RECRUITING

Multiple Doses of Neural Stem Cell Virotherapy (NSC-CRAd-S-pk7) for the Treatment of Recurrent High-Grade Gliomas

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase I trial studies the effect of multiple doses of NSC-CRAd-S-pk7 in treating patients with high-grade gliomas that have come back (recurrent). NSC-CRAd-S-pk7 consists of neural stem cells that carry a virus, which can kill cancer cells. Giving multiple doses of NSC-CRAd-S-pk7 may kill more tumor cells.

Official Title

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

Quick Facts

Study Start:2023-05-02

Study Completion:2025-08-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05139056

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Jana L Portnow

PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Study Locations (Sites)

City of Hope Medical Center

Duarte, California, 91010

United States

Standford University

Stanford, California, 94305

United States

Northwestern University

Chicago, Illinois, 60611

United States

Wake Forest University

Winston-Salem, North Carolina, 27109

United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

Jana L Portnow, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-02

Study Completion Date2025-08-07

Study Record Updates

Study Start Date2023-05-02

Study Completion Date2025-08-07

Terms related to this study

Additional Relevant MeSH Terms

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