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

This study has been terminated.
(Low accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00477087
First Posted: May 22, 2007
Last Update Posted: November 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bayer
Information provided by (Responsible Party):
Sandy Srinivas, Stanford University
  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.

Condition Intervention Phase
Prostatic Neoplasms Drug: Mitoxantrone Drug: GM-CSF Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Granulocyte-Macrophage Colony Stimulating Factor Plus Mitoxantrone for the Treatment of Hormone Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Sandy Srinivas, Stanford University:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.


Enrollment: 10
Study Start Date: July 2006
Study Completion Date: January 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   males (prostate cancer)
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00477087


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Bayer
Investigators
Principal Investigator: Dr. Sandy Srinivas Stanford University
  More Information

Responsible Party: Sandy Srinivas, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00477087     History of Changes
Other Study ID Numbers: IRB-04738
96817 ( Other Identifier: Stanford University alternate IRB Number )
PROS0017 ( Other Identifier: OnCore Number )
First Submitted: May 18, 2007
First Posted: May 22, 2007
Results First Submitted: May 10, 2017
Results First Posted: November 29, 2017
Last Update Posted: November 29, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Mitoxantrone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action