NCT00198276

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P25-P50 for phase_4 cancer

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_4 cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

October 3, 2017

Status Verified

September 1, 2017

Enrollment Period

4.6 years

First QC Date

September 12, 2005

Last Update Submit

September 27, 2017

Conditions

Cancer

Keywords

cancercutaneoussubcutaneousMedPulserbleomycinelectroporationCutaneous or subcutaneous cancer

Outcome Measures

Primary Outcomes (1)

  • Local tumor control

    6 Months

Secondary Outcomes (3)

  • Pharmacoeconomic factors (e.g. hospital costs, extent of medical interventions, medication use)

    24 Months

  • MedPulser instrument and applicator performance

    6 Months

  • Adverse events

    6 Months

Study Arms (1)

Bleomycin

EXPERIMENTAL

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

Combination Product: MedPulser Electroporation with bleomycin

Interventions

MedPulser Electroporation with bleomycinCOMBINATION_PRODUCT

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.

Bleomycin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Total volume of disease treated will require a dose of bleomycin sulfate less than 80 units.
  • Tumors and margins must be completely accessible to intralesional bleomycin injections and the EPT applicator electrodes.
  • Age: 18 years or older.
  • Male or female.
  • Men and women of childbearing potential must be using physician prescribed contraceptive methods while undergoing protocol related therapy.
  • 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.
  • Life expectancy of at least 6 months.
  • Sign a written Informed Consent prior to receiving any study procedures or treatments.

You may not qualify if:

  • 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.
  • Subjects with tumors having bone invasion.
  • Subjects with hypersensitivity to bleomycin.
  • Subjects who have received or will exceed a total lifetime dose of bleomycin greater than 400 units.
  • Subjects with a significant history of emphysema or pulmonary fibrosis.
  • Subjects with indwelling cardiac pacemakers who cannot tolerate a period with pacemaker turned off.
  • Subjects with a history of uncontrolled cardiac arrhythmia.
  • Women who are pregnant, or are nursing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inovio Biomedical Corporation

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Bleomycin

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Paul Goldfarb, MD

    Inovio Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: MedPulser Electroporation with Belomycin
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

February 1, 2004

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

October 3, 2017

Record last verified: 2017-09

Locations

US(1)