Bevacizumab With or Without Anti-Endoglin Monoclonal Antibody TRC105 in Treating Patients With Recurrent Glioblastoma Multiforme

Completed · Phase 1/Phase 2

Conditions studied: Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Adult Mixed Glioma, Recurrent Adult Brain Neoplasm

In brief

This partially randomized phase I/II trial studies the side effects and the best dose of anti-endoglin monoclonal antibody TRC105 when given together with bevacizumab and to see how well they work in treating patients with glioblastoma multiforme that has come back. Monoclonal antibodies, such as anti-endoglin monoclonal antibody TRC105 and bevacizumab, may find tumor cells and help kill them. Giving anti-endoglin monoclonal antibody TRC105 together with bevacizumab may be an effective treatment for glioblastoma multiforme.

Key facts

Study ID

NCT01648348

Run by

National Cancer Institute (NCI)

People needed

116

Starts

2012-11-01

Expected to finish

2017-04-15

Last updated by the study team

2018-05-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological confirmation of grade 3 or 4 glioma, including astrocytoma, oligodendroglioma, and mixed gliomas, as determined by pre-registration central pathology review (Phase I)
• Histological confirmation of glioblastoma multiforme (grade 4 astrocytoma) as determined by pre-registration central pathology review; note: gliosarcomas and other grade 4 astrocytoma variants (e.g., giant cell) are eligible; glioblastoma (GBM) with oligodendroglial features are NOT PERMITTED in this study if they are 1p19q co-deleted; sites submitting GBM with oligodendroglial features will be asked to provide results of 1p/19q co-deletion status (Phase II)
• Evidence of tumor progression by MRI or computed tomography (CT) scan following radiation therapy or following the most recent anti-tumor therapy; note: patients who have had surgical treatment at recurrence are eligible if they had a resection with measurable or non-measurable residual disease on postoperative imaging or if there is imaging evidence of disease progression as compared to the first postoperative scan
• Measurable or evaluable disease by gadolinium MRI or contrast CT scan; note: patients who have had a gross total resection (GTR) are eligible on the basis of evaluable disease
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
• Absolute neutrophil count (ANC) >= 1,500/mm\^3
• Platelet count >= 100,000/mm\^3
• White blood cells (WBC) >= 3,000/mL
• Hemoglobin >= 10.0 g/dL; note: this level may be reached by transfusion
• Total bilirubin =< institutional upper limit of normal (ULN)
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2 x ULN
• Creatinine =< ULN
• Life expectancy >= 12 weeks
• Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
• Urine protein creatinine (UPC) ratio < 1; note: urine protein must be screened by urine analysis for UPC ratio; for UPC ratio >= 1.0, 24-hour urine protein must be obtained and the level should be < 1,000 mg for registration
• Fixed or decreasing dose of corticosteroids (or no corticosteroids) >= 7 days prior to registration
• Calculated glomerular filtration rate (GFR) must be >= 60 ml/min; GFR will be calculated as needed per institutional guidelines
• Any number of prior chemotherapy regimens for recurrent disease (Phase I); =< 1 chemotherapy or other non-antiangiogenic regimen for recurrent disease (Phase II)
• Last dose of bevacizumab >= 2 weeks prior to registration (Phase I); note: for the phase II study only, prior exposure to bevacizumab is not allowed
• Surgery >= 4 weeks prior to registration
• Completion of radiation therapy >= 12 weeks prior to registration and prior chemotherapy >= 4 weeks prior to registration (>= 6 weeks from nitrosourea-containing regimens)
• Small molecular cell cycle inhibitors >= 2 weeks from registration
• Ability to provide informed written consent
• Ability to complete questionnaire(s) by themselves or with assistance
• Willing to return to enrolling institution for follow-up

You may not qualify if…

• Any of the following:
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the duration of the study and for at least 6 months after treatment has ended
• Prior hypersensitivity to bevacizumab or toxicity requiring discontinuation of bevacizumab (Phase I)
• Any prior exposure to any VEGF or VEGF inhibitor including, but not limited to, bevacizumab, cediranib, vandetanib, sunitinib, pazopanib, aflibercept, or sorafenib (Phase II)
• Prior hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies (Phase I and II)
• Prior hypersensitivity to triptan derivatives (Phase I and II)
• Other active malignancy =< 3 years prior to registration; exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix; note: if there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer
• Uncontrolled infection
• Immunocompromised patients or patients known to be human immunodeficiency virus (HIV) positive and currently receiving combination antiretroviral therapy; patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the prescribed regimens
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
• History of hypertensive crisis or hypertensive encephalopathy
• Clinically significant cardiovascular disease defined as follows:
• Inadequately controlled hypertension (i.e., systolic blood pressure [SBP] > 160 mm Hg and/or diastolic blood pressure [DBP] > 90 mm Hg despite antihypertensive therapy)
• History of cerebrovascular accident (CVA) within 6 months
• Myocardial infarction or unstable angina within 6 months
• New York Heart Association classification II, III, or IV cardiovascular disease
• Serious and inadequately controlled cardiac arrhythmia
• Significant vascular disease (i.e., aortic aneurysm, history of aortic dissection)
• Clinically significant peripheral vascular disease
• Evidence or history of bleeding diathesis (greater than normal risk of bleeding, i.e., hereditary hemorrhagic telangiectasia type I or HHT-1) or coagulopathy in the absence of therapeutic anti-coagulation or any hemorrhage/bleeding event > grade 3 within 4 weeks prior to registration; note: patients with full-dose anticoagulants are eligible provided the patient has been on a stable dose for at least 2 weeks of low molecular weight heparin; therapeutic Coumadin and aspirin doses > 325 mg daily are not allowed
• Receiving any other investigational agent that would be considered as a treatment for the primary neoplasm
• Prior treatment with TRC105

Where it is running

• Saint Jude Medical Center — Fullerton, California, United States
• Saint Joseph Hospital - Orange — Orange, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• UCSF Medical Center-Mount Zion — San Francisco, California, United States
• UCSF Medical Center-Parnassus — San Francisco, California, United States
• Greenwich Hospital — Greenwich, Connecticut, United States
• Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut, United States
• Stamford Hospital/Bennett Cancer Center — Stamford, Connecticut, United States
• Beebe Medical Center — Lewes, Delaware, United States
• Christiana Gynecologic Oncology LLC — Newark, Delaware, United States
• Delaware Clinical and Laboratory Physicians PA — Newark, Delaware, United States
• Helen F Graham Cancer Center — Newark, Delaware, United States
• Medical Oncology Hematology Consultants PA — Newark, Delaware, United States
• Regional Hematology and Oncology PA — Newark, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• Beebe Health Campus — Rehoboth Beach, Delaware, United States
• Nanticoke Memorial Hospital — Seaford, Delaware, United States
• Christiana Care Health System-Wilmington Hospital — Wilmington, Delaware, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Florida Hospital Orlando — Orlando, Florida, United States
• Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho, United States
• Kootenai Medical Center — Coeur d'Alene, Idaho, United States
• Kootenai Cancer Center — Post Falls, Idaho, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.