Not recruiting

Study of Nivolumab with Chemotherapy for Children and Teenagers with Refractory or Relapsing Solid Tumors or Lymphoma

Verified siteRegistered drugNo 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 treatments for children and teenagers with refractory or relapsing solid tumors. These are types of cancer that have not responded to standard treatments or have returned after treatment. The study will explore the use of a medication called Nivolumab, which is an anti-PD1 drug, in combination with different chemotherapy regimens. Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells. The chemotherapy drugs being tested in this study include Cyclophosphamide, Vinblastine, and Capecitabine. These drugs will be given in a specific way called metronomic chemotherapy, which involves taking lower doses of chemotherapy drugs more frequently.

The purpose of the study is to find out which combination of these treatments is safe and effective for young patients with these challenging types of cancer. In the first stage of the study, researchers will determine which of the three chemotherapy regimens is safe to use with Nivolumab. The regimens being tested are: Cyclophosphamide and Vinblastine; Capecitabine alone; and a combination of Cyclophosphamide, Vinblastine, and Capecitabine. In the second stage, the study will focus on the most promising regimen from the first stage, with or without Nivolumab, to see how well it works in preventing the cancer from getting worse.

Participants in the study will receive their treatments either through an intravenous method, which means the medication is given directly into a vein, or orally, which means taking the medication by mouth. The study will monitor the participants over time to assess the safety of the treatments and their effectiveness in controlling the cancer. The study aims to provide valuable information that could lead to better treatment options for children and teenagers facing these difficult cancers.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.
A series of tests and evaluations are performed to ensure the patient meets the study criteria, such as blood tests and imaging scans.
Step 2
Treatment assignment
Patients are assigned to one of three treatment groups, known as Arm A, Arm B, or Arm C.
Arm A involves taking cyclophosphamide and vinblastine. Arm B involves taking capecitabine. Arm C involves taking cyclophosphamide, vinblastine, and capecitabine.
Step 3
Medication administration
For Arm A and Arm C, vinblastine is administered through an intravenous (IV) infusion. Cyclophosphamide is taken orally.
For Arm B and Arm C, capecitabine is taken orally. The specific dosage and frequency are determined by the study team.
Step 4
Nivolumab administration
In the second stage of the trial, nivolumab may be administered in combination with the selected chemotherapy regimen. This is given through an IV infusion.
The frequency and duration of nivolumab administration are determined by the study protocol.
Step 5
Regular monitoring
Throughout the trial, regular monitoring is conducted to assess health status and response to treatment. This includes physical exams, blood tests, and imaging scans.
Patients are required to report any side effects or changes in health to the study team promptly.
Step 6
Follow-up assessments
Follow-up assessments are scheduled at specific intervals to evaluate the effectiveness of the treatment and monitor for any long-term effects.
These assessments may continue for a period after the treatment has ended, as specified by the study protocol.

Who can join the trial?

16 criteria

Diagnosis of a solid malignant tumor or lymphoma that is confirmed by a test called a histology.
The disease must be progressive (getting worse) or refractory (not responding to treatment) despite standard therapy, or there is no effective standard therapy available.
Patients who are sexually active must agree to use appropriate birth control while taking the study drug and for 6 months after stopping for young men, and for 12 months after stopping for young women.
Patients can be on stable doses of corticosteroids (less than 0.25 mg per kg per day of prednisolone or equivalent) during the 7 days before receiving study drugs.
Written informed consent must be provided by parents or legal representatives, and the patient must agree if they are old enough to understand, before any study-specific procedures are done.
Patients must be part of a social security system or have similar coverage according to local requirements.
Patients may have had previous treatment with anti-PD1 or anti-PDL1 drugs if they had at least stable disease for 6 months or a partial or complete response.
Patients with a known partial deficiency of an enzyme called dihydro-pyrimidine-deshydrogenase (DPD) are eligible if their uracilemia value is between 16 ng/ml and 150 ng/ml.
Adult patients or their parents/legal representatives must understand how to prepare a liquid form of the drug capecitabine at home.
Patients must be less than 18 years old at the time of joining the study. Patients 18 years and older may be included after discussion if they have a pediatric cancer diagnosed before the age of 18.
The disease must be measurable or evaluable by standard imaging criteria for the specific type of tumor.
Patients must have a performance status score of 70% or higher, which means they are able to carry out daily activities with some limitations.
Life expectancy must be at least 3 months.
Patients must have adequate organ function, including blood, heart, kidney, and liver function, as defined by specific medical tests.
Patients must be able to comply with scheduled follow-up visits and manage any side effects of the treatment.
Females who can have children must have a negative pregnancy test within 7 days before starting treatment.

Who cannot join the trial?

8 criteria

Patients with a progressive or refractory pediatric solid tumor cannot participate. This means the tumor is either growing despite treatment or not responding to treatment.
Patients who are not within the age range of 2 to 18 years old are excluded.
Patients who are not able to follow the study procedures or take the study medications as required will be excluded.
Patients who have other medical conditions that might interfere with the study or pose a risk to their health if they participate will not be allowed to join.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who have received certain treatments or medications that might interfere with the study drugs will be excluded.
Patients who have a history of severe allergic reactions to any of the study drugs or similar drugs will not be allowed to participate.
Patients who have an active infection or other serious illness that could affect their ability to participate in the study will be excluded.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France
Centre Leon Berard
Verified
Lyon, France

Trial locations

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Investigated drugs

Nivolumab
is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, Nivolumab is being tested in combination with other treatments to see if it can help treat children and teenagers with solid tumors or lymphoma that have not responded to other treatments or have come back after treatment.
Cyclophosphamide
is a chemotherapy drug that works by slowing or stopping the growth of cancer cells. It is used in this trial as part of a combination treatment to see if it can help treat solid tumors or lymphoma in children and teenagers when other treatments have not worked.
Vinblastine
is another chemotherapy medication that helps stop the growth of cancer cells. In this trial, it is used in combination with other drugs to test its effectiveness in treating children and teenagers with solid tumors or lymphoma that are difficult to treat.
Capecitabine
is a chemotherapy drug that is taken by mouth and is converted into another drug called 5-fluorouracil in the body. It works by interfering with the growth of cancer cells. In this trial, Capecitabine is being tested to see if it can help treat solid tumors or lymphoma in children and teenagers when used with other medications.

What is already known about the treatment

Nivolumab
Nivolumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating progressive or refractory pediatric solid tumors. The main therapeutic use of Nivolumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein called PD-1, which can prevent the immune system from attacking cancer cells. Nivolumab is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system fight cancer.
Cyclophosphamide
Cyclophosphamide is taken orally in pill form or administered intravenously. It is being evaluated in combination with other drugs for treating pediatric solid tumors that are difficult to treat or have returned after treatment. Cyclophosphamide works by interfering with the DNA of cancer cells, preventing them from growing and dividing. It is classified as an alkylating agent, a type of chemotherapy that damages the DNA of cancer cells.
Vinblastine
Vinblastine is administered intravenously, directly into the bloodstream. It is part of a combination treatment being tested for pediatric solid tumors that are resistant to other treatments. Vinblastine works by disrupting the process of cell division, which stops cancer cells from multiplying. It is classified as a vinca alkaloid, a type of chemotherapy derived from the periwinkle plant.
Capecitabine
Capecitabine is taken orally in pill form. It is being studied as part of a combination therapy for treating difficult-to-treat pediatric solid tumors. Capecitabine is converted into 5-fluorouracil (5-FU) in the body, which interferes with the DNA and RNA of cancer cells, preventing them from growing. It is classified as an antimetabolite, a type of chemotherapy that mimics the building blocks of DNA and RNA, disrupting cancer cell growth.

Investigated diseases

Progressive or refractory pediatric solid tumor – Pediatric solid tumors are abnormal masses of tissue that can occur in various parts of a child's body, such as the brain, bones, or organs. These tumors are considered progressive when they continue to grow or spread despite treatment. Refractory tumors are those that do not respond to standard treatments. The progression of these tumors can vary depending on their location and type, but they generally involve the growth of cancerous cells that can invade nearby tissues. Over time, these tumors may spread to other parts of the body, a process known as metastasis. The behavior and progression of pediatric solid tumors can be unpredictable, requiring ongoing monitoring and evaluation.