What side effects are associated with this type of intervention?

Common treatments for Low Grade Glioma (LGG) that involve immune modulation, such as Poly-ICLC, can have a range of side effects. These may include flu-like symptoms (fever, chills, fatigue), injection site reactions, and gastrointestinal issues (nausea, vomiting). Additionally, immune modulation therapies can sometimes lead to more serious immune-related adverse effects, such as inflammation of organs (e.g., colitis, hepatitis) and autoimmune reactions. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate these risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Low Grade Glioma (LGG), primarily focusing on chemotherapy and radiation therapy. Temozolomide, an oral alkylating agent, is commonly used and has shown efficacy in treating LGG. Immune modulation therapies like Poly-ICLC (Hiltonol®), which is being studied for its efficacy in pediatric patients with progressive LGG, represent a newer approach. While specific FDA approvals for immune modulation therapies in LGG are limited, ongoing trials like the one for Poly-ICLC are exploring their potential benefits.

What other types of research exist?

Promising novel alternatives to Poly-ICLC for Low Grade Glioma patients include immune checkpoint inhibitors such as nivolumab and pembrolizumab, which target PD-1/PD-L1 pathways. Additionally, combination therapies involving immune checkpoint inhibitors and other agents like bevacizumab or temozolomide are being explored. These therapies aim to enhance the immune response and improve outcomes in glioma patients.

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Virus Therapy

Poly-ICLC for Low-Grade Glioma (NF111 Trial)

Phase 2

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

-- Growth factor(s): Must not have received any hematopoietic growth factors within 7 days of study entry or > 14 days if pegylated GCSF is used.

-- Renal Function: Serum creatinine which is less than 1.5 times ULN for age (as per the table below) or GFR > 70 ml/min/1.73m2

Must not have

Patients with a prior diagnosis of malignant peripheral nerve sheath tumor or other malignancy requiring treatment in the last 48 months.

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, impaired gastrointestinal function, or psychiatric illness/social situations that would limit compliance with study requirements.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a medication called Poly-ICLC that boosts the immune system in children with NF1 who have brain tumors that don't respond to usual treatments. The goal is to see if this medication can help shrink or control the tumors by enhancing the body's natural defenses.

Who is the study for?

This trial is for pediatric patients under 22 years with Neurofibromatosis type 1 (NF1) and progressive low-grade gliomas. They must have had previous treatment, measurable tumor growth, and be in stable condition without recent surgeries or radiation therapy. Patients can't join if they've had certain other cancers, are pregnant/breastfeeding, on immunosuppressants, or unable to follow the study plan.

What is being tested?

The trial tests poly-ICLC (Hiltonol®) for treating progressive low-grade brain tumors in children with NF1. It aims to see how well it works within the first year of treatment by measuring tumor response rates. The study will also explore secondary outcomes related to the drug's effects.

What are the potential side effects?

While specific side effects of poly-ICLC aren't listed here, similar drugs often cause flu-like symptoms such as fever, fatigue, headache and muscle pain; injection site reactions; and potential changes in blood counts which could affect organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't taken any blood cell growth boosters in the last 7 days.

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My kidney function is within the normal range based on creatinine levels or GFR rate.

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I can do most of my daily activities on my own.

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I have a confirmed diagnosis of NF1, either through genetic testing or clinical criteria.

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I received my last chemotherapy dose 4 weeks ago, or 6 weeks if it was nitrosourea.

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I cannot have or refuse surgery for my low-grade glioma due to high risk or personal choice.

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I am under 22 years old.

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I have new or worsening symptoms caused by my brain tumor.

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I don't have shortness of breath at rest and my oxygen levels are above 92%.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was diagnosed with a cancer affecting my nerves or another cancer needing treatment in the last 4 years.

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I do not have any severe illnesses that could interfere with the study.

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I have been diagnosed with a high-grade brain tumor.

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I am currently on IV antibiotics for a severe infection that hasn't improved.

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I am not currently on any other cancer treatments.

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I have been treated with poly-ICLC before.

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I have had radiation treatment for a low-grade brain tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluate the efficacy of poly-ICLC

Secondary study objectives

Assess toxicity

Determine progression free survival (PFS)

Evaluate efficacy by best objective tumor response rate (CR+PR)

+1 more

Side effects data

From 2018 Phase 2 trial • 60 Patients • NCT02129075

100%

General disorders and administration site conditions

67%

Musculoskeletal and connective tissue disorders

57%

Nervous system disorders

50%

Skin and subcutaneous tissue disorders

50%

Metabolism and nutrition disorders

50%

Gastrointestinal disorders

47%

Investigations

43%

Blood and lymphatic system disorders

43%

Respiratory, thoracic and mediastinal disorders

33%

Injury, poisoning and procedural complications

27%

Vascular disorders

23%

Infections and infestations

20%

Psychiatric disorders

13%

Eye disorders

10%

Ear and labyrinth disorders

10%

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Surgical and medical procedures

Renal and urinary disorders

Reproductive system and breast disorders

Cardiac disorders

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (CDX-301, CDX-1401, and Poly-ICLC)

Arm II (CDX-1401 and Poly-ICLC)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Administer Poly-ICLCExperimental Treatment1 Intervention

Enrolled participants will receive poly-ICLC 20 mcg/kg/dose twice weekly IM (using Monday/Thursday or Tuesday/Friday schedule if possible).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Poly ICLC

2014

Completed Phase 2

~270

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Poly-ICLC (Hiltonol®) is an immune modulator that activates the body's immune response to target and destroy tumor cells, which is particularly important for treating progressive low-grade gliomas (LGG) in pediatric patients with NF1. Traditional chemotherapy agents like carboplatin and vincristine work by interfering with the DNA replication process in rapidly dividing tumor cells, leading to cell death. Targeted agents such as selumetinib and everolimus inhibit specific molecular pathways that are crucial for tumor growth and survival. These treatments are vital for LGG patients as they offer different mechanisms to control tumor progression, potentially improving outcomes and quality of life.