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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Bayer |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00734526 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma Gliosarcoma |
Drug: Temozolomide Radiation: Radiation Drug: Sorafenib |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Study of Sorafenib With Radiation and Temozolomide in Newly Diagnosed Glioblastoma or Gliosarcoma |
| Estimated Enrollment: | 51 |
| Study Start Date: | August 2008 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Temozolomide + Radiation, Followed by Higher Dose Temozolomide in a Shorter Cycle
|
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. Total of 60 Gy delivered over 30 Days (approximately 6 weeks).
Other Names:
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. Other Name: BAY43-9006
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|
Experimental: 2
Temozolomide + Lower Dose Sorafenib + Radiation, Followed by Higher Dose Temozolomide in a Shorter Cycle + Higher Dose Sorafenib
|
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. Total of 60 Gy delivered over 30 Days (approximately 6 weeks).
Other Names:
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. Other Name: BAY43-9006
|
|
Experimental: 3
Temozolomide + Lower Dose Sorafenib + Radiation, Followed by Lower Dose Temozolomide in a Longer Cycle + Lower Dose Sorafenib
|
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. Total of 60 Gy delivered over 30 Days (approximately 6 weeks).
Other Names:
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. Other Name: BAY43-9006
|
|
Experimental: 4
Temozolomide + Higher Dose Sorafenib + Radiation, Followed by Lower Dose Temozolomide in a Longer Cycle + Higher Dose Sorafenib
|
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. Total of 60 Gy delivered over 30 Days (approximately 6 weeks).
Other Names:
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. Other Name: BAY43-9006
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Vinay K. Puduvalli, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00734526 History of Changes |
| Other Study ID Numbers: | 2008-0059 |
| Study First Received: | August 12, 2008 |
| Last Updated: | October 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Glioblastoma Gliosarcoma Brain Cancer Sorafenib |
Temozolomide Radiation Radiotherapy XRT |
|
Glioblastoma Gliosarcoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Temozolomide Dacarbazine Sorafenib Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors |