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Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma

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ClinicalTrials.gov Identifier: NCT04051047
Recruitment Status : Not yet recruiting
First Posted : August 9, 2019
Last Update Posted : August 12, 2019
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

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.

Condition or disease Intervention/treatment Phase
Glial Tumor of Brain Diffuse Intrinsic Pontine Glioma Glioma Drug: Gemcitabine Procedure: Tumor biopsy and blood draw Early Phase 1

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Early Phase 1 Trial of Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma
Estimated Study Start Date : November 30, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: 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.
Drug: Gemcitabine
Participants receive a one time IV dose of gemcitabine prior to having standard of care surgery.
Other Name: Gemzar

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




Primary Outcome Measures :
  1. Number of participants with detectable intratumoral gemcitabine after systemic treatment with the drug [ Time Frame: Day 1 ]
    Gemcitabine will be considered to be detectable in a participant's tumor sample if gemcitabine or one of its metabolites (difluorodeoxyuridine [dFdU] or gemcitabine triphosphate [dFdCTP]) is detected at a measurable level in any of the participant's tumor samples. Undetectable gemcitabine will be defined as gemcitabine, dFdU, and dFdCTP levels below the detectable limits for all of an individual participant's samples, in the setting of detectable gemcitabine, dFdU, or dFdCTP in the plasma and/or cerebrospinal fluid (CSF) for that patient, and the pathologic review showing viable tumor tissue.


Secondary Outcome Measures :
  1. Concentration of gemcitabine in patient tumor sample [ Time Frame: Day 1 ]
    Gemcitabine, dFdU and dFdCTP will be quantified in the available tumor sample(s), in plasma, and in CSF (if available). For this pilot trial, gemcitabine PK results will be analyzed descriptively, and this trial is not designed for statistical analysis.



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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051047


Locations
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United States, Michigan
The University of Michigan Rogel Cancer Center Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Alyssa Paul       arpaul@med.umich.edu   
Principal Investigator: Carl Koschmann         
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
University of Colorado, Denver
Investigators
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Principal Investigator: Carl Koschmann, M.D. University of Michigan

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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT04051047     History of Changes
Other Study ID Numbers: UMCC 2018.159
HUM00135182 ( Other Identifier: University of Michigan )
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Michigan Rogel Cancer Center:
Glioma
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs