Study of PM14 Alone and with Radiotherapy for Patients with Advanced Soft Tissue Sarcomas and Other Solid Tumors

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment called PM14 on certain types of cancers known as soft tissue sarcomas and other solid tumors. Soft tissue sarcomas are a group of cancers that begin in the tissues that connect, support, or surround other structures and organs of the body. Solid tumors refer to abnormal masses of tissue that usually do not contain cysts or liquid areas. The treatment being tested, PM14, is a medication that is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of this study is to explore different ways of using PM14, both on its own and in combination with radiotherapy, which is a treatment that uses high doses of radiation to kill cancer cells and shrink tumors. The study is divided into different groups, or cohorts, each testing a specific treatment plan. Some groups will receive PM14 alone, while others will receive PM14 along with radiotherapy. The study aims to find the best dose of PM14 that can be safely used and to see how well it works in stopping the cancer from growing or spreading.

Participants in the study will receive PM14 in different schedules, such as a 24-hour infusion or shorter infusions over consecutive days. The study will also look at how the treatment affects the participants’ quality of life and any side effects they may experience. The trial will provide valuable information about the potential benefits and risks of PM14 for treating these types of cancers, helping to determine if it could be a useful option for patients in the future.

1 initial treatment phase

Upon joining the study, the patient will begin treatment with PM14, a medication administered through a vein (intravenous).

The medication is provided as a powder that is mixed into a solution for infusion.

2 treatment schedule

The treatment involves different schedules depending on the cohort:

Cohorts A and E: PM14 is given over 24 hours.

Cohorts B and F: PM14 is given over 3 hours for 3 consecutive days.

Cohort C: PM14 is combined with radiotherapy, which involves 3 Gy of radiation for 10 days, totaling 30 Gy.

Cohort D: PM14 is combined with a different radiotherapy schedule, involving 1.8 Gy of radiation for 25 days, totaling 45 Gy.

3 monitoring and assessments

Throughout the trial, the patient’s response to treatment will be monitored through regular assessments.

These assessments include physical examinations, laboratory tests, and imaging studies to evaluate the size and progression of tumors.

The patient’s quality of life will also be assessed using a questionnaire.

4 evaluation of treatment response

The effectiveness of the treatment will be evaluated by measuring the progression-free survival rate at 6 months for certain cohorts.

For other cohorts, the overall response rate will be assessed, focusing on the reduction in tumor size or complete disappearance of the tumor.

5 end of treatment

The trial is expected to conclude by December 19, 2025.

At the end of the treatment period, a final assessment will be conducted to determine the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

Patients must voluntarily sign the informed consent before any study test is conducted that is not part of routine patient care.
Patients must have a diagnosis of advanced soft tissue sarcoma, or recurrent head and neck cancer suitable for reirradiation, or other advanced or metastatic solid tumor not suitable for surgery. A centralized diagnosis will be performed, and the tumor sample must be available and sent before starting treatment.
Patients must have received a previous chemotherapy treatment for advanced disease.
A centralized diagnosis of sarcoma is required, which includes specific types like undifferentiated pleomorphic sarcoma, leiomyosarcoma, and others.
Disease distribution must allow meeting normal tissue constraints of radiation therapy, confirmed by a radiation oncologist.
Metastatic spread could be present in several organs, but not all locations need to be irradiated.
Lesions considered for radiation therapy should be related to symptoms.
Not all lesions need to be under radiation fields, but priority is given to those with greater size increase and those related to symptoms.
Radiological disease progression must be documented within 6 months before study entry.
Patients must be eligible for systemic chemotherapy, with a maximum of three previous treatments for advanced/metastatic disease allowed.
Normal heart function is required, with a left ventricular ejection fraction (LVEF) of at least 50%.
Age must be between 18 and 75 years.
Measurable disease according to specific criteria is required.
Performance status must be 0 or 1, which indicates the patient’s ability to perform daily activities.
Men and women of childbearing potential must use effective contraception before and during the study, and for a period after the study ends. Women must have a negative pregnancy test before entering the study.
Patients must have a diagnosis of localized soft tissue sarcoma with specific risk criteria.
Patients must be diagnosed by core-biopsy, with the time between biopsy and enrollment being less than 6 weeks.
Patients must have a central venous catheter for treatment.
Patients must have a diagnosis of soft tissue sarcoma with metastasis, not suitable for surgery, with a centralized diagnosis confirmation.
HBV and HCV serologies must be performed before inclusion. If positive, further testing or preventive treatment may be required.

Who Cannot Join the Study?

Patients who are not able to understand or follow the study instructions.
Patients who have a medical condition that could interfere with the study results.
Patients who are currently participating in another clinical trial.
Patients who have had another type of cancer in the past, unless it was treated and cured.
Patients who are pregnant or breastfeeding.
Patients who have an infection that is not well controlled.
Patients who have a history of severe allergic reactions.
Patients who have a serious heart condition.
Patients who have a serious liver or kidney disease.
Patients who have a mental health condition that could interfere with the study.
Patients who have used certain medications that could affect the study results.
Patients who have a history of drug or alcohol abuse.
Patients who have had a major surgery recently.
Patients who have a condition that affects their immune system.
Patients who have a blood disorder that affects clotting.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario De Canarias	La Laguna	Spain
Hdnrbyxr Ujcgsxxrusame Dklkihoe	Donostia / San Sebastian	Spain
Husefdfs Dj Lf Sqtsm Clbu I Sddf Pzk	Barcelona	Spain
Hbgeujwe Vhiy dqdtqina	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.09.2021

Trial locations

PM14 is an investigational medication being studied for its potential use in treating advanced sarcomas and other solid tumors. It is being tested in different dosing schedules to find the most effective and tolerable way to administer it. The goal is to determine the maximum dose that patients can tolerate and to evaluate how well it works in stopping the progression of the disease.

Radiotherapy is a treatment that uses high doses of radiation to kill cancer cells and shrink tumors. In this trial, radiotherapy is combined with PM14 to see if the combination is more effective than PM14 alone. The radiotherapy is given in specific doses over a set number of days, depending on the type of cancer being treated. The aim is to assess the response of the tumors to this combined treatment and to provide relief from symptoms.

Investigated diseases:

Soft tissue sarcoma

Soft Tissue Sarcomas – Soft tissue sarcomas are a group of cancers that begin in the tissues that connect, support, or surround other structures and organs of the body. These tissues include muscle, fat, blood vessels, nerves, tendons, and the lining of the joints. The disease can occur anywhere in the body but is most commonly found in the arms, legs, and trunk. As the sarcoma grows, it may cause a noticeable lump or swelling. Over time, it can invade nearby tissues and spread to other parts of the body. The progression of the disease varies depending on the type and location of the sarcoma.

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in any organ or tissue, including the bones, muscles, and organs. Unlike blood cancers, solid tumors form a mass and can be benign (non-cancerous) or malignant (cancerous). As they grow, they may press on nearby organs, nerves, and blood vessels, causing symptoms. The growth rate and spread of solid tumors depend on their type and location. Malignant solid tumors can invade surrounding tissues and metastasize to distant parts of the body.

Trial ID:

2024-519893-38-00

NCT ID:

NCT05146440

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of PM14 Alone and with Radiotherapy for Patients with Advanced Soft Tissue Sarcomas and Other Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?