Vaccine Therapy With or Without Docetaxel in Treating Patients With Metastatic Prostate Cancer
Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of androgen-independent metastatic adenocarcinoma of the prostate, confirmed by 1 of the following: Histologically confirmed disease Pathologically documented disease and clinical course consistent with prostate cancer Castrate levels of testosterone with progressive disease by at least 1 of the following parameters: 2 consecutively rising prostate-specific antigen levels, separated by at least 1 week, with at least 1 measurement that is 50% above the nadir reached after the last therapeutic maneuver (must be at least 5 ng/mL) At least 1 new metastatic deposit on technetium Tc 99 bone scintigraphy Progression of soft-tissue metastases by imaging or palpation, as indicated by: Development of new area of malignant disease At least 20% increase in sum of the longest dimension of target lesions Serum testosterone less than 50 ng/dL if no prior surgical castration Luteinizing hormone-releasing hormone therapy must continue HLA-A2 positive No brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy More than 6 months Hematopoietic Granulocyte count at least 1,500/mm^3 Lymphocyte count at least 500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin less than 1.5 mg/dL AST and ALT less than 2.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN OR Hepatic alkaline phosphatase fraction less than 2.5 times ULN Renal Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 40 mL/min Proteinuria grade 0-1 OR Protein less than 1,000 mg by 24-hour urine collection No hematuria No abnormal sediment unless non-renal Cardiovascular No unstable or newly diagnosed angina pectoris No myocardial infarction within the past 6 months No New York Heart Association class II-IV congestive heart failure No concurrent clinically significant cardiomyopathy requiring treatment Immunologic No prior allergy or untoward reaction to vaccinia virus vaccination No altered immune function, including: Eczema Atopic dermatitis HIV Autoimmune disease Autoimmune neutropenia Thrombocytopenia Hemolytic anemia Systemic lupus erythematosus Sjogren's syndrome Scleroderma Myasthenia gravis Goodpasture syndrome Addison's disease Hashimoto's thyroiditis Active Graves' disease Multiple sclerosis No extensive psoriasis, severe acneiform rash, impetigo, varicella zoster, burns, or other traumatic or pruritic skin condition No known allergy to eggs Other No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the bladder No other life-threatening or serious illness No unhealed surgical scars No household or close physical contact with persons with any of the following conditions during or for 2 weeks after study treatment: Eczema or eczematoid skin disorders Acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) Pregnant or nursing women Children under 5 years of age Immunodeficient or immunosuppressed (including HIV positive) individuals No history of seizures or encephalitis PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior taxanes for metastatic prostate cancer Endocrine therapy See Disease Characteristics At least 4 weeks since prior flutamide At least 6 weeks since prior bicalutamide or nilutamide No concurrent steroids except topical steroids, inhaled steroids for mild or moderate asthma, or decadron as premedication for chemotherapy Radiotherapy Not specified Surgery See Disease Characteristics No prior splenectomy Other Recovered from prior therapy
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support