>> I'm going to be talking about BTTCO9O1,
a phase one/two trial of Everolimus and Sorafenib for patients with recurrent malignant gliomas.
BTTC 09-01 Study
>> This is a phase one/two trial using two
drugs called Everolimus and Sorafenib in combination to treat patients with recurrent glioblastoma
or recurrent anaplastic gliomas.
The basis for this study is to determine one, if the combination is safe, which is a phase
one, which has now been completed.
And the second phase is, the phase two, is using a combination to see if we can improve
outcomes for patients who have recurrent glioblastoma who have either failed Bevacuzumab or have
not been treated with Bevacuzumab.
As well as a group of grade three patients who have never been treated with Bevacuzumab
before.
Eligibility Criteria
>> As part of the eligibility criteria for
this study patients will have to have a recurrent malignant glioma.
These can either be a grade three tumor or a grade four tumor often called anaplastic
astrocytomas or glioblastomas.
Other parts of the major eligibility criteria are that these patients will have to have
recurrent tumors.
So, they are not newly diagnosed.
They will have to have normal laboratory parameters to make sure their kidney, their liver, their
blood counts are all under normal limits.
They can also not have prior history of hepatitis or HIV.
Or any intrinsic lung disease, kidney disease or cardiac dysfunction, which could be problematic
for patients taking these medications.
The medications are provided on the trial.
All patients will be given a study calendar to use prior to taking the drugs at home.
As both of them are administered as oral pills for the patients to take.
They do not require coming to the hospital.
The drugs are provided by the clinical trial.
And most aspects of the clinical trial will be billed to the patient's insurance company.
However, if their specific study requirements related to research, those will be covered
by the clinical trial.
Potential Risks and Benefits
>> As with all chemotherapeutic agents, there's
a number of side effects that patients can endure while they're on the study.
Most of the side effects we've learned about come from other indications where these drugs
have been used.
But we will be monitoring for safety while patients are on this study.
There are certain risks and some of them maybe unique for patients with brain tumors.
Although most of the time we do not see any unique toxicities in this patient population.
While we don't know if the medications will help treat your tumor, that is the real hope
of study that we can control your disease for a period of time, if not potentially indefinitely.
Patients will remain on the study for as long as they're tolerating the medication.
That means not having any adverse side effects which cannot be controlled with either lowering
a dose, holding the dose or by stopping the medication for short period of time.
As long as they want to be on the clinical trial.
And as long as we see the drug is benefiting them and their tumor has not started to recur.
Enrollment
>> The trial will enroll approximately 30
patients in each arm for the phase two study.
The phase one study was a smaller number of patients which is now completed.
For more information about the trial, we would like you to go to the BTTC website to learn
more about it to see if it's something that you're interested in or if it fits your specific
disease criteria.
Everolimus and Sorafenib Rationale
>> I encourage you to watch my other video
on how the mechanism of action of these two drugs work.
And the rationale for combining them in an attempt to try to treat your tumor.
>> For more information, visit ccr.cancer.gov/neuro-oncology-branch/bttc.
Protocol number: 16-C-0011.
>> U.S. Department of Health and Human Services.
National Institutes of Health.
National Cancer Institute.
Cancer.gov. 1-800-4-CANCER.
Produced December 2017