Safety Study of HPV DNA Vaccine to Treat Head and Neck Cancer Patients (NCT01493154) | Clinical Trial Compass
TerminatedPhase 1
Safety Study of HPV DNA Vaccine to Treat Head and Neck Cancer Patients
Stopped: Study Funding Terminated
United States2 participantsStarted 2012-04
Plain-language summary
This study will test the safety of an HPV DNA vaccine after it is injected into your muscle using an electroporation device (TriGridTM Delivery System made by Ichor Medical Systems), and will test the ability of the vaccine to help your body's immune system to recognize HPV-infected and associated cancer cells. In addition to giving the vaccine using an electroporation device, we are giving the vaccine in combination with an immunomodulatory agent to further enhance immune responses against HPV-infected and associated cancer cells.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
✓. 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.
What they're measuring
1
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
Timeframe: 5 years
Trial details
NCT IDNCT01493154
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
✕. Prior enrollment in any vaccine study in the past 24 months.
✕. 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 requirements.
✕. Presence or history of autoimmune disease such as multiple sclerosis, exclusive of a history of thyroiditis, psoriasis, inflammatory bowel disease, or Sjogren's syndrome.
✕. 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 serum -hcg 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.