Phase I Study of Plerixafor (AMD3100) and Bevacizumab for Recurrent High-Grade Glioma
- 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. 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 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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determination of Maximum Tolerated Dose (MTD)
To determine the maximum tolerated dose (the highest dose combination that causes DLT in no more than 1 of 6 patients) of plerixafor 3 weeks on, 1 week off in combination with bevacizumab (every two weeks) in this patient population.
Patrick Y. Wen, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|