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Tolerance and Pharmacokinetic Study of Chlorogenic Acid to Advanced Glioblastoma

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ClinicalTrials.gov Identifier: NCT02728349
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : November 1, 2018
Sponsor:
Collaborator:
Beijing Shijitan Hospital
Information provided by (Responsible Party):
Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd

Brief Summary:

The purpose of this study:

Determining the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), pharmacokinetics characteristic, and dosage regimen of phase II/III of Chlorogenic acid for injection in the advanced Glioblastoma Patients ;


Condition or disease Intervention/treatment Phase
Glioblastoma Drug: Chlorogenic acid Phase 1

Detailed Description:
  1. Investigate the tolerance of Chlorogenic acid for injection in human body, determine the Maximum Tolerated Dose (MTD) and Dose-Limiting Toxicity (DLT) of Chlorogenic acid for injection in the advanced Glioblastoma Patients ;
  2. Determine the human pharmacokinetics characteristic of Chlorogenic acid for injection;
  3. Preliminary observation the effectiveness and effective dose;
  4. Provide the basis for the dosage regimen of phase II/III.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Trial of Tolerance and Pharmacokinetic of Chlorogenic Acid for Injection in the Advanced Glioblastoma Patients
Actual Study Start Date : April 12, 2016
Actual Primary Completion Date : August 23, 2017
Actual Study Completion Date : September 13, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chlorgenic acid, Treatment, powder
Chlorogenic acid for injection(30mg/bottle) is white or off-white freeze-dried lump or powder,it can be easily dissolved in water, which solubility is 20%.
Drug: Chlorogenic acid
Chlorogenic acid for injection is polyphenols, micromolecular and un-endogenous substance. It might play the role of cancer treatment via balancing tumor micro-environmental immune status according to the stability and rationality of immunodeficiency and endogenous immune material expression around the tumor. Chlorogenic acid for injection is made from chlorogenic acid (purity≥98%) which is extracted from folium cortex eucommiae.Chlorogenic acid and its preparations have not been reported as chemical drug and marketed around the world.




Primary Outcome Measures :
  1. Number of adverse events [ Time Frame: Within the first 30 days after the first dose of chlorogenic acid ]
  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0,grade ≥3 (DLT) [ Time Frame: Within the first 30 days after the first dose of chlorogenic acid ]
  3. Maximum Tolerated Dose [ Time Frame: Within the first 30 days after the first dose of chlorogenic acid ]
  4. Area under the plasma concentration versus time curve (AUC) of chlorogenic acid [ Time Frame: Within the first 30 days after the first dose of chlorogenic acid ]
  5. Peak Plasma Concentration (Cmax) of chlorogenic acid [ Time Frame: Within the first 30 days after the first dose of chlorogenic acid ]

Secondary Outcome Measures :
  1. Improvement in cancer-related symptoms [ Time Frame: Within 1 year after the first dose of chlorogenic acid ]
  2. disease control rate(DCR) [ Time Frame: Within the first 30 days after the first dose of chlorogenic acid ]
  3. objective response rate (ORR) [ Time Frame: Within the first 30 days after the first dose of chlorogenic acid ]
  4. progress free survival(PFS) [ Time Frame: Within the first 30 days after the first dose of chlorogenic acid ]
  5. overall survival (OS) [ Time Frame: Within the first 30 days after the first dose of chlorogenic acid ]
  6. Improvement in quality of life [ Time Frame: Within 1 year after the first dose of chlorogenic acid ]

Other Outcome Measures:
  1. Changing in number of red blood cell [ Time Frame: Within 1 year after the first dose of chlorogenic acid ]
  2. Changing in cytokines in peripheral blood [ Time Frame: Within 1 year after the first dose of chlorogenic acid ]
  3. Changing in level of hemoglobin [ Time Frame: Within 1 year after the first dose of chlorogenic acid ]
  4. Changing in lymphocyte subsets [ Time Frame: Within 1 year after the first dose of chlorogenic acid ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with pathologic or/and FNAC confirmation of advanced glioblastoma(WHO,III-IV grade) but without effective treatment or with treatment failure;
  2. Between 18 and 65 years of age, KPS≥40;
  3. According to RANO(2010), the parents will be eligible if one of the following conditions apply: steroid dose increased or stable,the enhanced tumor lesion increased more than 25%; the unenhanced tumor lesion increased because of the progressive tumor,even if the lesion was unmeasurable.
  4. Life expectancy of at least three (3) months at the enrollment;
  5. Patients who have sufficient baseline organ function and whose laboratory data can meet the following criteria at the enrollment:

1)PLT count≥100×10~9/L, 2)WLB count≥4.0×10~9/L and ≤12×10~9/L, 3)Neutrophil granulocyte count≥2.0×10~9/L, 4)HGB count≥90g/L, 5)Total bilirubin <=1.5 times of ULN, 6)ALT/AST ≤2.5 times of ULN, 7)SCr≤1.5 times of ULN, 8)Normal ECG with LVEF (≥50%) measured by echocardiography; 6.Female patients with negative pregnant test, and male/female patients of reproductive age without pregnancy planning in the next 12 months; 7.Volunteered for the phase 1 trial and sign the informed consent without protest;

Exclusion Criteria:

  1. Patients who have received large area radiotherapy (>30% marrow capacity);
  2. Without pathologic or/and FNAC confirmation of advanced glioblastoma;
  3. Patients who has primary immunodeficiency diseases;
  4. Patients who suffer from other serious complication, such as uncontrollable infection, myocardial infarction within the past 6 months at the enrollment , uncontrollable hypertension ,thromboembolism and etc.;
  5. Patients who have received the therapy of chemotherapy or radical radiotherapy within 4 weeks before enrollment;
  6. Patients who have used nitrosoureas drug or mitomycin within 6 weeks or tyrosine kinase inhibitor within 2 weeks before enrollment;
  7. Patients who have received therapy of major surgery within 4 weeks or biopsy surgery within 2 weeks before enrollment;
  8. Patients who experience grade 2 or more than grade 2 toxicity caused by the past therapies;
  9. Patients who have history of drug abuse;
  10. Uncontrollable psychopaths;
  11. Uncontrollable diabetes;
  12. Pregnant or breast-feeding women, or patients(male and female) who have pregnancy plan;
  13. Patients who had received a therapy of another investigational drug within 12 weeks or patients who are still in another clinical trial at the enrollment;
  14. Known active hepatitis B/hepatitis C, positive HIV/ syphilis antibody;
  15. Patient who need long term treatment of cortical hormone or other immunosuppressive drugs such as visceral organ transplanters;
  16. Allergic to the investigational drug;
  17. Other patients judged ineligible for enrollment in the study by the investigator (sub-investigator).
  18. Patients who have received the therapy of adrenal steroid hormones within 1 week before enrollment or will receive the therapy for a long period time,except for Corticosteroid nasal spray,Inhaled Steroid and Topical steroids .

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): NCT02728349


Locations
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China
Beijing Shijitan Hospital,Capital Medical University
Beijing, China, 100038
Sponsors and Collaborators
Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd
Beijing Shijitan Hospital
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Responsible Party: Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd
ClinicalTrials.gov Identifier: NCT02728349    
Other Study ID Numbers: LYS-I-03
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue