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

NCT ID: NCT00477087

Last Updated: 2017-11-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2010-01-31

Brief Summary

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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

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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.

Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

GM-CSF

Intervention Type DRUG

GM-CSF is a biologic response modifier, classified as a colony stimulating factor.

Mitoxantrone

Intervention Type DRUG

Mitoxantrone is an anti-cancer chemotherapy drug that is classified as an antitumor antibiotic.

Interventions

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GM-CSF

GM-CSF is a biologic response modifier, classified as a colony stimulating factor.

Intervention Type DRUG

Mitoxantrone

Mitoxantrone is an anti-cancer chemotherapy drug that is classified as an antitumor antibiotic.

Intervention Type DRUG

Other Intervention Names

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Novantrone Sargramostim Leukine Granulocyte-Macrophage Colony Stimulating Factor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Sandy Srinivas

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. Sandy Srinivas

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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96817

Identifier Type: OTHER

Identifier Source: secondary_id

PROS0017

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-04738

Identifier Type: -

Identifier Source: org_study_id