TRC105 for Recurrent Glioblastoma

Stopped early · Phase 2

Conditions studied: Glioblastoma Multiforme

In brief

Background: \- Glioblastoma is an aggressive type of brain cancer that often resists treatment. TRC105 is an experimental drug that blocks the growth of new blood vessels. It is being studied for possible use in treating different kinds of cancer. Researchers want to see if TRC105 can be used to treat glioblastoma that has not responded to standard treatments. Objectives: \- To test the safety and effectiveness of TRC105 in adults who have glioblastoma that has not responded to standard treatments. Eligibility: \- Individuals at least 18 years of age who have glioblastoma that has not responded to standard treatments. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies and other tests will be used to study the tumor before the start of treatment. * Participants will have 28-day (4-week) cycles of treatment. * Participants will have TRC105 intravenously once a week. The first infusion will take about 4 hours. The length of time needed for the infusion may be slowly reduced if it is well tolerated. * At the end of the first cycle (the first 4 weeks), the imaging studies will be repeated before continuing TRC105. * Participants will take TRC105 for as long as the tumor does not grow and the side effects are not too severe. They will have imaging studies at the end of every cycle to evaluate the tumor.

Key facts

Study ID

NCT01778530

Run by

National Cancer Institute (NCI)

People needed

2

Starts

2012-12-01

Expected to finish

2014-02-01

Last updated by the study team

2015-10-07

Who can join

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

You may not qualify if…

• Patients who are receiving any other investigational agents and/or who have received an investigational agent in the prior 28 days.
• Patients may not have had prior therapy with vascular endothelial growth factor (VEGF) receptor inhibitors.
• Patients with a history of peptic ulcer disease or erosive gastritis within the past 6 months, unless treated for the condition and complete resolution has been documented by esophagogastroduodenoscopy (EGD).
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to TRC105.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Exclude patients who have had angina, MI, symptomatic congestive heart failure (CHF), cerebral vascular accident (CVA), transient ischemic attack (TIA), arterial embolism, pulmonary embolism, deep vein thrombosis (DVT), percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within the last 6 months.
• Exclude patients with cardiac arrhythmias > grade 2 in the last 28 days.
• Exclude patients with chronic hypertension, systolic BP > 140 and/or diastolic BP > 90 despite optimal treatment.
• Exclude human immunodeficiency virus (HIV)+ patients who have CD4 counts which are below the lower limit of normal for the institution
• Patients known to have a malignancy (other than their glioblastoma) that has required treatment in the last 12 months and/or is expected to require treatment in the next 12 months (except non-melanoma skin cancer or carcinoma in-situ in the cervix)
• Patients are not allowed to receive concurrent anti-coagulation, and may not have received thrombolytic or anticoagulant agents (except heparin or alteplase to maintain intravenous (IV) catheters) within 10 days prior to drug administration
• Serious or non-healing wound, ulcer or bone fracture
• History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months
• Evidence of bleeding diathesis or coagulopathy
• Patients with a history of hereditary hemorrhagic telangiectasia (HHT)
• Pregnant women are excluded from this study because TRC105 and antiangiogenic agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TRC105, breastfeeding should be discontinued if the mother is treated with TRC105.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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