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Cytokine

Trastuzumab + GM-CSF for Ependymoma

Q: Who is eligible to partake in this research study?

This ependymoma trial is recruiting 33 minors ranging from 1 month to 21 years of age. In addition, the participants must have clinical indication for standard of care surgical resection and meet certain performance standards based on their age: patients aged 12 months - 16 years require a Lansky score of 50 or greater while those over 16 will be assessed by Karnofsky scores with an expected minimum rating of 50.

Q: Has the FDA sanctioned Trastuzumab in conjunction with SubQ GM-CSF?

Our internal evaluation at Power judged Trastuzumab combined with SubQ GM-CSF to have a safety rating of 1. This is due to it being an initial, Phase 1 trial, thus there is limited empirical evidence backing its security and efficacy.

Q: What is the current capacity of this clinical research program?

Affirmative. The clinicaltrials.gov website reports that this experiment is currently recruiting patients; it was initially posted on December 1st 2016 and updated most recently on December 2nd 2021. 33 participants are required to join the study at a single centre.

Q: Is this clinical trial open to individuals aged fifty-five and over?

The criteria for participation in this trial necessitates that participants are within 12 months to 21 years of age. There are 54 studies for individuals below the legal age and 199 specifically tailored for those 65 or older.

Q: What is the usual application of Trastuzumab in conjunction with SubQ GM-CSF?

Trastuzumab and SubQ GM-CSF is an oft used treatment for <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a>, but it has also been validated to tackle other conditions such as high risk of recurrence, first line treatment, or post surgery.

Q: Does this experiment have any available slots for volunteers?

Affirmative. The clinicaltrials.gov page for this trial demonstrates that it is currently enrolling patients, having initially been posted on December 1st 2016. 33 individuals are needed to be recruited from a single medical centre, with the information being updated as recently as December 2nd 2021.

Phase 1

Recruiting

Led By Kathleen Dorris, 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 ≥ 12 months and < 21 years at the time of study enrollment

Patients must be diagnosed with relapse of previously histologically confirmed PFEPN

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

Study Summary

This trial will test if a single dose of intrathecal trastuzumab, given with subcutaneous Granulocyte-macrophage colony-stimulating factor, can help children with relapsed posterior fossa ependymoma by detecting the presence of trastuzumab in tumor specimens.

Who is the study for?

This trial is for children and young adults aged between 1 and 21 years with a specific type of brain tumor called relapsed posterior fossa ependymoma. They must have good organ function, no widespread cancer in the spine or brain, and be able to undergo surgery if needed. Participants need acceptable performance scores indicating they can perform daily activities.Check my eligibility

What is being tested?

The study tests how well trastuzumab, given through the spinal canal after a dose of GM-CSF under the skin, works on this kind of brain tumor. It aims to see if trastuzumab reaches the tumor and assesses any side effects when combined with GM-CSF.See study design

What are the potential side effects?

Possible side effects include reactions at injection sites, flu-like symptoms from GM-CSF such as fever or muscle aches, allergic responses to trastuzumab including rash or breathing difficulties, and potential impact on blood cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 1 and 20 years old.

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My PFEPN cancer has come back.

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My brain MRI shows cancer hasn't spread widely in my brain or blocked fluid flow.

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I need surgery for my relapsed PFEPN tumor to join Stratum 1.

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I can take care of myself but may not be able to do active work or play.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Stratum 1: Detection of trastuzumab in tumor following IT administration

Stratum 2: Determine the Maximum Tolerated Dose (MTD) for IT trastuzumab in combination with fixed doses of subQ GM-CSF

Trial Design

2Treatment groups

Experimental Treatment

Group I: IT trastuzumab in combination with subQ GM-CSFExperimental Treatment1 Intervention

Patients with localized recurrent PFEPN will be treated with IT trastuzumab in combination with GM-CSF to establish a maximum tolerated dosage. GM-CSF will be administered at 250 mcg/m2/dose subQ daily for three (3) days prior to the IT trastuzumab dose.

Group II: IT trastuzumab after subQ GM-CSFExperimental Treatment1 Intervention

Patients with localized recurrent PFEPN will be treated with IT trastuzumab following 5-day course of subQ GM-CSF. Surgical resection should be planned (based on institutional surgical scheduling standards) for ideally 2-7 days after IT trastuzumab dosage.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,493 Total Patients Enrolled

Children's Hospital ColoradoOTHER

116 Previous Clinical Trials

5,132,582 Total Patients Enrolled

Kathleen Dorris, MDPrincipal InvestigatorUniversity of Colorado, Denver

1 Previous Clinical Trials

27 Total Patients Enrolled

Media Library

GM-CSF (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT02774421 — Phase 1

Posterior Fossa Ependymoma Research Study Groups: IT trastuzumab after subQ GM-CSF, IT trastuzumab in combination with subQ GM-CSF

Posterior Fossa Ependymoma Clinical Trial 2023: GM-CSF Highlights & Side Effects. Trial Name: NCT02774421 — Phase 1

GM-CSF (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02774421 — Phase 1

Frequently Asked Questions

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

Who is eligible to partake in this research study?

"This ependymoma trial is recruiting 33 minors ranging from 1 month to 21 years of age. In addition, the participants must have clinical indication for standard of care surgical resection and meet certain performance standards based on their age: patients aged 12 months - 16 years require a Lansky score of 50 or greater while those over 16 will be assessed by Karnofsky scores with an expected minimum rating of 50."

Answered by AI

Has the FDA sanctioned Trastuzumab in conjunction with SubQ GM-CSF?

"Our internal evaluation at Power judged Trastuzumab combined with SubQ GM-CSF to have a safety rating of 1. This is due to it being an initial, Phase 1 trial, thus there is limited empirical evidence backing its security and efficacy."

Answered by AI

What is the current capacity of this clinical research program?

"Affirmative. The clinicaltrials.gov website reports that this experiment is currently recruiting patients; it was initially posted on December 1st 2016 and updated most recently on December 2nd 2021. 33 participants are required to join the study at a single centre."

Answered by AI

Is this clinical trial open to individuals aged fifty-five and over?

"The criteria for participation in this trial necessitates that participants are within 12 months to 21 years of age. There are 54 studies for individuals below the legal age and 199 specifically tailored for those 65 or older."

Answered by AI

What is the usual application of Trastuzumab in conjunction with SubQ GM-CSF?

"Trastuzumab and SubQ GM-CSF is an oft used treatment for breast cancer, but it has also been validated to tackle other conditions such as high risk of recurrence, first line treatment, or post surgery."

Answered by AI

Does this experiment have any available slots for volunteers?

"Affirmative. The clinicaltrials.gov page for this trial demonstrates that it is currently enrolling patients, having initially been posted on December 1st 2016. 33 individuals are needed to be recruited from a single medical centre, with the information being updated as recently as December 2nd 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pilot Study of the Effect of Trastuzumab and GM-CSF on Children With Recurrent Ependymoma

2016. "Pilot Study of the Effect of Trastuzumab and GM-CSF on Children With Recurrent Ependymoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02774421.

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