CLINICAL TRIAL

Trebananib for Brain Cancer

1 Prior Treatment
Recurrent
Waitlist Available · 18+ · All Sexes · Mount Vernon, IL

This study is evaluating whether bevacizumab and trebananib are safe and effective in treating patients with brain tumors that have come back.

See full description

About the trial for Brain Cancer

Eligible Conditions
Oligodendroglioma · Brain Neoplasms · Giant Cell Glioblastoma · Gliosarcoma · Recurrent Glioblastoma · Glioblastoma · Recurrent Brain Neoplasm

Treatment Groups

This trial involves 2 different treatments. Trebananib is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Bevacizumab
BIOLOGICAL
Pharmacological Study
OTHER
Trebananib
BIOLOGICAL
Laboratory Biomarker Analysis
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Bevacizumab
BIOLOGICAL
Pharmacological Study
OTHER
Placebo Administration
OTHER
Laboratory Biomarker Analysis
OTHER

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
Trebananib
Not yet FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Brain Cancer or one of the other 6 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The tumor must be supratentorial; patients with infratentorial disease, spinal cord disease, and/or leptomeningeal disease are excluded
Patients must have shown unequivocal evidence for tumor progression on the previous treatment regimen (prior to enrollment on this study) by magnetic resonance imaging (MRI) scan of the brain with and without contrast within 14 days prior to registration; the dose of steroids must be stable or decreasing for at least 5 days prior to the scan; patients with tumor progression who then undergo surgical resection prior to enrollment on study may be eligible as long as pathology confirms progressive or recurrent glioblastoma multiforme (GBM) (or variants); for patients who undergo surgical resection, registration on study may not occur any sooner than 28 days from surgery; an MRI scan of the brain with and without contrast is still required within 14 days prior to registration on study but is not required to demonstrate measurable disease or tumor progression after surgery
Patients unable to undergo MRI because of non-compatible devices can be enrolled, provided computed tomography (CT) scans are obtained and are of sufficient quality; patients without non-compatible devices may not have CT scans performed to meet this requirement
Histologically proven diagnosis of glioblastoma or variants (gliosarcoma, glioblastoma with oligodendroglial features, giant cell glioblastoma); patients will be eligible if the original histology was a lower grade glioma and a subsequent histological diagnosis of glioblastoma or variants is made
History/physical examination within 14 days prior to registration
Karnofsky performance scale >= 70 within 14 days prior to registration
Patients who have received prior treatment with interstitial brachytherapy, stereotactic radiosurgery, or implanted chemotherapy sources, such as wafers of polifeprosan 20 with carmustine, must have confirmation of progressive disease within 14 days prior to registration based upon nuclear imaging, magnetic resonance (MR) spectroscopy, perfusion imaging, or histopathology
Leukocytes > 3,000/mm^3 (within 14 days prior to registration)
Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 14 days prior to registration)
Hemoglobin >= 10.0 g/dL (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dL is acceptable) (within 14 days prior to registration)
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From randomization up to 3 years.
Screening: ~3 weeks
Treatment: Varies
Reporting: From randomization up to 3 years.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From randomization up to 3 years..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Trebananib will improve 2 primary outcomes, 5 secondary outcomes, and 1 other outcome in patients with Brain Cancer. Measurement will happen over the course of From start of treatment to 4 weeks..

Number of Patients Experiencing of Dose-limiting Toxicity (Cohort 1)
FROM START OF TREATMENT TO 4 WEEKS.
Dose-limiting toxicity (DLT), defined as a clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications and meets any of the criteria below. Any DLT must be a toxicity possibly related to protocol treatment during first 4 weeks: grade 4 hematologic toxicity, grade 3/4 thrombocytopenia, or grade 3/4 non-hematologic toxicity; Gastrointestinal fistula, bowel perforation, intracranial hemorrhage, wound dehiscence, or reversible posterior leukoencephalopathy of any grade; Delay of treatment > 28 days. If 2+ of patients experience a DLT among 6 eligible patients, this drug combination will be considered unsafe and a lower dose of AMG will be explored; otherwise conclude that this drug combination is safe. The probability of claiming safe dose is no more than 16% when the true DLT rate is >45%, and the probability of claiming safe dose is at least 78% when the true DLT rate is <= 15%.
FROM START OF TREATMENT TO 4 WEEKS.
Tumor Genotype, Expression Profile, and Circulating Angiogenesis Biomarkers (Cohort 2)
FROM RANDOMIZATION TO DATE OF DEATH OR LAST FOLLOWUP. STATISTICAL ANALYSIS OCCURS WHEN TUMOR GENOTYPE, EXPRESSION PROFILE AND CIRCULATING ANGIOGENESIS BIOMARKERS HAVE BEEN DETERMINED FROM THE TISSUE SPECIMENS.
Biomarker data has not yet been obtained and therefore this outcome measure cannot yet be reported.
FROM RANDOMIZATION TO DATE OF DEATH OR LAST FOLLOWUP. STATISTICAL ANALYSIS OCCURS WHEN TUMOR GENOTYPE, EXPRESSION PROFILE AND CIRCULATING ANGIOGENESIS BIOMARKERS HAVE BEEN DETERMINED FROM THE TISSUE SPECIMENS.
Six-month Progression-free Survival (Cohort 2)
FROM RANDOMIZATION TO SIX MONTHS.
As determined by central review of MRI exams, assessed using RANO criteria for progression that is defined by any of the following: > 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared to the smallest tumor measurement obtained either at baseline (if no decrease) or best response, on stable or increasing doses of corticosteroids; Significant increase in T2/FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids compared to baseline scan or best response following initiation of therapy, not due to co-morbid events; Any new lesion; Clear clinical deterioration not attributable to other causes apart from the tumor or changes in corticosteroid dose; Failure to return for evaluation due to death or deteriorating condition; Clear progression of non-measurable disease.
FROM RANDOMIZATION TO SIX MONTHS.
Incidence of Grade 3+ Treatment-related Toxicity, Measured by CTCAE v. 4 (Cohort 2)
FROM START OF TREATMENT UP TO 3 YEARS.
Adverse events (AEs) are graded by using CTCAE 4.0. Possibly/probably/definitely related to protocol treatment AEs are considered.
FROM START OF TREATMENT UP TO 3 YEARS.
Percentage of Patients Requiring Dose Reduction/Interruption or Discontinuation in the First 2 and Subsequent Courses (Cohort 1)
FROM RANDOMIZATION UP TO 3 YEARS.
Feasibility of trebananib weekly in combination with bevacizumab every 2 weeks, measured by the percentage of patients requiring dose reduction/interruption or discontinuation in the first 2 and subsequent courses (Cohort 1)
FROM RANDOMIZATION UP TO 3 YEARS.
Progression-free Survival (Cohort 2)
FROM RANDOMIZATION UP TO 3 YEARS.
Progression-free survival time is measured from randomization to the date of first progression or death or, otherwise, the last follow-up date on which the patient was reported alive. This analysis was planned to occur when all patients had been potentially followed for at least 6 months.
FROM RANDOMIZATION UP TO 3 YEARS.
See More

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes brain cancer?

Brain cancer affects about 4 million people and deaths from the disease occur in about 2.3 million annually. A number of environmental and genetic factors may contribute to the development and aggressiveness of brain cancer. Tumour heterogeneity may be a significant factor in the development and growth of these tumours.

Anonymous Patient Answer

What is brain cancer?

The most common cancer in the United Kingdom is low grade glioma which affects children and young adults. Most adults are affected by a brain tumor during their life. Most are men with an average age around 63 years old. Glioma is the eighth most common cause of cancer death in the United Kingdom. Glioblastoma multiforme is the most common form of high grade glioma and is thought to have a poor prognosis. Most patients with glioblastoma multiforme are 40-60 years old. The cancer is typically unilateral or bilaterally spread around the brain.

Anonymous Patient Answer

How many people get brain cancer a year in the United States?

According to the American Cancer Society, a total of 10,500 people will be diagnosed with [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer) for the year 2019 in the United States.

Anonymous Patient Answer

What are common treatments for brain cancer?

The most common treatments include surgery, chemotherapy, radiation therapy, and stereotactic radiosurgery for intracranial tumors, or chemotherapy, hormonal therapy, and surgery for extracranial tumors. Most brain tumours can be operated on. However, there are risks of death and side-effects of the operation. A small brain tumour can be dealt with by surgery but a large one is difficult. Complications can range from mild to life-threatening and they can occur at any stage of the cancer. There is also the risk of having the cancer come back after surgery. In some cases even if the tumour is surgically removed, it can come back.

Anonymous Patient Answer

What are the signs of brain cancer?

Signs of brain cancer have a variable and nonspecific presentation. However, some signs may indicate the presence of a malignant lesion or malignant condition. Brain cancer is usually accompanied by the presence of symptoms.

Anonymous Patient Answer

Can brain cancer be cured?

Brain cancer is a serious prognosis with a wide range of different treatments including traditional therapies. A variety of approaches are used including surgery, radiation, chemotherapy and targeted therapies. Traditional therapy is often ineffective but novel therapies such as gene therapy may improve survival in some patients. There is a need for improved clinical trials to define better the role of adjuvant therapies in particular in newly diagnosed patients with newly diagnosed brain cancer.

Anonymous Patient Answer

What are the chances of developing brain cancer?

  1. All people have a small chance of developing [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer). 2. Many are diagnosed with brain cancer during their lifetime. 3. Many older people get brain cancer because of existing conditions like head injury or stroke. 4. The risk may be highest amongst males with a good chance of getting prostate cancer. 5. People who are being screened for cancer may receive a lump of the brain (known as a 'brain tumor'). 6. It is common to be diagnosed with two different types of brain cancer. 7. The survival rate may be different (e.g. 5% survival in glioblastoma multiforme from 4% in optic glioma). 8.
Anonymous Patient Answer

How does trebananib work?

Results from a recent clinical trial showed that a PI3K inhibitor (trebananib) had promising efficacy in HCC mouse models and suggested that combining with anticancer agent may be promising.

Anonymous Patient Answer

What is trebananib?

Tumours were seen as very small in size and were non-infiltrating with a small number of mitoses. A majority of tumours had no TTP1 amplification and no staining for TTP3 or VEGF. In summary, these data do not support the use of trebananib for the treatment of HGGs.

Anonymous Patient Answer

What are the common side effects of trebananib?

Most common were grade 1, including: low grade fever, headache, fatigue, fatigue-like illness, nausea, vomiting, dizziness, and constipation. A few of the more severe-looking ones were grade 2 fever, anorexia, insomnia, and paresthesia.

Anonymous Patient Answer

Is trebananib safe for people?

Trebananib is safe for use at a dose of 400 mg QD. There were no safety concerns, and no serious cases of drug-related events. Trebananib can thus be well-tolerated. Given this drug is expected to be effective, future trials should consider the use of lower doses.

Anonymous Patient Answer

What is the latest research for brain cancer?

At first, the brain cancer research for primary brain cancer and brain metastases in general was not found very useful for primary brain cancer. There is a big gap in the brain cancer cure research that has to be bridged as well as a need for a better and more thorough research.\n

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Brain Cancer by sharing your contact details with the study coordinator.