Clinical trial NCT00477087: Phase II GM-CSF Plus Mitoxantrone in 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2007-05-22
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This trial evaluates if the addition of GM-CSF to standard-of-care therapy after 1st-line docetaxel improves tumor control and survival. Because the 2 drugs have completely different mechanisms of action as well as non-overlapping metabolism, clinically significant drug-drug interactions are not anticipated, and therefore both drugs will be given at standard (approved) doses.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: 18 months
Secondary outcomes:
measure: Number of Participants With > 50% Decrease in Prostate-specific Antigen Levels (PSA Response)
timeFrame: 18 months
measure: Overall Survival (OS)
timeFrame: 18 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Dr. Sandy Srinivas
role: PRINCIPAL_INVESTIGATOR
References: