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Protocol No. UW15020

Principal Investigator Puccetti, Diane

Phase III

Age Group Both

Scope National

Sponsor Type Institutional

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

Objective 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 inmproved quaity of life for LGG patients and their families.

Treatment In order to compare the effects of the two different treatments, those taking part in the study will be randomized. Each child and young adult taking part will get either treatment with carboplatin alone or treatment with a combination of carboplatin and vincristine. During the study, there will be ongoing evaluation of results. If one treatment plan is found to be better during the course of the study, all children will be assigned to that treatment plan.

Description If you are on Regimen A (combination of carboplatin and vincristine) you will get your treatment in two phases called Induction and Maintenance. During induction you will get 10 weeks of induction therapy followed by 2 weeks of rest. Both drugs are given as intravenous (IV) infusions. After induction therapy you will go into maintenance therapy. Each cycle will consist of 4 weekly IV infusions of carboplatin and 3 weekly IV infusions of vincristine. If you are on Regimen B (carboplatin only) you will get the treatment in one phase. You will get carboplatin as an IV infusion over 60 minutes. This will be given once every 4 weeks. Every 4 week period is called a cycle. You will stay on study for 13 cycles, over the course of 52 weeks Click here for more info.

Key Eligibility
  • Newly diagnosed patients, OR previously diagnosed patients, who have not been treated with any modality besides surgery or corticosteroids with glial tumors, neuronal tumors, chiasmatic-hypothalamic, or low grade glioma (not otherwise specified)
  • Patients must be less than 21 years of age at study entry
  • Tumors of all locations in the central nervous system, with appropriate histology, are eligible for study
  • Treatment must be scheduled to commence within 14 working days after study entry and may not begin prior to study entry
  • Patients must have received no previous therapy for the tumor with the exception of corticosteroids and surgery. Patients with a gross total resection will not be eligible
  • 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
  • Patients with a seizure disorder should be well controlled
  • All subjects must have MRI scans of the brain within 28 days prior to registration. An MRI of the spine should be performed if clinically indicated
  • 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 are excluded
  • Patients with Subepenydmal Giant Cell Astrocytomas are excluded
  • Patients with intrinsic brainstem tumors of the pons will be excluded from the study
  • Females who are pregnant or breast feeding are excluded since there are unknown teratogenic effects of these agents

Applicable Disease Sites Brain/Central Nervous System

Drugs Involved carboplatin; cbdca (carboplatin); oncovin (vincristine); paraplatin (carboplatin); vcr (vincristine); vin (vincristine); vincristine

Status Open

Participating Institutions UW Hospital and Clinics