Clinical Trials

Clinical trials are studies to test new drugs, already approved drugs, devices, or other forms of treatments such as radiation. Given the limited effectiveness of chemotherapy in ACC, medical oncologists might suggest a clinical trial involving targeted drugs and/or immunotherapy.

Patients should discuss the scientific reasoning of any drug and the availability of drugs within or outside their medical center. Most clinical trials are often found at comprehensive cancer centers and each medical institution may have different trials available. Usually, clinical trials are conducted by government health agencies such as NIH, researchers affiliated with a hospital or university medical program, independent researchers, or private industry. In some cases, if a clinical trial is closed or not available, with the guidance of their doctor, a patient may be offered the treatment outside of a clinical trial.

Phases of clinical trials

Clinical trials are usually conducted in three (3) phases that build on one another to assure safety, effectiveness and the risks vs. benefit. Knowing the phase of the clinical trial is important because it can give you some idea about how much is known about the treatment being studied.

Phase I clinical trials: Is the treatment safe?

Phase I studies of a new drug are usually the first that involve people. Phase I studies are done to find the highest dose of the new treatment that can be given safely without causing severe side effects. They are also looking at what the drug does to the body and what the body does with the drug. These studies also help to decide on the best way to give the new treatment.

Phase II clinical trials: Does the treatment work?

If a new treatment is found to be safe in phase I clinical trials, a phase II clinical trial is done to see if it works in certain types of cancer. It may mean the cancer shrinks or disappears. Or it might mean there’s a long period of time where the cancer doesn’t get any bigger, or there’s a longer time before the cancer comes back. If the treatment shows an acceptable balance between potential benefit(s) and known risks during phase II testing, it will be further studied in phase III testing.

Phase III clinical trials: Is it better than what’s already available?

Phase III clinical trials compare the safety and effectiveness of the new treatment against the current standard treatment. Depending upon the balance of risk versus benefit, the sponsor of the trial determines whether FDA approval for the drug will be pursued. The data is also used to help create the drug’s labeling if approved by the FDA.

FDA Approval

If the sponsor of the phase III clinical trial determines that the experimental treatment is at least as good as existing treatments and the benefit for patients outweighs the risks associated with the drug, it submits an application to the U.S. Federal Drug Administration (FDA) seeking approval to market the drug. The FDA reviews all the information from pre-clinical testing and clinical trial and decides whether to approve the drug. The FDA only approves drugs for the specific group of people and disease studied in the phase III clinical trial.

Sponsorship, Costs and Insurance Coverage

Clinical trials are sponsored by government agencies such as the National Institutes of Health (NIH), including the National Cancer Institute (NCI), pharmaceutical companies, individual doctors and health care institutions. Currently, Medicare provides coverage of routine costs for most cancer clinical trials. Additionally, several states have enacted laws or negotiated agreements for insurers to provide coverage. Any cost to the participant should be explained during the informed consent process. More information on the costs can be found here https://www.cancer.net/research-and-advocacy/clinical-trials/health-insurance-coverage-clinical-trials

Where to get information about current clinical trials

The National Institute of Health (NIH) provides the most definitive list of clinical trials around the world. To use their online search tool simply focus your search by typing ‘adenoid cystic carcinoma’ when visiting https://clinicaltrials.gov.

You can ask for help with a search by calling 1-800-4-CANCER (1-800-422-6237).
The National Cancer Institute also provides general information about clinical trials here https://www.cancer.gov/about-cancer/treatment/clinical-trials

For information about clinical trials conducted in Europe
https://www.clinicaltrialsregister.eu/

For information about clinical trials conducted in the UK
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial

For information about ACC clinical trials for those with progressive disease. This website may not list all the pertinent and available trials. https://accrf.org/treatments/clinical-trials/open-studies/

Clinical trials sponsored by private sources can be found here:
https://www.centerwatch.com/

Clinical Trials

Clinical trials are studies to test new drugs, already approved drugs, devices, or other forms of treatments such as radiation. Given the limited effectiveness of chemotherapy in ACC, medical oncologists might suggest a clinical trial involving targeted drugs and/or immunotherapy.

Phases of clinical trials

Where to get information about current clinical trials

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