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