CELLECTRA®2000 EP Device supplied by Geneos Therapeutics for Glioblastoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University School of Medicine, Saint Louis, MO
Glioblastoma
CELLECTRA®2000 EP Device supplied by Geneos Therapeutics - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a personalized neoantigen vaccine may help treat glioblastoma.

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether CELLECTRA®2000 EP Device supplied by Geneos Therapeutics will improve 4 primary outcomes and 8 secondary outcomes in patients with Glioblastoma. Measurement will happen over the course of Week 10 post-vaccination.

12 months
Overall survival rate
Week 4
Feasibility of generating a personalized neoantigen DNA vaccine for patients with newly diagnosed, unmethylated GBM as measured by the ability to administer the vaccine to a patient
Feasibility of generating a personalized neoantigen DNA vaccine for patients with newly diagnosed, unmethylated GBM as measured by the ability to identify candidate tumor-specific neoantigens
Feasibility of generating a personalized neoantigen DNA vaccine for patients with newly diagnosed, unmethylated GBM as measured by the ability to manufacture a neoantigen-based DNA vaccine
6 months
Progression-free survival (PFS) rate
Up to 30 days
Safety and tolerability of a personalized neoantigen DNA vaccine as measured by dose-limiting toxicities (DLTs)
Week 10 post-vaccination
Immunogenicity of a personalized neoantigen DNA vaccine as measured by the ability to generate a measurable neoantigen-specific CD8 T cell response in vaccinated patients
Immunogenicity of a personalized neoantigen DNA vaccine as measured by the number of individual neoantigens per number of neoantigens vaccinated against, with which a measurable CD8 T cell-specific response is identified
Week 24 post-vaccination
Immunogenicity of a personalized neoantigen DNA vaccine as measured by T-cell phenotype, myeloid derived suppressor cell frequency by flow cytometry
Immunogenicity of a personalized neoantigen DNA vaccine as measured by diversity of clonality from T cell receptor sequencing
Immunogenicity of a personalized neoantigen DNA vaccine as measured by putative antigen specificity from T cell receptor sequencing
Number of high quality candidates neoantigens present in patients with newly diagnosed GBM

Trial Safety

Trial Design

1 Treatment Group

Vaccine (GNOS-PV01 + INO-9012)
1 of 1
Experimental Treatment

This trial requires 12 total participants across 1 different treatment group

This trial involves a single treatment. CELLECTRA®2000 EP Device Supplied By Geneos Therapeutics is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Vaccine (GNOS-PV01 + INO-9012)Standard radiation therapy will be administered per standard of care and is outside the scope of this study. GNOS-PV01 + INO-9012 will be given on Days 1, 22, and 43 of Cycle 1 and then on Day 1 of each subsequent cycle beginning with Cycle 2 for a total of 8 cycles or until intolerance or progression

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Closest Location

Washington University School of Medicine - Saint Louis, MO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Glioblastoma. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People with newly diagnosed glioblastoma multiforme that is histologically confirmed to have no MGMT methylation will be allowed to participate in the study show original
The subject consents to having their genome sequenced and to having the resulting data shared in the dbGaP database show original
AST(SGOT)/ALT(SGPT) ≤ 3. show original
Creatinine levels below an institutional normal value, or a creatinine clearance of 60 mL/min/1.73 m2 or greater, are acceptable for patients with creatinine levels above an institutional normal value. show original
You must be at least 18 years old to use this service. show original
The person has a Karnofsky performance status of ≥ 60%. show original
(1.5 × 109/L) The patient must have an absolute neutrophil count of at least 1,500/mcL. show original
Platelets ≥ 100,000/mcL
Total bilirubin ≤ 1.5 x IULN
Patients who have had a craniotomy with a biopsy, subtotal resection, total gross resection, or re-resection in the past are allowed to participate in the study. show original

Patient Q&A Section

What causes glioblastoma?

"The cause of glioblastoma is unknown, but there is compelling evidence that many of the genes associated with the development of glioblastoma are overexpressed in normal glial cells. It is also suspected that many of the genes associated with cancer are overexpressed in glioblastoma to enable the development of a tumor. Genetic changes can lead to the production of an aberrant protein, which may be responsible for the development of glioblastoma. The exact role of smoking, alcohol, cannabis, and other drugs in the causation of glioblastoma remains uncertain, but there is evidence to suggest that such agents may trigger genomic changes that have important implications for the development of the tumor." - Anonymous Online Contributor

Unverified Answer

What is glioblastoma?

"This is a cancer that forms inside the brain in individuals over the age of 50. It can be malignant, meaning it can multiply or invade the blood vessels within the brain, and non-malignant, meaning it has low or limited capabilities to invade other areas of the brain.\n" - Anonymous Online Contributor

Unverified Answer

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

"About 15,000 new cases of glioblastoma are expected annually (12,000 cases will be fatal). The projected survival, survival adjusted relative to 1,500 patient deaths, and projected 5 year survival for survivors of glioblastoma are described. These data will be important for assessing future needs and for communicating with patients with this extremely rare malignancy." - Anonymous Online Contributor

Unverified Answer

Can glioblastoma be cured?

"For patients matched on age, no prognostic factors or genotype were predictive of remission. Patients with glioblastoma should be evaluated for the presence of epidermidine-plasma-proteinase activity; such patients may benefit from clinical trial treatments, including bevacizumab. However, the role of current conventional treatments deserves further investigation." - Anonymous Online Contributor

Unverified Answer

What are common treatments for glioblastoma?

"The standard of care and treatment for glioblastoma is highly variable among the world's leading centers. The identification of these variations and the determination of their impact on survival would be a critical step in enhancing survival rates. A significant proportion of patients with low/intermediate/high survival rates have a higher mortality due to poor compliance with or adherence to treatment guidelines." - Anonymous Online Contributor

Unverified Answer

What are the signs of glioblastoma?

"The early signs of glioblastoma are subtle with no visible enlargement of the tumor. These early signs include dizziness, visual disturbances, headache, abnormal vision, and loss of sensation. A headache history and neurologic exam (including peripheral neuropathy) should be obtained routinely in adult glioblastoma patients." - Anonymous Online Contributor

Unverified Answer

What is cellectra®2000 ep device supplied by geneos therapeutics?

"In a recent study, findings, we showed that the use of ep-CTX and cellectra®2000 ep device for long-term palliative treatment did not produce a significant therapeutic benefit for patients with recurrent/progressive glioblastoma. The safety profile of this regimen observed suggests that patients must be carefully monitored for potential side effects during treatment with the ep-CTX and cellectra®2000." - Anonymous Online Contributor

Unverified Answer

How does cellectra®2000 ep device supplied by geneos therapeutics work?

"Cellectra®2000 ep device supplied by Geneos was an effective treatment of the patients at the study site. Treatment with the Cellectra®2000 epid device was well tolerated." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of glioblastoma?

"A genetic abnormality in GBM may be involved in the pathogenesis of the neoplasm. This knowledge may lead to the development of improved glioblastoma approaches, potentially by suppressing the proliferative and/or invasive potential of glioblastoma cells, and/or by targeting mutated receptors." - Anonymous Online Contributor

Unverified Answer

What does cellectra®2000 ep device supplied by geneos therapeutics usually treat?

"TACE (transarterial chemoembolization), an interventional radiologic treatment, is now being routinely employed when conventional therapies fail or when patients are not available for conventional multimodal treatment. The technique involves injecting a radiochemically generated mixture of radioactive microspheres into the arteries supplying the tumor, causing cell death by necrosis, or cell death by apoptosis, depending on the type of cell and the cancer. When the cells are already dead they will not proliferate to form a tumor. This contrasts with most other treatments that do not involve the injection of radioactive materials - thereby affecting not only tumors, but also nearby healthy tissues." - Anonymous Online Contributor

Unverified Answer

Does cellectra®2000 ep device supplied by geneos therapeutics improve quality of life for those with glioblastoma?

"Data from a recent study showed that patients with glioblastoma had greater improvement in overall QoL and physical functioning with the Cellectra 2000 device. Additional investigation is required to test causal assumptions." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets glioblastoma?

"At this point we've only collected information from people with glioblastomas. The average age of diagnosis of glioblastoma is much higher than the one from the general population. The average age at diagnosis of pediatric patients with glioblastomas is 9.6 months, while in the United States the average age for pediatric patients with glioblastomas is 4.5 to 5.9 months. Therefore, this may indicate that pediatric patients are experiencing the disease later, or that there is a predisposing factor in younger children with the disease. Also, this is only a report from Iran where there is a high rate of children with the disease." - 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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