Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase II Trial of Bevacizumab in Combination With Temozolomide and Regional Radiation Therapy for Upfront Treatment of Patients With Newly-diagnosed Glioblastoma Multiforme
Verified date | April 2016 |
Source | Jonsson Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the
growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such
as temozolomide, work in different ways to stop the growth of tumor cells, either by killing
the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to
kill tumor cells. Giving bevacizumab together with temozolomide and radiation therapy may
kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving bevacizumab
together with temozolomide and external beam radiation therapy works when given as first-line
therapy in treating patients with newly diagnosed glioblastoma multiforme or gliosarcoma.
Status | Completed |
Enrollment | 70 |
Est. completion date | August 2015 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically confirmed intracranial glioblastoma multiforme (GBM) or gliosarcoma. - Prior histologic diagnosis of low-grade glioma allowed provided it has been upgraded to GBM after repeat resection - Has undergone surgery to collect tumor tissue 3-6 weeks ago - Measurable or assessable disease is not required - Karnofsky performance status 60-100% - Life expectancy > 8 weeks - White Blood Cell (WBC) = 3,000/mm³ - Absolute Neutrophil Count (ANC) = 1,500/mm³ - Platelet count = 100,000/mm³ - Hemoglobin = 10 g/dL (transfusion allowed) - Serum Glutamate Oxaloacetate Transaminase (SGOT) < 2.5 times upper limit of normal (ULN) - Bilirubin < 2.5 times ULN - INR (international normalized ratio) = 1.5 times ULN (except if on therapeutic anticoagulation therapy) - aPTT (activated partial thromboplastin time) = 1.5 times ULN (except if on therapeutic anticoagulation therapy) - Creatinine < 1.5 mg/dL - Urine protein:creatinine ratio < 1.0 - Negative pregnancy test - Fertile patients must use effective contraception - More than 28 days since prior major surgical procedures or open biopsy (other than craniotomy) - More than 7 days since prior minor surgical procedures (e.g., placement of PortoCath (port-a-cath - a port placed under the subjects skin), stereotactic biopsy, fine-needle aspirations, or core biopsies) - More than 4 weeks since prior and no concurrent participation in another experimental drug study. - Prior or concurrent corticosteroids, anti-epileptic drugs, analgesics, or other drugs to treat symptoms or prevent complications are allowed - Concurrent full-dose warfarin or its equivalent (i.e., unfractionated and/or low molecular weight heparin) allowed Exclusion Criteria: - unstable angina - BP > 150/100 mm Hg - New York Heart Association (NYHA) class II-IV congestive heart failure - myocardial infarction within the past 6 months - stroke within the past 6 months - clinically significant peripheral vascular disease - evidence of bleeding diathesis or coagulopathy - intracerebral abscess within past 6 months - abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months - serious, non-healing wound, ulcer, or bone fracture - Any wound requiring surgical intervention (including scalp wounds requiring cranioplasty) allowed provided the wound is clean and without further infection post-surgical intervention - significant traumatic injury within the past 28 days - concurrent serious uncontrolled medical illness including, but not limited to, the following: - Ongoing or active infection requiring IV antibiotics - Psychiatric illness/social situation that would limit compliance with study requirements - Disorders associated with significant immunocompromised state (e.g., HIV, systemic lupus erythematosus) - other cancer within the past 3 years, except nonmelanoma skin cancer or carcinoma in situ of the cervix - disease that would obscure toxicity or dangerously alter drug metabolism - significant medical illness that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate study therapy - prior radiotherapy to the brain - prior cytotoxic or non-cytotoxic drug therapy or experimental drug therapy for the brain tumor - prior Gliadel wafers - concurrent participation in any other clinical trial - concurrent GM-CSF (granulocyte-macrophage colony-stimulating factor) - concurrent stereotactic radiosurgery or brachytherapy - concurrent major surgical procedure - other concurrent anticancer therapy, including chemotherapy, hormonal therapy, radiotherapy, or immunotherapy |
Country | Name | City | State |
---|---|---|---|
United States | Jonsson Comprehensive Cancer Center, University of California, Los Angeles (UCLA) | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Jonsson Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | 2 years | ||
Secondary | Time to Disease Progression | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | 2 years | |
Secondary | Progression-free Survival at 6 Months | participants who were alive and disease progression free at 6 months | 6 months | |
Secondary | Radiographic Response (When Evaluable) | Radiation therapy (RT) median from diagnosis to RT. Patients will have brain MRI evaluation of response and progression every 8 weeks starting from the day 56 scan obtained 2 weeks after completion of radiation and daily temozolomide and assessment will be conducted on a 7-point scale. This scale is expected to be more useful in this study because many newly-diagnosed patients are likely not to have evaluable disease due to gross total resections. Determination of whether progression occurs based on the day 56 scan will take into account the untreated window between baseline MRI and day of 1 of study. 7 Point Likert Scale: 3 to -3, 3 means complete resolution of tumor, and -3 means new lesion. A -2 or -3 assessment will be taken as tumor progression. complete resolution of tumor: 3 tumor resolved 3 tumor definitely smaller: 2 tumor probably smaller: 1 tumor unchanged: 0 tumor probably worse: -1 tumor definitely worse: -2 New Lesion: -3 |
2 years | |
Secondary | Median Overall Survival (OS) Based on the MGMT Promoter Methylation Status | IDH1 and MGMT methylation are important independent prognostic biomarkers that have to be included in a Cox regression model. In addition, subgroup analysis could reveal differential sensitivities to the treatment arm. The MGMT promoter methylation status, IDH1 mutation status were not available for all of the control samples. Therefore, only the samples with both info available were included in the analysis. Baseline analysis results are included in the Baseline Characteristics module. | 2 years |
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