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Ttf-Ngr

This article discusses the use of tTF-NGR, a novel drug being studied in clinical trials for patients with metastatic or refractory soft tissue sarcoma. The drug is being tested in combination with trabectedin, a standard chemotherapy treatment, to potentially improve outcomes for patients who have not responded to or are not suitable for traditional first-line therapies. The trial aims to evaluate the safety and effectiveness of this combination in prolonging progression-free survival and overall survival in patients with various types of advanced soft tissue sarcomas.

Table of Contents

What is TTF-NGR?

TTF-NGR is a new investigational drug being studied for the treatment of soft tissue sarcomas[1]. Soft tissue sarcomas are a group of rare cancers that develop in the soft tissues of the body, such as muscles, fat, nerves, and blood vessels. TTF-NGR is being tested in combination with another cancer drug called trabectedin to see if it can improve treatment outcomes for patients with advanced or metastatic soft tissue sarcomas.

How does TTF-NGR work?

TTF-NGR is designed to work in a unique way. It’s a protein-based drug that targets a specific molecule called CD13, which is found on the surface of many cancer cells and blood vessels that feed tumors[1]. The drug is believed to help trap another cancer medication (trabectedin) inside the tumor, potentially making the treatment more effective. This approach is sometimes called “tumor trapping” or “entrapping.”

What conditions does TTF-NGR treat?

TTF-NGR is being studied for the treatment of various types of soft tissue sarcomas, including[1]:

  • Liposarcoma: A cancer that develops in fat cells
  • Leiomyosarcoma: A cancer that starts in smooth muscle cells
  • Synovial sarcoma: A rare cancer that can occur near joints
  • Angiosarcoma: A cancer that forms in the lining of blood vessels
  • Rhabdomyosarcoma: A cancer that develops in skeletal muscle cells
  • Fibrosarcoma: A cancer that develops in fibrous tissue
  • Undifferentiated sarcoma: A type of sarcoma that doesn’t fit into other categories

These cancers are considered advanced or metastatic, meaning they have spread to other parts of the body or are no longer responding to initial treatments.

How is TTF-NGR administered?

TTF-NGR is given as an intravenous (IV) infusion, which means it’s delivered directly into the bloodstream through a vein[1]. In the current study, it’s being tested in combination with trabectedin, another cancer drug. The treatment schedule typically looks like this:

  1. Trabectedin is given as a 24-hour IV infusion on day 1
  2. TTF-NGR is given as a 1-hour IV infusion for up to 4 consecutive days following each trabectedin treatment
  3. This cycle is repeated every 22 days

The exact dose and number of days TTF-NGR is given may vary based on how well patients tolerate the treatment.

Who is eligible for TTF-NGR treatment?

The current study is looking at TTF-NGR for patients who meet specific criteria[1]:

  • Adults aged 18-75 years
  • Diagnosed with advanced or metastatic soft tissue sarcoma
  • Previous treatment with anthracycline-based chemotherapy that didn’t work or stopped working
  • Tumors that test positive for CD13, the molecule targeted by TTF-NGR
  • Able to perform daily activities with minimal assistance (ECOG Performance Status ≤ 2)

There are also several factors that might make someone ineligible for the treatment, such as certain medical conditions or previous cancer treatments. A healthcare provider can determine if a patient meets all the necessary criteria.

Potential side effects and precautions

As TTF-NGR is still being studied, all of its potential side effects are not yet known. However, based on its mechanism of action and the exclusion criteria for the study, there are some potential risks to be aware of[1]:

  • Increased risk of blood clots
  • Potential effects on wound healing
  • Possible allergic reactions, especially in people who have had reactions to E. coli-derived products

Patients with a history of heart disease, stroke, blood clots, or certain inherited blood disorders may not be eligible for treatment due to these potential risks.

Ongoing research

TTF-NGR is currently being studied in a Phase III clinical trial called TRABTRAP[1]. This study is comparing the effectiveness of trabectedin alone versus trabectedin plus TTF-NGR in patients with metastatic or refractory soft tissue sarcoma. The main goal is to see if adding TTF-NGR to trabectedin can help patients live longer without their cancer progressing.

It’s important to note that as an investigational drug, TTF-NGR is not yet approved for general use. It’s only available to patients participating in clinical trials. The results of these studies will help determine if TTF-NGR is safe and effective enough to become an approved treatment option in the future.

Aspect Details
Study Type Phase III randomized clinical trial
Condition Metastatic or refractory soft tissue sarcoma
Intervention Trabectedin + tTF-NGR vs. Trabectedin alone
Primary Endpoint Progression-free survival (PFS)
Key Eligibility Criteria Age 18-75, CD13 positivity, failure of or contraindication to anthracycline therapy
Treatment Schedule Trabectedin every 22 days, tTF-NGR for up to 4 days following each trabectedin dose
Safety Measures Initial safety run-in phase, ongoing monitoring of adverse events

FAQ

  • What is tTF-NGR and how does it work? tTF-NGR is an experimental drug being tested in combination with trabectedin for treating metastatic soft tissue sarcoma. It is designed to potentially enhance the effectiveness of trabectedin by helping to trap it inside the tumor, potentially improving its anti-cancer effects.
  • Who is eligible for this clinical trial? The trial is open to patients aged 18-75 with advanced or metastatic soft tissue sarcoma who have either not responded to first-line anthracycline therapy or have contraindications to these drugs. Patients must have measurable disease and meet specific criteria regarding tumor type and CD13 positivity.
  • What are the main objectives of the trial? The primary objective is to evaluate whether adding tTF-NGR to trabectedin prolongs progression-free survival compared to trabectedin alone. Secondary objectives include assessing the combination's effect on overall survival, response rate, and safety profile.
  • How is the treatment administered in the trial? Patients in the experimental arm receive trabectedin as a 24-hour intravenous infusion, followed by tTF-NGR as a 1-hour infusion for up to 4 consecutive days. This cycle is repeated every 22 days until disease progression or the development of contraindications.
  • What are the potential risks or side effects of participating in this trial? While specific side effects are not detailed in the provided information, the trial includes a safety run-in phase to establish a safe dose of tTF-NGR when combined with trabectedin. Patients are closely monitored for adverse events throughout the study. As with any clinical trial, there may be unknown risks associated with the experimental treatment.

Ongoing Clinical Trials on Ttf-Ngr

  • Study of Trabectedin alone versus Trabectedin with tTF-NGR combination therapy in adults with metastatic or refractory soft tissue sarcoma who failed first-line treatment

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Soft Tissue Sarcoma (STS): A type of cancer that develops in soft tissues such as muscles, tendons, fat, blood vessels, and nerves. It can occur in various parts of the body.
  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • Refractory: A condition that does not respond to treatment or stops responding after initial improvement.
  • Trabectedin: A standard chemotherapy drug used to treat certain types of soft tissue sarcoma.
  • tTF-NGR: An experimental drug being tested in combination with trabectedin for treating soft tissue sarcoma.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives without the cancer getting worse.
  • Overall survival: The length of time from the start of treatment that patients are still alive.
  • Anthracycline: A type of chemotherapy drug commonly used as first-line treatment for soft tissue sarcoma.
  • CD13 positivity: A characteristic of cancer cells that is being used as a criterion for patient selection in this study.
  • RECIST criteria: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.
  • Best supportive care (BSC): Care given to improve the quality of life of patients with serious illnesses, focusing on comfort and symptom management.

References

  1. http://clinicaltrials.eu/trial/study-on-trabectedin-and-ttf-ngr-for-patients-with-metastatic-or-refractory-soft-tissue-sarcoma/