Malignancy
Conditions
Interventions
Dendritic cell vaccine therapy A vaccine of 10000000 dendritic cells per injection is transfused intradermally around the regional lymph node. The vaccine is injected intradermally every other week 1
Sponsors
Matsumoto Dental University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with cancer intractable to standard therapies, including surgery, radiotherapy, and chemotherapy. 2) Patients with progressive cancer (stage III or IV) representing metastasis. 3) Patients with recurrent cancer after the completion of standard therapy. 4) Patients with cancer at high risk of relapse, who hope for the combined use of dendritic cell therapy as a standard therapy. 5) Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2. 6) Patients without severe organ dysfunction, infection, dysemia, and a bleeding tendency. 7) Patients without cardiovascular disorders, who can tolerate blood component collection (apheresis) to collect peripheral blood mononuclear cells. 8) An excised tumor sample large enough to prepare a tumor cell lysate in order to conduct autologous dendritic cell therapy for cancer. 9) Informed consent to conduct this therapy as a medical treatment at the patient's own expense.
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women 2) &#8805;100 IU/l ALT or AST before the start of therapy 3) <50,000 platelet count 4) Allergy to penicillin or picibanil 5) Patients judged ineligible for the therapy by an attending physician 6) Juveniles 7) Adults with impaired judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The size of a measurable lesion is determined before and after therapy using various diagnostic imaging methods, such as CT, MRI, US, and PET. The sum of the longest diameters is calculated and evaluated based on the RECIST guideline as follows: - Complete Response (CR): Disappearance (confirmed at 4 weeks) - Partial Response (PR): &#8805;30% reduction (confirmed at 4 weeks) - Stable Disease (discontinuation of disease progression): Neither PR nor PD criteria are met. - Progressive Disease (PD): &#8805;20% increase (not diagnosed as CR, PR, or SD before the increase of a lesion) | — |
Countries
Japan
Contacts
Public ContactMegumi Tanaka
Matsumoto Dental University Matsumoto Dental University Hospital
Outcome results
None listed