We hypothesized that mesothelioma lysate–pulsed dendritic cell immunotherapy induces an immune response that is beneficial for pancreatic cancer.
ID
Source
Brief title
Condition
- Exocrine pancreas conditions
Health condition
Pancreatic cancer, alvleesklierkanker, pancreascarcinoom
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main goal of this study is to determine feasibility of MesoPher maintenance therapy in pancreatic cancer patients who underwent a radical tumor resection and received standard of care.
Secondary outcome
Secondary objectives are safety assessment after dendritic cell vaccination and the determination of an immunological response in blood with emphasis on T lymphocytes.
Background summary
The REACtiVe Trial is a single center, phase II study, that will be performed by the Erasmus Medical Center in Rotterdam. The main goal of this study is to determine the feasibility of dendritic cell based immunotherapy after surgery and standard of care for patients diagnosed with pancreatic cancer.
Study objective
We hypothesized that mesothelioma lysate–pulsed dendritic cell immunotherapy induces an immune response that is beneficial for pancreatic cancer.
Study design
The end of the study is defined as the last patient’s last visit.
Intervention
Leukapheresis is performed after which monocytes are used for differentiation to dendritic cells. Pulsed autologous dendritic cells (MesoPher) are re-injected 3 times every 2 weeks. After the 3rd injection with MesoPher, revaccinations to boost the immune system are given after 3 and 6 months.
Judith Verhagen
Dr. Molewaterplein 40, 3015 GD Rotterdam
Judith Verhagen
Dr. Molewaterplein 40, 3015 GD Rotterdam
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Surgically resected pancreatic cancer.
- Completed post-operative standard treatment. Standard of care treatment includes the choice of adjuvant chemotherapy. Patients who did not complete adjuvant chemotherapy 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 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 (see section 8.3 for DTH skin test procedure).
- 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, postovulation 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.
- Ability to return to the hospital for adequate follow-up as required by this protocol.
- Written informed consent according to ICH-GCP.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- 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 intervention 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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7432 |
| NTR-old | NTR7674 |
| CCMO | NL67169.000.18 |
| OMON | NL-OMON52670 |