Clinical Trial: Phase II Sorafenib With Radiation and Temozolomide in Newly Diagnosed Glioblastoma or Gliosarcoma

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Phase II Portion of Multi Phase Study of Sorafenib With Radiation and Temozolomide in Newly Diagnosed Glioblastoma or Gliosarcoma

Brief Summary: The goal of this clinical research study is to find the highest tolerable dose of sorafenib that can be given in combination with temozolomide. The safety of this combination will also be studied.

Detailed Summary:

The Study Drugs:

Sorafenib is designed to stop the cell growth and to block the formation of new blood vessels (the tubes that carry blood around the body), which are involved in the growth and development of tumors.

Temozolomide is designed to kill cancer cells by damaging DNA (the genetic material of cells). The damaged DNA may cause tumor cell death.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to 1 of 4 groups based on when you joined this study. You will remain in the same group for the entire study. In this study, the dose of the study drugs is different from group to group, and the doses are also different during and after radiation. During radiation, the study drugs and doses are as follows:

  • If you are in Group 1, you will take temozolomide.
  • If you are in Groups 2 or 3, you will take temozolomide and the lower dose of sorafenib.
  • If you are in Group 4, you will take temozolomide and the higher dose of sorafenib.
  • During radiation, all the groups will take the same dose of temozolomide.

After Radiation:

  • If you are in Groups 1 or 2, you will take the higher dose of temozolomide on a shorter cycle and the higher dose of sorafenib.
  • If you are in Group 3, you will take the lower dose of temozolomide on a longer cycle and the lower dose of sorafenib.
  • If you are in Group 4, you will take
    Sponsor: M.D. Anderson Cancer Center

    Current Primary Outcome: Time to Progression [ Time Frame: 15 Months or till progressive disease, severe toxicity or death. ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: M.D. Anderson Cancer Center

    Dates:
    Date Received: November 4, 2015
    Date Started: December 2008
    Date Completion:
    Last Updated: November 4, 2015
    Last Verified: November 2015