Malignant tumor
Conditions
Interventions
All patients are intradermally injected 5-7 times with dendritic cells in close proximity to the axial and/or inguinal lymph nodes. Injections are repeated every 14-21 days.
Sponsors
Medical Corporation Isokai Seren Clinic Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patient must suffice the following conditions: 1. Either in the post-curative operation status or post-complete remission status, but is predicted at a certain rate for recurrence, and desires to receive the dendritic cell-based immunotherapy as a recurrence prevention measure. 2. Standard therapies including surgery, chemotherapy, and radiation therapies are not effective, or for whom relapse is a strong concern during or after standard treatments. A patient with recurrent, unresectable, and metastatic disease is also included. 3. An expected prognosis of more than 4 months and likely to complete the 5 - 7 administrations. (2) The expression of cancer antigen to be used in the therapy has been confirmed with tumor markers or through other methods, such as RT-PCR or immunostaining, or has a type of cancer already verified of its expression in literature. (3) With a lesion on which assessment is available. (4) Performance status is 0-1. (5) Not under any other clinical studies or trials. (6) No serious vital organ dysfunction, infections, hematological disorder, or bleeding tendency. (7) Has a sufficiently functioning cardiovascular system to undergo apheresis to extract peripheral blood mononuclear cells. (8) Fully understands the given explanations concerning this therapy and consents to it. (9) Other inclusion criteria are as follows: White blood cell count of 2,000 cells/uL or higher Hemoglobin level of 9.0 g/dL or higher Platelet count of 80,000 counts/uL or higher Systolic blood pressure: 90 mm Hg or higher, and lower 180 mm Hg Temperature: 38.0 degree or less (10) HTLV-1-negative or HIV-negative.
Exclusion criteria
Exclusion criteria: The patients have been (1) Diagnosed or suspected of myelodysplastic syndrome (MDS). (2) Suspected of other severe clinical conditions or abnormal laboratory values. (3) Diagnosed or suspected of a mental disorder or mental symptoms. (4) Suspected of immunodeficiency and/or infection. Other exclusion criteria are as follows: (5) Pregnant, lactating or suspected of pregnancy. (6) Female patient rejecting to give consent to contraception during the therapy and for 70 days after the completion of the final administration. (7) Taking in adrenocortical steroid (at the equivalent of 10mg predonine or prednisolone per day). (8) Unsuitable for the therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety:Adverse event | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunological responses Overall survival Response of tumor-related markers | — |
Countries
Japan
Contacts
Public ContactKentaro Kawakami
Medical Corporation Isokai Seren Clinic Tokyo Purser department
Outcome results
None listed