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CX 4945 for Medulloblastoma

Stanford University and Lucile Packard Children's Hospital, Palo Alto, CA
MedulloblastomaCX 4945 - Drug
Eligibility
Any Age
All Sexes

Study Summary

This trial is testing a new drug, CX-4945, for patients with a specific type of brain cancer that has come back after treatment.

Eligible Conditions
  • Medulloblastoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

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CX-904
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Study Objectives

4 Primary · 5 Secondary · Reporting Duration: Up to 3 years from enrollment

4 weeks
Phase I: Maximum tolerated dose of CX-4945
Phase I: Plasma pharmacokinetics of CX-4945 in skeletally-immature children
Plasma pharmacokinetics of CX-4945 in skeletally-mature subjects
Surgical study: Reduction in CK2-mediated signaling in tumor.
At time of enrollment
Relative frequency of genomic alterations in archival tissue
Prior to starting CX-4945 (Day -5 or -7), prior to dose on Day -3, prior to dose on Day -1, day of surgery and during surgery at the time of tissue collection
Surgical Study: Intratumoral PK concentrations
Year 2
Objective response rate in the skeletally-immature cohort
Phase II: Sustained objective response rate (PR-CR) rate in the skeletally mature cohort
Year 3
Progression free survival

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
CX-904
1
ON123300
1
PEP-CMV

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

3 Treatment Groups

Phase I - Skeletally-immature
1 of 3
Phase II - Skeletally-mature
1 of 3
Surgical
1 of 3

Experimental Treatment

60 Total Participants · 3 Treatment Groups

Primary Treatment: CX 4945 · No Placebo Group · Phase 1 & 2

Phase I - Skeletally-immature
Drug
Experimental Group · 1 Intervention: CX 4945 · Intervention Types: Drug
Phase II - Skeletally-mature
Drug
Experimental Group · 1 Intervention: CX 4945 · Intervention Types: Drug
Surgical
Drug
Experimental Group · 1 Intervention: CX 4945 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years from enrollment

Who is running the clinical trial?

Pediatric Brain Tumor ConsortiumLead Sponsor
36 Previous Clinical Trials
1,222 Total Patients Enrolled
8 Trials studying Medulloblastoma
247 Patients Enrolled for Medulloblastoma
St. Jude Children's Research HospitalOTHER
409 Previous Clinical Trials
5,302,729 Total Patients Enrolled
13 Trials studying Medulloblastoma
2,836 Patients Enrolled for Medulloblastoma
National Cancer Institute (NCI)NIH
13,283 Previous Clinical Trials
41,235,338 Total Patients Enrolled
85 Trials studying Medulloblastoma
9,873 Patients Enrolled for Medulloblastoma
Ralph Salloum, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with medulloblastoma that has come back or is not responding to treatment, and there is enough tissue to determine which subtype of medulloblastoma you have.
You are a child or teenager between the ages of 3 and 18 years old, and your bones are still growing. Your doctor has confirmed this by checking your bone age, which is under 14 years for females and under 16 years for males. Your body surface area (BSA) must also meet the requirements stated in the study protocol.
You must be at least 18 years old or have reached a certain level of physical maturity (14 years old for females and 16 years old for males) before participating in the study.
You should have a disease that can be measured in two dimensions.
You must need a surgery for medical reasons.
References

Frequently Asked Questions

How many individuals are being helped by this research?

"That is correct, the available information does point to this clinical trial being open for recruitment. The original posting was on March 18th, 2019 with the most recent update coming on August 30th, 2022. They are trying to enroll 60 individuals at 12 different locations." - Anonymous Online Contributor

Unverified Answer

Are people still signing up for this experiment?

"The most up-to-date information indicates that this trial is actively recruiting patients. The listing was first posted on March 18th, 2019 and was last updated on August 30th, 2020." - Anonymous Online Contributor

Unverified Answer

Are research facilities in Canada actively pursuing this line of inquiry?

"A total of 12 sites are recruiting patients for this clinical trial, with Memorial Sloan-Kettering Cancer Center in New York, Baylor College of Medicine in Houston, and Ann & Robert H. Lurie Children's Hospital of Chicago in Chicago amongst them." - Anonymous Online Contributor

Unverified Answer

Do we have any previous data to review for CX 4945?

"So far, CX 4945 has been trialled 3 times with the most recent study taking place at Grenoble Alps Hospital in 2017. Presently, there are 3 more ongoing clinical trials, one of which is based in New York City." - Anonymous Online Contributor

Unverified Answer

What are the ultimate goals of this experiment?

"The purpose of this 4-week trial is to study the efficacy of CX-4945 in skeletally-mature subjects with advanced solid tumors. The primary endpoint is response rate, as measured by PR or CR, and secondary objectives include reduction in CK2 activity, percentage of genomic alterations, and plasma drug concentration of CX-4945." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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