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

This trial evaluates if the addition of GM-CSF to standard-of-care therapy after 1st-line
docetaxel improves tumor control and survival. Because the 2 drugs have completely different
mechanisms of action as well as non-overlapping metabolism, clinically significant drug-drug
interactions are not anticipated, and therefore both drugs will be given at standard
(approved) doses.

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