This randomized phase II trial studies how well glycosylated recombinant human interleukin-7 (CYT107) after vaccine therapy works in treating patients with castration-resistant prostate cancer that has spread to other areas of the body or has not responded to at least one type of treatment. Biological therapies, such as glycosylated recombinant human interleukin-7, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. It is not yet known whether glycosylated recombinant human interleukin-7 works better with or without vaccine therapy in treating prostate cancer.
PRIMARY OBJECTIVES: I. To determine whether CYT107 administration increases the vaccine-induced antigen-specific T-cell immune response to the sipuleucel-T fusion protein vaccine construct prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (PAP-GM-CSF) (PA2024). SECONDARY OBJECTIVES: I. To determine whether CYT107 administration increases the vaccine-induced antigen-specific T-cell immune response to PAP. II. To assess the character of the T-cell immune response to PAP and PA2024. III. To determine whether CYT107 administration increases the vaccine-induced antigen-specific antibody immune responses to PAP and PA2024. IV. To quantify the effects of CYT107 on T-cell repertoire diversity. V. To assess the effects of CYT107 on the immune competence of patients with advanced prostate cancer. VI. To assess the clinical efficacy and tolerability of sipuleucel-T plus CYT107 compared with sipuleucel-T alone. OUTLINE: Patients are randomized to 1 of 2 cohorts. COHORT I: Patients receive no treatment (observation) after completion of standard sipuleucel-T therapy. COHORT II: Patients receive glycosylated recombinant human interleukin-7 subcutaneously (SC) every week for 4 weeks (on days 0, 7, 14, and 21) beginning 3-7 days after completion of standard sipuleucel-T therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 53 weeks. Patients are followed by phone, once a year, after completion of Week 53 for overall survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Given SC
Correlative studies
UC San Diego Moores Cancer Center
La Jolla, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCSF Medical Center-Mount Zion
San Francisco, California, United States
UCSF Medical Center-Mission Bay
San Francisco, California, United States
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
...and 6 more locations
Quantification of T-cell Responses to Prostatic Acid Phosphatase Granulocyte-macrophage Colony-stimulating Factor (PAP-GM-CSF), Assessed by Quantification of Interferon Gamma Levels Measured Using Enzyme-linked Immunospot (ELISPOT)
The Mann-Whitney-Wilcoxon (MWW) test will be used as part of the statistical analysis to determine quantification of T-cell responses to prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (PAP-GM-CSF), as assessed by quantification of interferon gamma levels measured using enzyme-linked immunospot (ELISPOT). The power is roughly equivalent to that based on the t-test.
Time frame: Day 70 (week 11)
Change in Bystander Antigen Specific Immune Responses, Measured by Interferon Gamma Production in Response to Various Antigens as Quantified by Enzyme-linked Immunospot (ELISPOT)
Bystander antigen specific immune responses will be assessed to other ongoing and nascent antitumor responses (e.g., preferentially expressed antigen in melanoma, cancer/testis antigen 1B and/or tumor protein p53), additional tumor antigens specific to prostate cancer (e.g., prostate specific antigen \[PSA\] and/or prostate-specific membrane antigen), and memory viral responses (influenza A and cytomegalovirus, Epstein-Barr virus and influenza virus-derived peptides) using the interferon gamma ELISPOT assay.
Time frame: Baseline to up to week 53
Change in Circulating Tumor Cells
Enumerated by the approved Veridex assay.
Time frame: Baseline to up to week 53
Change in Number of Peripheral Blood Mononuclear Cell (PBMC) Subsets and T Lymphocyte Subsets
The absolute fold change from baseline of CD3+ cells
Time frame: Week 11
Change in Prostate Specific Antigen (PSA) Kinetics.
The change in prostate specific antigen (PSA) kinetics will be evaluated according to the recommendations from PSA Working Group (PSAWG). Analysis of PSA doubling time
Time frame: Baseline to up to week 53
Change in Vaccine-induced Antigen-specific Antibody Immune Response to Prostatic Acid Phosphatase (PAP)
Will be measured by change in immunoglobulin G (IgG) and immunoglobulin M (IgM) levels quantified by standard enzyme-linked immunosorbent assay (ELISA). Fold change from baseline in week 6 titer
Time frame: Baseline to up to week 6
Overall Survival
Number of participants that have survived
Time frame: Up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.