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

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.

Conditions

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

Interventions

DRUG

Plerixafor

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.

DRUG

Plerixafor

Given subcutaneously once daily; MTD determined in Part 1 will be used as dose in Part 3.

DRUG

Bevacizumab

Given intravenously on days 1 and 15 (10 mg/kg) of each 28-day cycle

DRUG

Plerixafor

Daily administration for 5-9 days prior to surgery

PROCEDURE

Surgery

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).

Sponsors & Collaborators

• Dana-Farber Cancer Institute

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Genzyme, a Sanofi Company

  collaborator INDUSTRY

• Patrick Y. Wen, MD

  lead OTHER

Principal Investigators

• Patrick Y. Wen, MD · Dana-Farber Cancer Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-12-31

Primary Completion

2014-04-30

Completion

2017-04-08

Countries

• United States

Study Locations