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

Conditions

• Anaplastic Astrocytoma (AA)
• Anaplastic Oligodendroglioma (AO)
• High Grade Glioma: Glioblastoma (GBM)
• High Grade Glioma: Gliosarcoma
• Mixed Anaplastic Oligoastrocytoma (AOA)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Plerixafor — DRUG
  Given 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.
• Plerixafor — DRUG
  Given subcutaneously once daily; MTD determined in Part 1 will be used as dose in Part 3.
• Bevacizumab — DRUG
  Given intravenously on days 1 and 15 (10 mg/kg) of each 28-day cycle
• Plerixafor — DRUG
  Daily administration for 5-9 days prior to surgery
• Surgery — PROCEDURE
  After 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).

Study Details

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.

Key Dates

First listed

Apr 20, 2011

Start date

Dec 31, 2011

Status verified

Nov 2017

Primary completion

Apr 30, 2014

Completion

Apr 8, 2017

Study Design

Enrollment

26 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Part 1
  Maximum Tolerated Dose Determination of Plerixafor (3 weeks on, 1 week off) and Bevacizumab (every 2 weeks)
• Experimental: Part 2
  Surgical Arm: Safety evaluation of Plerixafor (3 weeks on, 1 week off) and Bevacizumab (every 2 weeks)
• Experimental: Part 3
  Safety and tolerability of Plerixafor (daily) at MTD dose from Part 1 and Bevacizumab (every 2 weeks)

Primary Outcome Measure

Determination of Maximum Tolerated Dose (MTD) [ Time Frame: 9 months ]

Locations (2)

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