NCT00734526

Phase I Portion of Phase I/II Sorafenib With Radiation and Temozolomide in Newly Diagnosed Glioblastoma or Gliosarcoma

A Phase I Study of Sorafenib With Radiation and Temozolomide in Newly Diagnosed Glioblastoma or Gliosarcoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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 the lower dose of temozolomide on a longer cycle and the higher dose of sorafenib. The amount of study drugs you receive may change if you experience side effects. If at any time you experience any intolerable side effects, tell the study doctor right away. Study Drug Administration: During Radiation: As a part of standard of care, you will receive radiation therapy Monday-Friday for a total of 30 radiation treatments (about 6 weeks). Every day while you are receiving radiation, you will take the temozolomide by mouth once a day (up to a maximum of 7 weeks). On Monday-Friday, you will take temozolomide 1 hour before radiation therapy. On Saturday and Sunday, you will take temozolomide in the morning. You should swallow temozolomide whole, one right after the other, without chewing them. If you vomit while taking temozolomide, you cannot take more capsules before the next scheduled dose. They should be taken on an empty stomach (at least 1 hour before and 2 hours after eating) with 1 cup (about 8 oz.) of water. Every day while you are receiving radiation, you will take sorafenib by mouth 2 times a day (in the morning and evening) (up to a maximum of 7 weeks). You should take sorafenib without food (1 hour before or 2 hours after eating), with at least 1 cup (8 oz.) of water. If you are in Group 1, you will not take sorafenib. After Radiation: You will not take the study drug(s) for about 4 weeks after the radiation therapy ends. After 4 weeks: * If you are in Group 1 or 2, on Days 1-5 of every 28-day study cycle, you will take temozolomide by mouth once a day. * If you are in Group 3 or 4, on Days 1-21 of every cycle, you will take temozolomide by mouth once a day. Every day of each cycle, all groups will take sorafenib by mouth 2 times (in the morning and evening). Study Visits: During Radiation: Once a week while you are receiving radiation therapy, you will be asked about any drugs you may be taking and if you have experienced any side effects. Your blood pressure will be measured. Blood (about 3-4 teaspoons) will be drawn for routine tests. After Radiation: About 3-4 weeks after the end of radiation therapy, you will have a MRI scan to check the status of the disease. On Day 1 of every cycle, the following tests and procedures will be performed: * You will have a physical exam, including measurement of your vital signs. * You will have a neurological exam. * You will have a performance status evaluation. * You will be asked about any drugs you may be taking and if you have experienced any side effects. * Blood (about 3-4 teaspoons) will be drawn for routine tests. On Days 7, 14, and 21 of Cycle 1 and on Days 7 and 14 (or 21) of Cycles 2 and beyond, blood (about 3-4 teaspoons) will be drawn for routine tests. On Day 1 of every other cycle (Cycles 3, 5, 7, and so on), you will have a MRI scan to check the status of the disease. Every week of Cycle 1, your blood pressure will be measured. Length of Study: You will be on study for about 15 months total. You will be taken off study early if the disease gets worse or you experience intolerable side effects. End-of-Study Visit: After you go off study, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed: * You will have a physical exam, including measurement of your weight and vital signs. * You will be have a performance status evaluation. * You will be asked about any drugs you may be taking and if you have experienced any side effects. * You will have a neurological exam. * You will have a MRI scan to check the status of the disease. * Blood (about 3 teaspoons) will be drawn for routine tests. This is an investigational study. Temozolomide is FDA approved and commercially available for the treatment of brain tumors. Sorafenib is FDA approved and commercially available for the treatment of kidney cancer, but it is experimental for use in brain tumors. In addition, the combination of temozolomide and Sorafenib is experimental for use in brain tumors. At this time, the combination is only being used in research. Up to 51 participants will take part in this study. All will be enrolled at M. D. Anderson.

Conditions

• Glioblastoma
• Gliosarcoma

Interventions

Type	Name	Description
DRUG	Temozolomide	Groups 1 \& 2: 75 mg/m\^2 Once Daily by Mouth During Radiation; 4 Weeks after Completion of Radiation, 150-200 mg/m\^2 Once Daily by Mouth Days 1-5 of 1st 28-Day Cycle, then 75 mg/m\^2 Once Daily by Mouth Days 1-5 for Subsequent 28-Day Cycles. Groups 3 \& 4: 75 mg/m\^2 Once Daily by Mouth During Radiation; 4 Weeks after Completion of Radiation, 75-100 mg/m\^2 Once Daily by Mouth Days 1-21 every 28-Day Cycle.
RADIATION	Radiation	Total of 60 Gy delivered over 30 Days (approximately 6 weeks).
DRUG	Sorafenib	Group 1: 4 Weeks after Completion of Radiation, 400 mg Twice Daily by Mouth. Group 2: 200 mg Twice Daily by Mouth during Radiation; 4 Weeks after Completion of Radiation, 400 mg Twice Daily by Mouth. Group 3: 200 mg Twice Daily by Mouth during Radiation; 4 Weeks after Completion of Radiation, 200 mg Twice Daily by Mouth. Group 4: 400 mg Twice Daily by Mouth during Radiation; 4 Weeks after Completion of Radiation, 400 mg Twice Daily by Mouth.

Timeline

• Start date: 2008-12-18
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2008-08-14
• Last updated: 2018-11-09

Locations

1 site across 1 country: United States