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

Sponsor:	Inovio Pharmaceuticals
Information provided by:	Inovio Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00198328

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 base of the tongue, posterior lateral pharyngeal wall, hypopharynx or larynx.

Condition	Intervention	Phase
Head and Neck Cancer	Device: Medpulser Electroporation with Bleomycin Procedure: Surgical Excision	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

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 Pharmaceuticals:

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 intratumoral (IT) bleomycin-EPT administration [ Time Frame: 96 Hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	November 2004
Estimated Study Completion Date:	May 2009

Arms	Assigned Interventions
Active Comparator: Surgery Control Patients receive surgical excision of their tumor.	Procedure: Surgical Excision Patients have their tumor surgically removed.
Experimental: MedPulser EPT Patients receive electroporation with injection of Bleomycin Sulfate.	Device: Medpulser Electroporation with Bleomycin Patients receive injections of Bleomycin Sulfate at a concentration of 1 U/ml per cm3 of tumor treatment area followed by electroporation.

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.

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 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.
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.

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: NCT00198328

Locations

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

Sponsors and Collaborators

Inovio Pharmaceuticals

Investigators

Study Chair:

Paul Goldfarb, MD

Inovio Pharmaceuticals

More Information

No publications provided

Responsible Party:	Larry Young, Executive Director of Clinical Affairs, Inovio Biomedical Corporation
ClinicalTrials.gov Identifier:	NCT00198328 History of Changes
Other Study ID Numbers:	HNBE-03-02
Study First Received:	September 12, 2005
Last Updated:	December 5, 2007
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Ireland: Irish Medicines Board; Belgium: Pharmaceutical Inspectorate; Latvia: Ministry of Health; Lithuania: Ministry of Health; Ukraine: Ministry of Health

Keywords provided by Inovio Pharmaceuticals:

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

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell

Neoplasms by Site
Bleomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012