Why are we doing this study?
Patients with relapsed solid tumors such as sarcomas and neuroblastoma have a poor survival, generally < 20%. There is an urgent need for new treatments that are safe and effective. This study is for solid tumor cancers that are not responding to standard therapy or for which no standard therapy exists. Because of the limited availability of current therapies, we are pursuing new ways to potentially treat these types of cancers. This study is designed to see if this drug can be given safely and at what dose.
This is a study to find out and test the safety of a virus called HSV1716. HSV1716 is made from the herpes simplex virus (HSV), the virus that normally causes “fever blisters” or “cold sores”, but the HSV has been changed so that it infects tumor cells without harming other cells in the body. HSV1716 is thought to work on cancer by growing in the cancer cell and killing it. While HSV1716 is a virus, for this study, we are calling it a drug, as it is being used to try and kill cancer cells. This drug, HSV1716, has not been approved by the Food and Drug Administration and its use is considered experimental. It is being studied as an investigational agent through an application to the FDA.
This is a Phase I research study. The purpose of a Phase I study is to find out how much of a drug people can tolerate safely. The main purpose of this trial is to determine what dose levels are safe for people ages 7 to 30 years old. The dose that some people get may be too small to have any effect on their tumor(s), or it may be too high and cause bad side effects. This study will figure out if these doses of HSV1716 can be given without bad side effects.
Researchers also want to see what effects (good or bad) HSV1716 has on certain cancers in children and adults. For this study, HSV1716 will only be given to people who do not respond to standard therapy or for which no standard therapy exists. It is not known if HSV1716 will be effective in treating the tumors of people that decide to take part in this research study.
Who can participate in this study?
We are looking for people who are 7 to 30 years old who have been diagnosed with a relapsed solid tumor cancer. There are some other requirements you must meet to protect your safety. If you are interested in taking part in this study, the study team will discuss this with you.
What will happen during this study?
If you agree to be part of this research, you will have some tests done to make sure that is okay for you to be in this study. If your doctor decides it is okay, the HSV1716 will either be injected (IT) into the tumor or you will be given HSV1716 intravenously (IV). This will be done by a team of doctors who are trained to do these types of things. You will be in the research study for the rest of your life or for up to 15 years. This is the amount of time that the FDA requires for people who get experimental drugs. You will be asked to come in for 13 study visits the first year, then 2 visits a year for 5 years and lastly once a year for the rest of the study.
A number of tests will be performed throughout the study. Many of these are part of regular cancer care, but some are just for research. These include:
- Frequent blood tests to monitor your health
- X-rays and imaging scans to check your tumor
- Blood, buccal swabs, rectal swabs and urine tests for HSV infection
Is this risky or painful?
Since this is a research study using a new kind of drug, there may be bad effects from taking it. Some of these effects could be serious or may even cause you to die. HSV1716 has been used in research studies before in older adult patients and did not cause any bad effects.
Because we don’t know much yet about what happens when a virus is injected into a tumor, there is a chance it may spread to other areas of the body, maybe even areas that it would normally would not spread to. You could get an injection in a small part of your body, or it could spread to larger areas. If this happens, you will be given medicines that treat HSV infections and any other care that you need. You might feel nervous or worried about being given a virus. If you do, you might be given some medicines to help.
In addition to the possible bad effects that could happen because of the drug, there may be bad effects from some of the things that will be done as part of this study.
Some of the scanning procedures that may be used could expose you to an amount of radiation that is higher than you would normally receive. In addition, some of the scanners will require that you lay inside a big tube. This could cause you to feel uncomfortable. The doctors will talk with you about ways to help you feel more comfortable.
Blood will be taken for some of the testing that will be done. This could cause discomfort or pain and you may get a bruise, or maybe an infection.
There may be other effects that we don’t know about yet.
Does this cost anything?
The chart which lists all the tests for this study outlines what will be charged to you or your insurance company. You will not be charged for the drug HSV1716, the costs associated with getting HSV1716 and the special HSV studies. You or your insurance company will only be charged for tests related to your clinical care.
You or your insurance company will be charged for continuing medical care and/or hospitalization including tests and treatments of any side effects of HSV1716. You may want to check with your insurance company to find out whether costs associated with this experimental drug are covered. In the event that your insurance does not provide coverage, you may incur extracosts because of treatment of side effects.
What are the benefits?
Being in the research may help you if the HSV1716 causes your tumor or tumors to stop growing or makes them smaller. Since we are testing HSV1716, we are not sure if it will help you. Your cancer may continue to grow and become worse even with taking this drug.
When we finish with HSV1716 later on, we will know more about if using this drug is safe and if it may help others who have cancer.
Where can I get more information?
More information about this study can be found on ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT00931931