Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma

NCT ID: NCT04051047

Last Updated: 2019-11-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-30
• Study Completion Date: 2021-12-31

Brief 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.

Detailed Description

Participants in this study will be given a one-time, intravenous (IV) dose of gemcitabine prior to having standard-of-care surgery. During surgery, biopsies will be obtained for clinical and research purposes along with a blood sample. Cerebrospinal Fluid (CSF) is optional and will only be obtained if clinically indicated. This will be determined by the investigators and the provider performing the procedure.

Because patients will be undergoing a biopsy/resection as part of their standard-of-care therapy, this is an optimal time to obtain a tumor biopsy for this study. The biopsy will serve to see if the study drug is penetrating the tumor. Patients will then enter a follow-up period for 30 days post-surgery.

This trial is in conjunction with a University of Colorado trial started in 2016, "Gemcitabine in Children With Newly-Diagnosed Diffuse Intrinsic Pontine Glioma" (NCT02992015).

Conditions

Glial Tumor of Brain; Diffuse Intrinsic Pontine Glioma; Glioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Gemcitabine

Gemcitabine will be given at 2100 mg/m2 IV over 30 minutes within 4 hours of planned surgical procedure. The surgical procedure is standard of care.

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

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

Tumor biopsy and blood draw

Intervention Type: PROCEDURE

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

Interventions

Gemcitabine

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

Intervention Type: DRUG

Tumor biopsy and blood draw

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

Intervention Type: PROCEDURE

Other Intervention Names

Gemzar

Eligibility Criteria

Inclusion Criteria

• Age greater than or equal to 3 years and less than 18 years at the time of enrollment.
• Patients must meet both of the first two conditions, OR the third:

• Clinical findings consistent with a presumed new diagnosis of diffuse midline glioma (DMG) in the opinion of the treating neuro-oncologist, AND
• Brain MRI findings consistent with a new diagnosis of DMG based on multidisciplinary consensus after review of imaging
• OR, recurrent DMG requiring tumor resection or biopsy
• Adequate bone marrow, liver, renal and metabolic function (per protocol)
• Adequate coagulation defined as Prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ upper limit of normal (ULN ) for age
• Patients must meet one of the following performance scores:

• ECOG performance status scores of 0, 1, or 2; 8
• Karnofsky score of ≥ 60 for patients > 16 years of age; or
• Lansky score of ≥ 60 for patients ≤ 16 years of age
• DMG biopsy/resection is planned for the clinical care of the patient independent of study participation by the treating pediatric neurosurgeon and neuro-oncologist.
• Informed consent and assent obtained as appropriate.

Exclusion Criteria

• Pregnant or breastfeeding patients are not eligible due to teratogenic effects seen in animal/human studies
• Patients who have received any tumor-directed therapy prior to biopsy are not eligible. Concurrent treatment with corticosteroids is allowed.
• Any tumor-specific or clinical features that make surgical intervention unsafe in the opinion of the treating neurosurgeon.
• Patients with personal or family history of bleeding disorders are not eligible.
• Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements are not eligible.
• Patients with known hypersensitivity to gemcitabine

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carl Koschmann, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

The University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00135182

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2018.159

Identifier Type: -

Identifier Source: org_study_id