Access to stored clinical samples is restricted. Samples will b e stored until requested by a researcher named on the protocol . All requests are monitored an d tracked in LABrador. All researchers are required to sign a form stating that the sample s are only to be used for research purposes associated with this tr ial (as per the IRB approved pr otocol) and that any unused samples must be returned to the BPC. It is the responsibility o f the Principal Investigator to ensure that the samples request ed are being used in a manner co nsistent with IRB approval. Following completion of this stud y, samples will remain in stor age as detailed above. Access to these samples will only be grante d following IRB approval of an additional protocol, granting the rights to use the material. If, at any time, a patient withdr aws from the study and does no t wish for their existing samples to be utilized, the individual must provide a written request. Following receipt of this request, the samples will be destro yed and reported as such to the IRB. Any samples lost (in transit or by a researcher) or destroyed due to unknown sample integrity (i.e. broken freezer allows for extensive sample thawing, etc.) will be reported as such to the IRB. Sample barcodes are linked to pa tient demographics and limited clinical information. This information will only be provided to investigators listed on th is protocol, via registered use of the LABrador. It is critical that th e sample remains linked to pati ent information such as race, age, dates of diagnosis and death, and histological information abou t the tumor, in orde r to correlate genotype with these variables.6 DATA COLLECTION AND EVALUATION DATA COLLECTION The PI will be responsible for overseeing entry of data into an in-house password protected electronic system (C3D), and ensur ing data accuracy, consistency and timeliness. The PI, associate investigat ors/research nurses and/or a contracted dat a manager will assist with the data management efforts. All data obt ained during the conduct of the protocol will be kept in secure network drives or in approved alternative sites that comply with NIH security standards. Primary and final analyzed data will have identifiers so that research data can be attributed to an individual human subject participan t. Data will be entered into the NCI CCR C3D database. All adverse events (AEs), incl uding clinically significant abnor mal findings on laboratory evaluations, regardless of sev erity, will be followed until return to baseline or s tabilization of event. Patients will be followe d for adverse events from the ti me the patient receives the investigational agent/intervention to the time of the second fo llow-up evaluation, or until off- study, whichever comes first. An abnormal laboratory value will be recorded in the database a s an AE only if the laboratory abnormality is characterized by any of the following: xResults in discontinuation from the study Abbreviated Title: Personalized DC Vaccine Version Date: March 26, 2018 27xIs associated with clinical signs or symptoms xRequires treatment or any other therapeutic intervention xIs associated with death or anothe r serious adverse event, incl uding hospitalization. xIs judged by the Investigator to be of significant clinical imp act xIf any abnormal laboratory resu lt is considered clinically sign ificant, the investigator will provide details about the action taken with r espect to the test drug and about the patient’s outcome. All AEs must be recorded on the AE case report form. End of study procedures: Data will be stored according to HHS and FDA regulations, and NIH Intramural Records Retenti on Schedule as applicable. Loss or destruction of data: Should we become aware that a major breach in our plan to prote ct subject confidentiality and trial data has occurred, the IRB wi ll be notified. 6.1.1 Exclusions to Routine Adverse Event RecordingThere are no exclusions to routine adverse event reporting/reco rding for this protocol. DATA SHARING PLANS 6.2.1 Human Data Sharing PlanDe-identified human data genera ted for use in future and ongoin g research will be shared through a NIH-funded or approved r epository (ClinicalTrials.gov ) and BTRIS. At the completion of data analysis, data will be submitted to ClinicalTrials.gov either before publication or at the time of publication or shortly ther eafter. Data may also be use d to support long-term research efforts within the NCI SB and de-identified data may also be sha red with collaborators as specified in protocol 03-C-0277. 6.2.2 Genomic Data Sharing PlanThe NIH Genomic Data Sharing Policy does not apply to this stud y. RESPONSE CRITERIA For the purposes of this study , patients should be re-evaluated for response approximately two weeks following the last vaccination, then one month later x1, and then every 1-2 months for the first year, and then annually or a s clinically indicated. In add ition to a baseline scan, confirmatory scans should also be obtained at least 4 weeks foll owing initial documentation of objective response.Response and progression will be eva luated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid T umors (RECIST) guideline (version 1.1) 18. Changes in the large st diameter (unidimensional measurement) of the tumor lesions and the shortest diameter i n the case of malignant lymp h nodes are used in the RECIST criteria. 6.3.1 DefinitionsEvaluable for toxicity: All patie nts will be evalu able for toxic ity from the time of their first treatment with peptide load ed dendritic ce ll vaccine. Abbreviated Title: Personalized DC Vaccine Version Date: March 26, 2018 28Evaluable for objective response: Only those patients who have m easurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patie nts will have their response classified according to the definitions sta ted below. (Note : Patients who exhibit objective disease progression prior to the end of c ycle 1 will also be considered evaluable.) Evaluable Non-Target Disease Re sponse: Patients who have lesions present at baseline that are evaluable but do not meet the defi nitions of measurable disease , have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for non-target disease. The response assessmen t is based on the p resence, abse nce, or unequivocal progression of the lesions. 6.3.2 Disease Parameters Measurable disease: Measurable lesions are defined as those tha t can be accurately measured in at least one dimension (longest diameter to be recorded) as: xBy chest x-ray: 20 mm; xBy CT scan: oScan slice thickness 5 mm or under: 10 mm oScan slice thickness > 5 mm: double the slice thickness xWith calipers on clinical exam: 10 mm. All tumor measurements must be recorded in millimeters (or decim al fractions of centimeters). Note: Tumor lesions that are situated i n a previously irradiated area might or might not be considered measurable. If the investigator thinks it appropriate to include them, the conditions under which such lesions should be considered must be defined in the protocol. Malignant lymph nodes: To be considered pathologically enlarged and measurable, a lymph node must be >15 mm in short axis when assessed by CT scan (CT scan slice thickness recommended to be no greater tha n 5 mm). At baseline and in fol low-up, only the short axis will be measured and followed. Non-measurable disease: All other lesions (or sites of disease), including small lesions (longest GLDPHWHU PPRUSDWKRORJL FDOO\PSKQRGHVZLWKWR PP VKRUWD[LV DUHFRQVLGHUHG non-measurable disease. Bone lesions, leptomeningeal disease, a scites, pleural/pericardial effusions, lymphangitis cutis/pulmonitis, inflammatory breast d isease, and abdominal masses (not followed by CT or MRI), are considered as non-measurable. Target lesions: All measurab le lesions up to a maximum of 2 les ions per organ and 5 lesions in total, representa tive of all involved or gans, should be identif ied as target lesions and recorded and measured at baseline. Tar get lesions should be selected on the basis of their size (lesions with the longest diameter), be r epresentative of all involved o rgans, but in addition should be those that lend themselves to r eproducible repeated measurement s. It may be the case that, on occasion, the largest lesion does not lend itself to reproducib le measurement in which circumstance the next l argest lesion which can be measured repr oducibly should be selected. A sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) for all target lesions will be calculated and re ported as the baseline sum dia meters. If lymph nodes are to be included in the sum, then only the short axis is added into the sum. The baseline sum diameters Abbreviated Title: Personalized DC Vaccine Version Date: March 26, 2018 29will be used as reference to further characterize any objective tumor regression in the measurable dimension of the disease. Non-target lesions: All other le sions (or sites of disease) incl uding any measurable lesions over and above the 5 target lesions s hould be identif ied as non-targ et lesions and should also be recorded at baseline. Measureme nts of these lesions are not req uired, but the presence, absence, or in rare cases unequivocal progression of each should be note d throughout follow-up. 6.3.3 Methods for Evaluati on of Measurable Disease All measurements should be take n and recorded i n metric notatio n using a ruler or calipers. All baseline evaluations should be perfo rmed as closely as possible to the beginning of treatment and never more than 4 weeks before t he beginning of the treatment. The same method of assessment a nd the same technique should be used to characterize each identified and reported lesion at baseline and during follow-up . Imaging-based evaluation is preferred to evaluation by clin ical examination unless the lesi on(s) being followed cannot be imaged but are assessable by clinical exam.Clinical lesions: Clinical lesi ons will only be considered measu rable when they are superficial (e.g., skin nodules and palpable lymph nodes) and t10 mm diameter as assessed using calipers (e.g., skin nodules). In the case of skin lesions, documentatio n by color photography, including a ruler to estimate the size of the lesion, is recommended. Conventional CT and MRI: This g uideline has defined measurabili ty of lesions on CT scan based on the assumption that CT slice th ickness is 5 mm or less. If C T scans have slice thickness greater than 5 mm, the minimum si ze for a measurable lesion sho uld be twice the slice thickness. MRI is also acceptable in certai n situations (e.g. for body sca ns). Ideally, the same type of scanner should be used and the image acquisition protocol shoul d be followed as closely as possible to prior scans. Body scans should be performed with br eath-hold scanning techniques, if possible.FDG-PET: While FDG-PET response assessments need additional stud y, it is sometimes reasonable to incorporate the us e of FDG-PET scanning to complem ent CT scanning in assessment of progressi on (particularly possible 'new' disease) . New lesions on the basis of FDG- PET imaging can be identified according to the following algori thm: xNegative FDG-PET at baseline, with a positive FDG-PET at follow -up is a sign of PD based on a new lesion. xNo FDG-PET at baseline and a positiv e FDG-PET at follow-up: If the positive FDG-PET at follow-up corresponds to a new site of disease confirmed by CT, this is PD. If the positive FDG-PET at follow-up is not confirmed as a new site of disease on CT, additional follow-up CT scans are needed to determine if there is truly progression occurring at that site (if so, the date of PD will be the date of the initial abnormal FDG- PET scan). If the positive FDG-PET at follow-up corresponds to a pre-existing site of disease on CT that is not progre ssing on the basis of the anato mic images, this is not PD. xFDG-PET may be used to upgrade a r esponse to a CR in a manner similar to a biopsy in cases where a residual radiographic abnormality is thought to r epresent fibrosis or scarring. The use of FDG-PET i n this circumstance should be pro spectively described in the protocol and supported by dise ase-specific medical literature for the indication. Abbreviated Title: Personalized DC Vaccine Version Date: March 26, 2018 30However, it must be acknowledge d that both approaches may lead to false positive CR due to limitations of FDG-PET and bi opsy resolution/sensitivity . Note : A ‘positive’ FDG-PET scan lesion means one which is FDG avid with an uptake greater than twice that of the surroundi ng tissue on the attenuation co rrected image. 6.3.4 Response Criteria Evaluation of Target Lesions Complete Response (CR): Disappear ance of all target lesions. An y pathological lymph nodes (whether target or non-target) m ust have reduction in short axi s to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At leas t a 20% increase in the sum of the diameters of target lesions, taking as reference the smalle st sum on study (this includes th e baseline sum if that is the smallest on study). In addition to t he relative increase of 20% , the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither su fficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. Evaluation of Non-Target Lesions Complete Response (CR): Disappearan ce of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). Note: If tumor markers are in itially above the upper normal lim it, they must normalize for a patient to be considered in c omplete clinical response. Non-CR/Non-PD: Persis tence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Progressive Disease (PD): Appearance of one or more new lesions a nd/or unequivocal progression of existing non-target lesions. Unequivocal progres sion should not normally trump target lesion status. It must b e representative of overall dise ase status change, not a single lesion increase.Although a clear progression of “ non-target” lesions only is exc eptional, the opinion of the treating physician should prevail in such circumstances, and th e progression status should be confirmed at a later time by the review panel (or PI). Evaluation of Best Overall Response The best overall response is the best response recorded from th e start of the treatment until disease progression/recurrence (taking as reference for progres sive disease the smallest measurements recorded since the treatment start ed). The patient 's best response assignment will depend on the achievement of both m easurement and confirmation criteria. For Patients with Measurable Disease (i.e., Target Disease) Abbreviated Title: Personalized DC Vaccine Version Date: March 26, 2018 31Target LesionsNon-Target LesionsNew LesionsOverall ResponseBest Overall Response when Confirmation is Required* CR CR No CR >4 wks. Confirmation** CR Non-CR/Non-PD No PR >4 wks.