; Lithuania: Ministry of Health; Ukraine: Ministry of Health

Keywords provided by Inovio Biomedical Corporation:

Squamous Cell Carcinoma
Carcinoma
Head and Neck Cancer
Oral
Soft Palate

Cancer
Medpulser
Electroporation
Local recurrent or second primary squamous cell carcinoma of anterior oral cavity, soft palate, or tonsil

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Antineoplastic Agents
Antibiotics, Antineoplastic
Bleomycin
Pharmacologic Actions
Carcinoma
Neoplasms

Neoplasms by Site
Head and Neck Neoplasms
Therapeutic Uses
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 30, 2009