NCT00198328

Brief Summary

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.

Trial Health

57
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Trial Health Score

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

Enrollment
84

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months 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
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

March 4, 2022

Status Verified

March 1, 2022

Enrollment Period

2.6 years

First QC Date

September 12, 2005

Last Update Submit

March 2, 2022

Conditions

Head Neck Cancer

Keywords

Squamous Cell Carcinomacarcinomahead and neck cancerlarynxelectroporationmedpulserbleomycincancerLocally recurrent or second primary squamous cell carcinoma of the base of the tongue, posterior lateral pharyngeal wall, hypopharynx, or larynx

Outcome Measures

Primary Outcomes (1)

  • Function status at 4 months using the performance status scale for head and neck cancer (PSSHN) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck (EORTC-QLC-H&N35)

    4 Months

Secondary Outcomes (5)

  • Local tumor recurrence, disease free survival and overall survival rates through 2 years after bleomycin-EPT or surgery treatment

    4 Months

  • Safety through 6 months after the study treatment

    6 Months

  • Durability of function status outcomes at 8 months after bleomycin-EPT or surgery treatment

    8 Months

  • Pharmacoeconomic parameters through 8 months after bleomycin-EPT or surgery treatment

    8 Months

  • Bleomycin systemic absorption and plasma pharmacokinetics following intratumoral (IT) bleomycin-EPT administration

    96 Hours

Study Arms (2)

Surgery Control

ACTIVE COMPARATOR

Patients receive surgical excision of their tumor.

Procedure: Surgical Excision

MedPulser EPT

EXPERIMENTAL

Patients receive electroporation with injection of Bleomycin Sulfate.

Combination Product: Medpulser Electroporation with Bleomycin

Interventions

Medpulser Electroporation with BleomycinCOMBINATION_PRODUCT

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

Also known as: MedPulser EPT
MedPulser EPT
Surgical ExcisionPROCEDURE

Patients have their tumor surgically removed.

Surgery Control

Eligibility Criteria

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

You may qualify if:

  • The presence of SCC of the base of the tongue, posterior lateral pharyngeal wall, hypopharynx, or larynx must be confirmed by histological examination of a tissue sample (e.g., biopsy) obtained within 1 month of the patient receiving the study treatment.
  • Recurrent or second primary disease in patients where surgical resection is seen as an option for disease control.
  • The length of the longest diameter of the study lesion must be \< 5 cm and the calculated treatment volume must be \< 60.0 cm3 (tumor volume plus a 0.5 cm margin around the tumor) for the study lesion \[where treatment volume = 0.5 (A+1) (B+1)2 and where A = length of the longest diameter (cm), B = the next longest diameter perpendicular to "A" (cm)\].
  • Tumor burden must be completely encompassed by surgery or bleomycin-EPT.
  • Age: 18 years or older.
  • Men and women of childbearing potential must use physician approved contraceptive methods for 7 days following bleomycin-EPT.
  • Hematopoietic status:
  • Absolute neutrophil count (ANC) \> 1000/uL
  • Platelets \> 75,000/mm3
  • Prothrombin time: international normalized ratio (PT: INR) 1.5 (correctable with vitamin K injection)
  • Blood chemistry status:
  • Transaminases \< 3 times upper limit of normal
  • Total bilirubin \< 2.5 mg/dL
  • Creatinine \< 2.5mg/dL
  • A written Informed Consent form must be signed prior to the patient receiving any study procedures or treatments.

You may not qualify if:

  • Patients 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.
  • Patients with tumors having bone invasion.
  • Patients with any metallic implants in the treatment field.
  • Patients with hypersensitivity to bleomycin.
  • Patients who have received or will exceed a total lifetime dose of bleomycin greater than 400 units.
  • Patients deemed unsuitable for general anesthesia.
  • Patients with a significant history of emphysema or pulmonary fibrosis.
  • Patients with indwelling cardiac pacemakers who cannot tolerate a period with pacemaker turned off.
  • Patients with a history of uncontrolled cardiac arrhythmia.
  • Women who are pregnant, or are nursing. Women of childbearing potential must have a negative beta human chorionic gonadotropin (beta hCG) test within 7 days of study treatment.
  • Radiation therapy to the treatment area within 8 weeks of study treatment.
  • Chemotherapy or other cancer therapy (e.g., surgery, cryotherapy, etc.) to the treatment area within 4 weeks of study treatment.
  • Patients participating in a clinical study for an investigational drug or device within 4 weeks prior to the study treatment.
  • Patients previously randomized to this study.

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

Head and Neck NeoplasmsCarcinoma, Squamous CellCarcinomaLaryngeal DiseasesNeoplasms

Interventions

Bleomycin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous CellRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Paul Goldfarb, MD

    Inovio Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

November 1, 2004

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

March 4, 2022

Record last verified: 2022-03

Locations

US(1)