TerminatedPhase 1

Plerixafor (AMD3100) and Bevacizumab for Recurrent High-Grade Glioma

Stopped: Low accrual rate

United States26 participantsStarted 2011-12

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Histologic diagnosis of glioblastoma (GBM), gliosarcoma, anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), or anaplastic mixed oligoastrocytoma (AOA). Patients are eligible if the original histology was lower-grade glioma. * Unequivocal progression by MRI or CT * Patients with recurrence who undergo resection and are left without measurable or evaluable disease are eligible. * Patients must have recurrent disease and may have had any number of prior relapses (including no prior relapses) on NON-anti-VEGF(R) containing regimens. Relapse is defined as progression following initial therapy. For patients who progressed on a prior anti-VEGF(R) containing regimen including bevacizumab, only one prior relapse on an anti-VEGF(R) containing regimen is allowed. * 18 years of age or older * Karnofsky performance status of 60 or greater * Normal organ and marrow function as outlined in the protocol * Ability to understand and willingness to sign a written informed consent document. * Protocol treatment must begin within 5 consecutive days after registration * Patients enrolled in Part 2 must be willing to undergo surgical resection and have sufficient pre-treatment archival tumor tissue available for molecular analysis * Women of child-bearing potential must have a negative serum or urine pregnancy test within 72 hours before the start of the investigational product. In addition, female subjects of child-bearing potential and male subjects with partne…

What they're measuring

Determination of Maximum Tolerated Dose (MTD)

Timeframe: 9 months

Trial details

NCT IDNCT01339039

SponsorPatrick Y. Wen, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-04