RT, Temozolomide, and Bevacizumab Followed by Bevacizumab/Everolimus in First-line Treatment of GBM
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ClinicalTrials.gov Identifier: NCT00805961 |
Recruitment Status :
Completed
First Posted : December 10, 2008
Results First Posted : September 21, 2012
Last Update Posted : August 28, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glioblastoma Multiforme | Radiation: Radiation therapy Drug: Temozolomide Drug: Bevacizumab Drug: Everolimus | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 68 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of Concurrent Radiation Therapy, Temozolomide, and Bevacizumab Followed by Bevacizumab/Everolimus in the First-line of Treatment of Patients With Glioblastoma Multiforme |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | October 2009 |
Actual Study Completion Date : | May 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Intervention
Combined Modality Treatment and Systemic Therapy Combined Modality Therapy - Radiation Therapy: 2 Gy/fraction, single daily fractions Monday-Friday, to total of 60 Gy Temozolomide: 75 mg/m2 by mouth daily Bevacizumab: 10 mg/kg IV every 2 weeks (Weeks 1, 3, 5, and 7) After the last dose of radiation, patients exhibiting an objective response, stable disease on MRI scan, or have stable/improved tumor-related symptoms will begin systemic therapy Systemic Therapy - Bevacizumab: 10 mg/kg IV every 2 weeks Everolimus: 10 mg by mouth daily |
Radiation: Radiation therapy
Radiation therapy, 2.0 Gy daily, 5 days per week by single daily dose, to a total of 60 Gy over 6 weeks
Other Name: Combined Modality Treatment Drug: Temozolomide Temozolomide 75mg/m2 by mouth daily, beginning day 1 of radiation therapy and continuing through the last day of radiation therapy
Other Name: Combined Modality Treatment Drug: Bevacizumab Bevacizumab 10mg/kg IV, every 2 weeks, beginning day 1 of radiation therapy
Other Name: Combined Modality Treatment Drug: Bevacizumab Bevacizumab 10mg/kg IV, every 2 weeks, beginning Week 11
Other Name: Systemic Therapy Drug: Everolimus Everolimus 10mg by mouth daily, beginning Week 11
Other Name: Systemic Therapy |
- Progression-free Survival (PFS) [ Time Frame: 18 months ]
- To Assess the Toxicity of This Novel Multimodality Regimen [ Time Frame: 18 months ]
- To Assess the Overall Survival of Patients With Glioblastoma Multiforme Following Treatment With This Novel Multimodality Regimen [ Time Frame: 18 months ]
- To Assess the Complete Response Rate of Patients With Glioblastoma Multiforme Following Treatment With This Novel Multimodality Regimen [ Time Frame: 18 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age >=18 years.
- Histologically confirmed intracranial glioblastoma multiforme (WHO grade 4).
- Patients who have had partial or complete surgical debulking are eligible, as are those with inoperable glioblastoma.
- No previous treatment with radiotherapy or systemic therapy. Local therapy with a Gliadel wafer placed at the time of surgical debulking is permitted.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate bone marrow function
- Adequate liver function:
- Serum creatinine <=1.5 x institutional ULN.
- Ability to swallow whole pills.
- Women of child-bearing potential must have a negative serum pregnancy test performed within 7 days prior to start of treatment. Women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control) while receiving study treatment and for 6 months after the last study treatment. Hormonal contraceptives are not acceptable as a sole method of contraception. Female patients must not breast feed.
- INR <1.3 or PT/PTT within normal limits in patients not receiving anticoagulation. However, patients receiving anticoagulation treatment with an agent such as warfarin or heparin are also eligible. For patients on warfarin, the INR should be measured prior to initiation of everolimus and monitored at least weekly, or as defined by the local standard of care, until INR is stable.
- Fasting serum cholesterol <=300 mg/dL OR <=7.75 mmol/L AND fasting triglycerides <= 2.5 x institutional ULN.
Exclusion Criteria:
- New York Heart Association (NYHA) grade II or greater congestive heart failure (see Appendix B) or symptomatic congestive heart failure.
- Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg).
- History of myocardial infarction or unstable angina within 6 months prior to beginning study treatment.
- History of stroke or transient ischemic attack within 6 months prior to beginning study treatment.
- Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to beginning study treatment.
- Prior history of hypertensive crisis or hypertensive encephalopathy.
- History of hemoptysis (>=1/2 teaspoon of bright red blood per episode) within 1 month prior to beginning study treatment.
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
- History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1.
- Serious, non-healing wound, active ulcer, or untreated bone fracture.
- Proteinuria as demonstrated by urine dipstick for proteinuria >=2+. For patients with >=2+ proteinuria on dipstick urinalysis, a urine protein: creatinine (UPC) ratio will be determined or a 24-hour urine collection will be done. Patients with a UPC ratio <1 or a 24-hour urine protein <1 gram are eligible.
- Minor surgical procedures (excluding placement of a vascular access device), fine-needle aspirations, or core biopsies within 7 days prior to starting treatment.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting protocol treatment or anticipation of need for major surgical procedure during the course of study treatment. Patients who have not recovered from the side effects of any major surgery are not eligible.
- Treatment with any investigational agents within 4 weeks of study entry.
- Chronic, systemic treatment with corticosteroids or other immunosuppressive agents. Topical or inhaled steroids are allowed.
- Other malignancies within the past 3 years except for adequately treated carcinoma in situ of the cervix or basal cell or superficial squamous (skin cell) carcinomas.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805961
United States, Alabama | |
Clearview Cancer Institute | |
Huntsville, Alabama, United States, 35805 | |
United States, Florida | |
Florida Cancer Specialists | |
Fort Myers, Florida, United States, 33901 | |
United States, Georgia | |
Northeast Georgia Medical Center | |
Gainesville, Georgia, United States, 30501 | |
United States, Kentucky | |
Consultants in Blood Disorders and Cancer | |
Louisville, Kentucky, United States, 40207 | |
United States, Maryland | |
Center for Cancer and Blood Disorders | |
Bethesda, Maryland, United States, 20817 | |
United States, Michigan | |
Grand Rapids Clinical Oncology Program | |
Grand Rapids, Michigan, United States, 49503 | |
United States, Missouri | |
St. Louis Cancer Care | |
Chesterfield, Missouri, United States, 63017 | |
Research Medical Center | |
Kansas City, Missouri, United States, 64132 | |
United States, Nebraska | |
Methodist Cancer Center | |
Omaha, Nebraska, United States, 68114 | |
United States, South Carolina | |
South Carolina Oncology Associates, PA | |
Columbia, South Carolina, United States, 29210 | |
United States, Tennessee | |
Tennessee Oncology, PLLC | |
Nashville, Tennessee, United States, 37023 | |
United States, Virginia | |
Peninsula Cancer Institute | |
Newport News, Virginia, United States, 23601 | |
Virginia Cancer Institute | |
Richmond, Virginia, United States, 23235 |
Study Chair: | John D Hainsworth, M.D. | SCRI Development Innovations, LLC |
Responsible Party: | SCRI Development Innovations, LLC |
ClinicalTrials.gov Identifier: | NCT00805961 |
Other Study ID Numbers: |
SCRI CNS 10 |
First Posted: | December 10, 2008 Key Record Dates |
Results First Posted: | September 21, 2012 |
Last Update Posted: | August 28, 2013 |
Last Verified: | August 2012 |
Glioblastoma Multiforme Radiation Therapy Temozolomide Bevacizumab Everolimus |
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Bevacizumab Everolimus Temozolomide |
Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Immunosuppressive Agents Immunologic Factors Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |