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

NCT04433169 | Unknown Phase 2

• 1 other identifier: 2020HNRT02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adenoid Cystic Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants With at Least One Grade 3-4 Toxicity

  6 months

• Progression-Free Survival

  6 months

Study Arms (2)

Experimental group

EXPERIMENTAL

ATRA 20 mg, three times a day (tid), for 28 consecutive days, 28 days per cycle (q4w), 6 planned cycles; combined with the treatment regimen chosen by the investigator since Day 6 of cycle 1.

Drug: All-trans Retinoic Acid

Control group

ACTIVE COMPARATOR

The investigator chooses the treatment regimen based on the following regimens (including but not limited to: 1. VEGFR inhibitor; 2. chemotherapy).

Drug: VEGFR inhibitor; Drug: Chemotherapy

Interventions

All-trans Retinoic Acid DRUG

ATRA 20 mg, three times a day, for 28 consecutive days, 28 days per cycle (q4w), 6 planned cycles

Also known as: Ailike

Experimental group

VEGFR inhibitor DRUG

VEGFR inhibitor

Control group

Chemotherapy DRUG

chemotherapy

Control group

Eligibility Criteria

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

You may qualify if:

• \. 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:
• Criteria for routine blood test: (no blood transfusion within 14 days)
• HB ≥ 90 g/L;
• WBC ≥ 3.5 × 109/L and \< 10 × 109/L;
• ANC ≥ 1.5 × 109/L;
• PLT ≥ 80 × 109/L
• Criteria for biochemical tests:
• BIL \< 1.25 × upper limit of normal (ULN)
• ALT and AST \< 2.5 × ULN; in the presence of metastases to liver, ALT and AST \< 5 × ULN;
• 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.

You may not qualify if:

• Previous or existing concomitant malignancies except cured skin basal cell carcinoma or cervical carcinoma in situ;
• Coagulation abnormal (INR\>1.5, APTT\>1.5×ULN), history of gastrointestinal hemorrhage in the past 6 months or bleeding tendency \[e.g., presence of active ulcer focus in the stomach, stool occult blood (++), melena and/or hematemesis, hemoptysis in the past 3 months\];
• Confirmed hypersensitivity to ATRA;
• Grade I and above coronary artery diseases, arrhythmias \[including QTc prolongation (males: \> 450 ms, females: \> 470 ms)\] and cardiac dysfunction;
• Presence of multiple factors affecting oral administration (e.g. dysphagia, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.);
• Pregnant or lactating women;
• History of psychotropic abuse with abstinence failure, or existing mental disorder;
• Participation in other drug clinical trials within 4 weeks;
• Other concomitant diseases which seriously jeopardize the patient's safety or prevent the patient from completing the study, as judged by the investigator.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

MeSH Terms

Interventions

Tretinoin; Drug Therapy

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Therapeutics

Central Study Contacts

Guopei Zhu, M.D

CONTACT

021-23271699; antica@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 16, 2020
• Study Start: June 3, 2020
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: February 2, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)