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

Trial ID or NCT#

NCT00477087

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Phase II Study of Granulocyte-Macrophage Colony Stimulating Factor Plus Mitoxantrone for the Treatment of Hormone Refractory Prostate Cancer

Eligibility Criteria

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  2. * 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:
  1. * 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:
  2. * 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

Investigator(s)

Sandy Srinivas
Sandy Srinivas
Medical oncologist, Urologic specialist, Genitourinary specialist
Professor of Medicine (Oncology) and, by courtesy, of Urology

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Contact

Denise Haas
6507361252