Nivolumab for Brain Cancer
Trial Summary
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on a corticosteroid dose greater than physiologic replacement dosing (30 mg of cortisone per day or its equivalent). It's best to discuss your current medications with the trial team.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot be on a corticosteroid dose greater than 30 mg of cortisone per day or its equivalent, and you cannot be receiving any other investigational agents.
What data supports the idea that Nivolumab for Brain Cancer is an effective treatment?
The available research shows that Nivolumab, when used for non-small cell lung cancer (NSCLC) with brain metastases, has shown some positive results. In one study, out of five patients with brain metastases, one had a complete response and another had a partial response in the brain. This suggests that Nivolumab might have some effectiveness in treating brain-related conditions, although more research is needed to confirm its effectiveness specifically for brain cancer.12345
What data supports the effectiveness of the drug Nivolumab for brain cancer?
What safety data exists for Nivolumab in treating brain cancer?
Nivolumab, also known as Opdivo, is associated with immune-related adverse events, including rare cases of encephalitis. Reports indicate that encephalitis occurs in 1% to 3% of treated cases and can be managed with steroids. Neurologic adverse events range from mild headaches to severe encephalitis, which is reversible with prompt treatment. While CNS toxicities are rare, they require early recognition and management to prevent severe outcomes.678910
What safety information is available for Nivolumab (Opdivo) in humans?
Is the drug Nivolumab (Opdivo) a promising treatment for brain cancer?
How does the drug Nivolumab work differently for brain cancer compared to other treatments?
Nivolumab is unique because it is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells, which is different from traditional chemotherapy that directly kills cancer cells. Although it is primarily used for lung cancer, its potential to treat brain cancer is being explored, especially since it may have some ability to affect brain tumors despite the blood-brain barrier.111121314
What is the purpose of this trial?
Background:More than 130 primary tumors of the central nervous system (CNS) have been identified. Most affect less than 1,000 people in the United States each year. Because these tumors are so rare, there are few proven therapies. This study will test whether the immunotherapy drug nivolumab is an effective treatment for people with rare CNS tumors.Objectives:To learn if stimulating the immune system using the drug nivolumab can shrink tumors in people with rare CNS (brain or spine) tumors or increase the time it takes for these tumors to grow or spread.Eligibility:Adults whose rare CNS tumor has returned.Design:Individuals will be screened:* Heart and blood tests* Physical and neurological exam* Hepatitis tests* Pregnancy test* MRI. They will lay in a machine that takes pictures.* Tumor tissue sample. This can be from a previous procedure.At the start of the study, participants will have blood tests. They will answer questions about their symptoms and their quality of life.Individuals will get nivolumab in a vein every 2 weeks for up to 64 weeks.Individuals will have monthly blood tests. Every other month they will have an MRI and a neurologic function test. They will also answer questions about their quality of life.Genetic tests will be done on individuals' tumor tissue. Individuals will be contacted if any clinically important results are found.After treatment ends, individuals will be monitored for up to 5 years. They will have a series of MRIs and neurological function tests. They will be asked to report any symptoms they experience....
Research Team
Byram H Ozer, M.D.
Principal Investigator
National Cancer Institute (NCI)
Eligibility Criteria
Adults with certain rare brain or spine tumors that have come back can join this trial. They must be over 18, in good health, and not on high steroid doses. Participants need to have had all COVID-19 shots, agree to use birth control if needed, and provide a tumor tissue sample. People who've had other cancers or severe illnesses, are pregnant or breastfeeding, allergic to the drug's ingredients, unable to get MRIs or vaccinated against COVID-19 can't join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nivolumab intravenously every 2 weeks for cycles 1-2, then every 4 weeks for up to 64 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment with MRIs and neurological function tests
Treatment Details
Interventions
- Nivolumab
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
- Advanced or metastatic gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Hepatocellular carcinoma
- Esophageal squamous cell carcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor