Quality-of-Life Assessment for Recurrent Glioblastoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
City of Hope Medical Center, Duarte, CA
Recurrent Glioblastoma+2 More
Quality-of-Life Assessment - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether IL13Ralpha2-CRT T cells and nivolumab work better together than either alone in treating patients with glioblastoma.

See full description

Eligible Conditions

  • Recurrent Glioblastoma
  • Refractory Glioblastoma

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Quality-of-Life Assessment will improve 6 primary outcomes and 13 secondary outcomes in patients with Recurrent Glioblastoma. Measurement will happen over the course of Up to 28 days.

At 9 months
Overall Survival
Survival
Pre- and post-therapy
PD-L1 levels on tumor cells
Up to 14 days
Feasibility (neoadjuvant therapy)
Up to 15 years
Biomathematical modeling of tumor growth
CAR T and endogenous cells detected in tumor tissue
Cytokine levels in TCF, PB, and CSF
Disease response
IL13Ralpha2 antigen expression levels in tumor tissue
Incidence of adverse events
Overall survival (OS)
Progression free survival (PFS)
Quality of life
Quality of life (QOL)
T cell levels
Time to progression
Up to 28 days
Area under the curve (AUC) for CD3, IFNgamma, and IP-10 levels over time for the DLT evaluation period
Dose-limiting toxicity (DLT)
Feasibility (adjuvant therapy)

Trial Safety

Trial Design

3 Treatment Groups

Arm III (IL13Ra2 CAR T cells)
1 of 3
Arm II (nivolumab, IL13Ra2 CAR T cells)
1 of 3
Arm I (nivolumab, ipilimumab, IL13Ralpha2 CAR T cells)
1 of 3
Experimental Treatment

This trial requires 60 total participants across 3 different treatment groups

This trial involves 3 different treatments. Quality-of-Life Assessment is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Arm III (IL13Ra2 CAR T cells)Patients receive IL13Ralpha2 CAR T cells infusion over 5 minutes via Rickham catheter (ICV/ICT) every week. Treatment repeats weekly for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After cycle 4, patients may receive additional CAR T cells weekly at the discretion of the principal investigator and oncologist.
Arm II (nivolumab, IL13Ra2 CAR T cells)Patients receive IL13Ralpha2 CAR T cells infusion over 5 minutes via Rickham catheter (ICV/ICT) every week and nivolumab IV over 30 minutes every other week. Treatment repeats weekly for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After cycle 4, patients may receive additional CAR T cells weekly and nivolumab IV every other week or monthly at the discretion of the principal investigator and oncologist.
Arm I (nivolumab, ipilimumab, IL13Ralpha2 CAR T cells)Patients receive nivolumab intravenously (IV) over 60 minutes and ipilimumab IV over 90 minutes on day -14. Patients then receive IL13Ralpha2 CAR T cells infusion over 5 minutes via Rickham catheter (ICV/intracranital ICT) every week and nivolumab IV over 30 minutes every other week. Treatment repeats weekly for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After cycle 4, patients may receive additional CAR T cells weekly and nivolumab IV every other week or monthly at the discretion of the principal investigator and oncologist.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 15 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 15 years for reporting.

Closest Location

City of Hope Medical Center - Duarte, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Recurrent Glioblastoma or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
, Prior therapy This text is discussing an agreement between two parties show original
The person has a tumor that is classified as grade IV by the World Health Organization, or had a tumor that was grade II or III and has now progressed to the point where it is classified as grade IV. show original
The person has a disease that has come back after treatment, and it has progressed to the point where it can be seen on an x-ray after 12 weeks. show original
The COH Clinical Pathology Department confirms that the tumor expresses the IL13Rα2 protein by immunohistochemistry at the initial tumor presentation or during recurrent disease (with a H-score of more than 50; see Appendix B for more information). show original
People with a known history of congestive heart failure, cardiac symptoms consistent with NYHA classification III-IV, cardiomyopathy, myocarditis, or exposure to cardiotoxic medications must have an EKG and ECHO performed within 42 days prior to registration, and as clinically indicated while on treatment. show original
The researchers will get written consent from the participant or their legal representative before starting the study show original
3. Ages ≥18 years
This patient has a good prognosis with a KPS of ≥ 60% and an ECOG of ≤ 2. show original
The patient has a life expectancy of at least four weeks and their illness is of a nature that meets one or more of the illness-related criteria set out below show original
Signed Informed Consent form The text describes what is needed in order for someone to participate in a study show original

Patient Q&A Section

Can glioblastoma be cured?

"While some patients with glioblastomas may have long-term survival as a result of therapy, others live only a few months following diagnosis. Further studies are required to identify the variables predictive of prognosis in glioblastoma, and to assess the possible role of radiation and chemotherapy in this aggressive tumour." - Anonymous Online Contributor

Unverified Answer

What is glioblastoma?

"GBM is a fatal brain cancer that can form as well as a tumor that can be benign in appearance. In many cases, patients survive for a while after initial diagnosis, even when they have a high grade, invasively growing tumor. GBM often begins with a non-malignant tumor whose grade increases with time from onset to diagnosis. Patients often have trouble adjusting to life with the disease because of the loss of health, mobility and ability to work. The average length of survival for the disease is only about 12–18 months." - Anonymous Online Contributor

Unverified Answer

What are the signs of glioblastoma?

"Recent findings underscore the limitations of clinical signs for diagnostic detection of glioblastomas in routine clinical practice. Brain MRI is a safe examination and the presence of T2-weighted hyperintense lesions without enhancement on contrast material should prompt further investigation of these lesions, which may represent brain tumours including glioblastomas." - Anonymous Online Contributor

Unverified Answer

How many people get glioblastoma a year in the United States?

"Although glioblastoma is the most common [brain tumor](https://www.withpower.com/clinical-trials/brain-tumor) and has been associated with unusually short survival compared with other brain tumors, data are scarce on trends in overall survival for this tumor. Results from a recent clinical trial suggests that mortality rates from this tumor are unlikely to be decreasing among the population, but trends in overall survival should be monitored." - Anonymous Online Contributor

Unverified Answer

What are common treatments for glioblastoma?

"Pro- and anti-tumor effects of many of the investigated agents in GBM were not statistically significant. Although some compounds are used in glioma therapy, no potent and safe agents can be identified to treat this disease. Clinical use of most GBM-specific agents, such as temozolomide and vincristine, can be only limited. Further work in identification of potentially effective treatment for GBM is required." - Anonymous Online Contributor

Unverified Answer

What causes glioblastoma?

"Genetic heterogeneity in glioblastomas has recently received significant attention using genomic technologies and high throughput methods. In the past this heterogeneity was considered an impediment to developing effective personalized medicine and was considered indicative of treatment resistance. Findings from a recent study obtained in the present study point out a different image as a potential benefit: a very heterogeneous tumor where an individualizing personalized therapy based on the profiling of individual patients is possible. However, this approach would imply a more complete knowledge of GBM biology, the definition of molecular subtype, and an individualized therapy." - Anonymous Online Contributor

Unverified Answer

Has quality-of-life assessment proven to be more effective than a placebo?

"In this post hoc analysis, there was greater benefit in the overall improvement in quality-of-life scores when the QOL questionnaire was compared to a placebo, as opposed to a control. Further prospective trials, using QOL as an outcome measure are required to fully demonstrate the efficacy of QOL-focused therapies. Randomized, controlled trials were funded by the National Brain Tumour Foundation of Canada (NBTFC-NCOG). Clinically funded trials of the same interventions have also been undertaken by clinicians in Ontario and Western Australia. These trials, funded by the NBTFC are currently underway and are aiming to confirm the utility of QOL as a primary outcome." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for glioblastoma?

"In a recent study, findings demonstrated that the survival rates of glioblastoma improved significantly when the patients had a complete resection of the glioblastoma and had a younger age. It seems the survival rates could be improved further by the adjuvant therapy." - Anonymous Online Contributor

Unverified Answer

How quickly does glioblastoma spread?

"The authors' results suggest that while the patient with glioblastoma may be a suitable person for clinical trials, they would also be candidates for trials for patients with limited dissemination." - Anonymous Online Contributor

Unverified Answer

Is quality-of-life assessment safe for people?

"Concerns are raised about the implications of QoL assessment for people with glial tumors. This work could be useful in informing oncologists when selecting patients for QoL assessment and in developing patient information to assist in the decision making process." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in quality-of-life assessment for therapeutic use?

"Results from a recent clinical trial indicate that the use of the SF-36 and the EORTC QLQ-C30 provides information about a patient's quality of life that is complementary to that provided by a traditional health-related quality-of-life scale such as the HADS and EORTC QLQ-C30 scales. Thus these instruments are preferable to traditional health-related quality-of-life scales for patient and patient-caregiver assessment." - Anonymous Online Contributor

Unverified Answer

How does quality-of-life assessment work?

"QoL is determined with the EQ-5D-5L in glioblastoma patients, and it is influenced by treatment choice and tumor location. In a recent study, findings of the present study have implications for patient counseling." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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