All studies
CompletedPhase I/IIInterventional

Vaccination with Adjuvants, Peptides and Elimination of Regulatory Cells: Enhancement of the body's anticancer immunity by vaccination

This clinical trial is studying a new treatment approach for people living with advanced cancer. The treatment combines an experimental cancer vaccine with a low-dose chemotherapy medicine called cyclophosphamide. Cancer cells often find ways to hide from the body's natural defences. The vaccine in this trial is designed to act like a training session for the immune system, teaching it to spot cancer cells. At the same time, the low-dose chemotherapy temporarily clears away certain immune cells that act as brakes, giving the vaccine a better opportunity to work. Because this is an early-stage (Phase I/II) trial, the main aims are to test how safe the treatment is, check what side effects occur, and see if it triggers an anti-cancer response. The trial is open to adults aged 18 to 85 whose cancer has not responded to standard therapies.

At a glance

Status
Completed
Phase
Phase I/II
Enrolment target
30
Start
04 Feb 2013
Estimated completion
31 Dec 2018

What is this study about?

The immune system is designed to protect our bodies from illness, but cancer cells can sometimes avoid detection or switch off the body's natural immune defences. Researchers are testing whether a cancer vaccine can help the body recognise tumours and mount a stronger defence against them.

This trial uses an experimental vaccine made of tiny protein pieces (peptides) that are commonly found on cancer cells. Along with the vaccine, participants receive small doses of an existing cancer medicine called cyclophosphamide. Instead of destroying tumours directly, this low dose is used to calm down 'regulatory' immune cells—cells that normally stop the immune system from attacking too strongly. Removing these brakes helps the vaccine do its job more effectively.

The study is in its early stages (Phase I/II). This means researchers are focused on finding out whether the combination is safe, what dose works best, and whether it produces a measurable immune response. While it may not cure the cancer, the information gathered could help scientists design more effective immunotherapy treatments for the future.

Key takeaways

  • Tests a new vaccine combined with low-dose chemotherapy for advanced cancer.
  • Aims to safely train the body's immune system to recognise tumour cells.
  • Open to adults aged 18 to 85 who have completed standard cancer treatments.
  • Requires regular visits to the hospital for injections, tests, and monitoring.
  • Participation is completely voluntary, and you can withdraw at any time.

Who may be eligible?

This study is open to adults aged between 18 and 85 who have a confirmed diagnosis of advanced cancer. To be considered, you must have finished all standard cancer therapies at least four weeks ago, with no other routine treatments currently suitable for you. You should also be reasonably well in yourself, able to manage your daily self-care, and have an estimated life expectancy of at least seven months.

The study is not suitable for people whose cancer has spread to the brain, or for those with autoimmune conditions or weakened immune systems. You cannot join if you are pregnant, breastfeeding, or have a history of heart conditions, stroke, stomach ulcers, or inflammatory bowel disease.

Because of the medications used, you will also be excluded if you have known allergies to certain anti-inflammatory drugs (such as aspirin or celecoxib) or sulphonamide antibiotics. Both men and women taking part must agree to use reliable contraception during the study.

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.

  1. You are between 18 and 85 years old.
  2. You have advanced cancer and have finished standard treatments at least 4 weeks ago.
  3. You are well enough to carry out everyday activities and care for yourself.
  4. Your cancer has not spread to your brain.
  5. You do not have a history of serious heart disease, stroke, or stomach ulcers.
  6. You are not allergic to aspirin, celecoxib, or sulphonamide medicines.
Answer every question to see your result.

What does participation involve?

If you decide to take part, you will attend regular hospital appointments. During your visits, you will receive the vaccine injections and doses of cyclophosphamide. The healthcare team will carry out standard health checks, including blood tests, physical examinations, and imaging scans to track your health and measure how your immune system is responding. The treatment phase usually lasts several months, followed by regular check-ups to monitor your well-being. Your clinical team will explain the exact visit schedule and expected total time before you agree to join.

Potential risks and benefits

Taking part in an early trial may not directly shrink your tumour, but it could help doctors learn how to improve cancer treatments for others in the future. Potential risks include side effects from the vaccine, such as redness or soreness where the injection was given, fatigue, and mild flu-like symptoms. The low-dose chemotherapy can also cause temporary side effects, such as mild sickness or a temporary drop in infection-fighting blood cells. Joining this study is entirely your choice, and you are free to leave at any time without your regular NHS care being affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Nottingham University Hospitals NHS Trust - Queen's Medical Centre Campus
    City only
    Nottingham, England

Common questions

Is this vaccine meant to prevent cancer from developing?

No. Unlike vaccines for illnesses like the flu, this is a treatment vaccine designed to help the immune system fight cancer that is already present.

Can I stay on my current cancer therapy while doing this trial?

No. Participants must have finished their previous cancer treatments at least four weeks before joining the trial.

Will the chemotherapy make my hair fall out?

The chemotherapy drug in this study is used at very low doses to adjust the immune system, so it usually causes far fewer side effects than standard chemotherapy. Your trial doctor can give you full details.

Will taking part cost me anything?

The trial treatments and extra tests are provided free of charge, though you may need to cover your travel costs to and from the hospital clinic.

What happens if I change my mind after starting?

You can leave the trial at any point. You do not need to give a reason, and your regular doctors will continue to look after you.

How to find out more

Oleg Eremin

Always speak to your GP or specialist before deciding to take part in a study.

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