A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/29/2019
Start Date:December 8, 2017
End Date:October 2020
Contact:Boston Biomedical
Email:info@bostonbiomedical.com
Phone:617-674-6800

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

A Randomized, Multicenter, Phase 2 Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab Versus Bevacizumab Alone in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy

This is a randomized, active-controlled, multicenter, open-label, parallel groups, Phase 2
study of DSP-7888 Dosing Emulsion plus Bevacizumab versus Bevacizumab alone in patients with
recurrent or progressive glioblastoma multiforme (GBM) following treatment with first line
therapy consisting of surgery and radiation with or without chemotherapy.


Inclusion Criteria:

1. Patients or their legal representatives must be able to provide written informed
consent.

2. Histologically confirmed diagnosis of supratentorial GBM (Grade 4 astrocytoma).

3. Radiographic evidence of first recurrence or progression of GBM following primary
therapy consisting of surgery (biopsy or resection) and chemoradiation; patients may
have undergone a second debulking surgery following initial recurrence or progression.
Patients whose tumors are O6 methyl guanyl-methyl-transferase (MGMT)
methylated-promoter negative need not have received chemotherapy in the past to be
eligible.

4. Human leukocyte antigen type HLA-A*02:01, HLA-A*02:06, or HLA-A*24:02.

5. Age ≥18.

6. KPS score of ≥60.

7. Serum creatinine value <2X the upper limit of normal (ULN) for the reference
laboratory.

8. Alanine aminotransferase/aspartate aminotransferase <3X the ULN and total bilirubin
<2× the ULN for the reference laboratory.

9. Men and women of childbearing potential must agree to use a reliable method of
contraception (oral contraceptives, implantable hormonal contraceptives, or double
barrier method) or agree to completely refrain from heterosexual intercourse for the
duration of the study and for 180 days following the last dose of DSP-7888 Dosing
Emulsion.

10. Patients must have recovered from the effect of all prior therapy to Grade 2 or less.

11. Patients must be at least 28 days from any major surgery, and any surgery incisions or
wounds must be completely healed.

12. Patients must be at least 12 weeks from the completion of prior radiation therapy (RT)
in order to discriminate pseudo progression of disease from progression.

13. Patients must be at least 4 weeks from the completion of prior systemic or
intracranial chemotherapy.

14. Patients must stop Novo-TTF treatment one day prior to study therapy (no washout
period is needed). However, any wounds from TTF must be adequately healed per
Inclusion Criterion #11.15. For patients who are not receiving therapeutic
anticoagulation treatment, an international normalized ratio (INR) and a PTT ≤ 1.5 ×
the ULN; patients who are receiving anticoagulation treatment should be on a stable
dose.

16. Patient's left ventricular ejection fraction (LVEF) > 40%. 17. Patient has a resting
pulse oximetry of 90% or higher.

Exclusion Criteria:

Patients with any of the following will be excluded from the study:

1. Prior therapy with Bev.

2. Patients with secondary GBM.

3. Any anti-neoplastic therapy, including RT, for first relapse or recurrence.

4. Evidence of leptomeningeal spread of tumor or any history, presence, or suspicion of
metastatic disease extracranially.

5. Evidence of impending herniation on imaging.

6. Has known multifocal disease. Multifocal disease is defined as discrete sites of
disease without contiguous T2/FLAIR abnormality that require distinct radiotherapy
ports. Satellite lesions that are associated with a contiguous area of T2/FLAIR
abnormality as the main lesion(s) and that are encompassed within the same
radiotherapy port as the main lesion(s) are permitted.

7. Patients with infections that have required treatment with systemic antibiotics within
7 days of first dose of protocol therapy.

8. The need for systemic glucocorticoids in doses in excess of 4 mg/day of dexamethasone
or in comparable doses with other glucocorticoids.

9. Treatment with any investigational agents within 5 half-lives of the agent in question
or, if the half life is unknown, within 28 days of enrollment.

10. Pregnant or lactating females.

11. Prior history of malignancy within 3 years of enrollment other than basal or squamous
cell carcinoma of the skin, cervical intra-epithelial neoplasia, in situ carcinoma of
the breast, or prostate cancer treated with surgery or RT with a prostate specific
antigen of <0.01 ng/mL.

12. Patients with active autoimmune diseases within 2 years of enrollment into the study
including, but not limited to, rheumatoid arthritis, systemic lupus erythematosus,
systemic sclerosis, Sjogren's syndrome, Wegener's granulomatosis, ulcerative colitis,
Crohn's disease, myasthenia gravis, Graves' disease, or uveitis except for psoriasis
not requiring systemic therapy, vitiligo or alopecia areata, or hypothyroidism; if an
autoimmune condition has been clinically silent for 12 months or greater, the patient
may be eligible for enrollment.

13. Patients on immunosuppressive therapies; the use of topical, inhalational,
ophthalmologic or intra articular glucocorticoids, or the use of physiologic
replacement doses of glucocorticoids are permitted.

14. Patients with primary immunodeficiency diseases.

15. Patients with significant bleeding in the preceding 6 months or with known
coagulopathies.

16. History of abdominal fistula, intestinal perforation, or intra-abdominal abscess in
the preceding 12 months.

17. Positive serology for human immunodeficiency virus (HIV) infection, active hepatitis
B*, or untreated hepatitis C; patients who have completed a course of anti-viral
treatment for hepatitis C are eligible.

*In cases of negative results for HepB surface antigen with positive HepB core
antibody, HBV DNA testing is required.

18. Patient has a medical history of frequent ventricular ectopy, e.g., non-sustained
ventricular tachycardia (VT).

19. Significant cardiovascular disease, including New York Hospital Association Class III
or IV congestive heart failure, myocardial infarction within 6 months of enrollment,
unstable angina, poorly controlled cardiac arrhythmias, or stroke within the preceding
6 months.

20. Any other uncontrolled inter current medical condition, including systemic fungal,
bacterial, or viral infection; uncontrolled hypertension; diabetes mellitus; or
chronic obstructive pulmonary disease requiring 2 or more hospitalizations in the
preceding 12 months.

21. Any psychiatric condition, substance abuse disorder, or social situation that would
interfere with a patient's cooperation with the requirements of the study.

22. Known sensitivity to Bev or any of the components of DSP-7888 Dosing Emulsion.

23. Patient has a QTcF (QT corrected based on Fridericia's equation) interval > 480 msec
(CTCAE = Grade 2) or other factors that increase the risk of QT prolongation or
arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT
interval syndrome) at screening. (Patients with bundle branch block and a prolonged
QTc interval should be reviewed by the Medical Monitor for potential inclusion.)

24. Patient has dyspnea at rest (CTCAE ≥ Grade 3) or has required supplemental oxygen
within 2 weeks of study enrollment.
We found this trial at
45
sites
Minneapolis, Minnesota 55455
(612) 625-5000
Phone: 844-904-7088
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: 844-904-7088
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
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Phone: 844-904-7088
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
?
mi
from
Boston, MA
Click here to add this to my saved trials
2010 E 90th St
Cleveland, Ohio 44195
(866) 223-8100
Phone: 844-904-7088
Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Phone: 844-904-7088
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Phone: 844-904-7088
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
Phone: 844-904-7088
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
2200 Santa Monica Blvd
Santa Monica, California 90404
(310) 582-7438
Phone: 844-904-7088
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
2450 E. River Road
Tucson, Arizona 85718
520-320-2147
Phone: 844-904-7088
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Amherst, New York
Phone: 844-904-7088
?
mi
from
Amherst, NY
Click here to add this to my saved trials
Atlanta, Georgia
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78705
Phone: 844-904-7088
?
mi
from
Austin, TX
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Phone: 844-904-7088
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
11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
Phone: 844-904-7088
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
660 Hall Street
Dallas, Texas 75246
Phone: 844-904-7088
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Denver, Colorado 80218
Phone: 844-904-7088
?
mi
from
Denver, CO
Click here to add this to my saved trials
Detroit, Michigan 48202
Phone: 844-904-7088
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Edmonton, Alberta
Phone: 833-394-6555
?
mi
from
Edmonton,
Click here to add this to my saved trials
8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Phone: 844-904-7088
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
Fayetteville, Arkansas 72703
Phone: 844-904-7088
?
mi
from
Fayetteville, AR
Click here to add this to my saved trials
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Phone: 844-904-7088
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
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
Phone: 844-904-7088
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
Phone: 844-904-7088
?
mi
from
Houston, TX
Click here to add this to my saved trials
1926 Alcoa Highway
Knoxville, Tennessee 37920
Phone: 844-904-7088
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
La Jolla, California 92093
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Los Angeles, California 90095
Phone: 844-904-7088
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
4733 Sunset Blvd
Los Angeles, California 90027
(800) 954-8000
Phone: 844-904-7088
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
Louisville, Kentucky 40207
Phone: 844-904-7088
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Madison, Wisconsin 53792
Phone: 844-904-7088
?
mi
from
Madison, WI
Click here to add this to my saved trials
200 Old Country Road
Mineola, New York 11501
Phone: 844-904-7088
?
mi
from
Mineola, NY
Click here to add this to my saved trials
800 E 28th St
Minneapolis, Minnesota 55407
(612) 863-4000
Phone: 844-904-7088
Abbott Northwestern Hospital Our hospital has a long and proud history as a health care...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10065
Phone: 844-904-7088
?
mi
from
New York, NY
Click here to add this to my saved trials
Omaha, Nebraska 68114
Phone: 844-904-7088
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Orange, California 92868
Phone: 844-904-7088
?
mi
from
Orange, CA
Click here to add this to my saved trials
Phoenix, Arizona 85013
Phone: 844-904-7088
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
Phone: 844-904-7088
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Santa Barbara, California 93105
Phone: 844-904-7088
?
mi
from
Santa Barbara, CA
Click here to add this to my saved trials
5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Phone: 844-904-7088
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
The Woodlands, Texas 77380
Phone: 844-904-7088
?
mi
from
The Woodlands, TX
Click here to add this to my saved trials
2801 W. Bancroft
Toledo, Ohio 43606
419.530.4636
Phone: 844-904-7088
University of Toledo The University of Toledo is one of 14 state universities in Ohio....
?
mi
from
Toledo, OH
Click here to add this to my saved trials
Washington, District of Columbia 20037
Phone: 844-904-7088
?
mi
from
Washington,
Click here to add this to my saved trials