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Anti-metabolites

Gemcitabine for Brain Tumor

Q: Is the age limit for recruitment of participants in this trial higher than 35?

This clinical trial has determined that the minimum age requirement to participate is 3 years old and not exceeding 17.

Q: What has been the primary application of Gemcitabine to date?

Typically, gemcitabine is used to address small cell lung carcinoma; however it can also be prescribed for head and neck carcinoma, locally advanced pancreatic adenocarcinomas, and cervical cancers.

Q: Could you give an overview of the experiments that have been performed using Gemcitabine?

Currently, 447 trials are underway for Gemcitabine; 134 of these studies being in the third phase. Although many experiments center around Adelaide, South Australia, 24587 different locations across the globe carry out this medication's research.

Q: Are there any available slots for participants of this experiment?

As evidenced on clinicaltrials.gov, this investigation is actively searching for participants. The trial was first advertised in September 2016 and the most recent update to its information occurred at the end of January 2022.

Q: To what magnitude is enrollment into this clinical trial progressing?

Affirmative. The clinicaltrials.gov website confirms that this study has been recruiting participants since September 23rd, 2016 and is still doing so today with the most recent update occurring on January 31st 2022. 10 participants will be enrolled at a single location for the trial.

Q: Is there an opportunity for me to participate in this research?

This clinical trial is seeking to enrol 10 children aged between 3 and 17 who have diffuse intrinsic pontine <a href="https://www.withpower.com/clinical-trials/glioma">glioma</a>.

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am between 3 and 18 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Ischaemic stroke

Cerebral infarction

Dyspnoea

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

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

~2070

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,143,581 Total Patients Enrolled

1 Trials studying Diffuse Intrinsic Pontine Glioma

Children's Hospital ColoradoOTHER

115 Previous Clinical Trials

5,127,613 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for recruitment of participants in this trial higher than 35?

"This clinical trial has determined that the minimum age requirement to participate is 3 years old and not exceeding 17."

Answered by AI

What has been the primary application of Gemcitabine to date?

"Typically, gemcitabine is used to address small cell lung carcinoma; however it can also be prescribed for head and neck carcinoma, locally advanced pancreatic adenocarcinomas, and cervical cancers."

Answered by AI

Could you give an overview of the experiments that have been performed using Gemcitabine?

"Currently, 447 trials are underway for Gemcitabine; 134 of these studies being in the third phase. Although many experiments center around Adelaide, South Australia, 24587 different locations across the globe carry out this medication's research."

Answered by AI

Are there any available slots for participants of this experiment?

"As evidenced on clinicaltrials.gov, this investigation is actively searching for participants. The trial was first advertised in September 2016 and the most recent update to its information occurred at the end of January 2022."

Answered by AI

To what magnitude is enrollment into this clinical trial progressing?

"Affirmative. The clinicaltrials.gov website confirms that this study has been recruiting participants since September 23rd, 2016 and is still doing so today with the most recent update occurring on January 31st 2022. 10 participants will be enrolled at a single location for the trial."

Answered by AI