CLINICAL TRIAL

Peptides for Glioblastoma

Grade IV
Newly Diagnosed
Waitlist Available · 18+ · All Sexes · New York, NY

Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma

See full description

About the trial for Glioblastoma

Treatment Groups

This trial involves 2 different treatments. Peptides 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Peptides
BIOLOGICAL
Tumor Treating Fields
DEVICE
Poly-ICLC
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peptides
2016
Completed Phase 1
~60
Poly-ICLC
2016
Completed Phase 1
~90

Eligibility

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
First vaccine treatment start date at least 4 weeks out but not more than 8 weeks from the last dose of concomitant Temozolomide or radiotherapy.
Age ≥ 18
Confirmation of GBM (WHO grade IV).
Maximal debulking surgery and undergo radiotherapy concomitant with Temozolomide (45-70Gy)
Stable disease after treatment of radiation with chemotherapy
Life expectancy > 16 weeks.
Performance status of 0-2 (Eastern Cooperative Oncology Group).
Must have tumor tissue sufficient sequencing.
Have adequate bone marrow function
Require Dexamethasone ≤ 4mg daily on a stable dose
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Peptides will improve 1 primary outcome and 4 secondary outcomes in patients with Glioblastoma. Measurement will happen over the course of 42 weeks.

Dose-limiting toxicities (DLT)
42 WEEKS
Feasibility administration of one vaccine; toxicity will be measured by severity of Adverse events with toxicity grading defined by Cancer Therapy Evaluation Program's (CTEP) v4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale
42 WEEKS
The percent Progression Free Survival (PFS)
6 MONTHS
6 MONTHS
Toxicity grading using CTCAE scale
1 YEAR
Safety will be measured by number of Adverse events with toxicity grading defined by Cancer Therapy Evaluation Program's (CTEP) v4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale
1 YEAR
Overall Survival (OS) Rate
1 YEAR
1 YEAR
Overall Response Rate
2 YEARS
Overall response as measured by RANO Response Criteria: Complete response, Partial response, Stable Disease, and Progressive Disease
2 YEARS

Patient Q & A Section

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

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

Approximately 3.7 million US adults are diagnosed with Glioblastoma in 2018 and 2.2 million will die of this disease. Despite this, research is underrepresented in the literature and there is a lot of gap in our knowledge. I propose to implement an official, comprehensive national program of health surveillance of brain cancer.

Anonymous Patient Answer

What are common treatments for glioblastoma?

Given the vast knowledge of molecular mechanisms behind the initiation and progression of glioblastoma, the following medications and therapies may be utilized to treat the disease. (1) Topoisomerase II inhibitors, (2) Epidermal growth factor receptor antagonists, (3) Phosphatidylinositol 3-kinase inhibitors, (4) Angiogenesis blockers, (5) Microtubule stabilizers, and (6) Targeted gene therapy.

Anonymous Patient Answer

What are the signs of glioblastoma?

The signs of glioblastoma include motor and visual changes, brainstem dysfunction, seizures, and other types of changes to the whole brain that occur after about 1 month following diagnosis of the glioblastoma. The brain can seem to become a ‘slow-motion movie’ after this early 'dance'. Other signs may occur depending on which part of the brain is affected. Although they do not always occur at the same time, some of the early signs of disease can indicate brain stem issues that may lead to a decreased ability to breathe quickly enough to sustain life. A new set of signs, which are not yet well understood, include abnormal smells or sounds, or difficulty feeling.

Anonymous Patient Answer

What is glioblastoma?

  1. Glioblastoma is the most common form of brain cancer, representing roughly 15% of brain malignancies. The majority of glioblastomas are associated with a poor prognosis, however.\n2. The diagnosis is complicated by symptom overlap between high fever headache and [migraine headache](https://www.withpower.com/clinical-trials/migraine-headache), in which migraine without aura are more likely to be associated with glioblastoma than migraine with aura.\n3. Glioblastoma is not treatable, since it is fatal without the proper treatment after its detection.
Anonymous Patient Answer

Can glioblastoma be cured?

This report provides compelling evidence that the survival of children diagnosed with glioblastoma is improved by intensive, multimodal chemotherapy and that the standard treatment for primary pediatric brain tumors - maximal resection followed by radiotherapy plus radiochemotherapy - can result in durable disease-free survival. We conclude that there exists a high likelihood that GBM can be cured and that a cure for this disease is achievable in the near future.

Anonymous Patient Answer

What causes glioblastoma?

The etiology of glioblastoma may be a complex result of the accumulation of minor environmental or genetic damages which alter cell fates in neural cells. We discuss the implication of a multi-factorial etiology of glioblastoma.

Anonymous Patient Answer

Is peptides typically used in combination with any other treatments?

The observed frequency of peptides employed in conjunction with other chemotherapy regimens in recent glioblastoma trials does not support the use of peptides in this setting.

Anonymous Patient Answer

What is the average age someone gets glioblastoma?

The average age is 62.7, with a 1.6-month standard deviation. It is slightly higher than the expected average of 61 for cancer overall. However, the true variability is higher than previously thought.

Anonymous Patient Answer

How does peptides work?

Based on these studies, peptides represent a strong candidate for targeted therapy of GBM. Indeed, they are well tolerated by patients and are able to bind tumor epitopes preferentially. Clinical trials in GBM are feasible.

Anonymous Patient Answer

What is the latest research for glioblastoma?

There was a growing trend of research towards personalized therapy after the first decade of this century. The new data on targeted biological therapy, immune-oncology and immunotherapy could open up interesting new approaches in treating glioblastoma. In addition, the development of novel therapeutic agents, such as the epothilone derivative 5-aminolevulinic acid, could lead to more effective and selective therapeutic approaches to glioblastoma.

Anonymous Patient Answer

Have there been other clinical trials involving peptides?

There has been a substantial body of work demonstrating the clinical activity of certain peptides in the treatment of various types of human malignancies. It is now time to test the most promising of these treatments in larger, comprehensive clinical studies.

Anonymous Patient Answer

Has peptides proven to be more effective than a placebo?

Vaccination against peptides may show benefits in long-term protection against glioblastoma multiforme. We discuss the possible use of a vaccine targeting the LN-1A component as well as the potential mechanisms of action of vaccine-induced immune responses.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Glioblastoma by sharing your contact details with the study coordinator.