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