Studying the Safety and Determining the Optimal Dose of Novobiocin in Patients With Tumors That Have Alterations in DNA Repair Genes
This research study is looking into a new medication, novobiocin, for patients with advanced solid cancers. These are cancers that have spread (metastatic) or cannot be removed by surgery (unresectable) and have specific changes in their DNA repair genes. The main goals are to understand how safe novobiocin is, what side effects it might cause, and to find the best dose to use. Novobiocin works by blocking a protein that helps cancer cells fix their damaged DNA. If these cancer cells can't repair themselves, they die. Researchers hope this treatment could help shrink or stabilise cancers with these particular gene changes. Patients will be carefully monitored for safety and any positive effects on their cancer.
At a glance
What is this study about?
This study is investigating a new drug called novobiocin. We already know novobiocin as an antibiotic, but researchers are now looking at whether it can also fight certain types of cancer. The focus is on cancers that have specific problems with their 'DNA repair genes'. Think of DNA as the instruction manual for every cell in your body. Sometimes, this manual gets damaged. Healthy cells have special repair teams to fix these damages. However, some cancer cells have faulty repair teams due to changes in these genes. Novobiocin targets a specific protein involved in these repair processes, making it harder for these particular cancer cells to fix themselves.
The idea behind this treatment is that if these cancer cells can't repair their DNA, they become too damaged to survive and will die. This could potentially slow down or even shrink the cancer. This first stage of research, called a Phase 1 trial, is all about safety. We need to find out if the drug is safe to use in people, what side effects it might cause, and what the best dose is to give. This helps us make sure that any future studies can be as effective and safe as possible.
We'll be carefully watching how your body reacts to novobiocin. This includes checking for any changes in your cancer over time. Understanding how this drug works at a dose that is both safe and effective is a crucial step in developing new treatments for people living with these types of advanced cancers.
Key takeaways
- This is an early stage (Phase 1) study for advanced solid cancers.
- It tests a new drug, novobiocin, for cancers with specific DNA repair gene changes.
- The main goals are to find a safe dose and any initial signs of it shrinking or controlling cancer.
- Novobiocin aims to stop cancer cells from repairing themselves, leading to their death.
- Patients will undergo regular checks for safety and treatment effectiveness.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study might be suitable for you if you have a solid cancer that has either spread to other parts of your body (metastatic) or can't be removed by surgery, and if standard treatments are no longer working or available.
Your cancer must also have specific changes in certain 'DNA repair genes'. These changes will be confirmed by special tests. You can have had previous cancer treatments, and if your cancer is one for which PARP inhibitor drugs are usually given, you must have already tried one of these. If PARP inhibitors aren't standard for your cancer, then you might not have received one before, or your cancer might have stopped responding to one.
To join, you need to be at least 18 years old and generally well enough to take part in a study, as determined by your doctors. There are also specific requirements for your blood tests and kidney function to ensure it's safe for you to take the study drug.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Do I have a solid cancer that is advanced (spread or can't be removed)?
- Have standard treatments stopped working or aren't available for my cancer?
- Does my cancer have specific changes in its 'DNA repair genes'?
- Am I over 18 years old?
- Am I generally well enough to participate in a study?
What does participation involve?
If you decide to take part, you'll have several assessments before starting any treatment, including a small sample (biopsy) of your cancer and various scans. Then, you'll receive the novobiocin medication on a schedule of 5 days on (taking the drug) and 2 days off (not taking the drug). This will continue as long as the drug is helping you and you are not experiencing significant side effects.
During the study, you'll have regular visits for blood tests, physical exams, and more scans to check how you're responding and to monitor for any side effects. You may also need additional biopsies to help researchers understand how the drug is working. The exact number of visits will depend on how long you receive the treatment, but you can expect frequent checks, especially in the beginning. The total duration of your participation will vary, as you'll continue treatment as long as it's beneficial and safe for you.
Potential risks and benefits
Locations (23)
- City of Hope Comprehensive Cancer CenterVerified postcodeDuarte, United States· Recruiting
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareVerified postcodeIrvine, United States· Recruiting
- UC San Diego Moores Cancer CenterVerified postcodeLa Jolla, United States· Recruiting
- Los Angeles General Medical CenterVerified postcodeLos Angeles, United States· Recruiting
- USC / Norris Comprehensive Cancer CenterVerified postcodeLos Angeles, United States· Recruiting
- UC Irvine Health/Chao Family Comprehensive Cancer CenterVerified postcodeOrange, United States· Recruiting
- University of California Davis Comprehensive Cancer CenterVerified postcodeSacramento, United States· Recruiting
- UC San Diego Medical Center - HillcrestVerified postcodeSan Diego, United States· Recruiting
- University of Chicago Comprehensive Cancer CenterVerified postcodeChicago, United States· Recruiting
- National Cancer Institute Developmental Therapeutics ClinicVerified postcodeBethesda, United States· Recruiting
- National Institutes of Health Clinical CenterVerified postcodeBethesda, United States· Active not recruiting
- Beth Israel Deaconess Medical CenterVerified postcodeBoston, United States· Recruiting
Common questions
What is a 'solid cancer'?
A solid cancer is a tumour that forms a lump, such as in the breast, lung, or bowel, as opposed to blood cancers like leukaemia.
What does 'metastatic' or 'unresectable' mean?
'Metastatic' means the cancer has spread from where it started to other parts of the body. 'Unresectable' means the cancer cannot be removed by surgery.
What are 'DNA repair genes'?
These are specific instructions within your cells that help fix damage to your DNA. If these genes have changes, it can make cancer cells more vulnerable to certain treatments.
Will I get novobiocin or a placebo (dummy drug)?
Everyone in this study will receive novobiocin. There is no placebo group in this type of early phase study, as the goal is to find a safe dose and look for any effects of the drug.
How long will I be on the treatment?
You will continue receiving novobiocin as long as the treatment is helping your cancer and you are not experiencing severe side effects. The exact duration will vary for each person.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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