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Effect of Ruxolitinib on Tumor Infiltrating Myeloid Cells

Sponsor
Oncology Institute of Southern Switzerland (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03274778
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
30.7
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Ruxolitinib will be dispensed to patients candidate to prostatectomy immediately after histological diagnosis of prostate adenocarcinoma. The treatment will be given for 28 days followed by a prostatectomy thereafter.

Tumor material and blood samples will be analysed before, during and after the treatment with Ruxolitinib.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ruxolitinib 20 MG
 N/A

Detailed Description

Patients with suspected localized prostate cancer will undergo biopsies spotting different prostate sites, as per standard clinical practice. Patients with histologically confirmed prostate adenocarcinoma and candidate for prostatectomy, after signing the Informed Consent Form, will receive Ruxolitinib for 4 weeks (the time normally elapsing between histological diagnosis and surgery) and will thereafter undergo prostatectomy.

Remaining biological material from the diagnosis and the prostatectomy will be sent to the Molecular Oncology Laboratory for molecular analysis.

In addition, blood samples will be drawn before, during Ruxolitinib treatment (Week 2), at the end of treatment (Week 4), and after prostatectomy (Week 5), to assess the frequency and subtype of immune subsets and the circulating levels of cytokines and secreted.

Patients will be monitored for occurrence of adverse events/surgical complications during treatment and up to 4 weeks after the intervention.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Exploratory proof-of Mechanism Study to Assess the Effect of Ruxolitinib on Tumor Infiltrating Myeloid Cells and Additional Immune Subsets in Prostate Cancer Patients
Actual Study Start Date :
Sep 1, 2017
Actual Primary Completion Date :
Mar 24, 2020
Actual Study Completion Date :
Mar 24, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ruxolitinib

Oral administration of Ruxolitinib 20mg BID for 28 consecutive days

Drug: Ruxolitinib 20 MG
tablets
Other Names:
  • Jakavi

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Tumor immune response [9 wks]

      Tumor immune response modification induced by Ruxolitinib

    Secondary Outcome Measures

    1. pSTAT3 [5 wks]

      Decrease of pSTAT3

    2. Cytokines [6 wks]

      Reduction of cytokines associated to myeloid cells recruitment and tumor-promoting factors (e.g. IL8, IL6, TGF)

    3. KI-67 [9 wks]

      Reduction by 50% of KI-67

    4. biomarkers [5 wks]

      Increase of senescence and apoptosis markers (p16, p21, Beta-galactosidase, Caspase-3, Caspase-8)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age 18-70 years

    • Histological diagnosis of prostate adenocarcinoma

    • Stage ≥T2b for which surgery is indicated

    • No distant metastasis (M0)

    • NLR ≥3 in the blood or NLR ≥3 in the tumor biopsies or a percentage of MDSCs ≥ 30% in the tumour biopsies

    • PS (ECOG scale) 0-1

    • Adequate hepatic function: ALT and ASAT ≤ 2.5 x ULN, Bilirubin ≤ 1.5 ULN (exception if Gilbert's syndrome ≤ 2.5 x ULN)

    • Adequate renal function: calculated creatinine clearance ≥ 50 ml/min according to the formula of Cockcroft-Gault

    • Hemoglobin ≥ 10 g/dl, leukocyte count ≥ 4.0 x 103/µl, platelet count ≥ 200 x 103/µl

    • Informed Consent as documented by the patient's signature

    Exclusion Criteria:

    • No history of coagulation disorders and normal INR

    • Significant cardiovascular disorders in the last 12 months

    • Other clinically significant concomitant disease states which in the opinion of the Investigator may represent contraindications to study participation

    • Known or suspected non-compliance

    • Participation in another study with investigational drug within the 30 days preceding and during the present study

    • Ongoing treatment with strong CYP3A4 inhibitors or dual CYP2C9 and CYP3A4 inhibitors

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istituto Oncologico della Svizzera Italiana (IOSI) Bellinzona Switzerland 6500

    Sponsors and Collaborators

    • Oncology Institute of Southern Switzerland

    Investigators

    • Study Director: Andrea Alimonti, Prof., Institute of Oncology Research (IOR)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrea Alimonti, Prof. dr. med., Oncology Institute of Southern Switzerland
    ClinicalTrials.gov Identifier:
    NCT03274778
    Other Study ID Numbers:
    • IOSI-IOR-001
    First Posted:
    Sep 7, 2017
    Last Update Posted:
    Mar 26, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Mar 26, 2020