Not yet recruitingRare disease

Study of Sodium Valproate and Lenvatinib in Patients with Recurrent or Metastatic Adenoid Cystic Carcinoma

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial investigates a rare cancer called Adenoid Cystic Carcinoma that has returned or spread to other parts of the body. The treatment combines an oral medication called lenvatinib with another oral drug known as sodium valproate. Both drugs are taken by mouth each day.

The purpose of the study is to evaluate how the addition of sodium valproate influences patients' quality of life and tumor response. Participants will receive the medicines for several months, attend regular clinic visits, complete a quality‑of‑life questionnaire called EORTC QoL Q30 – HN43/ EORTC QLQ-C30, and undergo imaging scans that are assessed using the standard measurement system RECIST 1.1. The study tracks changes in daily well‑being and the size of the cancer over time.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline assessments
After joining the study, you will complete a series of baseline evaluations. these include blood tests, imaging scans to view the tumor, and a quality of life questionnaire called the eortc qol q30 – hn43 / eortc qlq-c30. the purpose is to record your health status before starting any medication.
Step 2
Start study medication
You will begin taking two oral drugs every day:
lenvatinib – a tablet containing 24 mg (milligrams). the tablet is swallowed with water.
sodium valproate – a dose calculated from your body weight, 25 mg per kilogram (mg/kg). the exact number of milligrams will be determined by the study team and taken as a tablet or liquid, also swallowed with water.
Step 3
Daily medication routine
Take both medications at the same time each day, preferably at a time that fits your daily schedule. keep a record of each dose to help you stay consistent. if you miss a dose, follow the instructions provided by the study team.
Step 4
Regular follow‑up visits
You will attend scheduled clinic visits throughout the trial. during each visit, the study staff will:
• review any side effects you may have experienced
• repeat blood tests to monitor safety
• ask you to complete the same quality of life questionnaire to track changes over time
Step 5
Periodic imaging assessments
At intervals defined by the study protocol, you will undergo imaging scans (such as CT or MRI) to evaluate how the tumor is responding to the treatment. the results help determine the overall response rate.
Step 6
End of study procedures
When the study period ends or if you stop the medication early, you will have a final set of assessments. these include the last blood tests, imaging scan, and quality of life questionnaire to summarize the overall effect of the treatment.

Who can join the trial?

18 criteria

Confirmed diagnosis of adenoid cystic carcinoma by examining a tissue sample under a microscope (this is called a histological confirmation).
No psychological, family, social, or location problems that would make it difficult to follow the study rules and visit schedule.
For women who could become pregnant: a negative pregnancy test must be done within 3 days before the first dose, and you must use a highly effective birth‑control method during the study and for 180 days after the last dose.
For men: you must agree not to donate sperm and to use a male condom while in the study and for at least 90 days after the last dose; your partner should also use effective birth control.
Signing the Informed Consent form, which means you understand the study and agree to take part.
The cancer must be locally advanced or metastatic (meaning it has grown too large or spread and cannot be cured with surgery or radiation).
If the cancer has come back in the same area (locoregional recurrence) and cannot be cured with standard treatments, it must have gotten worse (progressed) in the last 6 months.
If the cancer has spread to distant parts of the body (metastatic disease) and cannot be treated with surgery or radiation, it must have gotten worse (progressed) in the last 6 months.
You must have measurable disease that can be seen on scans, with at least one spot that can be measured using the RECIST 1.1 criteria (a standard way doctors size tumors). All scans must be done within 28 days before joining.
Age must be 18 years or older.
Your Performance Status (ECOG) score must be 0‑1 (a simple rating that shows you are fully active or able to carry out light work).
Expected life expectancy greater than 3 months.
Good blood and organ function, including:
- White blood cells (absolute neutrophil count) > 1500 per mm³.
- Platelet count > 100,000 per mm³.
- Hemoglobin (a protein that carries oxygen) > 9 g/dL.
- Kidney function (creatinine clearance) > 60 ml/min.
- Liver function: bilirubin less than twice the normal limit, and liver enzymes (AST and ALT) less than 2.5 times normal (or less than 5 times if you have liver metastases).
- Urine protein less than 1 g per 24 hours.

Who cannot join the trial?

12 criteria

Having a severe allergy or an anaphylactic reaction (a sudden, life‑threatening allergic response) to the study medicines.
Not fully recovered (still at grade 2 or higher) from side effects of previous chemotherapy, radiation, biologic therapy, immunotherapy, or experimental treatments.
Having any medical condition that could interfere with the study treatment.
Being a woman who is pregnant, breastfeeding, or planning to become pregnant during the study or for 180 days after the last dose.
Having acute (sudden) hepatitis, chronic (long‑term) hepatitis, a liver disorder called hepatic porphyria, or a blood‑clotting disorder.
Having a heart rhythm problem called long QT syndrome or a QTc interval longer than 480 milliseconds (a measure of the heart’s electrical activity).
Having serious heart failure (congestive heart failure worse than NYHA class II), unstable chest pain (angina), a heart attack or stroke within the past six months, or dangerous heart rhythm problems.
Having active coughing up of blood (hemoptysis) or recent clotting or bleeding problems within three weeks before starting treatment.
Having an active infection that requires treatment.
Having mitochondrial disorders (problems with the cell’s energy factories), known urea cycle disorders (issues processing waste nitrogen), or untreated systemic primary carnitine deficiency (a problem using fats for energy).
Having previously taken lenvatinib or currently taking VPA (the study drug).
Having uncontrolled cancer spread to the brain (CNS metastases) or to the membranes covering the brain and spinal cord (leptomeningeal metastases).

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
I.F.O. Istituti Fisioterapici Ospitalieri
Verified
Rome, Italy
IRCCS Humanitas Research Hospital
Verified
Rozzano, Italy

Trial locations

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Investigated drugs

Lenvatinib
is a medicine taken by mouth that blocks signals which help tumors grow and form new blood vessels. In this study it is used as the standard treatment that all participants receive, so the researchers can see how adding another drug might change the results.
Sodium Valproate
(also known as valproic acid) is a medication taken by mouth that can affect the way cells grow and die. In this trial it is given in addition to lenvatinib to test whether it improves patients’ quality of life and helps the cancer respond better to treatment.

What is already known about the treatment

Lenvatinib
Lenvatinib is taken by mouth as a tablet, usually at a dose of 24 mg daily. It is an approved cancer drug that is already used for thyroid, kidney and liver cancers and has been studied extensively in medical literature. In this trial it is being tested for recurrent or metastatic adenoid cystic carcinoma, where it works by blocking several enzymes called tyrosine kinases that help tumors grow new blood vessels. It belongs to the class of multi‑targeted tyrosine‑kinase inhibitors.
Sodium Valproate
Sodium valproate is also taken orally, given at about 25 mg per kilogram of body weight. It is an established medication for epilepsy and mood disorders and is listed in many drug references, while researchers are exploring its use in cancer because it can change how genes are turned on and off. In this study it is added to lenvatinib to see if it improves treatment response in adenoid cystic carcinoma, acting mainly by inhibiting sodium channels and blocking histone deacetylase enzymes. It is classified as an anticonvulsant and a histone deacetylase inhibitor.

Investigated diseases

Recurrent and/or Metastatic Adenoid Cystic Carcinoma - Adenoid cystic carcinoma is a slow‑growing tumor that usually starts in the salivary glands. It can return after initial treatment, which is described as recurrent disease. When cancer cells spread to other parts of the body, it is termed metastatic disease. The tumor may grow in the original site and also form new nodules in distant organs such as the lungs or liver. Over time, the disease can involve multiple locations, leading to a pattern of gradual spread.