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A Study Comparing Two Carboplatin Containing Regimens for Children and Young Adults With Previously Untreated Low Grade Glioma

NCT02455245 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2024-11-26

No results posted yet for this study

Summary

This study is trying to learn and understand if the chemotherapy drug called carboplatin works as well as the standard therapy. The standard therapy for Low Grade Glioma (LGG) in children and young adults is using a combination of carboplatin and vincristine. Studies in children have shown that the use of carboplatin alone has promise of being just as effective for treating LGG as standard therapy. Additionally, this study will try to understand if treatment with carboplatin alone is associated with an improved quality of life for LGG patients and their families.

Conditions

  • Low Grade Glioma

Interventions

DRUG

Carboplatin and Vincristine

Carboplatin 175 mg/m2 IV infusion Vincristine 1.5mg/m2 IV

DRUG

Carboplatin

Carboplatin 560 mg/m2 (or 19 mg/kg for children weighing less than 12 kg) IV

Sponsors & Collaborators

  • Alicia Lenzen

    lead OTHER

Principal Investigators

  • Alicia Lenzen, MD · Attending

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2025-08-31
Completion
2025-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02455245 on ClinicalTrials.gov