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Phase II for Ependymoma

Phase 1 & 2

Recruiting

Led By Marta Penas-Prado, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18 years

Karnofsky >= 70%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial will test a drug in people with brain/spinal cord tumors to see if it can help reduce tumor size and improve survival. Eligible participants must be 18 or older; some must have tumors with changes in certain genes.

Who is the study for?

Adults with certain brain or spinal cord tumors, specifically those with changes in MYC or MYCN genes. They must have had previous specific treatments, be able to perform most daily activities (Karnofsky >= 70%), and have proper organ function. Women who can bear children and men must use contraception; breastfeeding women must stop breastfeeding.Check my eligibility

What is being tested?

The trial is testing PLX038, a drug for brain/spinal cord tumors with genetic changes. Participants receive PLX038 via IV on day one of each 21-day cycle and self-inject another drug at home after three days to prevent infection. The treatment lasts up to seven months, followed by check-ups for five years.See study design

What are the potential side effects?

Possible side effects of PLX038 are not detailed but may include reactions similar to other drugs in its class. Side effects could involve the immune system, blood counts, liver function, and risk of infection due to the need for additional medication.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am mostly able to care for myself.

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I am breastfeeding but willing to stop for the trial.

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My brain tumor diagnosis is confirmed by a specific lab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Phase I: To confirm the RP2D of PLX038 in participants with progressive or recurrent primary CNS tumors

Phase II: To assess the efficacy of PLX038 in primary CNS tumors containing MYC or MYCN amplifications

Secondary outcome measures

Determine overall survival (OS)

Determine progression free survival (PFS)

Determine the treatment-related toxicities

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase IIExperimental Treatment1 Intervention

RP2D of PLX038

Group II: Phase IExperimental Treatment1 Intervention

Escalating and de-escalating doses of PLX038

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PLX038

2016

Completed Phase 1

~40

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,669 Previous Clinical Trials

40,926,201 Total Patients Enrolled

81 Trials studying Ependymoma

8,760 Patients Enrolled for Ependymoma

Marta Penas-Prado, M.D.Principal InvestigatorNational Cancer Institute (NCI)

1 Previous Clinical Trials

180 Total Patients Enrolled

1 Trials studying Ependymoma

180 Patients Enrolled for Ependymoma

Frequently Asked Questions

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

Is enrollment in this research endeavor open at the present time?

"Qualified participants for this research must have a brain tumor and be aged between 18 to 120 years old. Approximately 120 applicants are being considered in total."

Answered by AI

Is the enrollment age for this research study limited to individuals above fifty years old?

"This clinical trial is seeking participants who are of age or older and aged below 120 years."

Answered by AI

What objectives is this experiment seeking to accomplish?

"During the 42-day period, this trial seeks to quantify PLX038's efficacy in treating primary central nervous system tumours with MYC or MYCN amplifications. Secondary objectives include assessing patient reported outcomes (PRO) via compliance rate calculations, determining overall survival rates and treatment-related toxicities using descriptive statistics from the safety analysis set (SAS)."

Answered by AI

Is there any availability for individuals to join this clinical trial?

"Based on the data hosted by clinicaltrials.gov, this medical study is not presently seeking candidates. This trial was first posted on December 13th 2023 and has since been edited for the final time on December 7th 2023. Although enrollment in this particular research project is no longer available, there are 481 other trials that are still recruiting participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications

2024. "PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06161519.

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