Introduction

This clinical trial summary is about the Children's Oncology Group study ACNS1833. It tells who is eligible and gives basic information about the study. More details about the study are in the consent form. You can get this from your oncologist.

ACNS1833 is a Phase 3 clinical trial. A trial is another word for a study. This study (clinical trial) is a therapeutic clinical trial. The purpose of a Phase III trial is to learn if a drug or therapy known to work in treating a certain type of cancer is the same as the standard treatment. For example: better cure rates, longer control of disease, fewer or less serious side effects, or fewer days in the hospital.

ACNS1833 compares two different treatments. These treatments are called study arms. Usually, one study arm is the standard or the best proven current treatment. The other study arms have some changes or additions. The new treatment is thought to be at least as good as the standard treatment. It is not known if the new treatment will be better than the standard treatment.

In a Phase 3 trial, each child is assigned to a study arm by a method called randomization. This process is like flipping a coin to decide which study arm will be assigned to each child.

In most clinical trials, we will not know which treatment is better until all of the children taking part in the trial have completed treatment and have been followed for several years. If one of the treatments is found to be better or safer than the other(s) while the trial is still ongoing, the trial will be stopped. Then, all children receiving therapy will be given the treatment with the best known results.

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

ACNS1833

Study Title

A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) not associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)

Study Opening Date

ACN1833 opened on 1/3/20. The committee hopes to enroll 220 patients on this study.

General Patient Eligibility

  • Age: patients must be at least 2 years old and less than 22 year old
  • Diagnosis: Low Grade Gliomas (LGGs)
  • Your child must have tissue from tumor for study enrollment
  • Your child must be able to swallow pills
  • Patients with the following may not be eligible:
    • If your child has had prior chemotherapy or radiation to treat the tumor.
    • Patients diagnosed with Neurofibromatosis 1 (NF1) are not eligible for this study, but may be eligible for ACNs1831

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

General Background and Study Goal

LGG can cause damage to surrounding brain tissue. The most common way to treat newly diagnosed LGGs that cannot be removed surgically has been with 2 chemotherapy agents, carboplatin and vincristine.

Recent discoveries in the genetics of these tumors have led to the development of medicines that work in different ways than standard chemotherapy. One of these types of medicines is called a MEK inhibitor. Studies of these medicines have shown that they can be effective in treating LGGs, but it is not yet known if a MEK inhibitor is more or less effective than carboplatin and vincristine in treating LGGs.

In this study, a MEK inhibitor, called selumetinib, will be compared against carboplatin and vincristine. The primary goal of this study is to see if selumetinib is at least as effective as carboplatin and vincristine at treating LGG.

Other goals of this study are to evaluate the following in children and adolescents with LGGs:

  • Visual acuity in patients that have tumors that are in the optic pathway
  • Motor function
  • Differences in response in tumors with different genetics
  • Quality of life
  • Cognitive, social, emotional and behavioral functioning
  • Tumor tissue for genetic and biologic factors related to LGGs

 

Summary of the Treatment

Children and adolescents that meet eligibility criteria will be randomly assigned to one of two arms of the study. A computer will choose which treatment arm will be assigned and twice as many patients will go on the selumetinib arm (Arm 2) of the study than will go on the carboplatin and vincristine arm (Arm 1).

Arm 1:
Patients assigned to Carboplatin and Vincristine will receive:

  • 12 weeks of Induction
  • 8 cycles of Maintenance. Maintenance cycles are 6 weeks. Chemotherapy is given IV once per week for 4 weeks, over several hours in a clinic, then 2 weeks of no chemotherapy before starting the next cycle.
  • Treatment lasts for 60 weeks total (approximately 15 months).

Arm 2:
Patients assigned to selumetinib will receive:

  • 27 cycles of treatment lasting approximately 2 years.
    • Selumetinib is given as a pill, twice per day for 28 days (1 cycle).
    • The medication should only be paused if directed by the care team.
    • Clinic visits for labs and assessments will be scheduled.

Both arms of treatment will require lab checks, ongoing scans to assess the tumor changes, and other tests to make sure that you or your child is doing well on the medications. You will get more details once you are assigned to an arm of the study.

Special Considerations

Selumetinib will be provided and paid for by the study.

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 explained 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

Dr. Peter de Blank, MD
Cincinnati Children's Hospital Medical Center

FAMILY PROTOCOL SUMMARY REVIEW/APPROVALS

Initial development Name Date
Written by (protocol nurse) Corrine Hoeppner, ARNP December 27, 2019
Reviewed/approved by (PI) Dr. Peter de Blank, MD April 15, 2020
Ongoing review
Reviewed and updated by