All-trans Retinoic Acid (ATRA) in the Treatment of Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck

Adenoid Cystic Carcinoma of the Head and Neck Clinical Trial

— Aplus  

Official title:

A Prospective, Open-label, Randomized Controlled Clinical Study to Evaluate the Efficacy and Safety of All-trans Retinoic Acid (ATRA) in the Treatment of Patients With Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04433169
• Other study ID #: 2020HNRT02
• Status: Recruiting
• Phase: Phase 2
• Start date: June 3, 2020
• Est. completion date: June 2023

Study information

• Verified date: June 2020
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Guopei Zhu, M.D
• Phone: 021-23271699
• Email: antica[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, open-label, randomized controlled clinical intervention study to evaluate the efficacy and safety of all-trans retinoic acid (ATRA) in treating patients with recurrent metastatic adenoid cystic carcinoma of the head and neck.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years, male or female; 2. ECOG PS (performance status) score: 0-1; 3. Pathologically or histologically confirmed advanced, recurrent/metastatic ACC, with measurable disease (=10 mm by spiral CT scan, meeting RECIST 1.1 criteria); 4. Patients with therapeutic indications; 5. Main organ functions normal, i.e., meeting the criteria below:

1. Criteria for routine blood test: (no blood transfusion within 14 days)

1. HB = 90 g/L;

2. WBC = 3.5 × 109/L and < 10 × 109/L;

3. ANC = 1.5 × 109/L;

4. PLT = 80 × 109/L

2. Criteria for biochemical tests:

1. BIL < 1.25 × upper limit of normal (ULN)

2. ALT and AST < 2.5 × ULN; in the presence of metastases to liver, ALT and AST < 5 × ULN;

3. Serum Cr = 1 × ULN, endogenous creatinine clearance > 50 mL/min (Cockcroft-Gault equation); 5. Subjects who volunteer to participate in this study, sign the informed consent, have good compliance and cooperate in follow-up; 6. Patients who, in the doctor's opinion, can benefit from the treatment.

Exclusion Criteria:

1. Previous or existing concomitant malignancies except cured skin basal cell carcinoma or cervical carcinoma in situ;

2. Coagulation abnormal (INR>1.5, APTT>1.5×ULN), history of gastrointestinal hemorrhage in the past 6 months or bleeding tendency [e.g., presence of active ulcer focus in the stomach, stool occult blood (++), melena and/or hematemesis, hemoptysis in the past 3 months];

3. Confirmed hypersensitivity to ATRA;

4. Grade I and above coronary artery diseases, arrhythmias [including QTc prolongation (males: > 450 ms, females: > 470 ms)] and cardiac dysfunction;

5. Presence of multiple factors affecting oral administration (e.g. dysphagia, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.);

6. Pregnant or lactating women;

7. History of psychotropic abuse with abstinence failure, or existing mental disorder;

8. Participation in other drug clinical trials within 4 weeks;

9. Other concomitant diseases which seriously jeopardize the patient's safety or prevent the patient from completing the study, as judged by the investigator.

Related Conditions & MeSH terms

• Adenoid Cystic Carcinoma of the Head and Neck
• Carcinoma
• Carcinoma, Adenoid Cystic

Intervention

Drug:
• All-trans Retinoic Acid
ATRA 20 mg, three times a day, for 28 consecutive days, 28 days per cycle (q4w), 6 planned cycles
• VEGFR inhibitor
VEGFR inhibitor
• Chemotherapy
chemotherapy

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (CR+PR)	Objective Response Rate as defined by RECIST 1.1 after induction therapy followed by definitive chemoradiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.	6 months
Secondary	Number of Participants With at Least One Grade 3-4 Toxicity	Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.	6 months
Secondary	Progression-Free Survival	Time to death or progression defined by imaging of target lesions via CT or MRI scan every 3 months.	6 months