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A Pilot Study of Hormonal Therapy Combined With Central Memory T Cells (Tcm) for Patients With Advanced Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03587285
Recruitment Status : Unknown
Verified July 2019 by Songtao Xiang, Guangzhou University of Traditional Chinese Medicine.
Recruitment status was:  Active, not recruiting
First Posted : July 16, 2018
Last Update Posted : August 1, 2019
Sponsor:
Collaborator:
Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Songtao Xiang, Guangzhou University of Traditional Chinese Medicine

Brief Summary:
The purpose of this study is to evaluate the feasibility, safety and oncological efficacy of hormonal therapy combined with autologous Tcm cells for patients with advanced prostate cancer.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Biological: Tcm+ Goserelin acetate+ Bicalutamide Biological: Tcm+Goserelin acetate+Abiraterone acetate Phase 1 Phase 2

Detailed Description:

Adoptive cancer immunotherapy,the infusion of tumor-reactive T cells to patients,represents a promising approach for the treatment of advanced metastatic disease.It has been shown that central memory T cells (Tcm) were the optimal antitumor T cells for adoptive cell transfer in cancer patients.However,the potential of autologous Tcm cells to treat the advanced prostate cancer has not been evaluated.

This is an open-label pilot study to determine if the infusion of autologous Tcm cells combined with hormonal therapy is safe and effective for the treatment of advanced prostate cancer.This study will have the following two cohorts:Cohort A) metastatic hormone-sensitive prostate cancer (mHSPC) treated with maximal androgen blockade plus autologous Tcm cells and Cohort B) metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone acetate plus autologous Tcm cells.A total of 60 evaluable subjects will be enrolled over an enrollment period of 24 months.The study is planned to enroll approximately 30 evaluable subjects in each treatment cohort.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Hormonal Therapy Combined With Central Memory T Cells (Tcm) for Patients With Advanced Prostate Cancer
Actual Study Start Date : September 23, 2018
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1
metastatic hormone-sensitive prostate cancer (mHSPC):After diagnosis of mHSPC, patients receive infusions of autologous Tcm cells intravenously on Day 1 and Day 42, followed by hormonal therapy of maximal androgen blockade (LHRH-a + Anti-androgen).
Biological: Tcm+ Goserelin acetate+ Bicalutamide
Autologous Tcm cells administered intravenously on Day 1 and Day 42,3.6mg goserelin acetate injection administered subcutaneously monthly,50 mg bicalutamide administered orally daily

Experimental: Arm 2
metastatic castration-resistant prostate cancer (mCRPC):After diagnosis of mCRPC, patients receive infusions of autologous Tcm cells intravenously on Day 1 and Day 42, followed by goserelin acetate monthly. Abiraterone acetate 1000 mg orally daily plus prednisone 5 mg orally twice daily will be also administered continuously during the duration of the trial.
Biological: Tcm+Goserelin acetate+Abiraterone acetate
Tcm cells administered intravenously on Day 1 and Day 42,3.6mg goserelin acetate injection administered subcutaneously monthly,1000 mg abiraterone acetate administered orally daily plus 5 mg prednisone administered orally twice daily




Primary Outcome Measures :
  1. Incidences of adverse events or serious adverse events (AE and SAE) [ Time Frame: 2 years ]
    This is graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grading scale, version 4.0


Secondary Outcome Measures :
  1. Time to castration-resistance (TCR) in mHSPC patients [ Time Frame: 2 years ]
    Defined as the time from treatment initiation to the first castration-resistant event (radiographic disease progression, prostate-specific antigen (PSA) progression or the occurrence of the first symptomatic skeletal event), whichever occurs first

  2. Overall survival (OS) [ Time Frame: 2 years ]
    Defined as time from treatment initiation to death

  3. Progression-free survival (PFS) [ Time Frame: 2 years ]
    Defined as the time from treatment initiation to disease progression, relapse or death due to any cause, whichever occurs first



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who understand and sign the consent form for this study
  • Males age ≥18 years
  • Subjects diagnosed with metastatic hormone-sensitive prostate cancers (mHSPC) or metastatic castration-resistant prostate cancer (mCRPC)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Expected survival time of at least 24 months
  • Adequate hematologic, renal, and liver function: WBC greater than 3.5 x 109/L; Absolute neutrophils count greater than 1.5 x 109/L; Platelet count greater than 80 x 109/L; Hemoglobin at least 90g/L; AST less than 2 x upper limit of normal (ULN); Creatinine less than 1.5 x ULN
  • No obvious abnormalities in the electrocardiogram

Exclusion Criteria:

  • Clinically significant cardiovascular disease: New York Heart Association (NYHA) class III or IV chronic congestive heart failure, coronary heart disease (myocardial infarction within 6 months); cardiac arrhythmia requiring anti-arrhythmic drug (beta-blocker or digoxin is allowed to be used); uncontrolled high blood pressure
  • HIV infection
  • Acute exacerbation of chronic hepatitis A or hepatitis B infection
  • The subject has uncontrollable seizures required pharmacotherapy (such as steroids or antiepileptic drugs)
  • The subject has a history of allogeneic organ transplants
  • Subject with irregular hemorrhagic disease
  • The subject receives dialysis treatment The subject has a history of other malignant tumor except subjects with curable basal cell carcinoma, superficial bladder tumor or other tumors has been cured over three years of study entry
  • The subject has a history of gastrointestinal hemorrhage within 30 days of study entry
  • The subject has an allergic history or is allergic to the drug in this study
  • The subject has serious diseases of respiratory, nervous or mental system
  • Subject with immune disease, auto-immune disease requires systemic ongoing immunosuppressive therapy
  • The subject has problems with drug or alcohol abuse
  • Major surgery within 4 weeks of enrollment
  • Prior autologous bone marrow transplantation within 4 weeks of enrollment
  • The subject has participated in any other therapeutic clinical trial with an experimental drug in the 4 weeks prior to this trial
  • The subject has any other unsuitable or adverse condition to be determined by the investigator
  • Any medical intervention or any circumstances that could compromise the safety and compliance of the trial subjects

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): NCT03587285


Locations
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China, Guangdong
Guangdong Provincial Hospital of Chinese Medicine, Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Guangzhou University of Traditional Chinese Medicine
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Songtao Xiang, MD Guangzhou University of Chinese Medicine
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Responsible Party: Songtao Xiang, MD, PhD, Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03587285    
Other Study ID Numbers: S2017-05-01
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Songtao Xiang, Guangzhou University of Traditional Chinese Medicine:
prostate cancer
central memory T cell
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Goserelin
Abiraterone Acetate
Bicalutamide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 Enzyme Inhibitors
Androgen Antagonists