Clinical trial for Currently Only Enrolling Glioblastoma Patients at First Recurrence
Official title Multiple Intracerebral Doses of Neural Stem Cell-Based Virotherapy (NSC-CRAd-S-pk7) for the Treatment of Recurrent High-Grade Gliomas
ClinicalTrials.gov ID: NCT05139056
What this study is testing
What is Neural Stem Cells-expressing CRAd-S-pk7?
Neural Stem Cells-expressing CRAd-S-pk7 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for currently only enrolling glioblastoma patients at first recurrence.
Also referred to as CRAd-S-pk7 loaded NSCs, NSC-CRAd-S-pk7.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase I trial studies the safety of giving multiple intracerebral doses of NSC-CRAd-S-pk7 to treat patients with glioblastoma at first recurrence. NSC-CRAd-S-pk7 consists of neural stem cells that can target glioblastoma cells and carry a virus, which can kill cancer cells.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient must be age \>= 18 years
- Patient has a Karnofsky performance status of \>= 70%
- Patient has a life expectancy of \>= 3 months
- When determining the maximum tolerated number of treatment cycles (MTC): patient has a histologically confirmed diagnosis of a grade 3 or 4 glioma...
- When enrolling to Treatment Schedules 4 and 4a: patient has glioblastoma at first recurrence.
You likely can't join if
- Patient has multi-focal disease.
- Patient is receiving radiation, chemotherapy, or another investigational agent.
- Patient has had prior therapy with neural stem cells.
- Patient has not recovered from any toxicity (\> grade 1) of prior therapies, except alopecia.
- Patient is unable to undergo a brain MRI.
- Patient has chronic or active viral infections of the central nervous system (CNS).
See the full eligibility criteria
- Patient must be age \>= 18 years
- Patient has a Karnofsky performance status of \>= 70%
- Patient has a life expectancy of \>= 3 months
- When determining the maximum tolerated number of treatment cycles (MTC): patient has a histologically confirmed diagnosis of a grade 3 or 4 glioma (eg., glioblastoma, grade 4 astrocytoma, grade 3 astrocytoma, grade 3...
- When enrolling to Treatment Schedules 4 and 4a: patient has glioblastoma at first recurrence.
- Imaging studies show evidence of recurrent, supratentorial tumor(s).
- Patient's high-grade glioma has recurred or progressed after prior treatment with brain radiation and temozolomide
- The patient must be in need of surgery for tumor resection
- Based on the neurosurgeon's judgment, there is no anticipated physical connection between the post-resection tumor cavity and the cerebral ventricles
- Absolute neutrophil count (ANC) of \>= 1000 cells/mm\^3
- Platelet count \>= 100,000 cells/mm\^3
- Total bilirubin =\< 2.0 mg/dl
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =\< 4 times the institutional upper limit of normal
- Serum creatinine =\< the institutional upper limit of normal
- At least 2 weeks from taking the last dose of a targeted agent
- At least 4 weeks from the last dose of bevacizumab For temozolomide, an interval of 23 days is required from the last dose administered if the patient was recently treated with adjuvant temozolomide, consisting of...
- At least 2 weeks from taking the last dose of a targeted agent.
- At least 4 weeks from the last dose of bevacizumab.
- All significant toxicities from previous anticancer therapy must have stabilized to a new baseline or resolved.
- All participants must have the ability to understand and the willingness to sign a written informed consent.
- The effects of this treatment on a developing fetus are unknown. Therefore, female patients of childbearing potential and sexually-active male patients or who are able to impregnate their partner, must agree to use an...
- Patient has multi-focal disease.
- Patient is receiving radiation, chemotherapy, or another investigational agent.
- Patient has had prior therapy with neural stem cells.
- Patient has not recovered from any toxicity (\> grade 1) of prior therapies, except alopecia.
- Patient is unable to undergo a brain MRI.
- Patient has chronic or active viral infections of the central nervous system (CNS).
- Patient has a coagulopathy or bleeding disorder.
- Patient has an uncontrolled illness including ongoing or active infection.
- Patient has another active malignancy.
- Patient is pregnant or breastfeeding.
- A patient has a serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the safety monitoring requirements and completion of treatment according to this protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Stanford, California, United States
- Chicago, Illinois, United States
- Winston-Salem, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Stanford, California, United States; Chicago, Illinois, United States; Winston-Salem, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.