Study on Aldesleukin and Dendritic Cell Vaccine for Patients with Resected Stage IV Neuroendocrine Tumors and Soft Tissue Sarcoma

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What is this study about?

This clinical trial is focused on studying two rare types of cancer: neuroendocrine tumors and soft tissue sarcoma. The study involves a treatment using a special type of vaccine called DC-VACCINE_IRSTIRCCS, which is made from the patient’s own tumor cells. This vaccine is designed to help the body’s immune system recognize and fight cancer cells. Another treatment being studied is Proleukin, which contains the active substance aldesleukin. Aldesleukin is a protein that can boost the immune system’s ability to attack cancer cells.

The purpose of this study is to evaluate the safety and effectiveness of these treatments in helping the immune system fight cancer. Participants in the study will receive the treatments over a period of six months. The DC-VACCINE_IRSTIRCCS is given through an injection into the skin, while Proleukin is administered as an injection under the skin. Throughout the study, participants will be monitored for any side effects and changes in their immune response to the cancer.

The study aims to understand how well these treatments work in preventing the return of cancer and improving overall survival. Researchers will also look at how the treatments affect the immune system’s ability to target cancer cells. The study will help determine if these treatments can be a safe and effective option for patients with these rare cancers.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

A CT scan or MRI of the chest, abdomen, and pelvis is performed to ensure the absence of disease. If the resected lesions occurred in other sites, these areas are also scanned.

2 preparation of vaccine

The autologous surgical specimen, previously collected, is sent to the Somatic Cell Therapy Lab for preparation. This specimen is used to create a personalized vaccine.

3 vaccination phase

The vaccination involves the administration of DC-VACCINE_IRSTIRCCS, which is a cell suspension for injection. This vaccine is given intradermally.

The vaccine is administered in a series of injections. The exact schedule and number of injections are determined by the study protocol.

4 administration of aldesleukin

Alongside the vaccine, Proleukin (aldesleukin) is administered. This is a solution for injection or infusion given subcutaneously.

The dosage is 18 million international units (UI) per administration. The frequency and duration of administration are specified in the study protocol.

5 monitoring and follow-up

Regular follow-up visits are scheduled to monitor health and assess the immune response. These visits include physical examinations and laboratory tests.

The primary focus is on safety and the immunological efficacy of the treatment. Any adverse events are recorded and managed according to the study guidelines.

6 end of study evaluation

At the end of the study, a comprehensive evaluation is conducted. This includes assessing overall survival and relapse-free survival.

The study aims to determine the proportion of patients experiencing significant adverse events and the enhancement of immune response.

Who Can Join the Study?

Patients must have a confirmed diagnosis of stage IV NeuroEndocrine Tumors (NET) or Soft Tissue Sarcoma (STS) and have had surgery to remove the tumor completely.
Female patients who can have children and all male patients must agree to use a very effective birth control method from the time they sign the consent form until three months after the study ends. This includes methods like using two forms of barrier protection, one barrier method with a sperm-killing product, an intrauterine device, or birth control pills. Complete abstinence from sex is also acceptable if it fits the patient’s lifestyle and is strictly followed.
The patient must be willing and able to provide written consent to participate in the study.
The patient’s surgical tissue sample must have been collected and sent to a specific lab and meet all the necessary quality standards.
The patient must be free of disease, as shown by a CT scan or MRI of the chest, abdomen, and pelvis done within 60 days before joining the study. If the removed tumors were in other areas, these must also be checked in the initial and all future scans.
Patients should be free of disease and only need observation, as no standard treatment is available after surgery.
The patient must have recovered from any side effects of previous surgery to a mild level or less.
The patient must be at least 18 years old.
The patient must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest.
The patient must have acceptable organ function, which includes:
- Haemoglobin levels above 10 g/dl
- White blood cell count of at least 3000 per microliter
- Absolute neutrophil count of at least 1500 per microliter
- Platelet count of at least 75000 per microliter
- AST and ALT levels less than 3 times the normal upper limit
- Total bilirubin less than 1.5 times the normal upper limit
- Serum creatinine less than 1.5 times the normal upper limit
Patients aged 70 years or older must have a left ventricular ejection fraction of at least 55%, as measured by an echocardiogram. This is a test that checks how well the heart is pumping blood.

Who Cannot Join the Study?

Patients with other types of cancer that are not neuroendocrine tumors or soft tissue sarcoma cannot participate. Neuroendocrine tumors are a type of cancer that starts in certain cells that release hormones into the blood. Soft tissue sarcoma is a cancer that begins in the tissues that connect, support, or surround other body structures.
Individuals who are not within the specified age range for the study cannot participate. The age range is typically defined by the study and may include specific age groups.
Participants who are part of a vulnerable population, such as those who may not be able to give informed consent, are not eligible for the study.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Icchfrmc Rwucjvolv Pfi Lj Scpmel Dix Tkkqxc Ddck Aasiakl Icht Skyhyv	Meldola	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	12.12.2019

Trial locations

Investigated drugs:

Dendritic Cells Loaded with Autologous Tumor Homogenate
This therapy involves using a type of immune cell called dendritic cells. These cells are taken from the patient’s body and are then loaded with a homogenate made from the patient’s own tumor. The goal is to help the immune system recognize and attack any remaining cancer cells after the tumor has been surgically removed. This approach is being tested for its safety and ability to stimulate the immune system in patients with certain rare cancers, such as neuroendocrine tumors and soft tissue sarcoma.

Investigated diseases:

Soft tissue sarcoma

Neuroendocrine Tumors – These are a group of tumors that originate from neuroendocrine cells, which have traits similar to nerve cells and hormone-producing cells. They can occur in various parts of the body, including the gastrointestinal tract, pancreas, and lungs. The progression of these tumors can vary significantly; some grow slowly and may not cause symptoms for years, while others can be more aggressive. Symptoms often depend on the location of the tumor and may include hormonal imbalances, pain, or digestive issues. As the disease progresses, it may lead to more pronounced symptoms due to increased hormone production or tumor growth affecting nearby organs.

Soft Tissue Sarcoma – This is a type of cancer that begins in the soft tissues of the body, such as muscles, fat, blood vessels, nerves, tendons, and the lining of joints. It can occur anywhere in the body but is most commonly found in the arms, legs, and trunk. The disease often starts as a painless lump or swelling, which may grow over time. As the tumor enlarges, it can press on nerves and muscles, causing pain or functional impairment. The progression of soft tissue sarcoma can vary, with some tumors growing slowly and others more rapidly, potentially spreading to other parts of the body.

Trial ID:

2023-510251-31-00

Protocol code:

IRST100.42

NCT ID:

NCT04166006

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Aldesleukin and Dendritic Cell Vaccine for Patients with Resected Stage IV Neuroendocrine Tumors and Soft Tissue Sarcoma

What is this study about?

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