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


Phase 4
18 Years
N/A
Not Enrolling
Both
Cancer

Thank you

Trial Information

An Open-Label Study Using the MedPulser Electroporation System to Treat 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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local tumor control

Outcome Time Frame:

6 Months

Safety Issue:

Yes

Principal Investigator

Paul Goldfarb, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Inovio Pharmaceuticals

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

EU-CCBE-2003

NCT ID:

NCT00198276

Start Date:

February 2004

Completion Date:

September 2008

Related Keywords:

  • Cancer
  • cancer
  • cutaneous
  • subcutaneous
  • MedPulser
  • bleomycin
  • electroporation
  • Cutaneous or subcutaneous cancer

Name

Location
Inovio Biomedical Corporation San Diego, California  92121