Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer

Inclusion Criteria

• •Patients must have persistent or recurrent squamous or non-squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix with documented disease progression (disease not amenable to curative therapy); histologic confirmation of the original primary tumor is required via the pathology report
• •Patient must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• •* Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded)
• •* Each lesion must be \>= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam; or \>= 20 mm when measured by chest x-ray
• •* Lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI
• •Patient must have at least one ?target lesion? to be used to assess response on this protocol as defined by RECIST 1.1
• •* Tumors within a previously irradiated field will be designated as ?non-target? lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
• •Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists
• •* In general, this would refer to any active GOG phase III or rare tumor protocol for the same patient population
• •Patients must have a GOG performance status of 0 or 1
• •Recovered from effects of recent surgery, radiotherapy, or chemotherapy
• •Patients should be free of active infection requiring antibiotics
• •Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
• •* Continuation of hormone replacement therapy is permitted
• •Any other prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted (non-cytotoxic) agents and immunologic agents, must be discontinued at least three weeks prior to registration
• •Any prior radiation therapy must be completed at least 4 weeks prior to registration
• •Patients must have had one prior systemic chemotherapeutic regimen for management of advanced, metastatic, or recurrent carcinoma of the cervix
• •* Chemotherapy administered concurrent with primary radiation (e.g.; weekly cisplatin) is not counted as a systemic chemotherapy regimen for management of advanced, metastatic, or recurrent disease; adjuvant chemotherapy given following the completion of radiation therapy (or concurrent chemotherapy and radiation therapy) is not counted as a systemic chemotherapy regimen for management of advanced, metastatic, or recurrent disease (e.g.; paclitaxel and carboplatin for up to 4 cycles)
• •Patients are allowed to receive, but are not required to receive, biologic/targeted (non-cytotoxic) therapy as part of their primary therapy and/or as part of their therapy for advanced, metastatic, or recurrent disease (e.g., bevacizumab)
• •Platelet count greater than or equal to 75,000/mcL
• •Absolute neutrophil count (ANC) count greater than or equal to 1,000/mcL
• •Lymphocyte count greater than or equal to 700/mcL
• •Hemoglobin count greater than or equal to 9 g/dL or greater than or equal to 5.6 mmol/L
• •* Note: ANC, platelets, hemoglobin requirement cannot be met by the use of recent transfusions, or growth factor support (granulocyte colony-stimulating factor \[G-CSF\], erythropoietin, etc.) within 2 weeks prior to treatment initiation
• •Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN) or measured or calculated creatinine clearance greater than or equal to 50 mL/min for subject with creatinine levels greater than 1.5 x institutional ULN; (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) (creatinine clearance should be calculated per institutional standard)
• •Total bilirubin less than or equal to 1.5 x ULN
• •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x ULN
• •Alkaline phosphatase less than or equal to 2.5 x ULN
• •International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) less than or equal to 1.5 x ULN, unless patient is receiving anticoagulant therapy as long as PT or INR is within therapeutic range of intended use of anticoagulants
• •Neuropathy (sensory and motor) less than or equal to grade 1
• •Patients must have signed an approved informed consent and authorization permitting release of personal health information
• •Patients must meet pre-entry requirements as specified
• •Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and must agree to ongoing use of 2 methods of study doctor approved birth control or abstain from heterosexual activity for the course of the study from screening through 120 days after the last dose of study medication; patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year
• •Patients cannot be lactating
• •Patients must be able to swallow pills