Not recruiting

Study on the Effects of XP-DC+TL+KLH in Patients with Ovarian Cancer Undergoing Chemotherapy

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying ovarian cancer, a type of cancer that begins in the ovaries. The study is investigating a new treatment involving a special type of cell therapy. This treatment uses a substance called XP-DC+TL+KLH, which is a suspension for injection. The treatment is designed to help the body's immune system recognize and fight cancer cells more effectively.

The purpose of the study is to see if this new treatment can improve the immune response in patients with ovarian cancer who are also receiving chemotherapy. The study will involve patients receiving injections of the treatment, which is administered directly into the lymph nodes, a process known as intranodal injection. The study aims to observe how the immune system reacts to this treatment over time.

Participants in the study will receive the treatment alongside their regular chemotherapy. The study will monitor the immune response to see if the treatment helps the body to better target and attack cancer cells. This research is part of an effort to find more effective treatments for ovarian cancer and improve outcomes for patients with this disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be informed about the trial's purpose, procedures, and potential risks and benefits. You will be required to provide informed consent, confirming your understanding and willingness to participate.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes a review of your medical history and a series of tests to ensure you meet the study's criteria, such as blood tests and imaging studies.
Step 3
Treatment phase
During the treatment phase, you will receive a series of injections. The medication used is a suspension for injection containing xp-dc+tl+klh. These injections are administered intranodally, meaning they are given directly into the lymph nodes.
The frequency and duration of these injections will be determined by the study protocol, and you will be informed of the schedule in advance.
Step 4
Monitoring and follow-up
Throughout the trial, your health and response to the treatment will be closely monitored. This includes regular check-ups, blood tests, and other necessary assessments to evaluate the immune response and any side effects.
You will be required to attend follow-up visits as scheduled by the study team to ensure your safety and the collection of accurate data.
Step 5
Completion of the study
At the end of the study, a final assessment will be conducted to evaluate the overall outcomes and your health status. You will be informed about the results and any further steps if necessary.

Who can join the trial?

17 criteria

Women over 18 years old with a confirmed diagnosis of primary epithelial ovarian cancer.
Patients who cannot have primary debulking surgery and need chemotherapy before and after surgery.
Cancer type must be high-grade serous.
Cancer stage must be FIGO stage IIIb, IIIc, IVa, or IVb with specific conditions on lymph nodes.
Extensive spread of the tumor in the abdomen.
General health status must be good, with a WHO/ECOG performance status of 0-1, meaning fully active or restricted in physically strenuous activity but able to carry out light work.
Blood tests must show:
- Neutrophils (a type of white blood cell) greater than 1.5 x 10⁹/L
- Lymphocytes (another type of white blood cell) greater than 0.8 x 10⁹/L
- Platelets (cells that help with blood clotting) greater than 100 x 10⁹/L
- Hemoglobin (a protein in red blood cells) greater than 5.6 mmol/L (9.0 g/dl)
- Kidney function with an estimated glomerular filtration rate greater than 45 ml/min/1.73m²
- Liver enzymes (AST/ALT) less than 3 times the upper limit of normal
- Serum bilirubin (a substance made by the liver) less than 1.5 times the upper limit of normal, except for those with Gilbert’s syndrome
- Ability to attend follow-up appointments as expected.
- Must be postmenopausal or have evidence of not being able to have children. If of childbearing potential, a negative pregnancy test is required within 28 days before starting the study and confirmed on the first day of treatment. Postmenopausal is defined as:
  - No menstrual periods for 1 year or more after stopping hormone treatments
  - Or surgical sterilization (removal of ovaries or uterus)
  - Must provide informed consent, meaning they understand the study and agree to participate.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with ovarian cancer cannot participate.
Only female patients are eligible for this study.
Patients who are younger than 18 years old or older than 65 years old cannot participate.
Patients who are part of a vulnerable population are not eligible. This means groups that might need special protection, like children or people who cannot make decisions for themselves.

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Responsive
Stichting Radboud University Medical Center
Nijmegen, The Netherlands

Trial locations

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Investigated drugs

XP-DC is a type of therapy that uses special cells called dendritic cells. These cells are designed to help the body's immune system recognize and fight cancer cells. In this trial, the dendritic cells are loaded with tumor material, which helps them teach the immune system to target and destroy cancer cells more effectively. This therapy is being tested in patients with epithelial ovarian cancer who are also receiving chemotherapy.

Xp-Dc+Tl+Klh

What is already known about the treatment

XP-DC – This medication is administered through specialized dendritic cells that are loaded with tumor lysate, and it is given to patients with epithelial ovarian cancer as part of their chemotherapy treatment. Currently, XP-DC is being studied in clinical trials to assess its effectiveness in boosting the immune system's response against cancer cells. The main therapeutic indication for XP-DC is ovarian cancer, where it aims to enhance the body's immune response to fight the cancer more effectively. At the molecular level, XP-DC works by presenting cancer-specific antigens to the immune system, thereby activating T cells to target and destroy cancer cells. It falls under the pharmacological classification of immunotherapy, which is a type of treatment that uses the body's own immune system to combat diseases like cancer.

Investigated diseases

Ovarian cancer – Ovarian cancer is a type of cancer that begins in the ovaries, which are the female reproductive glands where eggs are produced. It often starts in the outer layer of the ovaries, known as the epithelium. The disease can progress silently, with symptoms often appearing only in advanced stages. As it advances, cancer cells can spread to nearby tissues and organs, such as the pelvis and abdomen. The progression may involve the formation of tumors that can affect the function of the ovaries and other organs. Over time, the cancer can metastasize to distant parts of the body through the lymphatic system or bloodstream.