Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Bayer

Stanford Investigator(s):

Intervention(s):

  • Drug: Mitoxantrone
  • Drug: GM-CSF

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - 75 Years

Genders Eligible for Study

Male

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Denise Haas
6507361252
Not Recruiting