Introduction

This clinical trial summary provides a general overview of the Children’s Oncology Group (COG) study ACNS1721. It tells who is eligible and gives basic information about the study. More details about the study are in the consent forms. You can get this from your oncologist.

ACNS1721 is a Phase 2 clinical trial. A trial is another work for a study. This study (clinical trial) is a therapeutic clinical trial. That means it is done to learn about treatment – its safety and how well it works. The purpose of a Phase 2 trial is to learn if a new treatment works in treating a specific type of cancer and how it affects the body.

In a Phase 2 trial, patients with a specific type of cancer receive a new treatment using a dose that was found to be safe in a Phase 1 trial. Patients are checked for side effects of the treatment and to see whether the cancer shrinks or goes away.

Phase 2 trials are offered to patients whose disease has not responded to standard types of treatments or to patients whose disease doesn’t have a standard treatment.

It is important to understand that participating in a clinical trial is entirely voluntary. The decision about whether or not to participate will not affect the care provided by the health care team in any way. You can find additional information about participation in clinical trials at www.childrensoncologygroup.org. Always discuss any questions that you may have with your health care team.

Study Number

ACNS1721

Official Title

A Phase 2 Study of Veliparib (ABT-888) and Local Irradiation, followed by Maintenance Veliparib and Temozolomide, in Children with Newly Diagnosed High-Grade Glioma (HGG) without H3 K27M or BRAFV600E Tumor Mutations

Study Opening Date

This study opened in October, 2018. Expected enrollment is approximately 115 patients.

General Patient Eligibility

• Age: Patients must be at least 3 years old and less than 22 years of age. Patients less than 25 years old may be eligible to enroll if they have a specific type of HGG.
• Diagnosis: Newly diagnosed High Grade Glioma, that does not include brainstem or spinal cord tumors, or disease that has spread to other parts of the body (metastatic disease)

Please consult your doctor to determine whether you or your child may participate in this study.

General Background and Study Goal

This study is aimed at improving the outcome for children with High Grade Glioma (HGG). Temozolomide, a medication taken by mouth, has been shown to improve survival in adults with glioblastoma, when taken during and after radiation. In this study, patients with a HGG that has specific molecular features (wild-type for H3-K27, IDH and BRAF) will receive experimental therapy of veliparib (given by mouth) during radiation therapy, followed by veliparib in combination with temozolomide.

This study will test whether this combination therapy may improve survival in children with newly diagnosed HGG that are wild-type for H3-K27, IDH and BRAF. Patients with IDH mutant glioma are also eligible. The outcomes of patients on this study will be compared to other patients with clinically and molecularly similar HGG treated with temozolomide alone.

Summary of the Treatment

Surgery will be done to remove as much of the tumor as possible.
Treatment with radiation therapy and veliparib begins within 31 days after surgery.

Radiation therapy will be given daily (Monday-Friday) for 6 weeks.
Veliparib is given by mouth two times a day for 5 days per week (Monday-Friday) during the 6 weeks of radiation therapy. This is called the Chemoradiotherapy Phase.

Four weeks after completion of radiation therapy, patients will start veliparib twice a day for 5 days AND temozolomide by mouth once a day for 5 days. This is called maintenance chemotherapy and will be repeated in cycles every 28 days. Maintenance chemotherapy will continue for up to 10 cycles.

Risks and Side Effects

Chemotherapy can cause side effects during and after treatment. All patients will be closely monitored for possible side effects of the medicines. All risks and side effects will be explain by your treatment team during the consent process. They can answer any questions that you may have about giving permission for your child to be in the clinical trial or other aspects of care. Please refer to the consent form for a detailed explanation of the side effects associated with the treatment on this study.

Contact Information

Your child’s oncologist and nurses are the best sources for further information.

Study Chair

Matthias Karajannis, MD, MS
Memorial Sloan-Kettering Cancer Center
New York, NY 10560

FAMILY PROTOCOL SUMMARY REVIEW/APPROVALS