Progressive hormone-refractory prostate cancer
Conditions
Interventions
Combination of the peptides and dexamethasone: Maximum of four kinds of peptide from those that have been recognized by the patient-specific immune system (serum IgG antibodies) or by the killer T-ce
Sponsors
Department of Urology, Kinki University School of Medicine
Jikei University School of Medicine Osaka University, Graduate school of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Eligible patients must meet the following criteria: 1. Hormone-refractory prostate cancer patients who have been histologically diagnosed as prostate adenocarcinoma. Hormone-refractory prostate cancer is defined as the disease that has progressed after remission by primary hormone therapy with antiandrogens and surgical or medical castration. Patients should have at least one measurable lesion 2 cm or larger by X-ray or should have consecutively-rising PSA detected three or more times by at least two-week interval evaluation after reaching the nadir by primary hormone therapy. Antiandrogen-withdrawal syndrome should be ruled out by ceasing the antiandrogen for at least six weeks. LH-RH agonist (leuprolide acetate, Leuplin) administration should be continued to maintain serum testosterone within castration levels when surgical castration has not been performed. 2. Patients are positive for HLA-A2, HLA-A24, or HLA-A3 super types (A3, A11, A31, A33). 3. Patients who have IgG or killer T-cell precursor that respond to one or more peptides prepared as candidate vaccines in the peripheral blood before vaccine administration. 4. No adverse effects or events occurring as a resulted from prior treatment should be carried over. Four or more weeks are required to wash out the pretreatment drug. 5. The patients' performance status (ECOG) should be 0 or 1. 6. Expected survival time should be three months or greater. 7. Serum PSA less than 10.0ng/ml 8. Written consent of participation after thorough explanation regarding this trial is required.
Exclusion criteria
Exclusion criteria: Any patient who falls under any of the following criteria is excluded as a candidate: 1. Patients who have any severe underlying medical condition such as severe active infection, cardiovascular disease, respiratory disease, renal dysfunction, immune dysfunction, blood coagulation disorder and so on. 2. Active double cancer. 3. Past history of severe allergic disease. 4. Patients previously treated with an adrenocortical steroid such as dexamethasone. Temporary use of a steroid against a non-prostate cancer related diseases, for example allergies, are not excluded. 5. Patients previously treated with systemic chemotherapy including Docetaxel and Cisplatin or radiotherapy against non-primary disease. 6. Hepatitis type B or C should be excluded. 7. Any patients disqualified by a study physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival Objective response rate Disease control rate Safety profile Evaluation will be performed on each evaluable lesion according to The Prostate Cancer Treatment Agreement in Japan (3rd edition. April, 2001). When the patient does not have measurable lesions, the serum PSA level will be assessed in accordance with Bubley's criteria. The initial evaluation will be performed 12 weeks after the initiation of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune response: Induction of cytotoxic T-lymphocytes and CTL-precursor cells. Induction of the anti-peptide antibodies. Immune response will be assessed by comparing the data from samples obtained before and after therapy administration. QOL score | — |
Countries
Japan
Contacts
Public ContactHirotsugu Uemura
Kinki University School of Medicine Department of Urology
Outcome results
None listed