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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Inovio Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00198276
First received: September 12, 2005
Last updated: April 24, 2013
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Cancer
 Device: MedPulser Electroporation with bleomycin
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study Using the MedPulser Electroporation System to Treat Cutaneous and Subcutaneous Foci of Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Inovio Pharmaceuticals:

Primary Outcome Measures:
  • Local tumor control [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacoeconomic factors (e.g. hospital costs, extent of medical interventions, medication use) [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • MedPulser instrument and applicator performance [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Enrollment: 88
Study Start Date: February 2004
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bleomycin
Bleomycin 4.0 U/mL at dose of 1 U/cm^3 of treatment area; Medpulser EP
 Device: 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.

Detailed 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.

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00198276

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: Inovio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00198276     History of Changes
Other Study ID Numbers: EU-CCBE-2003
Study First Received: September 12, 2005
Last Updated: April 24, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Paul-Ehrlich-Institut
Sweden: Medical Products Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by Inovio Pharmaceuticals:
cancer
cutaneous
subcutaneous
MedPulser
 bleomycin
electroporation
Cutaneous or subcutaneous cancer

Additional relevant MeSH terms:
Bleomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013