Study of Dendritic Cell Vaccine and Aldesleukin Treatment in Patients After Surgery for Stage IV Colorectal Cancer

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What is this study about?

This clinical trial is studying treatment for patients with stage IV colorectal cancer who have undergone surgery to remove their tumors. The study uses two treatments: DC-VACCINE_IRSTIRCCS, which is made from the patient’s own cells (specifically dendritic cells loaded with tumor material), and Proleukin (also known as aldesleukin). Dendritic cells are important immune system cells that help the body recognize and fight cancer cells.

The purpose of this study is to evaluate how safe the treatment is and how well it stimulates the immune system to fight against cancer cells. The treatment involves taking some of the patient’s tumor tissue removed during surgery and using it to create a personalized vaccine. This vaccine is then injected under the skin along with Proleukin, which helps strengthen the immune response.

The treatment period lasts up to 6 months. The vaccine is given through intradermal injection (into the skin), while Proleukin is administered through subcutaneous injection (under the skin). During the study, doctors will monitor patients’ immune responses and check for any side effects from the treatment. This is a phase II study, which means it follows initial safety testing of the treatment in humans.

1 Initial vaccination preparation

Your tumor tissue sample will be processed in the laboratory to create a personalized vaccine.

A CT scan or MRI of your chest, abdomen, and pelvis will confirm you are disease-free before starting the treatment.

2 Treatment administration – Vaccine

You will receive DC-VACCINE through intradermal injections (into the skin).

The vaccine contains your own processed cells (dendritic cells) combined with your tumor tissue.

3 Treatment administration – Supporting medication

Proleukin will be administered through subcutaneous injection (under the skin).

This medication helps support your immune system’s response to the vaccine.

4 Monitoring and testing

Regular blood samples will be collected to monitor your immune system’s response.

A skin test will be performed to evaluate your response to the treatment.

Regular imaging scans will check for any signs of disease return.

5 Follow-up period

Your progress will be monitored for up to two years after treatment.

Regular blood samples will continue to be collected during follow-up appointments.

Imaging scans will be performed according to the follow-up schedule.

Who Can Join the Study?

You must have confirmed stage IV colorectal cancer that has been surgically treated with the intention to remove all cancer
You must be willing and able to provide written consent to participate in the study
Your surgical tissue sample must have been collected and sent to the laboratory meeting specific quality standards
You must be cancer-free, as shown by CT scan (detailed X-ray imaging) or MRI (magnetic resonance imaging) of your chest, abdomen, and pelvis within 60 days before joining the study
You must have recovered from any surgery-related side effects to mild or no symptoms
You must be over 18 years old
You must have good physical function, being able to carry out all or most daily activities (ECOG status 0 or 1)
Your major organs must be functioning properly
If you are 70 years or older, your heart must be pumping normally (at least 55% pumping capacity as measured by heart ultrasound)
If you are a woman who can become pregnant or a male participant, you must agree to use reliable birth control methods

Who Cannot Join the Study?

Age below 18 or above 65 years
Presence of active autoimmune diseases (conditions where the immune system attacks healthy cells)
History of organ transplantation
Active or chronic infections including hepatitis B, hepatitis C, or HIV
Pregnancy or breastfeeding
Severe heart conditions or uncontrolled high blood pressure
Severe liver or kidney dysfunction
History of other cancers in the past 5 years (except successfully treated non-melanoma skin cancer)
Current participation in other clinical trials
Mental conditions that could interfere with following study procedures
Use of medications that suppress the immune system within 4 weeks before the study
Major surgery within 4 weeks before starting the study
Brain or central nervous system metastases (cancer spread to brain)
Known allergies to components of the study treatment

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Irgynevg Rfrewsjdm Pmj Lq Sfnsid Duw Tmwyqi Ddhw Abrgxhn Imix Shfxjl	Meldola	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	19.04.2016

Trial locations

Investigated drugs:

Autologous dendritic cell vaccine is a personalized treatment made from the patient’s own immune cells. These cells are collected from the patient’s blood, specially processed in a laboratory, and then loaded with proteins from the patient’s own tumor tissue. When injected back into the patient, these modified cells help train the immune system to recognize and fight against remaining cancer cells. This type of immunotherapy is designed to work specifically for each individual patient’s cancer.

Autologous tumor homogenate is material created from the patient’s own tumor tissue that has been removed during surgery. The tumor tissue is processed into a form that can be combined with dendritic cells to create the personalized vaccine. This ensures that the immune response is targeted specifically to the patient’s unique cancer characteristics.

Investigated diseases:

Colorectal cancer metastatic

Stage IV Colorectal Cancer – A condition where cancer that began in the large intestine (colon) or rectum has spread beyond its original location to distant parts of the body. The cancer cells from the colon or rectum have traveled through the bloodstream or lymphatic system to create new tumors in other organs, most commonly the liver or lungs. In this stage, the cancer has grown through the wall of the colon or rectum and has established itself in other parts of the body. It typically develops from small growths called polyps that form on the inner lining of the colon or rectum and gradually become cancerous. The progression from early-stage colorectal cancer to stage IV occurs when cancer cells break away from the primary tumor and establish new tumors in distant organs.

Trial ID:

2024-516221-31-00

NCT ID:

NCT02919644

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Dendritic Cell Vaccine and Aldesleukin Treatment in Patients After Surgery for Stage IV Colorectal Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?