Autologous Dendritic Cells Loaded with Allogenic Tumor Lysate for Surgically Resected Pancreatic Cancer Patients (REACtiVe Trial)
- Conditions
- pancreatic cancerpancreatic ductal adenocarcinoma1001567410017991
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 10
* Surgically resected pancreatic cancer.
* Completed post-operative standard treatment. Patients who did not complete standard of care due to toxicity or who are not able to start standard of care due to specific reasons are allowed to participate in the study after approval of the coordinating investigator.
* No disease activity as 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) and in stable medical condition.
* Patients must have normal organ function and adequate bone marrow reserve: absolute neutrophil count > 1.0 x 10E9/l, platelet count > 100 x 10E9/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 (see section 8.3 for DTH skin test procedure).
* Ability to return to the hospital for adequate follow-up as required by this protocol.
* Written informed consent according to ICH-GCP.
* Medical or psychological impediment to probable compliance with the protocol.
* Current or previous treatment with immunotherapeutic agents.
* Current use of steroids (or other immunosuppressive agents). Patients must have had 6 weeks of discontinuation and must stop any such treatment during the time of the study. Prophylactic usage of dexamethasone during chemotherapy is excluded from this 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 disease (asthma or COPD), cardiac disease (NYHA class III or IV), 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 keyhole limpet hemocyanin (KLH).
* Pregnant or lactating women.
* Inadequate peripheral vein access to perform leukapheresis.
* Concomitant participation in another clinical trial (except participation in a biobank study).
* An organic brain syndrome or other significant psychiatric abnormality which would compromise 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>The primary endpoint of this project proposal is to determine the feasibility<br /><br>of administering MesoPher after standard of care adjuvant therapy in patients<br /><br>with resected pancreatic cancer. We deem this treatment feasible in case 6 out<br /><br>of 10 patients are able to complete the proposed treatment. </p><br>
- Secondary Outcome Measures
Name Time Method <p>As a secondary endpoint we will assess the safety of MesoPher in surgically<br /><br>resected pancreatic cancer patients.<br /><br><br /><br>In addition, we will determine the systemic immune profile, with emphasis on T<br /><br>lymphocytes, in surgically resected pancreatic cancer patients; and investigate<br /><br>how these immune profiles are affected by MesoPher treatment for individual<br /><br>patients. </p><br>