Phase II GM-CSF Plus Mitoxantrone in Hormone Refractory Prostate Cancer

Exclusion Criteria

• •Concomitant hormonal therapy other than luteinizing hormone-releasing hormone (LHRH) agonist
• •Use of herbal products known to decrease PSA levels
• •Use of supplements or complementary medicines, except for:
• •* Conventional multivitamin supplements
• •* Selenium
• •* Lycopene
• •* Soy supplements
• •* Vitamin E
• •Initiation of bisphosphonates within one month prior to enrollment or throughout the study
• •Any prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment
• •Major surgery or radiation therapy completed \< 4 weeks prior to enrollment
• •Any concomitant second malignancy other than non-melanoma skin cancer
• •Any concomitant serious infection
• •Any nonmalignant medical illness
• •Absolute neutrophil count (ANC) \< 1,500/µL
• •Platelet count \< 100,000 µL
• •Hemoglobin \< 8 mg/dL
• •Total bilirubin greater than 1.5 x upper limit of normal (ULN)
• •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 x ULN if no demonstrable liver metastases, or greater than 5.0 x ULN in presence of liver metastases
• •Ejection fraction \< 50% as measured by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
• •Noncompliance with study procedures