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

NCT02159950 | Completed Phase 2 Results DMC

• 2 other identifiers: I 250813NCI-2014-01184
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Hormone-Resistant Prostate Cancer; Metastatic Prostate Carcinoma; Recurrent Prostate Carcinoma; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Immune Response Assessed by IFN-g ELISPOT Specific for PA2024

  Baseline up to 50 weeks

Secondary Outcomes (12)

• Change in PSA Response

  Baseline to up to 3 years

• Duration of PSA Response

  Up to 3 years

• Frequency of Toxicities Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4

  Up to 3 years

• Immune Response

  Week 6

• Immune Response

  Week 10

Other Outcomes (1)

• Effects of Tasquinimod on the Inhibition of Immune Cells

  Up to week 50

Study Arms (2)

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.

Other: Laboratory Biomarker Analysis; Biological: Sipuleucel-T

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.

Other: Laboratory Biomarker Analysis; Biological: Sipuleucel-T; Drug: Tasquinimod

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (sipuleucel-T); Arm II (tasquinimod, sipuleucel-T)

Sipuleucel-T BIOLOGICAL

Given IV

Also known as: APC8015, APC8015 Vaccine, PA2024 (PAP/GM-CSF)-Loaded Dendritic Cell Vaccine, Provenge

Arm I (sipuleucel-T); Arm II (tasquinimod, sipuleucel-T)

Tasquinimod DRUG

Given PO

Also known as: ABR-215050, TASQ

Arm II (tasquinimod, sipuleucel-T)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• Active Biotech AB: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

sipuleucel-T; tasquinimod

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and 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.

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Saby George

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2014
• First Posted: June 10, 2014
• Study Start: January 1, 2015
• Primary Completion: July 1, 2015
• Last Updated: April 27, 2023
• Results First Posted: May 20, 2016

Record last verified: 2023-04

Locations

US (1)