ACC is a cancer that is resistant to chemotherapy, with few patients benefiting substantially or sustainably from such treatments. Accordingly, the U.S. Food and Drug Administration (FDA) has not approved any drugs for use in ACC. In order to find better ways of controlling progressive disease, medical researchers conduct clinical trials with novel targeted drugs. Helpful background information on clinical trials is available from ClinicalTrials.gov and the National Cancer Institute.
Given the toxicity and unproven effectiveness of systemic therapy in ACC, most clinical trials limit enrollment to only those ACC patients with advanced disease (many measurable tumors). Increasingly, only patients with progressive disease (growing tumors) are being included in ACC studies. At the moment, there are no clinical trials that attempt to prevent recurrences in ACC survivors without evident disease.
Each patient’s decision to enter a clinical trial is very personal and will be based on a blend of the disease’s progression, the treatment’s anticipated effectiveness, the patient’s tolerance of side effects, financial constraints and travel limitations. Each situation is unique and should be discussed with a knowledgeable physician.
When a medical oncologist does recommend a clinical trial to a patient, the following questions may help guide patients to the best decision for their situation:
- What factors have changed to prompt the recommendation of a clinical trial? Such factors may include new metastases, faster tumor growth and encroachment on vital organs.
- Would surgery, radiation therapy, radio-frequency ablation or brachytherapy manage the disease adequately? How would the effectiveness and side effects of these treatment options compare to the recommended clinical trial?
- Why should the drug be particularly effective in ACC patients? What evidence supports the recommended clinical trial? Responses should relate to the drug’s mechanisms of action and how they relate to ACC, preclinical studies, phase I experiences and case studies of ACC patients.
- What other clinical trials are available? How do their rationales compare to the recommended clinical trial? The patient may not need to understand fully the competing rationales, but should have confidence that the physician is weighing them.
- Will travel be necessary? Will costs be covered by insurance or the clinical trial sponsor?
- What tests and procedures (biopsies, lab tests, imaging studies, etc.) will be required and how often?
- Are there any genomic tests that may indicate if my particular tumor is more likely to respond to the drug in the recommended clinical trial?
Patients may wish to refer their physician to this website to provide background information and context for the discussions. If a physician recommends (off-label) usage of a drug that is being studied in a clinical trial for ACC, patients should consider joining the clinical trial. Documenting and disseminating the results of such trials is of immense value to the entire ACC patient community.
For more background and details on clinical trials, please read ACCRF’s Guide to Systemic Therapy for Patients With Progressive ACC .