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

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ClinicalTrials.gov Identifier: NCT02159950
Recruitment Status : Completed
First Posted : June 10, 2014
Results First Posted : May 20, 2016
Last Update Posted : June 24, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Active Biotech AB
Information provided by (Responsible Party):
Roswell Park Cancer Institute

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:

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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Study Type : Interventional  (Clinical Trial)
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 : January 2015
Actual Primary Completion Date : July 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in Immune Response Assessed by IFN-g ELISPOT Specific for PA2024 [ Time Frame: Baseline up to 50 weeks ]

Secondary Outcome Measures :
  1. Change in PSA Response [ Time Frame: Baseline to up to 3 years ]
    PSA doubling time, PSA slope

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

  4. Immune Response [ Time Frame: Week 6 ]
  5. Immune Response [ Time Frame: Week 10 ]
  6. Immune Response [ Time Frame: Week 26 ]
  7. Immune Response [ Time Frame: Week 50 ]
  8. Immune Response (Arm 2 Only) [ Time Frame: Week 0 ]
  9. Objective Response Rates (Partial or Complete) [ Time Frame: Up to 3 years ]
  10. Overall Survival [ Time Frame: Up to 3 years ]
  11. Progression-free Survival [ Time Frame: Up to 3 years ]
  12. Time to PSA Progression [ Time Frame: Up to 3 years ]

Other Outcome Measures:
  1. Effects of Tasquinimod on the Inhibition of Immune Cells [ Time Frame: Up to week 50 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02159950


Locations
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United States, New York
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
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Principal Investigator: Saby George Roswell Park Cancer Institute

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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT02159950     History of Changes
Other Study ID Numbers: I 250813
NCI-2014-01184 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 250813 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Posted: June 10, 2014    Key Record Dates
Results First Posted: May 20, 2016
Last Update Posted: June 24, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
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Carcinoma
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs