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Trabectedin

Trabectedin, also known as Yondelis, is an investigational drug being studied in clinical trials for various types of cancer. This article summarizes key information about ongoing clinical trials evaluating trabectedin’s safety and effectiveness in treating conditions like soft tissue sarcomas, prostate cancer, breast cancer, and other solid tumors. The trials aim to determine optimal dosing, assess response rates, and identify potential biomarkers to predict treatment outcomes.

Table of Contents

What is Trabectedin?

Trabectedin, also known by its brand names Yondelis, ET-743, or IMLYGIC, is a chemotherapy drug used to treat certain types of cancers[1][2]. It is derived from a marine organism and belongs to a class of drugs called alkylating agents, which work by damaging the DNA of cancer cells to stop them from growing and dividing[3].

What Conditions Does Trabectedin Treat?

Trabectedin is primarily used to treat the following conditions:

  • Soft Tissue Sarcomas: These are rare cancers that develop in the body’s soft tissues, such as muscles, tendons, and fat[1][2].
  • Liposarcoma and Leiomyosarcoma: Specific types of soft tissue sarcomas that Trabectedin has shown effectiveness against[3].
  • Advanced Breast Cancer: Some studies have explored the use of Trabectedin in patients with advanced breast cancer[4].
  • Prostate Cancer: Research has been conducted on the potential use of Trabectedin in advanced prostate cancer[5][6].
  • Pediatric Solid Tumors: Some clinical trials have investigated the use of Trabectedin in children with refractory (resistant to treatment) solid tumors[7].
  • Pancreatic Cancer: Studies have explored the use of Trabectedin in metastatic pancreatic cancer after first-line chemotherapy[8].

How Does Trabectedin Work?

Trabectedin works by interfering with the DNA of cancer cells. It binds to the DNA, causing damage and preventing the cells from dividing and growing. This action can lead to the death of cancer cells or stop them from spreading further[3]. Additionally, some research suggests that Trabectedin may also affect the tumor microenvironment, which is the area surrounding the cancer cells, potentially enhancing its anti-cancer effects[1].

How is Trabectedin Administered?

Trabectedin is typically administered as an intravenous (IV) infusion, which means it is given directly into a vein. The specific dosage and schedule can vary depending on the condition being treated and the individual patient. Some common administration methods include:

  • A 24-hour infusion every 3 weeks[2]
  • A 3-hour infusion weekly for 3 weeks, followed by a week of rest[4]
  • Doses ranging from 1.0 to 1.5 mg/m² (milligrams per square meter of body surface area)[1][6]

Trabectedin is often given through a central venous catheter, which is a special tube placed into a large vein for easier administration of medications[4]. Patients may also receive other medications, such as dexamethasone, before Trabectedin to help manage potential side effects[6].

Clinical Trials and Research

Numerous clinical trials have been conducted to evaluate the effectiveness and safety of Trabectedin in various cancer types. These trials have explored different dosing regimens, combination therapies, and potential biomarkers that might predict treatment response[1][2][3]. Some notable areas of research include:

  • Combining Trabectedin with other cancer treatments, such as immunotherapy drugs (e.g., Ipilimumab and Nivolumab)[1]
  • Investigating the effectiveness of Trabectedin in specific soft tissue sarcoma subtypes[9]
  • Exploring the use of Trabectedin in patients who are not suitable for standard chemotherapy regimens[2]
  • Studying the impact of Trabectedin on the tumor microenvironment and immune cell trafficking[1]

Potential Side Effects

Like all cancer treatments, Trabectedin can cause side effects. The severity and types of side effects can vary from person to person. Some potential side effects include:

  • Fatigue
  • Nausea and vomiting
  • Decreased blood cell counts (which can increase the risk of infection, anemia, or bleeding)
  • Liver function abnormalities
  • Muscle and joint pain

It’s important to discuss potential side effects with your healthcare team, as they can provide guidance on managing these effects and may adjust your treatment if necessary[2][9].

Effectiveness of Trabectedin

The effectiveness of Trabectedin can vary depending on the type of cancer and individual patient factors. In clinical trials, Trabectedin has shown promising results in certain soft tissue sarcomas, particularly liposarcoma and leiomyosarcoma[3]. Some key points about its effectiveness include:

  • Trabectedin has been shown to improve progression-free survival (the time during which the cancer does not worsen) in some patients with soft tissue sarcomas[2][9].
  • Response rates (the percentage of patients whose cancer shrinks or disappears after treatment) vary but are generally modest, often around 10-30%[4][6].
  • Some patients experience stable disease, meaning their cancer neither grows nor shrinks significantly, which can be considered a positive outcome in advanced cancers[2].
  • Research is ongoing to identify which patients are most likely to benefit from Trabectedin and how to optimize its use in combination with other treatments[1][9].

It’s important to remember that the effectiveness of any cancer treatment, including Trabectedin, can vary greatly from person to person. Your oncologist is the best source of information about how this treatment might work for your specific situation.

Aspect Details
Drug Name Trabectedin (Yondelis, ET-743)
Cancer Types Studied Soft tissue sarcomas, prostate cancer, breast cancer, pancreatic cancer, pediatric solid tumors
Administration Intravenous infusion, various schedules (e.g. weekly, every 3 weeks)
Common Dosages 0.58-1.5 mg/m2, depending on schedule and cancer type
Key Outcomes Measured Tumor response rates, progression-free survival, overall survival, safety/toxicity
Notable Side Effects Bone marrow suppression, liver toxicity, fatigue
Treatment Duration Until disease progression or unacceptable toxicity; some trials up to 52 weeks or longer
Combination Therapies Some trials combining with radiation therapy or other drugs

FAQ

  • What types of cancer is trabectedin being studied for? Trabectedin is being investigated in clinical trials for several types of cancer, including soft tissue sarcomas, prostate cancer, breast cancer, pancreatic cancer, and other solid tumors in both adults and children.
  • How is trabectedin administered in these trials? Trabectedin is typically administered as an intravenous (IV) infusion. The dosing and schedule vary between trials, but common regimens include 3-hour infusions given weekly or 24-hour infusions given every 3 weeks.
  • What are some of the main outcomes being measured in trabectedin trials? Key outcomes being assessed include tumor response rates, progression-free survival, overall survival, safety/adverse events, and quality of life measures. Some trials are also looking at biomarkers that may predict response to treatment.
  • Are there any notable side effects of trabectedin reported in trials? While specific side effects vary between trials, common adverse events monitored include bone marrow suppression, liver toxicity, and fatigue. Patients typically receive premedication to help manage side effects.
  • How long do patients typically stay on trabectedin treatment in clinical trials? Treatment duration varies, but patients often continue receiving trabectedin in cycles (e.g. every 3 weeks) until disease progression or unacceptable toxicity occurs. Some trials allow treatment for up to 52 weeks or longer if patients are benefiting.

Ongoing Clinical Trials on Trabectedin

  • Study on Post-Operative Chemotherapy with Doxorubicin and Trabectedin for Patients with High-Risk Localized Uterine Leiomyosarcoma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study of Dostarlimab for Patients with Advanced or Metastatic Non-Colorectal/Non-Endometrial Cancer with dMMR/MSI, Compared to Standard Drug Combination

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study of Trabectedin and Low-Dose Radiation Therapy for Adults and Young Adults with Advanced or Metastatic Soft Tissue and Bone Sarcomas

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study Comparing Trabectedin and Gemcitabine for Patients with Advanced or Metastatic Leiomyosarcoma After Chemotherapy

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on Trabectedin for Adults and Young Adults with Advanced Mesenchymal Chondrosarcoma

    Recruiting

    1 1 1
    Investigated drugs:
    Italy

  • Study on Trabectedin and Radiotherapy for Patients with Soft Tissue Sarcoma

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Spain

  • Study on the Effectiveness and Safety of INT230-6 (Vinblastine Sulfate, Cisplatin) for Adults with Metastatic Soft Tissue Sarcomas

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Poland Spain

  • Study on Doxorubicin Hydrochloride and Trabectedin for Patients with Recurrent Ovarian Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

Glossary

  • Trabectedin: An investigational chemotherapy drug derived from a sea squirt, also known by the brand name Yondelis. It works by interfering with DNA in cancer cells to stop them from growing and dividing.
  • Soft tissue sarcoma: A type of cancer that develops in soft tissues like muscles, tendons, fat, blood vessels, and nerves. There are many subtypes of soft tissue sarcomas.
  • Metastatic: Cancer that has spread from where it started to other parts of the body. Also called stage IV cancer.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives without the cancer getting worse.
  • Overall survival (OS): The length of time from the start of treatment that patients diagnosed with the disease are still alive.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease associated with the use of a medical treatment or procedure.
  • Biomarker: A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease.
  • Pharmacokinetics: The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body.
  • Dose-limiting toxicity: Side effects of a drug that are severe enough to prevent an increase in dose or require a decrease in dose.
  • Central venous catheter: A thin, flexible tube inserted into a large vein, usually in the chest, to give medications or fluids or to take blood samples.

References

  1. https://clinicaltrials.gov/study/NCT03886311
  2. https://clinicaltrials.gov/study/NCT02066675
  3. https://clinicaltrials.gov/study/NCT03138161
  4. https://clinicaltrials.gov/study/NCT00050427
  5. https://clinicaltrials.gov/study/NCT00147212
  6. https://clinicaltrials.gov/study/NCT00072670
  7. https://clinicaltrials.gov/study/NCT00006463
  8. https://clinicaltrials.gov/study/NCT01339754
  9. https://clinicaltrials.gov/study/NCT02793050