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

Primary Purpose

Prostatic Neoplasms

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mitoxantrone
GM-CSF
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GM-CSF Plus Mitoxantrone

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)
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)
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)
Assessed as the time from the 1st dose of study drug to death.

Full Information

First Posted
May 18, 2007
Last Updated
October 23, 2017
Sponsor
Stanford University
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00477087
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Low accrual
Study Start Date
July 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Bayer

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GM-CSF Plus Mitoxantrone
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Mitoxantrone
Other Intervention Name(s)
Novantrone
Intervention Description
Mitoxantrone is an anti-cancer chemotherapy drug that is classified as an antitumor antibiotic.
Intervention Type
Drug
Intervention Name(s)
GM-CSF
Other Intervention Name(s)
Sargramostim, Leukine, Granulocyte-Macrophage Colony Stimulating Factor
Intervention Description
GM-CSF is a biologic response modifier, classified as a colony stimulating factor.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
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 Frame
18 months
Secondary Outcome Measure Information:
Title
Number of Participants With > 50% Decrease in Prostate-specific Antigen Levels (PSA Response)
Description
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.
Time Frame
18 months
Title
Overall Survival (OS)
Description
Assessed as the time from the 1st dose of study drug to death.
Time Frame
18 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
males (prostate cancer)
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Sandy Srinivas
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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