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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-12 hours post systemic admininstration of gemcitabine.

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

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Dyspnoea

Cerebral infarction

Ischaemic stroke

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met