A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma



Status:Completed
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/8/2017
Start Date:December 2011
End Date:May 17, 2016

Use our guide to learn which trials are right for you!

A Phase II Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma

The purpose of this research study is to find out whether adding an experimental vaccine
called rindopepimut (also known as CDX-110) to the commonly used drug bevacizumab can
improve progression free survival (slowing the growth of tumors) of patients with relapsed
EGFRvIII positive glioblastoma.

This Phase II study will enroll patients into three groups. Group 1 are patients who have
never been treated with bevacizumab. These patients will be randomly assigned to receive
either rindopepimut/GM-CSF or KLH, each along with bevacizumab. Treatment assignment for
Group 1 will be blinded. Group 2 and Group 2C patients are those who are refractory to
bevacizumab (experienced recurrence or progression of glioblastoma while on bevacizumab or
within 2 months of discontinuing bevacizumab). These patients will all receive
rindopepimut/GM-CSF along with bevacizumab. Patients will be treated until disease
progression or intolerance and all patients will be followed for survival. Patients may be
treated with other therapies that are not part of the study after discontinuing treatment
with the study vaccine.

Inclusion Criteria:

Among other criteria, patients must meet the following conditions to be eligible for the
study:

1. Age ≥18 years of age.

2. Histologic diagnosis of glioblastoma (WHO Grade IV).

3. Documented EGFRvlll positive tumor status (central lab confirmation).

4. First or second relapse of de novo glioblastoma or first diagnosis or first relapse
of secondary glioblastoma.

5. Previous treatment must include surgery, conventional radiation therapy and
temozolomide (TMZ).

6. Screening MRI must be obtained at least 4 weeks after any salvage surgery, and at
least 12 weeks after radiation therapy.

7. KPS of ≥ 70%.

8. If applicable, systemic corticosteroid therapy must be at a dose of ≤ 4 mg of
dexamethasone or equivalent per day during the week prior to Day 1.

9. Evaluable disease in Groups 1 and 2; measurable disease in Group 2C

10. Life expectancy > 12 weeks.

11. Patients in Group 2 and 2C must have had disease progression while receiving
bevacizumab or within 2 months of treatment with bevacizumab.

Exclusion Criteria:

Among other criteria, patients who meet the following conditions are NOT eligible for the
study:

1. Subjects unable to undergo an MRI with contrast.

2. History, presence, or suspicion of metastatic disease

3. Prior receipt of vaccination against EGFRvIII.

4. Any known contraindications to receipt of study drugs, including known allergy or
hypersensitivity to keyhole limpet hemocyanin (KLH), GM-CSF (sargramostim; LEUKINE®),
polysorbate 80 or yeast derived products, or a history of anaphylactic reactions to
shellfish proteins.

5. Use of non-protein based investigational therapy within 14 days prior to Day 1 or use
of antibody-based investigational therapy within 28 days prior to Day 1.

6. Clinically significant increased intracranial pressure (e.g., impending herniation),
uncontrolled seizures, or requirement for immediate palliative treatment

7. Evidence of recent hemorrhage on screening MRI of the brain

8. Evidence of current drug or alcohol abuse.

9. Patients in Group 1 must not have received prior treatment with bevacizumab.
We found this trial at
45
sites
Salt Lake City, Utah 84106
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
3700 Johnson Street
Hollywood, Florida 33021
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
24 Sturtevant St
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
?
mi
from
Providence, RI
Click here to add this to my saved trials
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
?
mi
from
Rochester, NY
Click here to add this to my saved trials
1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Allentown, PA
Click here to add this to my saved trials
?
mi
from
Amherst, NY
Click here to add this to my saved trials
1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Atlanta, Georgia 30309
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30005
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Austin, Texas 78705
?
mi
from
Austin, TX
Click here to add this to my saved trials
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-2273
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center We all know...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Commack, NY
Click here to add this to my saved trials
3310 Live Oak St
Dallas, Texas 75204
(214) 820-2687
Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Durham, NC
Click here to add this to my saved trials
?
mi
from
Edison, NJ
Click here to add this to my saved trials
Evanston, Illinois 60201
?
mi
from
Evanston, IL
Click here to add this to my saved trials
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Lansing, Michigan 48912
?
mi
from
Lansing, MI
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
4733 Sunset Blvd
Los Angeles, California 90027
(800) 954-8000
Kaiser Permanente Los Angeles Medical Center We've been there for you in the past, providing...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
?
mi
from
Orange, CA
Click here to add this to my saved trials
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
5150 Centre Ave
Pittsburgh, Pennsylvania 15232
(412) 647-2811
University of Pittsburgh Cancer Institute Founded in 1985, the University of Pittsburgh Cancer Institute (UPCI)...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Portland, Oregon 97232
?
mi
from
Portland, OR
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Seattle, Washington 98122
?
mi
from
Seattle, WA
Click here to add this to my saved trials
St. Louis, Missouri 63108
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
?
mi
from
Stanford, CA
Click here to add this to my saved trials
Stony Brook, New York 11794
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
Winston-Salem, North Carolina 27157
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials