Darolutamide for Salivary Gland Cancer
Trial Summary
What is the purpose of this trial?
This phase II trial tests how well darolutamide and leuprolide acetate work in treating patients with androgen receptor positive salivary cancer that has spread from where it first started (primary site) to other places in the body (metastatic), cannot be removed by surgery (unresectable) or that has come back after a period of responding to prior therapy (recurrent). Darolutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells. Leuprolide acetate is in a class of medications called gonadotropin-releasing hormone (GnRH) agonists. It works by decreasing the amount of certain hormones in the body. Giving darolutamide in combination with leuprolide acetate may help to stop the growth of tumor cells that need androgens to grow or shrink them.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but it does exclude patients on certain medications that interact with the trial drugs. It's important to discuss your current medications with the trial team to ensure there are no interactions.
What data supports the effectiveness of the drug Darolutamide for treating salivary gland cancer?
Darolutamide has been shown to be effective in treating prostate cancer by blocking androgen receptors, which are proteins that can promote cancer growth. While there is no direct evidence for its use in salivary gland cancer, its success in prostate cancer suggests it might help in other cancers that rely on similar growth pathways.12345
Is darolutamide safe for humans?
How is the drug Darolutamide unique for treating salivary gland cancer?
Darolutamide is unique because it is a second-generation androgen receptor inhibitor that does not cross the blood-brain barrier, reducing the risk of seizures, and it can inhibit resistant cancer cell variants. While primarily used for prostate cancer, its novel mechanism may offer new hope for salivary gland cancer, which lacks standard treatments.13589
Research Team
Alan L Ho, MD, PhD
Principal Investigator
JHU Sidney Kimmel Comprehensive Cancer Center LAO
Eligibility Criteria
Adults with advanced salivary gland cancer that has spread, can't be surgically removed, or has returned after treatment. Participants must have tumors responsive to androgen (a male hormone), measurable disease, acceptable organ function, no prior androgen-targeted therapy (except under certain conditions), and an ECOG performance status of <=2. They should not have severe heart issues or other illnesses that could affect the trial's safety.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive darolutamide orally twice daily and leuprolide acetate intramuscularly every 4 or 12 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up every 3-6 months for 2 years or until death.
Treatment Details
Interventions
- Darolutamide (Androgen Receptor Inhibitor)
- Leuprolide Acetate (Gonadotropin-releasing Hormone Agonist)
Darolutamide is already approved in Canada for the following indications:
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor