Phase II GM-CSF Plus Mitoxantrone in Hormone Refractory Prostate Cancer
Trial ID or NCT#
The purpose of this study is to evaluate the effect of the combination of mitoxantrone and granulocyte-macrophage colony stimulating factor (GM-CSF) on progression-free survival (PFS) and overall survival (OS), in patients with hormone-refractory prostate cancer.
Phase II Study of Granulocyte-Macrophage Colony Stimulating Factor Plus Mitoxantrone for the Treatment of Hormone Refractory Prostate Cancer
- - 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
- - 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
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