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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase II Trial of Pazopanib in Von Hippel-Lindau Syndrome

Brief Summary:

The goal of this clinical research study is to learn if pazopanib can help to control VHL. The safety of this drug will also be studied.

Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for tumor growth. This may prevent or slow the growth of cancer cells.


Detailed Summary:

Study Groups and Study Drug Administration:

If you are found to be eligible to take part in this study, you will take pazopanib by mouth 1 time every day, at about the same time each day, at least 1 hour before or 2 hours after a meal.

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.

Each study cycle is 4 weeks.

Study Visits:

On Day 1 of Cycle 1:

  • Your medical history will be recorded.
  • You will have a physical exam, including measurement of your vital signs and weight.
  • You will be asked about any drugs or treatments you may be receiving.
  • Your performance status will be recorded.

Every 2 weeks (for the first 8 weeks) and then once every cycle, blood (about 3 teaspoons) will be drawn for routine tests.

Every 12 weeks (+/-7 days):

  • Your medical history will be recorded.
  • You will have a physical exam, including measurement of your vital signs and weight.
  • Your performance status will be recorded.
  • You will be asked about any drugs or treatments you may be receiving and any side effects that you have had.

At the end of Cycles 3 and 6 and then every 12 week
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: RECIST Overall Response (OR) Rate = Number of Participants with Complete Response and Partial Response (CR+PR) at 24 weeks [ Time Frame: 24 weeks ]

Modified Response Evaluation Criteria in Solid Tumors (RECIST), evaluation of target lesions (organ-specific). Complete Response (CR): Disappearance all target lesions; Partial Response (PR): > 30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): > 20% increase in sum LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or > new lesions; Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD, reference smallest sum LD since treatment started.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: September 15, 2011
Date Started: January 2012
Date Completion:
Last Updated: September 14, 2016
Last Verified: September 2016