Phase II GM-CSF Plus Mitoxantrone in Hormone Refractory Prostate Cancer
Stopped early · Phase 2
Conditions studied: Prostatic Neoplasms
In brief
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.
Key facts
- Study ID
- NCT00477087
- Run by
- Stanford University
- People needed
- 10
- Starts
- 2006-07-01
- Expected to finish
- 2010-01-01
- Last updated by the study team
- 2017-11-29
Who can join
Age: 18 and older, up to 75. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Stanford University School of Medicine — Stanford, California, United States
Full record on ClinicalTrials.gov
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