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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Bayer |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00734526 |
Phase I:
To define the maximum tolerated dose (MTD) of sorafenib given during (concurrently with) external beam radiation therapy and daily temozolomide (75mg/m2), and with standard dose temozolomide (150-200mg/m2 5 days out of 28) after radiation therapy (adjuvant) in patients with newly diagnosed glioblastoma (GBM) or gliosarcoma.
To define the maximum tolerated dose (MTD) of sorafenib given during (concurrently with) external beam radiation therapy and daily temozolomide (75mg/m2), and with dose dense temozolomide (100mg/m2 21 days out of 28) after radiation therapy (adjuvant) in patients with newly diagnosed glioblastoma or gliosarcoma.
To characterize the safety profile of sorafenib combined with temozolomide given during (concurrent) or after radiation therapy (adjuvant) in patients with newly diagnosed glioblastoma or gliosarcoma.
Phase II:
Primary Aim:
To determine the efficacy of sorafenib in combination with temozolomide and radiation therapy for newly diagnosed glioblastoma as measured by progression-free survival.
Secondary Aims:
To determine the feasibility of using quantitative Reverse transcriptase-polymerase chain reaction (QRT-PCR) in Ribonucleic acid (RNA) derived from formalin-fixed paraffin-embedded tissue to prospectively determine molecular phenotype in newly diagnosed GBM.
Condition | Intervention | Phase |
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Glioblastoma Gliosarcoma |
Drug: Temozolomide Radiation: Radiation Drug: Sorafenib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Parallel Assignment, Safety/Efficacy Study |
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 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Temozolomide + Radiation, Followed by Higher Dose Temozolomide in a Shorter Cycle
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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 (approx. 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. |
2: Experimental
Temozolomide + Lower Dose Sorafenib + Radiation, Followed by Higher Dose Temozolomide in a Shorter Cycle + Higher Dose Sorafenib
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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 (approx. 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. |
3: Experimental
Temozolomide + Lower Dose Sorafenib + Radiation, Followed by Lower Dose Temozolomide in a Longer Cycle + Lower Dose Sorafenib
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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 (approx. 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. |
4: Experimental
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 (approx. 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. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients receiving anti-coagulation treatment with an agent such as warfarin or low molecular weight heparin may be allowed to participate with the following criteria:
Patients on full-dose anticoagulants (e.g., warfarin) are eligible provided that both of the following criteria are met:
Exclusion Criteria:
Severe, active co-morbidity, defined as follows:
Contact: Howard Colman, MD, PhD | 713-792-2883 |
United States, Texas | |
U.T. M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Howard Colman, MD, PhD |
Principal Investigator: | Howard Colman, MD, PhD | U.T. M.D. Anderson Cancer Center |
Responsible Party: | U.T. M.D. Anderson Cancer Center ( Howard Colman, MD, PhD / Assistant Professor ) |
Study ID Numbers: | 2008-0059 |
Study First Received: | August 12, 2008 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00734526 |
Health Authority: | United States: Food and Drug Administration |
Glioblastoma Gliosarcoma Brain Cancer Sorafenib |
Temozolomide Radiation Radiotherapy XRT |
Neuroectodermal Tumors Brain Neoplasms Glioblastoma Astrocytoma Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Glioma Gliosarcoma Sorafenib Temozolomide Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Neoplasms, Nerve Tissue |
Enzyme Inhibitors Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Protein Kinase Inhibitors Alkylating Agents Pharmacologic Actions |