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Anti-metabolites

Gemcitabine for Brain Tumor

Phase < 1
Waitlist Available
Led By Adam Green, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age greater than or equal to 3 years and less than 18 years at the time of enrollment
Be younger than 18 years old
Must not have
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.
Patients who have received any tumor-directed therapy prior to biopsy. Concurrent treatment with corticosteroids is allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-12 hours post systemic admininstration of gemcitabine.
Awards & highlights

Summary

This trial is testing whether the cancer drug gemcitabine can penetrate a type of brain tumor called DIPG, which is difficult to treat. A one-time dose of gemcitabine will be given, and then the tumor will be biopsied during surgery to see if the drug has penetrated it. The follow-up period is 30 days post surgery.

Who is the study for?
This trial is for children aged 3-18 with a new diagnosis of DIPG, a type of brain tumor. They must have normal organ function and no prior tumor-directed therapy. Surgery for biopsy must be planned as part of their care, and they can't be pregnant or have certain illnesses that would affect the study.
What is being tested?
The trial tests Gemcitabine's ability to reach DIPG tissue in the brain after being given through IV. It aims to see if this drug, which has shown promise in lab studies and crosses into the brain well, can actually get into the tumor during surgery.
What are the potential side effects?
While not detailed here, Gemcitabine may cause side effects like flu-like symptoms, nausea, low blood counts leading to increased infection risk or bleeding problems due to its impact on bone marrow where blood cells are made.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 3 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe illnesses that would stop me from following the study's requirements.
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I have had treatment for my tumor before a biopsy, and I may be taking corticosteroids.
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I have a bleeding tumor larger than 0.5 cm seen on scans before surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-12 hours post systemic admininstration of gemcitabine.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-12 hours post systemic admininstration of gemcitabine. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PK testing levels of gemcitabine, its metabolite difluorodeoxyuridine (dFdU), and gemcitabine necleotides in peripheral blood and DIPG tissue

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680
51%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Cerebral infarction
1%
Dyspnoea
1%
Ischaemic stroke
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)

Trial Design

1Treatment groups
Experimental Treatment
Group I: GemcitabineExperimental Treatment1 Intervention
The entire therapy on this study is one dose of gemcitabine. No intrapatient dose modifications are necessary. Gemcitabine will be given at 2100 mg/m2 IV over 30 minutes within 4 hours of planned surgical procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~1920

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,786 Previous Clinical Trials
2,787,606 Total Patients Enrolled
1 Trials studying Diffuse Intrinsic Pontine Glioma
Children's Hospital ColoradoOTHER
117 Previous Clinical Trials
5,132,669 Total Patients Enrolled
1 Trials studying Diffuse Intrinsic Pontine Glioma
53 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
Adam Green, MDPrincipal InvestigatorUniversity of Colorado, Denver

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02992015 — Phase < 1
Diffuse Intrinsic Pontine Glioma Research Study Groups: Gemcitabine
Diffuse Intrinsic Pontine Glioma Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT02992015 — Phase < 1
Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02992015 — Phase < 1
~0 spots leftby Sep 2025
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