A Clinical Trial to Assess PVX7 Immunotherapy Regimens in Advanced Cervical Cancer Patients
- Conditions
- Cervical Cancer
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Female subjects age 18 years or older with diagnosis of advanced cervical cancer and<br> have completed primary treatment within the past 12 months.<br><br> - No history of or current evidence of residual disease or disease recurrence based on<br> imaging and clinical assessments within 8 weeks of enrollment<br><br> - HIV uninfected<br><br> - Hepatitis B surface antigen negative<br><br> - Anti-hepatitis C (HCV) antibody negative or negative HCV polymerase chain reaction<br> (PCR)<br><br> - Patients who are able and willing to comply with all study procedures and<br> voluntarily sign an informed consent form<br><br> - Adequate organ function as defined by the following parameters:<br><br> - white blood cell count = 3,000<br><br> - lymphocyte number = 500<br><br> - absolute neutrophil count = 1,000<br><br> - platelets = 90,000<br><br> - hemoglobin = 9<br><br> - total bilirubin <1.5 X upper limit of normal (ULN), <3 x ULN if Gilbert's disease<br><br> - Aspartate Transferase(AST)/Alanine Transaminase (ALT) <3 X ULN<br><br> - creatinine < 1.5 X ULN or estimated creatinine clearance = 60 ml/min per Modified<br> Cockcroft-Gault Formula<br><br> - Eastern Cooperative Oncology Group performance status of 0 or 1<br><br> - All clinically significant toxicities related to prior therapy should be less than<br> or equal to Grade 1 at time of enrollment<br><br> - Ability and willingness for one month post vaccination to follow vaccine inoculation<br> site care and avoid close social contact with children under 1 year old or close<br> social or domestic contact with a pregnant woman or individuals at high risk of<br> serious adverse effects of vaccinia virus, for instance, those with past or present<br> eczema, or immunodeficiency states including HIV infection<br><br>Exclusion Criteria:<br><br> - Women of child-bearing potential (i.e., those who have had fertility-sparing<br> procedures for the management of cervical cancer) will be excluded unless agreed to<br> remain sexually abstinent or have a partner who is sterile (i.e. vasectomy), or use<br> methods of contraception (e.g., oral contraception, barrier methods, spermicide,<br> intrauterine device (IUD)), throughout the first 6 months of the study.<br><br> - Because there is a risk for adverse events in nursing infants, breastfeeding must be<br> discontinued if the mother is treated on study.<br><br> - Diagnosed with a recognized immunodeficiency disease including cellular<br> immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; patients<br> diagnosed with acquired, hereditary, or congenital immunodeficiencies<br><br> - Diagnosis with a medical condition that requires systemic treatment with<br> immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH),<br> alkylating agents, antimetabolites, radiation, Tumor Necrosis Factor (TNF)<br> inhibitors, or systemic corticosteroids, either chronically or within 30 days of<br> first PVX7 vaccination.<br><br> - Administration of any blood product within 30 days of signing informed consent.<br><br> - Need for ongoing therapeutic anticoagulation during the study period due to concern<br> for increased risk of bleeding.<br><br> - Previous severe allergic reaction or hypersensitivity to a vaccine or any of its<br> components<br><br> - Participation in a study with an investigational compound or device within 30 days<br> of signing informed consent<br><br> - History of seizures (unless seizure free for 5 years)<br><br> - Known active central nervous system disease<br><br> - Surgery within 30 days of first PVX7 vaccination, excluding minor procedures<br><br> - Diagnosis with an uncontrolled intercurrent illness including, but not limited to,<br> ongoing, or active infection, or psychiatric illness/social situations that would<br> limit compliance with study requirements<br><br> - Diagnosis with an active autoimmune disease (e.g., rheumatoid arthritis, systemic<br> lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis<br> (MS), ankylosing spondylitis)<br><br> - History of myocarditis or pericarditis.<br><br> - Known underlying heart disease (e.g., cardiomyopathy, congestive heart failure,<br> symptomatic arrhythmia not controlled by medication, unstable angina, history of<br> acute myocardial infarction or cerebrovascular accident within the past 6 months).<br><br> - Patients and the patients close social, sexual, or domestic contacts may not have<br> non-healed wounds or active exfoliative skin conditions such as: Eczema, Burns,<br> Impetigo, Varicella-zoster virus infection, Herpes simplex virus infection, Severe<br> acne, Severe diaper dermatitis with extensive areas of denuded skin, Psoriasis,<br> Lichen planus, Darier disease (keratosis follicularis).<br><br> - History or presence of atopic dermatitis<br><br> - Inability or unwillingness to for one month post vaccination follow vaccine<br> inoculation site care and avoid social contact with children under 1 year old or<br> close social or domestic contact with a pregnant woman or individuals at high risk<br> of serious adverse effects of vaccinia virus, for instance, those with past or<br> present eczema, or immunodeficiency states including HIV infection
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of PVX7 as assessed by adverse events;Feasibility of PVX7
- Secondary Outcome Measures
Name Time Method Cellular Immune Response;Immune Response;Presence of circulating HPV DNA