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Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma

NCT04051047 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2019-11-27

No results posted yet for this study

Summary

The primary aim of this study is to determine the presence of gemcitabine in childhood diffuse midline gliomas (DMG) (previously classified as diffuse intrinsic pontine glioma \[DIPG\]) after systemic treatment with the drug.

Conditions

  • Glial Tumor of Brain
  • Diffuse Intrinsic Pontine Glioma
  • Glioma

Interventions

DRUG

Gemcitabine

Participants receive a one time IV dose of gemcitabine prior to having standard of care surgery.

PROCEDURE

Tumor biopsy and blood draw

As part of standard of care, all participants will undergo tumor biopsy and collection of peripheral blood.

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Carl Koschmann, M.D. · University of Michigan

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-30
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Drug
Yes

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 NCT04051047 on ClinicalTrials.gov