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| ID | Type | Description | Link |
|---|---|---|---|
| 96817 | Other Identifier | Stanford University alternate IRB Number | |
| PROS0017 | Other Identifier | OnCore Number |
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Low accrual
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GM-CSF Plus Mitoxantrone | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitoxantrone | Drug | Mitoxantrone is an anti-cancer chemotherapy drug that is classified as an antitumor antibiotic. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 18 months |
| Overall Survival (OS) |
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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:
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:
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
males (prostate cancer)
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Sandy Srinivas | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Median | Full Range | weeks | 18 months |
|
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematuria | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandy Srinivas, MD; Professor of Medicine (Oncology) | Stanford University Medical Center | 650-725-2078 | sandysri@stanford.edu |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008942 | Mitoxantrone |
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| C081222 | sargramostim |
| D003115 | Colony-Stimulating Factors |
| ID | Term |
|---|---|
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| GM-CSF | Drug | GM-CSF is a biologic response modifier, classified as a colony stimulating factor. |
|
|
Assessed as the time from the 1st dose of study drug to death. |
| 18 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 18 months |
|
|
|
| Secondary | Overall Survival (OS) | Assessed as the time from the 1st dose of study drug to death. | Posted | Median | Full Range | Months | 18 months |
|
|
|
| 4 |
| 10 |
| 10 |
| 10 |
| Pancytopenic | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Progressive disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Non-systematic Assessment | Death due to progressive disease |
|
| Acute renal failure | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Diarrhea | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dizziness | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Chest pain | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dyspnea | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Night sweats | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Weight gain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |