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

Primary Purpose

Adenoid Cystic Carcinoma of the Head and Neck

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

All-trans Retinoic Acid

VEGFR inhibitor

Chemotherapy

About this trial

This is an interventional treatment trial for Adenoid Cystic Carcinoma of the Head and Neck

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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
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:

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.

Sites / Locations

Shanghai Ninth People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Progression-Free Survival

Time to death or progression defined by imaging of target lesions via CT or MRI scan every 3 months.

Full Information

NCT ID

NCT04433169

First Posted

June 12, 2020

Last Updated

January 31, 2021

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

1. Study Identification

Unique Protocol Identification Number

NCT04433169

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 3, 2020 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenoid Cystic Carcinoma of the Head and Neck

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

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.

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

All-trans Retinoic Acid

Other Intervention Name(s)

Ailike

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

VEGFR inhibitor

Intervention Description

VEGFR inhibitor

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Intervention Description

chemotherapy

Primary Outcome Measure Information:

Title

Objective Response Rate (CR+PR)

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Description

Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.

Time Frame

6 months

Title

Progression-Free Survival

Description

Time to death or progression defined by imaging of target lesions via CT or MRI scan every 3 months.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Guopei Zhu, M.D

Phone

021-23271699

Ext

5665

antica@gmail.com

Facility Information:

Facility Name

Shanghai Ninth People's Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200011

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lulu Ye, Master

Phone

021-23271699

Ext

5665

yee166@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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