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

Inclusion Criteria:

* Signed written informed consent
* Age ≥ 18 years
* Histologically-confirmed adenocarcinoma of the prostate
* Hormone-refractory prostate cancer
* Failed 1st-line docetaxel-containing regimen
* No prior immunotherapy including:

* Vaccines
* GM-CSF
* Minimum prostate-specific antigen (PSA) \> 5 mg/dL and rising according to the PSA Consensus Criteria
* Karnofsky Performance Status (KPS) \> 60%
* Eastern Cooperative Oncology Group (ECOG) Performance Status \< 3
* Life expectancy \> 6 months

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