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

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.