Clinical Trial Details
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NCT03050736 : Safety Study of VAL-083 and Radiotherapy in Patients With Newly Diagnosed GBM Having Unmethylated MGMT Expression
PhasePhase 2
AgesMin: 18 Years Max: 69 Years
Inclusion Criteria:

1. Newly diagnosed histologically proven supratentorial GBM

2. Tumor tissue specimens from the GBM surgery or open biopsy must be available for MGMT
gene promoter status analysis and central pathology review.

3. Documented unmethylated MGMT gene promoter status

4. Males or females =18< 70 years of age.

5. Interval of =2 weeks but =7 weeks after surgery or biopsy before first administration
of study treatment.

6. Cranial MRI must have been performed within 21 days of study entry and MRI must be
used throughout the period of protocol treatment for tumor measurement. If the
surgical procedure was a resection, cranial MRI performed within 72 hours of resection
is preferred

7. Stable or decreasing dose of steroids for =5 days prior to randomization.

8. Karnofsky performance score = 70%

9. Patients must begin treatment with VAL-083 chemotherapy no sooner than 2 weeks and no
later than 4 weeks from the diagnostic surgery.

10. ANC =1,500/ µl

11. Platelet count = 100,000/µl

12. Hemoglobin = 10 gm/dl

13. AST, ALT < 2.5 times ULN

14. Bilirubin < 2.5 ULN

15. Serum creatinine = 1.5x ULN or creatinine clearance > 50 mL/min (measured or
calculated by the Cockcroft-Gault formula) (Cockcroft, 1976) at screening

Exclusion Criteria:

1. Prior chemotherapy within the last 5 years.

2. Prior radiation therapy of the head.

3. Receiving concurrent investigational agents or has received an investigational agent
within the past 30 days prior to the first dose of VAL-083.

4. Prior systemic anti-angiogenic therapy.

5. Placement of Gliadel® wafer at surgery.

6. Planned surgery for other diseases (e.g. dental extraction).

7. History of recent peptic ulcer disease (endoscopically proven gastric ulcer, duodenal
ulcer, or esophageal ulcer) within 6 months of enrollment.

8. History of malignancy. Subjects with curatively treated cervical carcinoma in situ or
basal cell carcinoma of the skin, or subjects who have been free of other malignancies
for =5 years are eligible for this study.

9. History of coagulation disorder associated with bleeding or recurrent thrombotic

10. Clinically manifest myocardial insufficiency (New York Heart Association [NYHA] III,
IV) or history of myocardial infarction during the past 6 months; or uncontrolled
arterial hypertension.

11. Inability to undergo Gd-MRI.

12. Concurrent illness, including severe infection, which may jeopardize the ability of
the subject to receive the procedures outlined in this protocol with reasonable

13. Subject is pregnant (positive serum beta human chorionic gonadotropin [b-HCG] test at
screening) or is currently breast-feeding, anticipates becoming pregnant/ impregnating
their partner during the study or within 6 months after study participation, or
subject does not agree to follow acceptable methods of birth control, such as hormonal
contraception, intra-uterine pessar, condoms or sterilization, to avoid conception
during the study and for at least 6 months after receiving the last dose of study

14. Current alcohol dependence or drug abuse.

15. Known hypersensitivity to the study treatment.

16. Legal incapacity or limited legal capacity.

17. Presence of any psychological, familial, sociological, or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule.

18. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family
members who suffer(ed) from such.
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