Education and Training
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.
Stanford Investigator(s):
Intervention(s):
- drug: Mitoxantrone
- drug: GM-CSF
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