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Study of daily low-dose Temozolomide in patients with advanced neuroendocrine tumors (NETs) who are not eligible for standard treatments due to their health condition

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What is this trial about?

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

This clinical trial focuses on patients with neuroendocrine neoplasms (NENs), which are rare tumors that can develop in various parts of the body, particularly in the digestive system and lungs. The study specifically looks at patients who cannot receive standard cancer treatments due to their health condition. The treatment being tested is Temozolomide, a cancer medication that will be given in low doses continuously over time, which is known as metronomic therapy.

The study will examine how well this treatment works in preventing cancer progression in patients who have advanced or spreading NENs. The medication will be given as oral capsules that patients can take at home. The treatment period may last up to 12 months, with patients taking a daily dose of the medication.

The researchers will monitor how the disease responds to the treatment and track any side effects that may occur. They will also study certain characteristics of the tumors to understand which patients might benefit most from this treatment approach. This includes examining a specific marker called O6-methylguanine-DNA-methyltransferase (MGMT) in the tumor tissue, which may help predict how well the treatment will work.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation
You will undergo evaluation to confirm your eligibility for the study, including verification of neuroendocrine neoplasia (NENs) diagnosis
Your medical history and current health status will be assessed
Blood tests will be performed to check blood cell counts, kidney, and liver function
Step 2
Treatment initiation
You will begin taking Temozolomide orally in low daily doses
The medication must be taken in pill form
You will receive instructions on the proper way to take the medication
Step 3
Ongoing monitoring
Regular medical check-ups will be conducted to monitor your response to treatment
CT scans or MRI will be performed to track disease progression
Blood tests will be conducted to monitor your health status
Your quality of life will be evaluated through questionnaires
Step 4
Safety monitoring
Side effects and any health changes will be monitored throughout the treatment
Blood tests will be performed to check for potential complications
Treatment adjustments may be made based on your body's response
Step 5
Study completion
The study will continue until June 2025
Final evaluations will be conducted to assess treatment outcomes
A follow-up period may be required to monitor long-term effects

Who can join the trial?

15 criteria

Must be over 18 years of age
Must have confirmed diagnosis of low-grade neuroendocrine tumors (tumors that develop from hormone-producing cells) in the digestive system, lungs, or of unknown origin
Must have advanced disease that cannot be surgically removed or has spread to other parts of the body
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Must have at least one of these conditions:
- Reduced physical ability (difficulty performing daily activities)
- Low blood counts
- Moderate kidney problems
- Moderate liver problems
- Serious additional health conditions
- Previous treatment with more than 3 different anti-cancer therapies
- Can have tumors that either produce hormones or do not produce hormones
- Must show evidence that the disease is getting worse through scans (CT or MRI)
- Must have recovered from side effects of any previous treatments
- Must be able to swallow pills
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  For men who can father children:
  - Must agree to use effective birth control for 6 months after treatment ends
  - Must understand that treatment may cause permanent infertility

Who cannot join the trial?

14 criteria

Age below 18 years or above 65 years
Previous or current participation in other clinical trials within the last 30 days
Pregnant or breastfeeding women
Active antitumoral treatment (cancer-fighting therapy) in progress
Inability to provide informed consent
Severe psychiatric conditions that may affect participation
Life expectancy less than 3 months
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Uncontrolled medical conditions that could interfere with the study, such as:
- Severe heart disease
- Severe kidney problems
- Severe liver problems
- Uncontrolled diabetes
- Known allergies to study medications or their components
- Drug or alcohol abuse within the past 6 months
- Inability to follow study procedures or attend scheduled visits

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Verified sites

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

Verified
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
Alexandria, Italy
Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy

Trial locations

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Investigated drugs

Temozolomide is an oral chemotherapy medication used to treat various types of cancer. In this trial, it is being studied in a metronomic approach (given in lower doses but more frequently) for treating neuroendocrine neoplasms. This medication works by stopping cancer cells from growing and dividing. It belongs to a group of drugs called alkylating agents, which fight cancer by damaging the DNA of cancer cells.

Temozolomide

What is already known about the treatment

Temozolomide - An oral chemotherapy medication administered in tablet form that belongs to the alkylating agents class of cancer drugs. This medication works by damaging the DNA of cancer cells, preventing them from dividing and growing, and is primarily used in the treatment of brain tumors and neuroendocrine neoplasms. In this clinical trial, it is being studied using a metronomic approach (frequent, regular doses at lower concentrations) for patients with advanced neuroendocrine neoplasms who are not eligible for standard treatments due to their clinical condition. The drug crosses the blood-brain barrier effectively and is metabolized in the body to its active form, MTIC, which then interferes with cancer cell DNA replication.

Investigated diseases

Neuroendocrine Neoplasia (NEN) - A type of tumor that develops from specialized cells called neuroendocrine cells, which have traits common to both nerve cells and hormone-producing cells. These tumors can form in various parts of the body, most commonly in the digestive tract, pancreas, or lungs. They typically grow slowly over time and can produce excess hormones. The disease can spread to other parts of the body, particularly the liver. NENs can be classified as well-differentiated (which means the tumor cells look more like normal cells) or poorly-differentiated, with well-differentiated tumors generally growing more slowly.