Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02215512 |
| Other study ID # |
RRx001-22-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
February 6, 2015 |
| Est. completion date |
November 12, 2020 |
Study information
| Verified date |
November 2021 |
| Source |
EpicentRx, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In this dose-escalation study, the safety and tolerability of escalating dose levels of
RRx-001 administered intravenously twice a week in subjects with brain metastases receiving
whole brain radiation therapy (WBRT) will be assessed. Once a maximum tolerated dose is
identified, further (up to approximately 30) participants will be recruited. The study will
use MRI to monitor changes in tumor blood flow associated with RRx-001.
Description:
The purpose of this research study is to test the safety and activity of whole brain
radiation therapy with RRx-001, an experimental radiation sensitizer, in participants with
brain metastases. As a radiation sensitizer, RRx-001 may increase the effect of whole brain
radiation, the standard of care for brain metastases, on cancer cells in a specific target
area while reducing damage to normal healthy cells. The ability to sensitize the cancer cells
to radiation sets off a 'domino effect' of free radical damage in the tumor from a given
amount or dose of radiation.
This study, which is called BRAINSTORM, since RRx-001 is associated with the development of a
"free radical storm" in the brain tumors, is divided into two stages. In the first stage,
approximately 3 participants at a time will be entered at a particular dose level of RRx-001
and then observed in order to see whether that dose results in side effects with radiation.
If no bad side effects are observed, a second group of approximately 3 subjects will be given
a slightly higher dose of RRx-001 and also monitored for side effects with radiation. This
process will be repeated until a dose is reached, which has the most activity against the
cancer cells without unacceptable side effects. At this point, more participants will be
entered at this dose level until a maximum enrollment of approximately 30 participants has
been reached.
RRx-001 releases a gas called nitric oxide, which widens the diameter of blood vessels, and
allows the delivery of more oxygen to tumors. The presence of oxygen in tumors is critical
for the effectiveness of radiation therapy, since cancer cells are about two to three times
more vulnerable to radiation when oxygen is present. The reason that cancer cells are so much
more vulnerable to the effects of radiation when oxygen is present is that radiation relies
on the formation of harmful molecules known as free radicals that damage proteins and genetic
material (DNA); without oxygen lower levels of free radicals are produced. Changes in the
diameter go blood vessels will be studied by magnetic resonance imaging.
Unlike chemotherapies or other radiation sensitizers, RRx-001 does not have to enter the
tumor to be effective because nitric oxide, as a gas, is able to spread or diffuse from the
bloodstream into cancer cells.
