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Evaluation of FDOPA-PET/MRI in Pediatric Patients With CNS Tumors

NCT01999270 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2016-10-21

No results posted yet for this study

Summary

To determine if FDOPA-PET/MRI imaging can predict response to treatment of bevacizumab.

Conditions

  • Astrocytoma, Oligoastrocytoma, Mixed
  • Ganglioneuroma
  • Glioma
  • Ganglioglioma
  • Glioblastoma Multiforme Glioma

Interventions

DRUG

Irinotecan

Irinotecan IV over 90 minutes on Days 1, 15, and 29 of each cycle (except Cycle 1, when it will be started on Day 29) Note: Irinotecan can be removed from the treatment plan at the discretion of the healthcare provider.

DRUG

Bevacizumab

Bevacizumab will be given intravenously AFTER the irinotecan infusion is complete on Days 1, 15, and 29 of each cycle. The first dose will be given over 90 minutes, but doses after that may be given over 30-60 minutes.

DEVICE

FDOPA-PET/MRI imaging

FDOPA-PET/MRI imaging Baseline (before beginning Cycle 1 treatment) Cycle 1, Day 29 (before receiving your treatment with bevacizumab) and end of treatment or time of relapse

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Karen Gauvain, M.D. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01999270 on ClinicalTrials.gov