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

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

  • Clinical Trial Information

    Trial Contact: Leffin, Melissa; El-Shami, Jessica; Spinelli, Jennifer

  • IRB No: 19.156.04

    Protocol Abbrev: LGG-14C03

    Principal Investigator: Ana Eugenia Aguilar Bonilla, MD

    Phase: Drug: Phase III

    Age Group: Pediatric

    Secondary Protocol No: LGG-14C03

    Treatment: Drug: Carboplatin, Drug: Vincristine

    Therapies Involved: Chemotherapy ID: NCT02455245

  • Objective

    To compare the progression-free survival (PFS) in patients with previously untreated low grade glioma (LGG) among patients with and without Neurofibromatosis Type I (NF-1) utilizing two carboplatin containing regimens; carboplatin/vincristine (SOC) versus single agent carboplatin (research).

  • Key Eligibility

    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