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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00198276
• Other study ID #: EU-CCBE-2003
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: September 27, 2017
• Start date: February 2004
• Est. completion date: September 2008

Study information

• Verified date: September 2017
• Source: Inovio Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The presence of recurrent SCC, recurrent BCC, melanoma, adenocarcinoma (i.e., local recurrence of breast cancer), merkel cell carcinoma, cutaneous lymphoma, other subcutaneous solid tumors, or primary cutaneous tumors must be confirmed by histological examination of a tissue (e.g., biopsy) sample obtained within 1 month prior to a patient signing the informed consent form for the study.

2. Total volume of disease treated will require a dose of bleomycin sulfate less than 80 units.

3. Tumors and margins must be completely accessible to intralesional bleomycin injections and the EPT applicator electrodes.

4. Age: 18 years or older.

5. Male or female.

6. Men and women of childbearing potential must be using physician prescribed contraceptive methods while undergoing protocol related therapy.

7. Baseline performance status: ECOG 0-2

• Grade 0: Fully active, able to carry on all pre-disease performance without restriction.

• Grade 1: Restricted in a 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.

8. Life expectancy of at least 6 months.

9. Sign a written Informed Consent prior to receiving any study procedures or treatments.

Exclusion Criteria:

1. 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.

2. Subjects with tumors having bone invasion.

3. Subjects with hypersensitivity to bleomycin.

4. Subjects who have received or will exceed a total lifetime dose of bleomycin greater than 400 units.

5. Subjects with a significant history of emphysema or pulmonary fibrosis.

6. Subjects with indwelling cardiac pacemakers who cannot tolerate a period with pacemaker turned off.

7. Subjects with a history of uncontrolled cardiac arrhythmia.

8. Women who are pregnant, or are nursing.

Related Conditions & MeSH terms

• Cancer

Intervention

Combination Product:
• MedPulser Electroporation with bleomycin
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.

Locations

Country	Name	City	State
United States	Inovio Biomedical Corporation	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Inovio Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local tumor control		6 Months
Secondary	Pharmacoeconomic factors (e.g. hospital costs, extent of medical interventions, medication use)		24 Months
Secondary	MedPulser instrument and applicator performance		6 Months
Secondary	Adverse events		6 Months