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

• Status: Terminated
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

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: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Bayer
• Treatments: Hormones; Mitoxantrone; Molgramostim; Sargramostim

Criteria

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