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.]

NCT03374943 : A Trial of KB004 in Patients With Glioblastoma
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Adults (greater than or equal to 18 years of age) with histologically proven
glioblastoma

- Evidence of progressive glioblastoma (if within 3 months of radiotherapy, then
progression outside of radiotherapy field is required)

- Measurable disease by RANO (Response Assessment in Neuro-Oncology Criteria)

- ECOG (Eastern Cooperative Oncology Group score) 0 to 1

- Expected survival more than 3 months

- Steroid dose less than 2.5 mg per day dexamethasone equivalents and stable or reducing
for 1 week prior to day 1

- Archived (formalin fixed paraffin embedded) tissue or frozen tumour tissue or consent
to obtain a fresh tumour biopsy at enrolment is required.

- Adequate organ function. Out of range values that are not clinically significant will
be permitted, except for the following laboratory parameters which must be within the
ranges specified

- Neutrophils greater than or equal to 1.5 x 109 per L

- Platelets greater than or equal to 100 x 109 per L

- International Normalised Ratio less than or equal to 1.4

- Serum Aspartate aminotransferase and Alanine aminotransferase less than or equal to
2.5 x ULN (upper limit of normal)

- Serum bilirubin less than or equal to 1.5 x ULN (upper limit of normal)

Exclusion Criteria:

- Evidence of infratentorial, extracranial or leptomeningeal disease

- More than one prior systemic therapy for progressive disease or prior Steriotactic
radiosurgery (SRS) to sites of GB (glioblastoma).

- Prior treatment with bevacizumab or gliadel wafers

- Evidence of current or prior intracranial hemorrhage

- Need for anti-platelet or anti-coagulant drugs

- Use of anti-cancer therapy including craniotomy, chemotherapy, immunotherapy,
radiotherapy, or any investigational therapy within 28 days prior to Study Day 1

- History of major immunologic reaction to any immunoglobulin G containing agent

- Medical conditions which place the subject at an unacceptably high risk

- Subject is pregnant, lactating or unwilling or unable to use adequate contraception
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03374943      |      Link to official Clinicaltrials.gov listing
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