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Could dropping one chemo drug improve life for young brain tumor patients?

NCT ID NCT02455245

Disease control Sponsor: Alicia Lenzen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This phase III trial compares two chemotherapy approaches for children and young adults with previously untreated low grade glioma, a type of brain or spinal cord tumor. One group receives the standard combination of carboplatin and vincristine, while the other receives carboplatin alone. Researchers want to see if the single drug works just as well at controlling the tumor, and whether it leads to a better quality of life for patients and their families. The study includes people under 21 years old who have not had prior treatment except surgery or steroids.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
carboplatin
What this could lead to
If carboplatin alone works as well as the standard two-drug combination, children and young adults with low grade glioma could receive a simpler treatment with fewer side effects and a better quality of life.
What could go wrong
This is a phase III trial, but it is still possible that single-agent carboplatin is less effective than the standard combination. Chemotherapy carries risks like infection, fatigue, and nerve damage, and the trial is not designed to prove a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

95 people

The number who actually took part.

Started

Mar 2015

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Tumor Diagnosis: Low grade gliomas * Patients must be less than 21 years of age at study entry. * Central nervous system tumor. Patients with primary spinal cord lesions. Patients with metastatic disease are also allowed. * No previous therapy for the tumor with the exception of corticosteroids and surgery. * Performance status:Karnofsky Performance Scale (KPS for \> 16 yrs of age) or Lansky Performance Score (LPS for ≤ 16 years of age) ≥ 50 assessed within two weeks prior to registration * Seizure disorder should be well controlled. * Normal organ and marrow function * Female patients of childbearing potential must not be pregnant or breast-feeding. Female patients who have menstruated and are of childbearing potential must have a negative serum or urine pregnancy test prior to enrollment. * Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study and for 6 months after the last drug administration. * Ability of subject or parent/guardian to understand and the willingness to sign a written informed consent/assent document. Informed consent/assent must be signed prior to registration on this study. * Tissue blocks or slides must be sent. If tissue is unavailable, the study chair must be notified prior to enrollment. Exclusion Criteria: * Patients who are receiving any other investigational or chemotherapeutic agents will be excluded. * Patients with known inability to return for follow-up visits or obtain follow-up studies required to assess for toxicity to therapy. * Patients with Subepenydmal Giant Cell Astrocytomas are excluded. Patients with intrinsic brainstem tumors of the pons will be excluded from the study. * History of hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to platinum based chemotherapy. * Patients with uncontrolled inter-current illness are excluded. * Females who are pregnant or breast feeding are excluded.

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Conditions

The condition(s) this trial relates to.

low grade glioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Low grade glioma

Contacts and locations

Locations

  • Albany Medical Center

    Albany, New York, 12208-3479, United States

  • American Family Children's Hospital

    Madison, Wisconsin, 53792, United States

  • Ann & Robert H. Lurie Children's Hosptial of Chicago

    Chicago, Illinois, 60611, United States

  • Children's Hospital Medical Center of Akron

    Akron, Ohio, 44308-1062, United States

  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    Minneapolis, Minnesota, 55404, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Dayton Children's Hospital

    Dayton, Ohio, 45404-1815, United States

  • Duke University Medical School

    Durham, North Carolina, 27705-4682, United States

  • Medical College of Wiscosin

    Milwaukee, Wisconsin, 53226, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Orlando Health, Inc.

    Orlando, Florida, 32806, United States

  • Phoenix Children's Hospital

    Phoeniz, Arizona, 85016, United States

  • Rady Children's Hospital

    San Diego, California, 92123, United States

  • Saint Louis University at SSM Cardinal Glennon Children's Medical Center

    St Louis, Missouri, 63103-2006, United States

  • St. Vincent Peyton Manning Children's Hospital

    Indianapolis, Indiana, 46260, United States

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Michigan, C.S. Mott Children's Hospital

    Ann Arbor, Michigan, 48109-5652, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110-1010, United States

  • Yale University

    New Haven, Connecticut, 06520, United States

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