Clinical Trial: TKI 258 in Von Hippel-Lindau Syndrome (VHL)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Pilot Trial of TKI 258 (Dovitinib) in Von Hippel-Lindau Syndrome

Brief Summary: The goal of this clinical research study is to learn if dovitinib can safely be given to patients who have VHL with a measurable hemangioblastoma (tumor of the central nervous system). The effects of this drug on the disease will also be studied.

Detailed Summary:

The Study Drug:

Dovitinib is designed to perform several anti-tumor functions, including cutting off the blood supply to tumors.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will take 5 dovitinib capsules by mouth each day on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle.

You should take the dovitinib capsules with about a cup (8 ounces) of water and at least 1 hour before breakfast or at least 2 hours following breakfast.

If you have any side effects from the drug, tell the study doctor right away. The study doctor may then lower the dose or keep the dose level the same.

If you miss a dose of dovitinib on Days 1-4 (or 8-11, 15-18, or 22-25), you should not make up the dose on the same day. You should continue taking the drug as scheduled the following day. If you miss a dose on Day 5 (or 12, 19, or 26), you should skip the dose, rest 2 days, and begin dosing again as scheduled on Day 8 (or 15, 22, or 1 of the next cycle). The study doctor will tell you about any additional steps that should be taken if you miss a dose.

Every 4 weeks on this study is called a study "cycle."

Study Visits:

On Day 1 of Cycle 1, you will have an ECG.

On Day 14 (+/- 3 days) of Cycles 1 and 2:

-Blood (about 3 teaspoons) will be drawn for routine tests. This blood testing may be done at your local doctor's office and faxed to MD Anderson. You
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Most Frequent & Most Serious Adverse Events: Safety of Dovitinib for 6 Months [ Time Frame: Every 2 cycles (approximately 8 weeks) for 6 months ]

Most frequent & Most Serious Adverse Events: Safety of treatment with Dovitinib for 6 months in participants with VHL who have a measurable hemangioblastoma undergoing surveillance evaluated by toxicity scored using Common Toxicity Criteria (CTC) Version 4.0.


Original Primary Outcome: Safety of Dovitinib for 6 months in VHL patients with measurable hemangioblastoma undergoing surveillance [ Time Frame: Every 2 cycles (approximately 8 weeks) for 6 months ]

Safety of treatment with dovitinib for 6 months in patients with VHL who have a measurable hemangioblastoma undergoing surveillance evaluated by toxicity scored using Common Toxicity Criteria (CTC) Version 4.0.


Current Secondary Outcome: Number of VHL Participants With Response at 6 Months [ Time Frame: Every 2 cycles (approximately 8 weeks) for 6 months ]

Efficacy of treatment with dovitinib for 6 months in patients with VHL who have a measurable lesion evaluated by response using RECIST (Response Evaluation Criteria in Solid Tumors): Complete Response, Partial Response, Progressive Disease or Stable Disease.


Original Secondary Outcome: Number of VHL Patients with Response at 6 Months [ Time Frame: Every 2 cycles (approximately 8 weeks) for 6 months ]

Efficacy of treatment with dovitinib for 6 months in patients with VHL who have a measurable lesion evaluated by response using RECIST (Response Evaluation Criteria in Solid Tumors): Complete Response, Partial Response, Progressive Disease or Stable Disease.


Information By: M.D. Anderson Cancer Center

Dates:
Date Received: December 22, 2010
Date Started: November 2012
Date Completion:
Last Updated: December 21, 2016
Last Verified: December 2015