Phase II GM-CSF Plus Mitoxantrone in Hormone Refractory Prostate Cancer
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Intervention: Mitoxantrone; GM-CSF
Intervention description: Mitoxantrone is an anti-cancer chemotherapy drug that is classified as an antitumor antibiotic.; GM-CSF is a biologic response modifier, classified as a colony stimulating factor.
Intervention MeSH terms: Molgramostim; Mitoxantrone; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

Eligibility 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