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

NCT03587285 | Unknown Phase 1

• 1 other identifier: S2017-05-01
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms

Keywords

prostate cancer; central memory T cell

Outcome Measures

Primary Outcomes (1)

• Incidences of adverse events or serious adverse events (AE and SAE)

  This is graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grading scale, version 4.0

  2 years

Secondary Outcomes (3)

• Time to castration-resistance (TCR) in mHSPC patients

  2 years

• Overall survival (OS)

  2 years

• Progression-free survival (PFS)

  2 years

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Arm 2

EXPERIMENTAL

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

Interventions

Tcm+ Goserelin acetate+ Bicalutamide BIOLOGICAL

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

Arm 1

Tcm+Goserelin acetate+Abiraterone acetate BIOLOGICAL

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

Arm 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead
• Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Guangdong Provincial Hospital of Chinese Medicine, Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510000, China

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

Study Officials

• Songtao Xiang, MD

  Guangzhou University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 16, 2018
• Study Start: September 23, 2018
• Primary Completion: July 30, 2021
• Study Completion: July 31, 2021
• Last Updated: August 1, 2019

Record last verified: 2019-07

Locations

CN (1)