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

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ClinicalTrials.gov Identifier: NCT00477087
Recruitment Status : Terminated (Low accrual)
First Posted : May 22, 2007
Results First Posted : November 29, 2017
Last Update Posted : November 29, 2017
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Sandy Srinivas, Stanford University

May 18, 2007
May 22, 2007
May 10, 2017
November 29, 2017
November 29, 2017
July 2006
October 2009   (Final data collection date for primary outcome measure)
Progression-free Survival (PFS) [ Time Frame: 18 months ]
Assessed as the time from the 1st dose of study drug to death or disease progression (increase >25% over baseline PSA on 2 consecutive measurements 2 weeks apart, need for palliative therapy, formation/progression of new bone lesions, or decline of >20% KPS)
Time to Progression - 1st study drug dose to observation of disease progression (increase >25% over baseline PSA on 2 consecutive measurements 2 weeks apart, need for palliative therapy, formation/progression of new bone lesions, or decline of >20% KPS) [ Time Frame: two years ]
Complete list of historical versions of study NCT00477087 on ClinicalTrials.gov Archive Site
  • Number of Participants With > 50% Decrease in Prostate-specific Antigen Levels (PSA Response) [ Time Frame: 18 months ]
    Defined as the first evidence of a total serum PSA decline of > 50% from baseline, maintained for at least 28 days, and confirmed with 2 consecutive measurements taken 2 weeks apart.
  • Overall Survival (OS) [ Time Frame: 18 months ]
    Assessed as the time from the 1st dose of study drug to death.
  • PSA response, defined as the first evidence of a total serum PSA decline of >50% from baseline maintained for at least 28 days and confirmed with two consecutive measurements taken two weeks apart [ Time Frame: within the first 3 months ]
  • Time to sustained biochemical response, defined as the time from first administration of drug to first evidence of sustained response [ Time Frame: two years ]
  • Duration of sustained response, defined as time from PSA decrease of >50% from baseline to the first evidence of disease progression [ Time Frame: two years ]
  • Overall survival [ Time Frame: two years ]
Not Provided
Not Provided
 
Phase II GM-CSF Plus Mitoxantrone in Hormone Refractory Prostate Cancer
Phase II Study of Granulocyte-Macrophage Colony Stimulating Factor Plus Mitoxantrone for the Treatment of 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.
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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostatic Neoplasms
  • Drug: Mitoxantrone
    Mitoxantrone is an anti-cancer chemotherapy drug that is classified as an antitumor antibiotic.
    Other Name: Novantrone
  • Drug: GM-CSF
    GM-CSF is a biologic response modifier, classified as a colony stimulating factor.
    Other Names:
    • Sargramostim
    • Leukine
    • Granulocyte-Macrophage Colony Stimulating Factor
Experimental: GM-CSF Plus Mitoxantrone
GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days.
Interventions:
  • Drug: Mitoxantrone
  • Drug: GM-CSF
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
20
January 2010
October 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: males (prostate cancer)
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00477087
IRB-04738
96817 ( Other Identifier: Stanford University alternate IRB Number )
PROS0017 ( Other Identifier: OnCore Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: No
Sandy Srinivas, Stanford University
Stanford University
Bayer
Principal Investigator: Dr. Sandy Srinivas Stanford University
Stanford University
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP