Adoptive Cellular Therapy in Pediatric Patients With High-grade Gliomas (NCT03334305) | Clinical Trial Compass
TerminatedPhase 1
Adoptive Cellular Therapy in Pediatric Patients With High-grade Gliomas
Stopped: due to lack of accrual/feasibility to complete accrual due to competing trials
United States18 participantsStarted 2018-08-27
Plain-language summary
It is believed that the body's immune system protects the body by attacking and killing tumor cells. T-lymphocytes (T-cells) are part of the immune system and can attack when they recognize special proteins on the surface of tumors. In most patients with advanced cancer, T-cells are not stimulated enough to kill the tumor. In this research study, we will use a patient's tumor to make a vaccine which we hope will stimulate T-cells to kill tumor cells and leave normal cells alone.
High grade gliomas (HGGs) are very aggressive and difficult for the body's immune system to attack. Before T-cells can become active against tumor cells, they require strong stimulation by special "stimulator" cells in the body called Dendritic Cells (DCs) which are also part of the immune system. DCs can recognize the cancer cells and then activate the T lymphocytes, and create this strong stimulation.
The purpose of this research study is to learn whether anti-tumor T-cells and anti-tumor DC vaccines can be given safely. Most importantly, this study is also to determine whether the T-cells and DC vaccines can stimulate a person's immune system to fight off the tumor cells in the brain.
Who can participate
Age range
3 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Screening Eligibility:
* Patients with histologically confirmed WHO Grade III or IV malignant glioma
* Scheduled for definitive surgical resection of suspected HGG (biopsy only subjects are not eligible for this study)
Post-Surgical Resection Eligibility
* Histologically confirmed WHO Grade III or IV malignant glioma
* Karnofsky Performance Status (KPS) of ≥ 60% (KPS for ≥ 16 years of age) or Lansky performance Score (LPS) of ≥ 60 (LPS for \< 16 years of age) assessed within 2 weeks prior to registration
* Bone Marrow: ANC (Absolute neutrophil count) ≥ 1000/µl (unsupported); Platelets ≥ 100,000/µl (unsupported for at least 3 days); Hemoglobin \> 8 g/dL (may be supported)
* Renal:Serum creatinine ≤ upper limit of institutional normal
* Hepatic: Bilirubin ≤ 1.5 times upper limit of institutional normal for age. SGPT (ALT) ≤ 3 times upper limit of institutional normal for age. SGOT (AST) ≤ 3 times upper limit of institutional normal for age.
* Signed informed consent according to institutional guidelines.
* Patient or patient guardian consent to PBSC harvest following registration.
* Subjects of childbearing or child-fathering potential must be willing to use medically acceptable forms of birth control while being treated on this study.
* Subjects with post-surgical neurological deficits should have deficits that are stable for a minimum of 1 week prior to leukapheresis.
Exclusion Criteria:
* Pregnant or need to breast feed during the study period (Negative serum pregnancy …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate Safety of TTRNA-DCs and TTRNA-xALT
Timeframe: From first DC Vaccine through 30 days after administration of the last dose of trial drug or subject death, whichever occurs first, up to 10 months