Sipuleucel-T With or Without Tasquinimod in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

• Sponsor: Roswell Park Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02159950
• Collaborator: National Cancer Institute (NCI) (NIH), Active Biotech AB (Industry)
• Enrollment: 2
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hormone-Resistant Prostate Cancer; Metastatic Prostate Carcinoma; Recurrent Prostate Carcinoma; Stage IV Prostate Cancer	Other: Laboratory Biomarker Analysis; Biological: Sipuleucel-T; Drug: Tasquinimod	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. To determine whether tasquinimod augments immune response to sipuleucel-T.

SECONDARY OBJECTIVES:

1. To assess the safety and tolerability of the combination of sipuleucel-T and tasquinimod in patients with castration-resistant metastatic prostate cancer.

2. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Randomized Open Label Study of Sipuleucel-T vs. Sipuleucel-T and Tasquinimod in Patients With Metastatic Castrate-Resistant Prostate Cancer (CRPC)
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Biological: Sipuleucel-T; Given IV; Other Names: APC8015 APC8015 Vaccine PA2024 (PAP/GM-CSF)-Loaded Dendritic Cell Vaccine Provenge
Experimental: 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Biological: Sipuleucel-T; Given IV; Other Names: APC8015 APC8015 Vaccine PA2024 (PAP/GM-CSF)-Loaded Dendritic Cell Vaccine Provenge ; Drug: Tasquinimod; Given PO; Other Names: ABR-215050 TASQ

Outcome Measures

Primary Outcome Measures

1. Change in Immune Response Assessed by IFN-g ELISPOT Specific for PA2024 [Baseline up to 50 weeks]

Secondary Outcome Measures

1. Change in PSA Response [Baseline to up to 3 years]

   PSA doubling time, PSA slope

2. Duration of PSA Response [Up to 3 years]

3. Frequency of Toxicities Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 [Up to 3 years]

   The frequency of participants with toxicities will be tabulated by grade across all dose levels and courses.

4. Immune Response [Week 6]

5. Immune Response [Week 10]

6. Immune Response [Week 26]

7. Immune Response [Week 50]

8. Immune Response (Arm 2 Only) [Week 0]

9. Objective Response Rates (Partial or Complete) [Up to 3 years]

10. Overall Survival [Up to 3 years]

11. Progression-free Survival [Up to 3 years]

12. Time to PSA Progression [Up to 3 years]

Other Outcome Measures

1. Effects of Tasquinimod on the Inhibition of Immune Cells [Up to week 50]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Metastatic asymptomatic or minimally symptomatic castration-resistant prostate cancer (CRPC) patients who are eligible for sipuleucel-T

• Disease progression by PSA criteria (PSA Working Group Consensus Criteria Eligibility) and/or Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

• Life expectancy >= 6 months

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

• Hemoglobin >= 100 g/L (>= 10 g/dL)

• Leukocytes >= 3,000/mm^3

• Absolute neutrophil count >= 1,500/mm^3

• Platelets >= 100,000/mm^3

• Total bilirubin =< 1.5 x laboratory upper limit of normal

• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x laboratory upper limit of normal

• Creatinine =< 1.5 x laboratory upper limit of normal or calculated creatinine clearance of >= 50 mL/min (please use institutional formula)

• Prothrombin time (PT)/international normalized ratio (INR) =< 1.5

• Urine protein < 1+; if >= 1+, 24 hour urine protein should be obtained and should be < 1000 mg

• Central nervous system (CNS): no recent history (within 6 month) of cerebrovascular accident, transient ischemic attacks, central nervous system or brain metastases

• Ability to understand and the willingness to sign a written informed consent document

• Patient verbalizes the ability to swallow and retain oral medication

• Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

• Patients who have received systemic steroids within 4 weeks prior to starting study treatment

• Patients who have received prior immunotherapies

• History of therapy for an autoimmune disorder

• Patients receiving any other investigational agents

• Any medical condition that would preclude adequate evaluation of the safety and toxicity of the study combination

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Association class II, III, or IV), angina pectoris requiring nitrate therapy, recent myocardial infarction (less than the last 6 months), cardiac arrhythmia, history of cerebrovascular accident (CVA) within 6 months; no uncontrolled hypertension (defined as blood pressure of > 160/90 mmHg) on medication or, history of peripheral vascular disease

• Ongoing treatment with warfarin unless the international normalized ratio (INR) is well controlled and below 4

• History of psychiatric illness or social situations that would limit compliance with study requirements

• History of pancreatitis

• Human immunodeficiency virus (HIV)-positive patients receiving combination antiretroviral therapy are ineligible

• Systemic exposure to ketoconazole or other strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) isoenzyme inhibitors or inducers within 14 days prior to the start of study treatment; systemic exposure to aminodarone is not allowed within 1 year prior to the start of study treatment

• Ongoing treatment with sensitive cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2) substrate or CYP1A2 substrate with narrow therapeutic range at the start of study treatment

• Ongoing treatment with CYP3A4 substrate with narrow therapeutic range at the start of study treatment

• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 of therapy

• Unwilling or unable to follow protocol requirements

• Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Roswell Park Cancer Institute	Buffalo	New York	United States	14263

Sponsors and Collaborators

• Roswell Park Cancer Institute
• National Cancer Institute (NCI)
• Active Biotech AB

Investigators

• Principal Investigator: Saby George, Roswell Park Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roswell Park Cancer Institute
• ClinicalTrials.gov Identifier: NCT02159950
• Other Study ID Numbers: I 250813; NCI-2014-01184; I 250813; P30CA016056
• First Posted: Jun 10, 2014
• Last Update Posted: Jun 24, 2016
• Last Verified: May 1, 2016

• Additional relevant MeSH terms: Carcinoma; Prostatic Neoplasms; Vaccines

Study Results

Participant Flow

Arm/Group Title	Arm I (Sipuleucel-T)	Arm II (Tasquinimod, Sipuleucel-T)
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	0	2
COMPLETED	0	0
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	Arm I (Sipuleucel-T)	Arm II (Tasquinimod, Sipuleucel-T)	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	0	2	2
Age (participants) [Number]
<=18 years	0 NaN	0 0%
Between 18 and 65 years	0 NaN	0 0%
>=65 years	2 Infinity	2 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	75.4 (.70)	75.4 (.70)
Gender (participants) [Number]
Female	0 NaN	0 0%
Male	2 Infinity	2 100%

Outcome Measures

1. Primary Outcome

Title	Change in Immune Response Assessed by IFN-g ELISPOT Specific for PA2024
Time Frame	Baseline up to 50 weeks

Outcome Measure Data

Analysis Population Description

Due a Lack of funding data was not collected and no patients were analyzed.

Arm/Group Title	Arm I (Sipuleucel-T)	Arm II (Tasquinimod, Sipuleucel-T)
Arm/Group Description	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	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
Measure Participants	0	0

2. Secondary Outcome

Title	Change in PSA Response
Description	PSA doubling time, PSA slope
Time Frame	Baseline to up to 3 years

Outcome Measure Data

Analysis Population Description

Due a Lack of funding data was not collected and no patients were analyzed.

Arm/Group Title	Arm I (Sipuleucel-T)	Arm II (Tasquinimod, Sipuleucel-T)
Arm/Group Description	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	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
Measure Participants	0	0

3. Secondary Outcome

Title	Duration of PSA Response
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

Due a Lack of funding data was not collected and no patients were analyzed.

Arm/Group Title	Arm I (Sipuleucel-T)	Arm II (Tasquinimod, Sipuleucel-T)
Arm/Group Description	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	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
Measure Participants	0	0

4. Secondary Outcome

Title	Frequency of Toxicities Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4
Description	The frequency of participants with toxicities will be tabulated by grade across all dose levels and courses.
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

All treated and eligible patients.

Arm/Group Title	Arm I (Sipuleucel-T)	Arm II (Tasquinimod, Sipuleucel-T)
Arm/Group Description	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	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
Measure Participants	0	2
Grade 1	1 Infinity
Grade 4	1 Infinity

5. Secondary Outcome

Title	Immune Response
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

Due a Lack of funding data was not collected and no patients were analyzed.

Arm/Group Title	Arm I (Sipuleucel-T)	Arm II (Tasquinimod, Sipuleucel-T)
Arm/Group Description	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	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
Measure Participants	0	0

6. Secondary Outcome

Title	Immune Response
Time Frame	Week 10

Outcome Measure Data

Analysis Population Description

Due a Lack of funding data was not collected and no patients were analyzed.

Arm/Group Title	Arm I (Sipuleucel-T)	Arm II (Tasquinimod, Sipuleucel-T)
Arm/Group Description	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	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
Measure Participants	0	0

7. Secondary Outcome

Title	Immune Response
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

Due a Lack of funding data was not collected and no patients were analyzed.

Arm/Group Title	Arm I (Sipuleucel-T)	Arm II (Tasquinimod, Sipuleucel-T)
Arm/Group Description	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	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
Measure Participants	0	0

8. Secondary Outcome

Title	Immune Response
Time Frame	Week 50

Outcome Measure Data

Analysis Population Description

Due a Lack of funding data was not collected and no patients were analyzed.

Arm/Group Title	Arm I (Sipuleucel-T)	Arm II (Tasquinimod, Sipuleucel-T)
Arm/Group Description	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	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
Measure Participants	0	0

9. Secondary Outcome

Title	Immune Response (Arm 2 Only)
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

Due a Lack of funding data was not collected and no patients were analyzed.

Arm/Group Title	Arm I (Sipuleucel-T)	Arm II (Tasquinimod, Sipuleucel-T)
Arm/Group Description	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	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
Measure Participants	0	0

10. Secondary Outcome

Title	Objective Response Rates (Partial or Complete)
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

Due a Lack of funding data was not collected and no patients were analyzed.

Arm/Group Title	Arm I (Sipuleucel-T)	Arm II (Tasquinimod, Sipuleucel-T)
Arm/Group Description	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	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
Measure Participants	0	0

11. Secondary Outcome

Title	Overall Survival
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

Due a Lack of funding data was not collected and no patients were analyzed.

Arm/Group Title	Arm I (Sipuleucel-T)	Arm II (Tasquinimod, Sipuleucel-T)
Arm/Group Description	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	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
Measure Participants	0	0

12. Secondary Outcome

Title	Progression-free Survival
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

Due a Lack of funding data was not collected and no patients were analyzed.

Arm/Group Title	Arm I (Sipuleucel-T)	Arm II (Tasquinimod, Sipuleucel-T)
Arm/Group Description	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	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
Measure Participants	0	0

13. Secondary Outcome

Title	Time to PSA Progression
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

Due a Lack of funding data was not collected and no patients were analyzed.

Arm/Group Title	Arm I (Sipuleucel-T)	Arm II (Tasquinimod, Sipuleucel-T)
Arm/Group Description	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	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
Measure Participants	0	0

14. Other Pre-specified Outcome

Title	Effects of Tasquinimod on the Inhibition of Immune Cells
Time Frame	Up to week 50

Outcome Measure Data

Analysis Population Description

Due a Lack of funding data was not collected and no patients were analyzed.

Arm/Group Title	Arm I (Sipuleucel-T)	Arm II (Tasquinimod, Sipuleucel-T)
Arm/Group Description	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	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
Measure Participants	0	0

Adverse Events

Arm/Group Title	Arm I (Sipuleucel-T)		Arm II (Tasquinimod, Sipuleucel-T)
Arm/Group Description	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		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
All Cause Mortality
	Arm I (Sipuleucel-T)		Arm II (Tasquinimod, Sipuleucel-T)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm I (Sipuleucel-T)		Arm II (Tasquinimod, Sipuleucel-T)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		1/2 (50%)
Gastrointestinal disorders
Pancreatitis	0/0 (NaN)	0	1/2 (50%)	8
Other (Not Including Serious) Adverse Events
	Arm I (Sipuleucel-T)		Arm II (Tasquinimod, Sipuleucel-T)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		2/2 (100%)
Blood and lymphatic system disorders
Anaemia	0/0 (NaN)	0	1/2 (50%)	23
Gastrointestinal disorders
Abdominal discomfort	0/0 (NaN)	0	1/2 (50%)	30
Constipation	0/0 (NaN)	0	2/2 (100%)	10
Diarrhoea	0/0 (NaN)	0	2/2 (100%)	57
General disorders
Fatigue	0/0 (NaN)	0	2/2 (100%)	27
Malaise	0/0 (NaN)	0	1/2 (50%)	18
Investigations
Weight decreased	0/0 (NaN)	0	1/2 (50%)	8
Metabolism and nutrition disorders
Decreased appetite	0/0 (NaN)	0	1/2 (50%)	13
Renal and urinary disorders
Hydronephrosis	0/0 (NaN)	0	1/2 (50%)	3
Vascular disorders
Hypotension	0/0 (NaN)	0	1/2 (50%)	24

Limitations/Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.