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Trials / Terminated

TerminatedNCT01339039

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

Phase I Study of Plerixafor (AMD3100) and Bevacizumab for Recurrent High-Grade Glioma

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
26 (actual)
Sponsor
Patrick Y. Wen, MD · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

* 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.

Conditions

Interventions

TypeNameDescription
DRUGPlerixaforGiven subcutaneously once a day for 3 weeks followed by 1 week off (standard 3x3 design); MTD determined in Part 1 will be used as dose in Part 2.
DRUGPlerixaforGiven subcutaneously once daily; MTD determined in Part 1 will be used as dose in Part 3.
DRUGBevacizumabGiven intravenously on days 1 and 15 (10 mg/kg) of each 28-day cycle
DRUGPlerixaforDaily administration for 5-9 days prior to surgery
PROCEDURESurgeryAfter receiving 5-9 days of Plerixafor (AMD3100) monotherapy, patients proceed to surgery. After recovering from surgery, patients will proceed to 28-day post-surgical cycles of therapy (Plerixafor at the MTD established in Part 1, 21 days on / 7 days off; bevacizumab 10 mg/kg on days 1 \& 15).

Timeline

Start date
2011-12-01
Primary completion
2014-04-01
Completion
2017-04-08
First posted
2011-04-20
Last updated
2017-11-17

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01339039. Inclusion in this directory is not an endorsement.