NCT03999684

A Trial of All-trans Retinoic Acid (ATRA) in Advanced Adenoid Cystic Carcinoma

A Phase II Trial of All-trans Retinoic Acid (ATRA) in Advanced Adenoid Cystic Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research is studying how safe and effective all-trans retinoic acid (ATRA), is to treat advanced adenoid cystic carcinoma (ACC).

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved all-trans retinoic acid (ATRA) for this specific disease but it has been approved for other uses. The main purpose of this study is to see how effective all-trans retinoic acid (ATRA) is in treating tumor. Other reasons for conducting the study are: * To determine for how long all-trans retinoic acid (ATRA) may reduce the size or slow down the growth of tumor * To evaluate levels of circulating tumor DNA (ctDNA) released in the bloodstream as an indication of the disease activity * To better understand mechanisms of tumor resistance to ATRA

Conditions

• Adenoid Cystic Carcinoma

Interventions

Type	Name	Description
DRUG	Tretinoin	ATRA control normal cell growth, cell differentiation (the normal process of making cell different from each other), and cell death during embryonic development and in certain tissues later in life. Retinoids effects on the cells are controlled by receptors on the nucleus of each cell (nuclear receptors)

Timeline

• Start date: 2019-08-05
• Primary completion: 2020-04-15
• Completion: 2020-04-15
• First posted: 2019-06-27
• Last updated: 2023-01-23
• Results posted: 2021-08-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study