Safety and Effectiveness of a Vaccine for Prostate Cancer That Uses Each Patients' Own Immune Cells.
Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria: Disease Characteristics Histologically confirmed prostate carcinoma Progressive, disease required, i.e.: elevated PSA documented to be rising on 3 occasions, either despite castrate testosterone levels (below 50 ng/dl), or after definitive local therapy (prostatectomy or radiation). Prior/Concurrent Therapy -Biologic therapy: Recovered from toxicity of any prior therapy -Chemotherapy: At least 4 weeks since chemotherapy -Endocrine evaluation/therapy 3 rising PSA values at least 2 weeks apart At least 2 weeks since concurrent corticosteroids (other than for replacement therapy for adrenal insufficiency) Medical hormonal therapy to maintain castrate testosterone levels permitted -Radiotherapy: At least 4 weeks since radiotherapy -Surgery: Prior surgery allowed Patient Characteristics Age: 18 and over, able to give written informed consent. Individuals unable to provide informed consent must have consent provided by the legal guardian, or person designated by the subject to give consent on his behalf. Performance status: Karnofsky 70-100% Life expectancy: At least 1 year Hematopoietic: obtained twice, once within 45 days prior to study entry, and again within 72 hours of study entry. WBC greater than 3,800 Absolute neutrophils greater than 1,500 Absolute lymphocytes greater than 500 Platelets greater than 120,000 Hb at least 10 g/dl Hepatic: --Bilirubin less than 2.0 mg/dl OR --SGOT less than 2 x ULN Renal: Creatinine no greater than 2.0 mg/dl OR Creatinine clearance at least 40 ml/min Rheumatologic: --ANA no greater than upper limit of normal, or ANA abnormal in absence of clinical signs of autoimmunity. Rheumatoid factor (RF) no greater than upper limit of normal, or RF abnormal in absence of clinical signs of autoimmunity. Anti-ds DNA no greater than upper limit of normal, or anti ds DNA abnormal in absence of clinical signs of autoimmunity. Immunologic: Influenza serology (assessment made at time of screening). Assessment of DTH response to a standard anergy panel (to include candida, trichophyton and tetanus) or to a Multitest CMI (a disposable kit for DTH testing with standardized preloaded antigens). Endocrine: --TSH, T3, and T4 no greater than upper limit of normal Radiographic: Baseline bone scan Baseline CT or MRI of abdomen and pelvis Exclusion Criteria: Disease Characteristics -No active CNS metastases Prior/Concurrent Therapy Biologic therapy: No prior autologous or allogeneic tumor vaccines No concurrent other immunotherapy Chemotherapy --Not previously treated with more than 2 chemotherapy regimens No concurrent chemotherapy Radiotherapy --No concurrent radiotherapy Patient Characteristics -Cardiovascular: No NYHA class III/IV status No active angina, clinically significant cardiac arrythmia, recent (6 months) myocardial infarction Pulmonary: --No severe debilitating pulmonary disease Other: No active infection requiring antibiotics No active pain requiring chronic opioid analgesics. Not HIV, hepatitis B or hepatitis C virus positive; anti-HIV, HbsAg and Hep C antibody negative No history of hypersensitivity to vaccine components No serious uncontrolled medical illness No currently active second malignancy other than non-melanoma skin cancer (note: a patient is NOT considered to have currently active malignancy if they have completed therapy and are now considered by their physician to be at less than 30% risk for relapse) No history of total lymph node irradiation No history of vasculitis, including but not limited to systemic necrotizing vasculitides (polyarteritis nodosa group), hypersensitivity vasculitis, Wegener's granulomatosis. No history of autoimmune disease. No use of hydroxyurea within 45 days of study entry No receipt of immune modulators or suppressors within 30 days prior to study entry, including but not limited to interferons and thalidomide. No active requirement for corticosteroids; prior use is acceptable. No psychiatric illness or social condition that, in the opinion of the investigator, would interfere with adherence to study requirements. No alcohol or drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
Sites / Locations
- Rockefeller University Hospital
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
DC/LNCaP
12 patients in the placebo Arm for 8 weeks followed by DC/LNCAP, DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks.
12 patients, receiving DC/LNCaP, DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks