RRx-001 + Radiation + Temozolomide In Newly Diagnosed Glioblastoma and Anaplastic Gliomas
Status:
Active, not recruiting
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
This is a two-part Phase I add-on clinical trial in newly diagnosed glioblastoma or GBM. By
"add-on" what is meant is that the experimental intravenous therapy, RRx-001, is combined or
"added on" to standard of care. In newly diagnosed GBM standard of care consists of
radiotherapy + temozolomide (TMZ) for 6 weeks followed (after a 4-6 weeks break) by
maintenance TMZ given until the tumor progresses or worsens. By "maintenance" therapy what is
meant is that TMZ is given less frequently to prolong or extend the time during which the
tumor remains stable.
G-FORCE-1 will be conducted in two parts; in the first part of the study (Dose Escalation,
Part A) patients will be entered or assigned sequentially (that is consecutively) to
gradually escalating or increasing doses of RRx-001 after patients have been entered on the
previous dose until such time as it is no longer tolerated. At each dose level, a separate
cohort or small group of at least 3 evaluable patients will be treated. RRx-001 will be
administered by intravenous infusion (in other words, by slow injection in the veins) over
30-45 minutes once weekly during radiotherapy for 6 weeks followed by the FDA-approved
chemotherapy, temozolomide (TMZ) alone for up to 6 months or longer.
In the second part of this study (Part B), new groups or cohorts of patients will receive
RRx-001 at the dose established in Part A by intravenous infusion over 30-45 minutes once
weekly during radiotherapy for 6 weeks. Then, after a 4-6 weeks break, each cohort will
receive increasing doses of RRx-001 and temozolomide (in other words, a double dose
escalation) to establish an acceptable safety and activity window, in other words, a dose
range that is relatively free of toxicity as well as active against the tumor, although the
primary purpose of this study is to assess or evaluate safety.
The reason or rationale to "add on" RRx-001 to radiotherapy and TMZ, which is described in
more detail below on this page, is as follows: RRx-001 is a radiosensitizer and a
chemosensitizer, which means that experimentally it increases the activity of radiation and
chemotherapy in tumors. In addition, in other ongoing clinical trials, patients have
experienced minimal toxicity or side effects with RRx-001 alone and also in combination with
radiation in the brain; therefore, the hope is that RRx-001 will synergize or combine well
with radiotherapy and TMZ in GBM without adding toxicity