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

• ClinicalTrials.gov Identifier: NCT03639168
• Recruitment Status: Completed
• First Posted: August 21, 2018
• Last Update Posted: August 19, 2021
• Sponsor: Fudan University
• Information provided by (Responsible Party): Kai Xue, MD, Fudan University

Study Description

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; 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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 22 participants
• Allocation: N/A
• 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
• Actual Primary Completion Date: June 24, 2020
• Actual Study Completion Date: June 2, 2021

Arms and Interventions

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

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-QLQ-30 [ Time Frame: 6 weeks ]
   Quality of life was evaluated using EORTC-QLQ-30. All subscales are summed to compute a total score, and total scores are recorded. Lower scores represent a better outcome.

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

• 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

Locations

China, Shanghai

Kai Xue

Shanghai, Shanghai, China, 200032

Sponsors and Collaborators

Fudan University

Investigators

• Principal Investigator: Kai Xue, MD; Department of medical oncology,Fudan University, Shanghai Cancer Center

More Information

• Responsible Party: Kai Xue, MD, Clinical Professor, Fudan University
• ClinicalTrials.gov Identifier: NCT03639168
• Other Study ID Numbers: CC-HN-1
• First Posted: August 21, 2018
• Last Update Posted: August 19, 2021
• Last Verified: August 2021

• 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