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Chidamide Combined With Cisplatin in Head and Neck Adenoid Cystic Carcinoma (HNACC)

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ClinicalTrials.gov Identifier: NCT03639168
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Kai Xue, MD, Fudan University

Study Description
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Brief Summary:
The investigators conducted this study to evaluate the efficacy of Chidamide combined with cisplatin in recurrent or metastatic head and neck adenoid cystic carcinoma.

Condition or disease Intervention/treatment Phase
Adenoid Cystic Carcinomas Chidamide Cisplatin Drug: Chidamide combined with cisplatin Phase 2

Detailed Description:
Adenoid cystic carcinomas (ACCs) constitute of 1% of head and neck cancers. This type of tumor grows slowly with a high potential of local recurrence. Approximately 50% of patients develop distant metastases, and 33% patients die within 2 years. The initial therapy of these malignancies consists of surgical resection followed by radiotherapy. Systemic therapy is crucial in the management of recurrent and metastatic disease. However, nowadays, there were no standard chemoimmunotherapy regimes. Previous report showed that overall response rate was only less than 10% using single-agent chemotherapies, and the best results were achieved by cisplatin. Chidamide is a new benzamide class of histone deacetylase inhibitor with marked antitumor activity. And a phase I study has showed that one of three patients with submandibular adenoid cystic carcinoma achieved a partial response treated with Chidamide. The investigators conducted this study to evaluate the efficacy of Chidamide combined with cisplatin in recurrent or metastatic head and neck adenoid cystic carcinoma, in order to find a potential promising way to treat this kind of disease.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chidamide Combined With Cisplatin in Recurrent or Metastatic Head and Neck Adenoid Cystic Carcinoma: A Prospective, Open-label, Phase II Study of a Single Center
Actual Study Start Date : June 6, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids
Drug Information available for: Cisplatin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Chidamide combined with Cisplatin
Chidamide: 30mg,PO,biw one week before cycle 1 treatment Cisplatin 25mg/m2 ivgtt D1-3 Chidamide :20mg PO Biw, 2 week on , 1 week off
 Drug: Chidamide combined with cisplatin
Chidamide combined with cisplatin


Outcome Measures
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Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: 6 weeks ]
    Defined as numbers of patients achieved complete response and patial response of treatment


Secondary Outcome Measures :
  1. Disease control rate (DCR) [ Time Frame: 6 weeks ]
    Defined as numbers of patients achieved complete response, patial response, and stable disease of treatment

  2. Progression-free survival (PFS) [ Time Frame: 6 weeks ]
    Defined as the time from randomization until objective tumor progression or death

  3. Scoring of quality of life: EORTC-30 [ Time Frame: 6 weeks ]
    Quality of life evaluated using EORTC-30, the summed scores will be recorded.


Other Outcome Measures:
  1. Serum ctDNA biomarker [ Time Frame: throughout the treatment period，up to 6 months ]
    relationship between biomarker and treatment outcome


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age range 18-75 years old
  2. Histological confirmed recurrent or metastatic head and neck adenoid cystic carcinoma
  3. Unable to treat with surgery/radiotherapy, or previously failure to non-cisplatin systematic treatment;
  4. Eastern Cooperative Oncology Group performance status 0 to 2;
  5. Patients have written informed consent to participate in the study;
  6. anticipated to live ≧3 months;
  7. Absolute neutrophil count ≥ 1.5×109/L，platelet ≥ 100×109/L，hemoglobin ≥ 90 g/L
  8. total bilirubin < 1.5×upper limit of normal(ULN), ALT and AST < 3× ULN
  9. serum creatine <1.5×ULN, and creatinine clearance rate (CCR) ≥ 50 ml/min
  10. Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed no signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention.
  11. Measurable disease was defined as at least one lesion ≥1.5 cm in length-diameter and ≥0.5 cm in short-diameter by CT.

Exclusion Criteria:

  1. Previously treated with HDACi;
  2. Treated with cisplatin-contained regimes in the past half of the year, and not achieving PR/CR;
  3. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix;
  4. HIV, HCV, or syphilis infection；
  5. Pregnant or lactating women;
  6. Serious uncontrolled infection;
  7. Severe neurol of mental illness, including dementia and epilepsy;
  8. Having contraindications to the use of oral medication, such as unable to swallow, nausea and vomiting, chronic diarrhea or suffering from a bowel obstruction;
  9. Participated in other clinical trials in 4 weeks;
  10. Other coexisting diseases or situations that may cause patients to fail to complete clinical trials;
  11. History of QTc interval prolongation (Male >450ms，Female >470ms), ventricular tachycardia, auricular fibrillation, heart block of more than II degrees, myocardial infarction in 1 year, congenital heart disease, with symptomatic coronary heart disease requiring medication.
Contacts and Locations
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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): NCT03639168


Contacts
Contact: Kai Xue, MD 021-64175590 xuekaishanghai@126.com

Locations
China, Shanghai
Kai Xue Recruiting
Shanghai, Shanghai, China, 200032
Contact: Kai Xue, MD    13818659448    xuekaishanghai@126.com   
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Kai Xue, MD Department of medical oncology,Fudan University, Shanghai Cancer Center
More Information
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Responsible Party: Kai Xue, MD, Clinical Professor, Fudan University
ClinicalTrials.gov Identifier: NCT03639168     History of Changes
Other Study ID Numbers: CC-HN-1
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Adenoid Cystic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Adenocarcinoma
Cisplatin
Antineoplastic Agents