Autologous Dendritic Cells Loaded with Allogenic Tumor Lysate for Surgically Resected Pancreatic Cancer Patients (REACtiVe trial).
- Conditions
- 1001567410017991pancreatic ductal adenocarcinomapancreatic cancer
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 38
• 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.
• Patients who received standard of care post-operative treatment must be
included within six months after completion of treatment. Patients who did not
receive standard of care post-operative treatment must be included within six
months after resection.
• 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).
• Women of childbearing potential must have a negative serum pregnancy test at
screening and a negative urine pregnancy test just prior to the first study
drug administration on Day 1, and must be willing to use an effective
contraceptive method (intrauterine devices, hormonal contraceptives,
contraceptive pill, implants, transdermal patches, hormonal vaginal devices,
infusions with prolonged release) or true abstinence (when this is in line with
the preferred and usual lifestyle)* during the study and for at least 12 months
after the last study drug administration.
*True abstinence is acceptable when this is in line with the preferred and
usual lifestyle of the subject. Periodic abstinence (such as calendar,
ovulation, symptothermal, post-ovulation methods) and withdrawal are not
acceptable methods of contraception.
• Men must be willing to use an effective contraceptive method (e.g. condom,
vasectomy) during the study and for at least 12 months after the last study
drug administration.
• 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 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 8 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.<br /><br><br /><br>W will also look at efficacy of the treatment.</p><br>
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