A Trial of Poly-ICLC in the Management of Recurrent Pediatric Low Grade Gliomas

NCT01188096 | Completed Phase 2 Results DMC

• 2 other identifiers: Poly ICLC004385
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

This study is for patients up to 21 years of age who have a tumor called a low grade glioma of the central nervous system (brain and spinal cord). The tumor has grown despite attempts to control it with chemotherapy or radiation. Low grade gliomas are a group of tumors that tend to grow slowly and could be cured if every bit of the tumor were surgically removed. These tumors are called Grade I or II astrocytomas. These tumors often grow in parts of the brain that prevent total removal without devastating neurologic complications or death. Although some low grade gliomas never grow, most will and are treated with either chemotherapy or radiation. There is good data showing that the growth of most low grade gliomas can be controlled with chemotherapy or radiation. However, some low grade gliomas in children and young adults grow despite these treatments. Poly-ICLC is a new drug that has been used safely in children and adults with different types of brain tumors. Earlier studies showed that this drug worked better for children and young adults with low grade gliomas than for children with more aggressive brain tumors. The main purpose of this study is to use Poly-ICLC treatment in a larger number of patients to see how well it works and how many side effects occur. As Poly-ICLC is not FDA approved, this study is authorized to use it under Investigational New Drug (IND)# 43984, held by Oncovir. Subjects will get injections of Poly-ICLC into muscle two times weekly. The first treatments will be given in the clinic so allergic or other severe reactions, if any, can be monitored. If subjects tolerate the injections and don't have a severe reaction, then the rest of the injections will be given at home. Subjects/caregivers will be trained to give injections. Treatment will last for about 2 years. Subjects may stay on treatment for longer than 2 years if their tumor shrinks in response to the injections, if study doctors think it is safe, if subjects want to remain on treatment, and if Poly-ICLC is available. Risks: Poly-ICLC has been used safely in children and adults at the dose used in this study, and at higher doses. Frequently seen side effects include irritation of the skin at the injection site and mild flu-like symptoms. These are usually relieved or avoided by use of over-the-counter medicines like acetaminophen (Tylenol).

Conditions

Brain Tumors

Keywords

glioma; pediatrics; cancer; brain tumor; low grade glioma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Percentage with no progression of disease by MRI 3D Macdonald criteria. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

  6 months

Secondary Outcomes (3)

• Overall Response Rate

  at 6 months following start treatment with study drug

• Overall Response Rate

  at 2 years after start of treatment with study drug

• Overall Survival Rate

  month 6, 24 months

Other Outcomes (5)

• Toxicity Associated With Treatment With Poly-ICLC

  month 6, 24 months

• The Effect of Treatment With Poly-ICLC on the Signaling Pathways Controlling Apoptosis in Low Grade Glioma Tumor Cells.

  month 6, 24 months

• Surrogate Markers of Tumor Response and Progression Can be Identified in the Serum

  month 6, 24 months

Study Arms (1)

Poly ICLC

EXPERIMENTAL

Children will receive poly-ICLC 20 mcg/kg twice weekly intramuscular injection (IM). The first 2 doses will be administered in the clinic under supervision.

Drug: Poly ICLC

Interventions

Poly ICLC DRUG

Children will receive poly-ICLC 20 mcg/kg twice weekly IM (using Monday/Wednesday schedule if possible). The first 2 doses will be administered in the clinic under supervision.

Poly ICLC

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age:Patients must be between 0 - 21 years of age when registered on this protocol.
• Diagnosis:Patients must have pathologically confirmed low grade glioma with histologic subtypes interpreted as World Health Organization (WHO) grade I and II including:
• juvenile pilocytic astrocytoma (JPA)
• pleomorphic JPA
• diffuse astrocytoma (fibrillary, gemistocytic, giant cell, or pleomorphic xanthoastrocytoma)
• low grade oligoastrocytoma
• low grade oligodendroglioma
• low grade glioma not otherwise specified (NOS) Tumors of all regions of the CNS, with appropriate histology are eligible for study. However patients with tumors intrinsic to the optic nerve and involvement of the optic nerve cannot be biopsied/resected are eligible without histological confirmation.
• Patients with neurofibromatosis type 1(NF1) are also eligible.
• Patients must have demonstrated either tumor progression or recurrence by radiographic criteria and/or clinical criteria as defined below:
• Patients with progressive non-resectable disease regardless of location in the brain or spine are eligible for this study. Patients with evidence of leptomeningeal dissemination are eligible for this study. Patients do not require biopsy/histologic confirmation at the time of progression or relapse.
• Radiographic progression is defined as \>40% increase in the product of the three perpendicular diameters of initial tumor relative to the initial baseline measurement - length (L)x width (W) x transverse (T) (current scan) \> 1.4 x L x W x T (initial scan), or the development of any new sites of disease independent of the response of the initial tumor. See section 7.1.2 for methodology for tumor measurement.
• Post radiation changes are often seen on post-treatment imaging studies, so that classification of a patient as having progressive disease may require several serial MRI's if the child has received radiation within the preceding 12 months.
• Tumor volume includes the entire tumor volume seen on gadolinium enhanced T1 MRI plus non-enhancing abnormality seen on T2 or FLAIR.
• All tumor cysts will be included in the tumor volume

You may not qualify if:

• Pregnant or lactating females. Women of childbearing age will agree to use contraception during the protocol.
• Patients receiving other experimental immunotherapy.
• Patients may not have fever (38.50C) within 7 days of enrollment.
• No concurrent XRT or chemotherapy is allowed.
• Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Emory University: collaborator

Study Sites (2)

RADY Children's Hospital

San Diego, California, 92123, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

Location

Related Publications (1)

• Neuro-Oncology, Volume 20, Issue suppl_6, November 2018, Page vi201, https://doi.org/10.1093/neuonc/noy148.833 Published: 05 November 2018

  RESULT

Related Links

• clinical trials database
• Children's Healthcare of Atlanta
• Emory University

MeSH Terms

Conditions

Brain Neoplasms; Glioma; Neoplasms

Interventions

poly ICLC

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: Donald L. Durden, MD, PhD
• Organization: Atrium Health

donald.durden@atriumhealth.org

980-442-2048

Study Officials

• Donald Durden, MD, Ph.D.

  University of California Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2010
• First Posted: August 25, 2010
• Study Start: August 1, 2010
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: June 12, 2023
• Results First Posted: April 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)