Anaplastic Astrocytoma (AA) Clinical Trial
Official title:
Phase I Study of Plerixafor (AMD3100) and Bevacizumab for Recurrent High-Grade Glioma
Plerixafor in combination with bevacizumab is a drug combination that may stop cancer cells
from growing abnormally. Bevacizumab, also known as Avastin, is FDA approved for use in
patients with recurrent glioblastoma and has been studied extensively in other types of solid
tumors. Plerixafor, also known as Mozobil, is FDA approved for use in patients with
non-Hodgkin's lymphoma and multiple myeloma and has been used in treatment for other cancers.
Information from experiments in laboratories suggests that the combination of plerixafor and
bevacizumab may help prevent the growth of gliomas.
Part 1: The investigators are looking for the highest dose of plerixafor that can be given
safely with bevacizumab (with a 21 days on/7 days off regimen of plerixafor). The
investigators will also do blood tests to find out how the body uses and breaks down the drug
combination.
Part 2: The investigators are looking to see if plerixafor can get past the blood-brain
barrier and into brain tumors. The investigators will also do blood tests to find out how the
body uses and breaks down the drug combination.
Part 3: The investigators are looking for for more information re: safety and tolerability of
plerixafor in combination with bevacizumab (with a 28 days on/0 days off regimen of
plerixafor). The investigators will also do blood tests to find out how the body uses and
breaks down the drug combination.
- This study is organized into cycles. Each cycle lasts four weeks (28 days). Cycles occur
back to back without a break in between.
- Plerixafor is given as subcutaneous injection (under the skin). The injection should be
given at approximately the same time each day (If participants would like the option to
administer their Plerixfor in the evening rather than in the morning on non-clinic days,
this is a possibility, provided certain conditions are met). The research doctor will
specify which days participants should take plerixafor. In general, plerixafor will be
given once daily during the first three weeks of every cycle (during part 3, patients
will receive plerixafor the last week of each cycle, as well). For the first week (5-7
days) of Cycle 1, the injections will be given in the clinic and the nurses will teach
the participant and their spouse/friend/family member how to administer the injections.
- Bevacizumab (10 mg/kg) will be given as an infusion on Days 1 and 15 of each cycle.
- During Part 1 the investigators are looking for the highest dose of the study drug that
can be administered safely in combination with bevacizumab so not everyone who
participates will receive the same dose of the study drug. The dose given will depend
upon on the number of participants who have been enrolled and how well they have
tolerated their doses.
- During Part 2, before patient begins their post-surgical cycles of treatment, plerixafor
will be administered daily for 5-9 days at the MTD established in Part 1 of the study;
patient will continue to surgery; and once recovered from surgery, patient will begin
post-surgical cycles of treatment (plerixafor and bevacizumab) at the MTD/regimen
established in Part 1 of the study.
- In addition to taking the study medication, participants will have the following tests
and procedures done: physical and neurological exam, assessments of the tumor by MRI or
CT scan, routine and research blood tests, routine urine tests, pregnancy test (if
applicable), ECG, collection of cerebrospinal fluid (CSF) via spinal tap.
- Participants may remain in this research study as long as their tumor is responding or
it is determined that receiving further study drugs will not be safe.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01392209 -
Hypofractionated Stereotactic Radiotherapy With Bevacizumab in the Treatment of Recurrent Malignant Glioma
|
Phase 1 |