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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01184 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 250813 | Other Identifier | Roswell Park Cancer Institute |
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| Name | Class |
|---|---|
| Active Biotech AB | INDUSTRY |
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This randomized phase II trial studies how well sipuleucel-T with or without tasquinimod works in treating patients with hormone-resistant prostate cancer that has spread to other parts of the body. Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Tasquinimod may stop the growth of prostate cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether sipuleucel-T is more effective with or without tasquinimod in treating prostate cancer.
PRIMARY OBJECTIVES:
I. To determine whether tasquinimod augments immune response to sipuleucel-T.
SECONDARY OBJECTIVES:
I. To assess the safety and tolerability of the combination of sipuleucel-T and tasquinimod in patients with castration-resistant metastatic prostate cancer.
II. To obtain preliminary evidence of the clinical benefit of the combination of sipuleucel-T and tasquinimod; to include changes in prostate specific antigen (PSA) over time, and duration of progression-free survival/overall survival.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive sipuleucel-T intravenously (IV) over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive tasquinimod orally (PO) once daily (QD) beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.
After completion of study treatment, patients are followed up every 3 months for up to 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (sipuleucel-T) | Experimental | Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. |
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| Arm II (tasquinimod, sipuleucel-T) | Experimental | Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Immune Response Assessed by IFN-g ELISPOT Specific for PA2024 | Baseline up to 50 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PSA Response | PSA doubling time, PSA slope | Baseline to up to 3 years |
| Duration of PSA Response | Up to 3 years | |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of Tasquinimod on the Inhibition of Immune Cells | Up to week 50 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saby George | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Sipuleucel-T) | Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Sipuleucel-T: Given IV |
| FG001 | Arm II (Tasquinimod, Sipuleucel-T) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Sipuleucel-T | Biological | Given IV |
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| Tasquinimod | Drug | Given PO |
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| Frequency of Toxicities Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 |
The frequency of participants with toxicities will be tabulated by grade across all dose levels and courses. |
| Up to 3 years |
| Immune Response | Week 6 |
| Immune Response | Week 10 |
| Immune Response | Week 26 |
| Immune Response | Week 50 |
| Immune Response (Arm 2 Only) | Week 0 |
| Objective Response Rates (Partial or Complete) | Up to 3 years |
| Overall Survival | Up to 3 years |
| Progression-free Survival | Up to 3 years |
| Time to PSA Progression | Up to 3 years |
Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression. Laboratory Biomarker Analysis: Correlative studies Sipuleucel-T: Given IV Tasquinimod: Given PO |
| COMPLETED |
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| NOT COMPLETED |
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All treated and eligible patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Sipuleucel-T) | Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Sipuleucel-T: Given IV |
| BG001 | Arm II (Tasquinimod, Sipuleucel-T) | Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression. Laboratory Biomarker Analysis: Correlative studies Sipuleucel-T: Given IV Tasquinimod: Given PO |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Change in Immune Response Assessed by IFN-g ELISPOT Specific for PA2024 | Due a Lack of funding data was not collected and no patients were analyzed. | Posted | Baseline up to 50 weeks |
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| Secondary | Change in PSA Response | PSA doubling time, PSA slope | Due a Lack of funding data was not collected and no patients were analyzed. | Posted | Baseline to up to 3 years |
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| Secondary | Duration of PSA Response | Due a Lack of funding data was not collected and no patients were analyzed. | Posted | Up to 3 years |
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| Secondary | Frequency of Toxicities Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 | The frequency of participants with toxicities will be tabulated by grade across all dose levels and courses. | All treated and eligible patients. | Posted | Number | participants | Up to 3 years |
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| Secondary | Immune Response | Due a Lack of funding data was not collected and no patients were analyzed. | Posted | Week 6 |
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| Secondary | Immune Response | Due a Lack of funding data was not collected and no patients were analyzed. | Posted | Week 10 |
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| Secondary | Immune Response | Due a Lack of funding data was not collected and no patients were analyzed. | Posted | Week 26 |
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| Secondary | Immune Response | Due a Lack of funding data was not collected and no patients were analyzed. | Posted | Week 50 |
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| Secondary | Immune Response (Arm 2 Only) | Due a Lack of funding data was not collected and no patients were analyzed. | Posted | Week 0 |
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| Secondary | Objective Response Rates (Partial or Complete) | Due a Lack of funding data was not collected and no patients were analyzed. | Posted | Up to 3 years |
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| Secondary | Overall Survival | Due a Lack of funding data was not collected and no patients were analyzed. | Posted | Up to 3 years |
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| Secondary | Progression-free Survival | Due a Lack of funding data was not collected and no patients were analyzed. | Posted | Up to 3 years |
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| Secondary | Time to PSA Progression | Due a Lack of funding data was not collected and no patients were analyzed. | Posted | Up to 3 years |
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| Other Pre-specified | Effects of Tasquinimod on the Inhibition of Immune Cells | Due a Lack of funding data was not collected and no patients were analyzed. | Posted | Up to week 50 |
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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 | Arm I (Sipuleucel-T) | Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Sipuleucel-T: Given IV | 0 | 0 | 0 | 0 | ||
| EG001 | Arm II (Tasquinimod, Sipuleucel-T) | Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression. Laboratory Biomarker Analysis: Correlative studies Sipuleucel-T: Given IV Tasquinimod: Given PO | 1 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Malaise | General disorders | Systematic Assessment |
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| Weight decreased | Investigations | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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Due to the study's early closure, as a result of lack of funding, target accrual was not reached and no statistical inference of the primary and secondary aims were carried forth.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Administrator, Compliance - Clinical Research Services | Roswell Park Cancer Institute | 716-845-2300 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C511774 | sipuleucel-T |
| C516109 | tasquinimod |
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| >=65 years |
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