Symptoms and General Pathology

All Conditions

Neoplasms

Recurrence

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Bleomycin

Anti-Bacterial Agents

Antibiotics, Antitubercular

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

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.

Medpulser Electroporation with Bleomycin

Paul Goldfarb, MD

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.

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

An Open-Label Study Using the Medpulser® Electroporation System to Treat Head and Neck Cancer

Inovio Pharmaceuticals

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Patients will receive standard of care surgical removal of their tumor.

Patients who are eligible for surgical excision will receive MedPulser electroporation with injection of bleomycin sulfate into the tumor treatment area.

Patients receive electroporation with injection of bleomycin sulfate at a concentration of 1 U/ml per cm3 of tumor treatment area.

Medpulser electroporation with Bleomycin

Patients have their tumor surgically removed.

Tumor surgical excision

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.

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.

Medpulser Electroporation With Bleomycin Study to Treat Anterior Head and Neck Squamous Cell Carcinoma

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

Bleomycin 4.0 U/mL at dose of 1 U/cm\^3 of treatment area; Medpulser EP

The MedPulser device will be used in combination with Bleomycin Sulfate injection around the tumor area in a concentration of 1 U/ml per cm3 of tumor treatment area.

MedPulser Electroporation with bleomycin

The purpose of the study is to study the safety and efficacy of MedPulser Electroporation with bleomycin treatment of cutaneous and subcutaneous foci of cancer.

Electroporation therapy (EPT) 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 cutaneous lesions may lead to significant organ dysfunction and/or permanent disfigurement requiring reconstructive surgery (i.e. nose, eye area, ears, medial canthus, nasolabial fold, lip, scalp, etc.). In contrast, electroporation therapy may offer equivalent disease control to conventional surgery with a lessened need for reconstructive surgery.

The ability to ablate local cutaneous lesions with the MedPulser® System when used in conjunction with intralesional Bleomycin is an important new treatment for the local management of recurrent Basal Cell Carcinoma (BCC), recurrent Squamous Cell Carcinoma (SCC), Melanoma, Adenocarcinoma (i.e. local recurrence of breast cancer), Merkel Cell Carcinoma and Cutaneous Lymphoma and other solid tumors with symptomatic subcutaneous recurrences and provides an alternative treatment option to subjects who:

1. have failed standard treatments; or who
2. are unwilling or unsuitable to undergo conventional surgical excision or radiation.

EPT with Bleomycin spares normal tissue and its use in local disease management may preserve organ function and/or appearance relative to surgery.

Study Using the MedPulser Electroporation System With Bleomycin to Treat Cutaneous and Subcutaneous Cancer

An Open-Label Study Using the MedPulser Electroporation System to Treat Cutaneous and Subcutaneous Foci of Cancer

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Laryngeal Diseases

Patients receive surgical excision of their tumor.

Patients receive electroporation with injection of Bleomycin Sulfate.

Patients receive injections of Bleomycin Sulfate at a concentration of 1 U/ml per cm3 of tumor treatment area followed by electroporation.

Surgical Excision

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.

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.

Medpulser Electroporation With Bleomycin Study to Treat Posterior Head and Neck Squamous Cell Carcinoma

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study Using the Medpulser Electroporation System With Bleomycin to Treat Head and Neck Cancer	NCT00198263	Head and Neck C...	Medpulser Elect...	18 Years -	Inovio Pharmaceuticals
Medpulser Electroporation With Bleomycin Study to Treat Anterior Head and Neck Squamous Cell Carcinoma	NCT00198315	Head and Neck C...	Medpulser elect... Tumor surgical ...	18 Years -	Inovio Pharmaceuticals
Study Using the MedPulser Electroporation System With Bleomycin to Treat Cutaneous and Subcutaneous Cancer	NCT00198276	Cancer	MedPulser Elect...	18 Years -	Inovio Pharmaceuticals
Medpulser Electroporation With Bleomycin Study to Treat Posterior Head and Neck Squamous Cell Carcinoma	NCT00198328	Head Neck Cance...	Medpulser Elect... Surgical Excisi...	18 Years -	Inovio Pharmaceuticals

Spots Global Cancer Trial Database for medpulser electroporation with bleomycin