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A Phase I Clinical Trial Assessing the Safety and Feasibility of Administration of pNGVL4a-CRT/E7(Detox) DNA Vaccine Using the Intramuscular TriGridTM Delivery System in Combination With Cyclophosphamide in HPV-16 Associated Head and Neck Cancer

Phase 1
18 Years
75 Years
Open (Enrolling)
HPV-related Head and Neck Cancer

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Trial Information

A Phase I Clinical Trial Assessing the Safety and Feasibility of Administration of pNGVL4a-CRT/E7(Detox) DNA Vaccine Using the Intramuscular TriGridTM Delivery System in Combination With Cyclophosphamide in HPV-16 Associated Head and Neck Cancer

Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the
head and neck or unknown primary with level II/III (jugulodigastric) nodal
involvement (which have been found in previous studies to be the result of
subclinical oropharyngeal carcinoma).

- Candidates for neo-adjuvant chemotherapy and radiation therapy followed by a
therapeutic neck dissection 10-14 weeks after completion of concurrent
chemo-radiation therapy as part of routine standard of care for the patient.

- Head and neck cancer patients documented to have HPV-16 DNA within their tumors as
determined by in situ hybridization are eligible for this study.

- Fresh-frozen or paraffin-embedded material must be available for in situ
hybridization testing for HPV-16 DNA.

- Staging criteria established by the American Joint Committee on Clinical
Investigation (AJCC, Fifth Edition, 1997) for Stage III (T1-3N1M0, T3N0M0) or IV
(T1-4N2M0, T4N0-1M0 ) disease.

- Age ≥ 18 years

- Life expectancy of greater than 4 months.

- Baseline Eastern Cooperative Oncology Group performance status of 0, 1 at the time of
multi-modality treatment administration.

Exclusion Criteria:

- Diagnosis of immunosuppression or prolonged, active use of immunosuppressive
medications such as steroids.

- Prior enrollment in any vaccine study.

- Presence of uncontrolled concurrent illness including, but not limited to, ongoing or
active infection, symptomatic congestive heart failure, unstable angina pectoris, or
psychiatric illness/social situations that would limit compliance with study

- Presence or history of autoimmune disease such as multiple sclerosis, exclusive of a
history of thyroiditis, psoriasis, or inflammatory bowel disease.

- Pregnancy or breast feeding. Pregnancy is defined as any female subject of
reproductive potential [defined as girls who have reached menarche or women who have
not been post-menopausal for at least 24 consecutive months, i.e., who have had
menses within the preceding 24 months, or have not undergone surgical sterilization
(e.g., hysterectomy, bilateral oophorectomy, or bilateral tubal ligation)] must have
a negative urine pregnancy test within 3 days prior to study entry.

- History of prior malignancy permitted if patient has been disease free for ≥ 5 years,
however individuals with completely resected basal cell or squamous cell carcinoma of
the skin within this interval may be enrolled.

- Inability to understand or unwillingness to sign an informed consent document.

- Patients with a history of arterial or venous thrombosis.

- Patients with non-healed wounds.

- Patients with chronic infection with or a history of Hepatitis B, Hepatitis C, or HIV
infection as determined by serology tests obtained during the eligibility screening.

- Current use of any electronic stimulation device, such as cardiac demand pacemakers,
automatic implantable cardiac defibrillator, nerve stimulators, or deep brain

- History of, or documented in an EKG within 30 days of study eligibility screening,
cardiac arrhythmia or palpitations [e.g., supraventricular tachycardia, atrial
fibrillation, frequent ectopy, or sinus bradycardia (i.e., <50 beats per minute on
exam)] prior to study entry. NOTE: Sinus arrhythmia is not excluded.

- History of syncope or fainting episode within 1 year of study entry.

- Seizure disorder or any history of prior seizure.

- Presence of any surgical or traumatic metal implants at the site of administration
(deltoid muscles).

- Bleeding disorder or other contraindication for intramuscular injection.

- A skin-fold measurement of the cutaneous and subcutaneous tissue that exceeds 40mm at
one or more of the eligible injection sites (the medial deltoid muscles).

- History of axillary lymph node dissection.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with adverse events after administration of pNGVL4a-CRT/E7 (detox) DNA vaccine using the intramuscular TriGridTM Delivery System (TDS-IM) in combination with cyclophosphamide

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Sara I Pai, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

April 2012

Completion Date:

Related Keywords:

  • HPV-related Head and Neck Cancer
  • HPV
  • Head and Neck Cancer
  • Vaccine
  • Immunotherapy
  • Cyclophosphamide
  • Sexually Transmitted Diseases, Viral
  • Head and Neck Neoplasms



Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins HospitalBaltimore, Maryland  21287
Milton J. Dance, Jr. Head and Neck Center at Greater Baltimore Medical CenterBaltimore, Maryland  21204