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A Randomized Trial Comparing Preservation of Function Status After Either Medpulser Electroporation With Intratumoral Bleomycin Therapy or Surgery in Patients With Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Base of the Tongue, Posterior Lateral Pharyngeal Wall, Hypopharynx, or Larynx That Have Failed Primary Curative Therapy


Phase 3
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

A Randomized Trial Comparing Preservation of Function Status After Either Medpulser Electroporation With Intratumoral Bleomycin Therapy or Surgery in Patients With Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Base of the Tongue, Posterior Lateral Pharyngeal Wall, Hypopharynx, or Larynx That Have Failed Primary Curative Therapy


Recurrent tumors in head and neck squamous cell carcinoma usually have a poor prognosis. In
patients suitable for salvage surgery of their recurrent disease, the success rate for local
control has been reported to be 40-50%. The surgical treatment of H&N SCC frequently
results in significant loss of organ function (e.g., inability to swallow, speak, etc.)
and/or permanent disfigurement. There is a compelling and unmet medical need for a local
therapy that destroys tumors while preserving function status and appearance in patients
with primary, recurrent, or metastatic H&N SCC.

Comparison: To compare function status at 4 months after treatment with bleomycin-EPT or
surgery in patients with locally recurrent or second primary SCC of the base of the tongue,
posterior lateral pharyngeal wall, hypopharynx or larynx that have failed primary curative
therapy and in whom surgical resection is seen as an option for disease control.


Inclusion Criteria:



1. 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.

2. Recurrent or second primary disease in patients where surgical resection is seen as
an option for disease control.

3. 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)].

4. Tumor burden must be completely encompassed by surgery or bleomycin-EPT.

5. Age: 18 years or older.

6. Men and women of childbearing potential must use physician approved contraceptive
methods for 7 days following bleomycin-EPT.

7. 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)

8. Blood chemistry status:

- Transaminases < 3 times upper limit of normal

- Total bilirubin < 2.5 mg/dL

- Creatinine < 2.5mg/dL

9. A written Informed Consent form must be signed prior to the patient receiving any
study procedures or treatments.

Exclusion Criteria:

1. 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.

2. Patients with tumors having bone invasion.

3. Patients with any metallic implants in the treatment field.

4. Patients with hypersensitivity to bleomycin.

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

6. Patients deemed unsuitable for general anesthesia.

7. Patients with a significant history of emphysema or pulmonary fibrosis.

8. Patients with indwelling cardiac pacemakers who cannot tolerate a period with
pacemaker turned off.

9. Patients with a history of uncontrolled cardiac arrhythmia.

10. 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.

11. Radiation therapy to the treatment area within 8 weeks of study treatment.

12. Chemotherapy or other cancer therapy (e.g., surgery, cryotherapy, etc.) to the
treatment area within 4 weeks of study treatment.

13. Patients participating in a clinical study for an investigational drug or device
within 4 weeks prior to the study treatment.

14. Patients previously randomized to this study.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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)

Outcome Time Frame:

4 Months

Safety Issue:

No

Principal Investigator

Paul Goldfarb, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Inovio Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

HNBE-03-02

NCT ID:

NCT00198328

Start Date:

November 2004

Completion Date:

June 2007

Related Keywords:

  • Head and Neck Cancer
  • Squamous Cell Carcinoma
  • carcinoma
  • head and neck cancer
  • larynx
  • electroporation
  • medpulser
  • bleomycin
  • cancer
  • Locally recurrent or second primary squamous cell carcinoma of the base of the tongue, posterior lateral pharyngeal wall, hypopharynx, or larynx
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Inovio Biomedical CorporationSan Diego, California  92121