trial to test safety and efficacy of vaccination for incurable hpv 16-related oropharyngeal, cervical and anal cancer

Conditions: Cancer of Head and Neck; Cancer of Cervix; Cancer of Anus

Summary: this research study is studying a therapeutic vaccine, named dpx-e7, as a possible treatment for human papilloma virus or hpv related head and neck, cervical or anal cancer (positive for hla-a\*02).

this is a phase ib/ii clinical trial. dpx-e7 is a therapeutic vaccine, intended to treat hpv-related head and neck, cervical or anal cancer. dpx-e7 is an investigational vaccine and the fda (the u.s. food and drug administration) has not approved dpx-e7 vaccine as a treatment for any disease. dpx-e7 is being tested in humans for the first time. dpx-e7 is a kind of immunotherapy that will make the immune system to elicit an anti-tumor response by generating cd8+ t-cells. cd8+ t-cells play a very important role in fighting against viral infections

Eligibility criteria:
inclusion criteria: * each patient must be positive for hla-a\*02 and meet all of the following inclusion criteria to be enrolled in the study: * histologically or cytologically proven hpvoc or cervical cancer or anal cancer, based on expression of hpv type16 in immunohistochemistry and/or hpv 16 dna analysis by ish of tumor tissue from the primary or metastatic lesions. * incurable hpvoc, as defined by: * relapsed or progressive disease at the primary site and/or regional lymph nodes after initial treatment (e.g. surgery, radiotherapy or chemoradiotherapy) with no potentially curative option (i.e. surgery or radiation); or * distant metastasis * incurable cervical or anal cancer, as defined by: * relapsed or progressive disease at the primary site and/or regional lymph nodes after initial treatment (e.g. systemic chemotherapy) with no potentially curative option (i.e. surgery or chemoradiotherapy). chemotherapy administered in conjunction with primary radiation as a radiosensitizer will not be counted as a systemic chemotherapy regimen; or * distant metastasis refractory to initial treatment (at least one prior chemotherapeutic regimen which can include a single chemotherapeutic, a combination of chemotherapeutics, or biologic drugs such as bevacizumab). * accessible tumors for sequential biopsies terminology criteria for adverse events version 4.0 (ctcae v4.03) to grade 1 or better (except for \< grade 2 neuropathy, alopecia, xerostomia, dysphagia, or mucositis); * age ≥ 18 years; * measurable disease, according to modified recist 1.1 and irrecist (appendix b \& c); * eastern cooperative oncology group performance status (ecog ps) ≤ 2 (appendix a) * adequate bone marrow, liver and renal function, defined by: * hemoglobin ≥ 10 g/dl; * absolute neutrophil count (anc) ≥ 1000/μl; * absolute lymphocyte count ≥ 400/μl; * platelet count ≥ 100,000/μl; * alt and ast ≤ 2.5 x upper limit of normal (uln); * total bilirubin ≤ 1.5 x uln; and * serum creatinine ≤ 1.5 x uln; * women of child-bearing potential (wocbp) must be willing to use acceptable means of birth control; * men who could potentially father a child must also use birth control * signed informed consent exclusion criteria: * radiotherapy for primary hpvoc within 8 weeks, or radiotherapy for any other reason within 3 weeks prior to the first dose of trial treatment; * chemotherapy within 3 weeks prior to the first dose of trial treatment;other cancer in the past 5 years, except for carcinoma in situ of the cervix or bladder, or non-melanomatous skin cancer; * inaccessible tumor or lack of consent for sequential biopsies * uncontrolled central nervous system (cns) metastases (i.e. known cns lesions that are radiographically unstable, symptomatic and/or requiring escalating doses of corticosteroids); * active hepatitis, known hiv, or other condition that requires immunosuppressive therapy, including current use of high dose systemic corticosteroids; * autoimmune disease, such as systemic lupus erythematosis or rheumatoid arthritis, that is active and requires current immunosuppressive therapy; * active uncontrolled serious infection; * wocbp who have a positive β-hcg test or are breastfeeding. * acute or chronic skin disorders that would interfere with subcutaneous injection of the vaccine or subsequent assessment of potential skin reactions; * allergies to any vaccine, that after discussion with immunovaccine, are serious enough to warrant exclusion from this study

Keywords: hpv related head and neck cervical anal cancer