Autologous Dendritic Cells Loaded with Allogenic Tumor Lysate for Surgically Resected Pancreatic Cancer Patients (REACtiVe Trial)<br>

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 26

Inclusion Criteria

* Surgically resected pancreatic cancer
* Completed post-operative standard treatment
* No disease activity assessed by radiological imaging
* Patients must be at least 18 years old and must be able to give written informed consent.
* Patients must be ambulatory (WHO-ECOG performance status 0,1, or 2)
* Patients must have normal organ function and adequate bone marrow reserve: absolute neutrophil count > 1.0 x 109/l, platelet count > 100 x 109/l, and Hb > 6.0 mmol/l. (as determined during screening)
* Positive DTH skin test (induration > 2mm after 48 hrs) against at least one positive control antigen tetanus toxoid.
* Ability to return to the hospital for adequate follow-up as required by this protocol.
* Written informed consent according to ICH-GCP

Exclusion Criteria

* Medical or psychological impediment to probable compliance with the protocol.
* Previous or current treatment with immunotherapeutic agents..
* Current use of steroids (or other immunosuppressive agents). Patients must have had 6 weeks of discontinuation and must stop of any such treatment during the time of the study. Prophylactic usage of dexamethasone during chemotherapy is excluded from that 6 weeks interval
* Prior malignancy except adequately treated basal cell or squamous cell skin cancer, superficial or in-situ cancer of the bladder or other cancer for which the patient has been disease-free for five years.
* Serious concomitant disease, or active infections.
* History of autoimmune disease or organ allografts, or with active acute or chronic infection, including HIV and viral hepatitis.
* Serious intercurrent chronic or acute illness such as pulmonary (asthma or COPD) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the study coordinator to constitute an unwarranted high risk for investigational DC treatment.
* Known allergy to shell fish (may contain KLH).
* Pregnant or lactating women.
* Inadequate peripheral vein access to perform leukapheresis
* Concomitant participation in another clinical trial
* An organic brain syndrome or other significant psychiatric abnormality which would comprise the ability to give informed consent, and preclude participation in the full protocol and follow-up.
* Absence of assurance of compliance with the protocol. Lack of availability for follow-up assessment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the feasibility of the treatment procedure and determine the<br /><br>establishment of an immune response against mesothelin (TAA*s) in resected<br /><br>pancreatic cancer patients receiving MesoPher with or without concurrent<br /><br>low-dose gemcitabine.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To determine the systemic immune profile, with emphasis on T lymphocytes, in<br /><br>surgically resected pancreatic cancer patients; and investigate how these<br /><br>immune profiles are affected by MesoPher with or without concurrent low-dose<br /><br>gemcitabine for individual patients.<br /><br><br /><br>Study the safety, clinical response and survival of MesoPher with or without<br /><br>the addition of low-dose chemotherapy in surgically resected pancreatic cancer<br /><br>patients.</p><br>

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