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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
NF111 Trial Summary
This trial will test the efficacy of poly-ICLC in treating pediatric patients with NF1 who have progressive low-grade glioma.
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.Check my eligibility
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.See study design
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.
NF111 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't taken any blood cell growth boosters in the last 7 days.
Select...
My kidney function is within the normal range based on creatinine levels or GFR rate.
Select...
I can do most of my daily activities on my own.
Select...
I have a confirmed diagnosis of NF1, either through genetic testing or clinical criteria.
Select...
I received my last chemotherapy dose 4 weeks ago, or 6 weeks if it was nitrosourea.
Select...
I cannot have or refuse surgery for my low-grade glioma due to high risk or personal choice.
Select...
I am under 22 years old.
Select...
I have new or worsening symptoms caused by my brain tumor.
Select...
I don't have shortness of breath at rest and my oxygen levels are above 92%.
NF111 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate the efficacy of poly-ICLC
Secondary outcome measures
Assess toxicity
Determine progression free survival (PFS)
Evaluate efficacy by best objective tumor response rate (CR+PR)
+1 moreSide effects data
From 2018 Phase 2 trial • 60 Patients • NCT02129075100%
General disorders and administration site conditions
67%
Musculoskeletal and connective tissue disorders
57%
Nervous system disorders
50%
Metabolism and nutrition disorders
50%
Gastrointestinal disorders
50%
Skin and subcutaneous tissue 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%
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10%
Ear and labyrinth disorders
7%
Renal and urinary disorders
7%
Surgical and medical procedures
3%
Reproductive system and breast disorders
3%
Cardiac disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (CDX-301, CDX-1401, and Poly-ICLC)
Arm II (CDX-1401 and Poly-ICLC)
NF111 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
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,442 Total Patients Enrolled
Children's Healthcare of AtlantaOTHER
165 Previous Clinical Trials
105,110 Total Patients Enrolled
Children's Hospital Los AngelesOTHER
232 Previous Clinical Trials
5,076,504 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses that would stop me from safely receiving this treatment.My organs are functioning well.I haven't taken any blood cell growth boosters in the last 7 days.My kidney function is within the normal range based on creatinine levels or GFR rate.I have not received radiation therapy before.You have an ongoing autoimmune disease.I can do most of my daily activities on my own.My blood counts are within normal ranges.I was diagnosed with a cancer affecting my nerves or another cancer needing treatment in the last 4 years.I have recovered from side effects of my previous treatments.My vision has worsened in the past year due to my tumor.My white blood cell count is healthy and it's been over a week since my last growth factor treatment.I haven't taken any experimental drugs or immunotherapy for at least 14 days, or 5 half-lives, whichever is longer. It's been over 36 days since my last Bevacizumab dose.I am not on high doses of steroids or immunosuppressive therapy.I do not have any severe illnesses that could interfere with the study.I have been diagnosed with a high-grade brain tumor.I have a confirmed diagnosis of NF1, either through genetic testing or clinical criteria.I have received at least one treatment for my low-grade glioma.I received my last chemotherapy dose 4 weeks ago, or 6 weeks if it was nitrosourea.I have a low-grade glioma (LGG) in my brain or spinal cord.Participants who are capable of becoming pregnant or fathering a child.I am currently on IV antibiotics for a severe infection that hasn't improved.I am not pregnant or breastfeeding and agree to use birth control during and 90 days after treatment.My neurological symptoms have been stable for at least a week.It's been over 3 weeks since my major surgery or 1 week since minor surgery, and I've fully recovered.I cannot have or refuse surgery for my low-grade glioma due to high risk or personal choice.I am not currently on any other cancer treatments.I have been treated with poly-ICLC before.I am under 22 years old.I have had radiation treatment for a low-grade brain tumor.I have new or worsening symptoms caused by my brain tumor.My liver is working well.My cancer has come back or gotten worse after treatment.I don't have shortness of breath at rest and my oxygen levels are above 92%.
Research Study Groups:
This trial has the following groups:- Group 1: Administer Poly-ICLC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the U.S. Food and Drug Administration (FDA) sanctioned Poly ICLC?
"Our team's assessment of Poly ICLC landed it a score of 2. There is extant evidence that the drug is safe, but no proof yet on its efficacy from this Phase 2 trial."
Answered by AI
How many participants are engaged in this trial?
"This medical trial requires 20 suitable patients from various sites, including Washington University - St. Louis (Site 900) in Saint Louis and Childrens Medical Center - Univ. of Texas SW (Site 917) in Dallas. In order to be considered for inclusion all prospective participants must meet the specified criteria."
Answered by AI
What is the geographical scope of this experiment?
"This medical study is enrolling patients at Washington University - St. Louis (Site 900) in Saint Louis, MO; Childrens Medical Center - Univ. of Texas SW (Site 917) in Dallas, TX; and Cincinnati Children's Hospital Medical Centre (Site 800) in Cincinnati, OH as well as 19 other sites."
Answered by AI
Is there a current opportunity to partake in this scientific experiment?
"According to clinicaltrials.gov, this research project is currently recruiting participants; the original posting was on December 15th 2021 and latest edit occurred on January 20th 2022."
Answered by AI
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