๐ฌIn plain words
What the trial is, and whether it could suit you
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells.
Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T-cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat participants with cancers. They have shown promise, but have not been strong enough to cure most participants.
The study team has found from previous research that we can put a new gene (a tiny part of what makes-up DNA and carries the participants traits) into T cells that will make them recognize cancer cells and kill them. In the lab, the study team has made several genes c
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Procurement Inclusion Criteria:
* Diagnosis of GPC3-positive recurrent glioblastoma with previous resection planned for repeat resection (as determined by immunohistochemistry).
* Age โฅ18 years
* Karnofsky score โฅ60%
* Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent
Procurement Exclusion Criteria:
* History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies).
* History of organ transplantation
* Known HIV positivity
* Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections).
* Exhibits other risk factors of which administration of investigational agent is deemed not in the patient's best interest, in the opinion of the investigator
Treatment Inclusion Criteria:
* Age โฅ 18 years
* Diagnosis of GPC3-positive recurrent glioblastoma with previous resection
* Karnofsky score โฅ 60%-
* Stable neurologic exam for 7 days prior to enrollment
* Stable or decreasing dose of steroids over past 7 days prior to surgery and administration of therapy (max allowable dose is 0.1mg/kg dexamethasone or equivalent per day)
* Adequate organ function:
* Creatinine clearance as estimated by Cockcroft Gault or Schwartz โฅ 60 ml/min
* total bilirubin \< 3 times ULN for age
* INR โค1.7
* absolute neutrophil count \> 500/ฮผl
* platelet count \> 100,000/ฮผl (can be transfused but must be achieved prior to enrollment)
* Hgb โฅ 7.0 g/dl (can be transfused)
* Pulse oximetry \>90% on room air
* Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study
* Sexually active patients must be willing to utilize one of the more effective birth control methods for 3 months after the T-cell infusion.
* Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
Treatment Exclusion Criteria:
* Pregnancy or lactation
* Uncontrolled infection
* Known HIV positivity
* Active bacterial, fungal or viral infection
* History of organ transplantation
* History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies)
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