A trial of two treatments for vulval intraepithelial neoplasia (RT3 VIN)

Cancer type:

Vulval cancer

Status:

Results

Phase:

Phase 2

This trial looked at 2 drugs called cidofovir and imiquimod for vulval intraepithelial neoplasia. The trial was supported by Cancer Research UK.

Vulval intraepithelial neoplasia (VIN) means there are abnormal cells in the skin of the vulva Open a glossary item. It is not cancer, but if it isn’t treated it can develop into vulval cancer. There are 3 categories of VIN. This trial recruited women with VIN 3, which means the cells are very abnormal. Your doctor may also call this severe dysplasia.

More about this trial

Doctors usually treat VIN 3 with surgery or possibly laser treatment. In this trial, the researchers were looking at an anti viral treatment called cidofovir and a type of immunotherapy Open a glossary item called imiquimod. Imiquimod helps the immune system Open a glossary item to kill abnormal cells. Cidofovir is a gel and imiquimod is a cream.

The researchers hoped that the treatments would help women with VIN 3.

The aims of the trial were to find out

  • If cidofovir and imiquimod can help women with VIN 3
  • How safe these treatments are
  • More about the side effects

Summary of results

The researchers found that both cidofovir and imiquimod were safe and helped women with VIN 3.

180 women took part in this trial.

  • 89 applied cidofovir gel to the affected area 3 times a week for nearly 6 months
  • 91 applied imiquimod cream 3 times a week for nearly 6 months

The researchers have the results for 71 women who had cidofovir. They found that

  • In 41 women the abnormal cells (VIN) had disappeared
  • In 14 women the abnormal cells got a bit better
  • In 8 women the abnormal cells stayed the same
  • In 8 women the abnormal cells  got worse

The researchers have the results for 68 women who had imiquimod. They found that

  • In 42 women the abnormal cells had disappeared
  • In 10 women the abnormal cells got a bit better
  • In 6 women the abnormal cells  stayed the same
  • In 10 women the abnormal cells  got worse

The side effects were similar for both drugs. They included

  • Tiredness
  • Itchy skin and skin ulcers
  • Pain in the vulva
  • Headaches
  • Muscle pain

The researchers concluded that both cidofovir and imiquimod were safe and helpful treatments for VIN 3. They recommend that they are looked at in larger clinical trials. They also suggest that doctors could use either cidofovir or imiquimod instead of surgery for women who have VIN that hasn’t spread beyond the skin covering the vulva.
 
We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Amanda Tristram

Supported by

Cancer Research UK
Cardiff University
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Wales Cancer Trials Unit

Other information

This is Cancer Research UK trial number CRUK/06/024.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 816

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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