Last updated: September 30, 2021
Sponsor: Chembrain LTD
Overall Status: Active - Not Recruiting
Phase
1
Condition
Gliomas
Cancer/tumors
Astrocytoma
Treatment
N/AClinical Study ID
NCT05063682
6678EGFRvIII
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participant has been treated for leptomeningeal metastases after intrathecalchemotherapy and/or radiation OR refuses to undergo additional radiation and/orintrathecal chemotherapy
- Participant must have a Karnofsky performance status (KPS) >= 60
- Participant must have a life expectancy of >= 2 months
- Women of child-bearing potential must have negative serum pregnancy test and agree touse a reliable form of birth control prior to study entry and for at least two monthsfollowing study treatment. Male research participants must agree to use a reliableform of birth control and not donate sperm during the study and for at least twomonths following study treatment
- Participant has a histologically confirmed EGFRvII+ (epidermal growth factor receptor)tumor expression by immunohistochemistry (IHC) at the initial tumor presentation orrecurrent disease (H-score >= 50)
- Participant or legal guardian must have the ability to understand and the willingnessto sign a written informed consent
Exclusion
Exclusion Criteria:
- Research participant requires supplemental oxygen to keep saturation greater than 95%
- Research participant requires dialysis
- Research participant has uncontrolled seizure activity and/or clinically evidentprogressive encephalopathy
- Failure of research participant or legal guardian to understand the basic elements ofthe protocol and/or the risks/benefits of participating in the study.
- Participant is unwilling to stop treatment with chemotherapy or endocrine therapyand/or radiation one week prior and during the first 4 cycles of the study
- Participant has ventriculoperitoneal shunt
- Participant has a coagulopathy or bleeding disorder
- Participant is HIV+ (human immunodeficiency virus) or has acute CMV (cytomegalovirus)infection
- Participant has any uncontrolled illness, including ongoing or active infection;participant has known active hepatitis B or C infection; participants with any signsor symptoms of active infection, positive blood cultures or radiological evidence ofinfections
- Participant has an autoimmune disease that requires constant treatment
- Participant has another active malignancy
- Participant is unable to undergo a brain magnetic resonance imaging (MRI)
- Participant is pregnant or breast feeding
Study Design
Total Participants: 10
Study Start date:
May 15, 2020
Estimated Completion Date:
October 31, 2023
Study Description
Connect with a study center
Jyväskylä Central Hospital
Jyväskylä,
FinlandSite Not Available
University Of Oulu
Oulu,
FinlandSite Not Available
Apollo Hospital
New Delhi,
IndiaSite Not Available

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