Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02853565 : A Study of CAN008 for Newly Diagnosed Glioblastoma Multiforme
PhasePhase 1
AgesMin: 20 Years Max: 75 Years
Eligibility
Inclusion Criteria:

- Newly diagnosed and histologically confirmed glioblastoma multiforme

- Tumor must be surgically accessible and tissue must be available

- Age = 20 years and < 75 years

- Life expectancy = 6 months

- Baseline MRI images must be done within 2 days after surgery

- Patients must have a Karnofsky performances score = 60 prior to treatment.

- Patients must not have received prior cytotoxic drug therapy, non-cytotoxic drug
therapy, or experimental drug therapy for brain tumors.

- Adequate hematologic (absolute neutrophil count (ANC) = 1.5x109/L, platelet count =
100x109/L, hemoglobin = 10 g/dL ), renal (creatinine = 1.25xULN ), and hepatic
function (total bilirubin = 1.5xULN, aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) = 2.5xULN)

- Women with childbearing potential must have a negative serum pregnancy test less than
7 days prior to the first dose of study drug.

- Both men and women of reproductive potential agree to use approved contraception, such
as condom and placement of an intrauterine device (IUD), during the study and until 3
months after the discontinuation of study treatment.

- Willing and able to comply with the protocol as judged by the investigator

- Patients must provide written consent

Exclusion Criteria:

- Any prior chemotherapy (including carmustine-containing wafers) or immunotherapy
(including vaccine therapy )

- Any prior radiotherapy to the brain

- Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the
cervix. Patients with a previous malignancy but without evidence of disease for = 5
years will be allowed to enter the trial

- Any contraindication to TMZ listed in the local label

- Low-grade astrocytoma

- Unable to undergo MRI

- Past medical history of disease with poor prognosis according to the judgment of the
Investigator

- HIV infection

- Patients with positive anti-HCV

- Patients with positive HbsAG who received any related treatment within the past 6
months

- Patients suffering from hereditary fructose intolerance (HFI).

- Patients receive any investigational agent(s) or device(s) within 30 days prior to
entering the study

- Known coronary artery disease, significant arrhythmias or severe congestive heart
failure
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02853565      |      Link to official Clinicaltrials.gov listing
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