Poly ICLC for the Treatment of Progressive or Recurrent Low-Grade Gliomas in Children and Young Adults with Neurofibromatosis Type 1

Active:	Yes
Cancer Type:	Brain & Spinal Cord Tumor Cancer-Related Syndrome Unknown Primary	NCT ID:	NCT04544007
Trial Phases:	Phase II	Protocol IDs:	NF111 (primary) NCI-2022-03434
Eligibility:	0 - 22 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	University of Alabama at Birmingham Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT04544007

Summary

This phase II trial tests whether poly ICLC works to shrink low-grade gliomas that are growing, spreading, or getting worse (progressive) or that have come back (recurrent) in children and young adults with neurofibromatosis type 1. Poly ICLC, made from ribonucleic acid (RNA), may help the body build an effective immune response to kill tumor cells. Giving poly ICLC may help decrease the size of low-grade gliomas in patients with neurofibromatosis type 1.

Objectives

PRIMARY OBJECTIVE:
I. To evaluate the efficacy of poly-ICLC in pediatric neurofibromatosis type 1 (NF1) patients with progressive low-grade glioma (LGG) as measured by objective tumor response rate (complete response [CR] + partial response [PR]) within the first 48 weeks (12 cycles) of therapy.

SECONDARY OBJECTIVES:
I. Determine 12, 24 and 60 month progression free survival (PFS) in pediatric NF1 patients with progressive LGG treated with poly-ICLC.
II. Evaluate the efficacy of poly-ICLC in pediatric NF1 patients with progressive LGG as measured by best objective tumor response rate (CR+PR) within 24 cycles of therapy.
III. Evaluate the efficacy of poly-ICLC in pediatric NF1 patients with progressive LGG as measured by clinical benefit response rate (CR+PR + minor response [MR] + stable disease [SD]) after 12 and 24 cycles of therapy.
IV. Assess the toxicity associated with poly-ICLC treatment in pediatric NF1 patients with LGG.

EXPLORATORY OBJECTIVES:
I. Evaluate the visual outcome measures in children with progressive optic pathway gliomas treated with poly-ICLC.
II. Evaluate patient reported outcomes and quality of life measures.
III. Evaluate biological correlates.
IV. Compare Response Assessment in Neuro-Oncology (RANO) and Response Assessment in Pediatric Neuro-Oncology (RAPNO) response determinations in this population.

OUTLINE:
Patients receive poly ICLC intramuscularly (IM) twice weekly (BIW) (Monday/Thursday or Tuesday/Friday). Treatment repeats every 28 days for 24 cycles in the absence of disease progression or unacceptable toxicity. Patient undergo magnetic resonance imaging (MRI), and blood sample collection throughout the study.

After completion of study treatment, patients are followed up for 5 years.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.