Study of L-Annamycin Treatment for Patients with Previously Treated Metastatic Soft Tissue Sarcoma

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What is this study about?

This study focuses on patients with metastatic soft-tissue sarcomas, a type of cancer that develops in soft tissues and has spread to other parts of the body. The research evaluates a medication called Liposomal Annamycin, which belongs to a group of drugs known as anthracyclines that are used to treat various types of cancer. The medication is given through intravenous administration (directly into a vein).

The purpose of this research is to test how well patients tolerate Liposomal Annamycin when given weekly and to determine how effective it is in treating metastatic soft-tissue sarcomas. The study is divided into two parts: the first part focuses on finding the right dose that can be safely given to patients, while the second part examines how well the treatment works.

The study involves patients who have already received previous treatment for their cancer, including prior therapy with anthracycline medications. During the study, participants will receive Liposomal Annamycin treatment, and their response to the medication will be monitored through regular medical examinations and imaging tests. The treatment will continue as long as patients show benefit from it and do not experience unacceptable side effects.

1 Initial qualification

You must be 18 years or older with confirmed soft-tissue sarcoma and metastases

Your physical condition will be evaluated using the ECOG scale (a measure of your ability to perform daily activities)

Your life expectancy should be greater than three months

You must have at least one measurable tumor larger than 10 millimeters

2 Medical history verification

You must have previously received anthracycline therapy (a type of cancer medication)

For phase II trial participants: maximum of three previous treatment courses are allowed

At least two weeks must have passed since your last treatment

Any side effects from previous treatments must have improved to mild level or returned to your normal state within four weeks

3 Laboratory tests

Blood tests will check your:

– White blood cell count (neutrophils ≥ 1500/mL)

– Platelet count (≥100,000/mL)

– Hemoglobin levels (≥8.0 g/dL)

– Kidney function

– Liver function

4 Treatment administration

You will receive Liposomal Annamycin through an intravenous infusion (into your vein)

The medication will be given on a weekly schedule

Regular monitoring will assess how your body responds to the treatment

5 Ongoing monitoring

Your tumor size will be measured regularly using imaging tests

Your overall health status will be monitored throughout the study

The study will continue until December 31, 2025

6 Safety requirements

You must use effective contraception methods during the study and for six months after completing treatment

Women must use two forms of contraception (such as intrauterine device, oral contraceptive, or double barrier device)

Men and their partners must also use effective contraception methods during this period

Who Can Join the Study?

Must be 18 years or older when signing the consent form
Must have an ECOG performance status of 2 or less (meaning able to perform most daily activities) and life expectancy greater than 3 months
Must have confirmed soft tissue sarcoma (a type of cancer that develops in soft tissues) with spread to other parts of body (metastases) that cannot be cured with surgery
Must have at least one measurable tumor that is larger than 10 millimeters
Must have previously received anthracycline therapy (a type of chemotherapy) and shown disease progression
Must have completed previous treatments at least 2 weeks before starting the study, with side effects resolved
Must have adequate blood test results, including:
- Sufficient white blood cells and platelets
- Hemoglobin level of 8.0 g/dL or higher
- Good kidney function
- Normal or near-normal liver function tests
Must be able to understand and sign the consent form and follow study requirements
Must agree to use effective birth control methods during the study and for 6 months after:
- Women must use two forms of contraception
- Men and their partners must use effective contraception

Who Cannot Join the Study?

History of allergic reactions or severe sensitivity to similar drugs or their components
Presence of brain metastases (cancer that has spread to the brain) unless treated and stable for at least 4 weeks
Heart problems, including:
– Heart failure
– Irregular heartbeat
– Heart attack within the last 6 months
Severe liver problems or abnormal liver function tests
Kidney problems requiring dialysis
Active, uncontrolled infections requiring treatment
Other types of cancer within the last 3 years (except for adequately treated non-melanoma skin cancer or cervical cancer)
Blood disorders that significantly affect blood cell counts
Participation in other clinical trials within 4 weeks before starting this study
Pregnancy or breastfeeding
Inability or unwillingness to use effective birth control methods during the study
Any condition that, in the opinion of the study doctor, would make participation unsafe
Unable to understand or sign the informed consent form

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Nvhkngmo Ixpdcyep Odpvwgjje Ifz Mknkt Sdmvgvhcdgvygqwaegfdjnvbkccd Izflmplr Brrafeud	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	01.10.2022

Trial locations

Investigated drugs:

Annamycin

L-Annamycin (Liposomal Annamycin) is a medication being studied for treating soft tissue sarcomas that have spread to other parts of the body. It is a chemotherapy drug that has been modified with a special coating (liposomal) to help it work better in the body. This medication is designed to fight cancer cells in patients who have already received previous treatment for their sarcoma. The liposomal formulation may help reduce some side effects while maintaining the medication’s effectiveness against cancer cells.

Investigated diseases:

Soft tissue sarcoma

Soft Tissue Sarcoma – A group of cancers that develop in the body’s soft tissues, including muscles, tendons, fat, blood vessels, nerves, and deep skin tissues. This cancer can occur anywhere in the body, though it most commonly starts in the arms, legs, or abdomen. Soft tissue sarcomas typically begin as a painless lump that grows over time. When the disease spreads (metastasizes), it commonly travels to the lungs, though it can also spread to other organs. The cancer cells can break away from the original tumor and travel through the bloodstream or lymphatic system to form new tumors in other parts of the body.

Metastatic Soft Tissue Sarcoma – An advanced stage of soft tissue sarcoma where cancer cells have spread from their original location to other parts of the body. The metastatic process occurs when cancer cells break away from the primary tumor and travel through blood vessels or lymph nodes to establish new tumors in distant locations. In this stage, tumors can be found in multiple areas of the body simultaneously. The disease typically maintains similar characteristics to the original tumor but now affects multiple sites.

Trial ID:

2024-517678-12-00

Protocol code:

ANNA-SARC

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of L-Annamycin Treatment for Patients with Previously Treated Metastatic Soft Tissue Sarcoma

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