CYT107 After Vaccine Treatment (Provenge®) in Patients With Metastatic Castration-Resistant Prostate Cancer

NCT01881867 | Completed Phase 2 Results

• 6 other identifiers: CITN12-03NCI-2013-00998CITN12-03 IL7P30CA015704P50CA097186U01CA154967
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Castration Levels of Testosterone; Castration-Resistant Prostate Carcinoma; Metastatic Prostate Carcinoma; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 70 (week 11)

Secondary Outcomes (6)

• Change in Bystander Antigen Specific Immune Responses, Measured by Interferon Gamma Production in Response to Various Antigens as Quantified by Enzyme-linked Immunospot (ELISPOT)

  Baseline to up to week 53

• Change in Circulating Tumor Cells

  Baseline to up to week 53

• Change in Number of Peripheral Blood Mononuclear Cell (PBMC) Subsets and T Lymphocyte Subsets

  Week 11

• Change in Prostate Specific Antigen (PSA) Kinetics.

  Baseline to up to week 53

• Change in Vaccine-induced Antigen-specific Antibody Immune Response to Prostatic Acid Phosphatase (PAP)

  Baseline to up to week 6

Study Arms (2)

Cohort I (no therapy)

NO INTERVENTION

Patients receive no treatment (observation) after completion of standard sipuleucel-T therapy.

Cohort II (glycosylated recombinant human interleukin-7)

EXPERIMENTAL

Patients receive glycosylated recombinant human interleukin-7 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.

Biological: Glycosylated Recombinant Human Interleukin-7; Other: Laboratory Biomarker Analysis

Interventions

Glycosylated Recombinant Human Interleukin-7 BIOLOGICAL

Given SC

Also known as: CYT107, Glycosylated rhIL-7

Cohort II (glycosylated recombinant human interleukin-7)

Laboratory Biomarker Analysis OTHER

Correlative studies

Cohort II (glycosylated recombinant human interleukin-7)

Eligibility Criteria

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

You may qualify if:

• Asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC)
• Patients must have successfully completed therapy with sipuleucel-T within 3-7 days of planned CYT107 study drug treatment
• Assessable disease with a positive bone scan and/or measurable disease on computed tomography (CT) scan and/or magnetic resonance imaging (MRI) of the abdomen and pelvis
• Prior orchiectomy or must be on ongoing luteinizing hormone-releasing hormone (LHRH) agonist or antagonist (e.g., degarelix) therapy
• No ongoing anti-androgen therapy; patients must be off anti-androgen therapy for at least 30 days
• Patients receiving any other hormonal therapy, including any dose of megestrol acetate (Megace), Proscar (finasteride), any herbal product known to decrease prostate specific antigen (PSA) levels (e.g. saw palmetto, PC-SPES), or any systemic corticosteroid, must discontinue the agent for at least 30 days prior to study treatment
• Absolute neutrophil count (ANC) \>= 1500/uL
• Bilirubin \< 1.5 x upper limit of normal (ULN)
• Hemoglobin \>= 10 g/dL
• Platelets \>= 100,000/mcL
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN
• Creatinine clearance \>= 60 mL/min by the Cockcroft-Gault equation
• Testosterone =\< 50 ng/dL (documented at any time while on LHRH agonist or antagonists or s/p orchiectomy)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 or a Karnofsky performance status of \>= 80%
• Life expectancy of at least 6 months

You may not qualify if:

• Prior chemotherapy for castration resistant prostate cancer; neoadjuvant chemotherapy and chemotherapy given for hormone sensitive prostate cancer are allowed
• Prior investigational immunotherapy
• Prostate cancer pain requiring regularly scheduled narcotics
• Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography \> 50%) or spinal cord compression
• Current treatment with systemic steroid therapy (inhaled/topical steroids are acceptable); systemic corticosteroids must be discontinued for at least 30 days prior to first CYT107 injection
• Known central nervous system metastases
• History of severe asthma, as defined by prior or current use of systemic corticosteroids for disease control, with the exception of physiological replacement doses of cortisone acetate or equivalent, as defined by a dose of 10 mg or less
• Medical or psychiatric illness that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselves
• Cardiovascular disease that meets one of the following: congestive heart failure (New York Heart Association class III or IV), active angina pectoris, or recent myocardial infarction (within the last 6 months)
• Concurrent or prior malignancy except for the following:
• Adequately treated basal or squamous cell skin cancer
• Adequately treated stage I or II cancer from which the patient is currently in complete remission
• Any other cancer from which the patient has been disease-free for 5 years
• Known human immunodeficiency virus (HIV) or other history of immunodeficiency disorder; HIV-positive patients on combination antiretroviral therapy are ineligible
• Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or medical (e.g. infectious) illness

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• Cancer Immunotherapy Trials Network: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (16)

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

UCSF Medical Center-Mount Zion

San Francisco, California, 94115, United States

Location

UCSF Medical Center-Mission Bay

San Francisco, California, 94158, United States

Location

Emory University/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: CITN Director
• Organization: Cancer Immunotherapy Trials Network

mcheever@fredhutch.org

206-667-4141

Study Officials

• Lawrence Fong

  Cancer Immunotherapy Trials Network

  PRINCIPAL INVESTIGATOR

• Martin A. Cheever

  Fred Hutchinson Cancer Research Center/Cancer Immunotherapy Trials Network

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: June 20, 2013
• Study Start: September 10, 2013
• Primary Completion: May 15, 2017
• Study Completion: January 2, 2018
• Last Updated: July 9, 2019
• Results First Posted: December 11, 2018

Record last verified: 2019-06

Locations

US (16)