Clinical Trial: Vandetanib in Combination With Metformin in People With HLRCC or SDH-Associated Kidney Cancer or Sporadic Papillary Renal Cell Carcinoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional



Official Title: Phase I/II Trial of Vandetanib in Combination With Metformin in Subjects With HLRCC or SDH-Associated Kidney Cancer or Sporadic Papillary Renal Cell Carcinoma

Brief Summary:

Background:

- There are no established treatments for people with certain advanced kidney cancers. These tumors often don t respond well to currently available treatments. Researchers believe that two drugs that treat other diseases metformin and vandetanib could help people with advanced kidney cancer.

Objective:

- To test the combination of metformin and vandetanib in people with advanced kidney cancer. Phase I of the study will determine a safe dose for the drugs. Phase II will test this dose in people with certain kidney cancers.

Eligibility:

  • For Phase I, people 18 and over with advanced kidney cancer
  • For Phase II, people 18 and over with advanced hereditary leiomyomatosis and renal cell cancer (HLRCC), succinate dehydrogenase renal cell carcinoma (SDH-RCC), or advanced papillary renal cell carcinoma not related to a hereditary syndrome

Design:

  • The study will last many months.
  • Participants will be screened with medical history and physical exam.
  • Participants will take the study drugs by mouth every day.
  • Participants will measure and record their blood pressure every day.
  • Participants will have many tests:
  • Blood and urine tests
  • MRI, CT, PET scan, and other imaging tests: they will lie in machines that take pictures of their body.