Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Grade IV GBM Patients

NCT03758014 | Unknown Phase 2

• 1 other identifier: LYS-GBM-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of phase II/III study: Determining the Overall Survival（OS）of Chlorogenic acid for injection comparing to in the advanced Glioblastoma Patients through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine.

Conditions

GBM

Outcome Measures

Primary Outcomes (1)

• Overall Survival（OS）

  Through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine

Secondary Outcomes (5)

• progress free survival(PFS)

  Through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine

• disease control rate（DCR)

  Within the first 10 weeks after the first dose of chlorogenic acid for injection and Lomustine

• objective response rate (ORR)

  Within the first 10 weeks after the first dose of chlorogenic acid for injection and Lomustine

• Karnofsky score standard

  Through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine

• Montreal Cognitive Assessment score standard

  Through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine

Study Arms (2)

Chlorogenic Acid for Injection

EXPERIMENTAL

3 mg/kg per day, injection for 28 days，5 weeks per circle; max. 8 circles

Drug: Chlorogenic acid for Injection

Lomustine

ACTIVE COMPARATOR

110 mg/m2 taken as a single oral dose every 6 weeks; max. 4 circles

Drug: Lomustine

Interventions

Chlorogenic acid for Injection DRUG

Chlorogenic acid (CHA) is a class 1 innovative small molecular natural drug, developed by Sichuan Jiuzhang Biological Science and Technology Co., Ltd. The mechanism of broad-spectrum antitumor activity is immunoregulation.

Also known as: CHA

Chlorogenic Acid for Injection

Lomustine DRUG

Lomustine (INN), abbreviated as CCNU (original brand name (formerly available) is CeeNU, now marketed as Gleostine), is an alkylating nitrosourea compound used in chemotherapy. It is closely related to semustine and is in the same family as streptozotocin. It is a highly lipid-soluble drug, thus it crosses the blood-brain barrier. This property makes it ideal for treating brain tumors, which is its primary use.

Also known as: CCNU

Lomustine

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18;
• KPS ≥ 60;
• Recurrent GBM;
• Estimated lifetime ≥ 3 months；
• Female patients with negative pregnant test, and male/female patients of reproductive age without pregnancy planning in the next 12 months;
• Volunteered for the phase 2 trial and sign the informed consent without protest.

You may not qualify if:

• Patients who have received the therapy of chemotherapy or radical radiotherapy within 1 month before enrollment;
• Pregnant or breast-feeding women, or patients(male and female) who have pregnancy plan;
• Patients who had received a therapy of another investigational drug within 1 month；
• Known active hepatitis B/hepatitis C, positive HIV/ syphilis antibody;
• Patients who have received therapy of major surgery within 4 weeks or biopsy surgery within 1 week before enrollment;
• Patient who need long term treatment of cortical hormone or other immunosuppressive drugs such as visceral organ transplanters；
• Patients who have sufficient baseline organ function and whose laboratory data can meet the following criteria at the enrollment:1)PLT count\<80×10\~9/L； 2)NEUT# count\<1.5×10\~9/L ；3)HGB count\<90g/L；4)Total bilirubin \>1.5 times of ULN；5)ALT/AST \>1.5 times of ULN；
• History of drug abuse；
• Patients who was treated with Immunologic drugs（DC/CIK/CTL/PD-（L）1） in 3 months;
• Patients who are false progressers；
• Patients who can not be received MRI examination；
• Patients who had severe trauma or infectious diseases within 4 weeks；
• Patients who had cerebral stroke or Transient ischemic attack within 6 months；
• Patients who were performed important operations within 4 weeks；
• Uncontrollable psychopaths;

Sponsors & Collaborators

• Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Interventions

Chlorogenic Acid; Injections; Lomustine

Intervention Hierarchy (Ancestors)

Cinnamates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Cyclohexanecarboxylic Acids; Drug Administration Routes; Drug Therapy; Therapeutics; Nitrosourea Compounds; Urea; Amides; Nitroso Compounds

Study Officials

• Wenbin Li

  Beijing Tian Tan Hospital，Capital Medical University

  STUDY DIRECTOR

Central Study Contacts

Wenbin Li

CONTACT

8615301377998; neure55@126.com

Zhuang Kang

CONTACT

8615011281069; kzhaoren1984@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2018
• First Posted: November 29, 2018
• Study Start: November 27, 2018
• Primary Completion: October 30, 2020
• Study Completion: April 30, 2021
• Last Updated: November 29, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)