Using neural stem cells with a virus to treat recurrent high-grade brain tumors
A Phase I Study of Multiple Doses of Neural Stem Cell-Based Oncolytic Virotherapy (NSC-CRAd-S-pk7) Administered Intracerebrally to Patients With Recurrent High-Grade Gliomas
PHASE1 · City of Hope Medical Center · NCT05139056
This study is testing a new treatment using neural stem cells and a virus to see if it can help people with recurrent high-grade brain tumors feel better and live longer.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center (other) |
| Drugs / interventions | bevacizumab, chemotherapy, radiation |
| Locations | 4 sites (Duarte, California and 3 other locations) |
| Trial ID | NCT05139056 on ClinicalTrials.gov |
What this trial studies
This phase I trial investigates the effects of multiple doses of NSC-CRAd-S-pk7, a treatment involving neural stem cells that carry a virus designed to kill cancer cells, in patients with recurrent high-grade gliomas. The primary objective is to determine the maximum tolerated number of treatment cycles based on dose-limiting toxicities and overall toxicity profile. Secondary objectives include measuring immune responses, evaluating the distribution of the treatment in the brain, and assessing disease response rates and survival outcomes. The study aims to provide insights into the safety and efficacy of this innovative approach for treating aggressive brain tumors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with recurrent high-grade gliomas who require surgical intervention and have a Karnofsky performance status of 70% or higher.
Not a fit: Patients with low-grade gliomas or those who have not experienced recurrence after initial treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with recurrent high-grade gliomas, potentially improving survival rates and quality of life.
How similar studies have performed: While the use of oncolytic viruses in cancer treatment is an emerging field, this specific approach using neural stem cells is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient must be age \>= 18 years * Patient has a Karnofsky performance status of \>= 70% * Patient has a life expectancy of \>= 3 months * Patient has histologically-confirmed, diagnosis of a grade III or IV glioma (including glioblastoma, anaplastic astrocytoma, gliosarcoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, not otherwise specified \[NOS\]), or has a prior, histologically-confirmed, diagnosis of a grade II glioma and now has radiographic findings consistent with a high-grade glioma (grade III or IV) * Imaging studies show evidence of recurrent, supratentorial tumor(s). The presence of infratentorial tumor is allowed if the patient also has supratentorial disease that is amenable to placement of an intracavitary Rickham catheter * 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 6 weeks must have elapsed since taking a nitrosourea-containing chemotherapy regimen * At least 4 weeks since completing a non-nitrosourea-containing cytotoxic chemotherapy regimen (except temozolomide: only an interval of 23 days is required from the last dose administered when patient has been recently treated with the standard temozolomide regimen of daily for 5 days, repeated every 28 days) * At least 2 weeks from taking the last dose of a targeted agent * At least 4 weeks from the last dose of bevacizumab * There is no limit to the number of prior therapies for enrollment during treatment schedule escalation; however, once the maximum tolerated treatment schedule has been identified further enrollment to complete the accrual goal of 12 participants treated at the maximum tolerated treatment schedule will be limited to glioblastoma patients at first or second recurrence * 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 must agree to use an effective method of contraception while participating in this study. Women of childbearing potential must have a negative pregnancy test =\< 2 week prior to registration Exclusion Criteria: * Patient has anti-human leukocyte antigen (HLA) antibodies specific for HLA Class I antigens (A\*01, A\*31, B\*07, B\*15, C\*07) expressed by the neural stem cells * 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
Where this trial is running
Duarte, California and 3 other locations
- City of Hope Medical Center — Duarte, California, United States (RECRUITING)
- Standford University — Stanford, California, United States (NOT_YET_RECRUITING)
- Northwestern University — Chicago, Illinois, United States (RECRUITING)
- Wake Forest University — Winston-Salem, North Carolina, United States (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Jana L Portnow — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Recurrent Anaplastic Astrocytoma, Recurrent Anaplastic Oligoastrocytoma, Recurrent Anaplastic Oligodendroglioma, Recurrent Glioblastoma, Recurrent Gliosarcoma, Recurrent Malignant Glioma, Recurrent WHO Grade II Glioma, Recurrent WHO Grade III Glioma