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Virus Therapy

Modified Measles Virus Lumbar Puncture for Atypical Teratoid/Rhabdoid Tumor

Phase 1

Waitlist Available

Research Sponsored by Sabine Mueller, MD, PhD

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial will enroll three groups of patients who will each receive a different dose of MV-NIS.

Eligible Conditions

Atypical Teratoid/Rhabdoid Tumor
Medulloblastoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of Participants with Adverse Events as Assessed by CTCAE v5.

Recommended Phase 2 Dose.

Secondary outcome measures

Objective Response Rate (ORR)

Progression Free Survival (PFS)

Other outcome measures

The distribution of MV-NIS

Trial Design

3Treatment groups

Experimental Treatment

Group I: Locally Recurrent Medulloblastoma/ATRTExperimental Treatment1 Intervention

Patients must have local recurrent disease (defined as negative spine MRI and negative cytology within 21 days prior to study registration) and undergo resection of local recurrence as part of their standard of care. Patients must have undergone what is considered the standard of care as upfront therapy including either surgery followed by high dose chemotherapy with stem cell rescue or multi-modality therapy of surgery, radiation and chemotherapy. Patients will receive the modified measles virus, MV-NIS, directly into the tumor bed during standard of care resection.

Group II: Disseminated Recurrent MedulloblastomaExperimental Treatment1 Intervention

Patients must have disseminated recurrent medulloblastoma (defined as multifocal disease, positive spine MRI including leptomeningeal disease and/or positive cytology within 21 days prior to study registration) and have adequate CSF flow based on spine MRI with no evidence of bulky disease or if bulky disease is present based on a CSF flow study per institutional guidelines. Patients must have undergone what is considered the standard of care as upfront therapy including either surgery followed by high dose chemotherapy with stem cell rescue or multi-modality therapy of surgery, radiation and chemotherapy. Patients will receive the modified measles virus, MV-NIS, via lumbar puncture (modified measles virus lumbar puncture).

Group III: Disseminated Recurrent MB/ATRTExperimental Treatment1 Intervention

Patients must have disseminated recurrent medulloblastoma (MB) or ATRT (defined as multifocal disease, positive spine MRI including leptomeningeal disease and/or positive cytology within 21 days prior to study registration) and have adequate CSF flow based on spine MRI with no evidence of bulky disease or if bulky disease is present based on a CSF flow study per institutional guidelines. Patients must have undergone what is considered the standard of care as upfront therapy including either surgery followed by high dose chemotherapy with stem cell rescue or multi-modality therapy of surgery, radiation and chemotherapy. Patients will receive the modified measles virus, MV-NIS, via lumbar puncture (modified measles virus lumbar puncture).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Modified Measles Virus

2017

Completed Phase 1

~40

Modified Measles Virus Lumbar Puncture

2017

Completed Phase 1

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Matthew Larson Foundation for Pediatric Brain TumorsUNKNOWN

No More Kids With CancerUNKNOWN

Sabine Mueller, MD, PhDLead Sponsor

8 Previous Clinical Trials

449 Total Patients Enrolled

Frequently Asked Questions

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

How many participants are permitted to enroll in the experiment?

"The medical trial requires 46 participants who fulfill the specified inclusion criteria. The study can be joined from two major locations, namely Children's Hospital of Philadelphia in Pennsylvania and Nationwide Children's Hospital in Ohio."

Answered by AI

Does this clinical trial accept individuals over the age of fifty?

"The prerequisites for this clinical trial necessitate that all participants be between 12 months and 39 years old. This type of research is quite common, as there are 221 trials aimed at children under 18 and 930 studies focusing on adults over 65."

Answered by AI

How many different locations are actively overseeing this trial?

"The experimental treatment is being offered at a total of 11 medical centres, including Children's Hospital of Philadelphia in Pennsylvania, Nationwide Children's Hospital in Ohio and UCSF Helen Diller Family Comprehensive Cancer Center in California."

Answered by AI

Could you elucidate on the existing research surrounding Modified Measles Virus Lumbar Puncture?

"Currently, 8 experiments are running to explore the efficacy of Modified Measles Virus Lumbar Puncture. One of these studies is in its final Phase 3 stage. In Rochester, Minnesota alone there are 70 medical facilities carrying out research on this treatment protocol; however it is being trialed across a much larger area."

Answered by AI

Does the Federal Drug Administration sanction Modified Measles Virus Lumbar Puncture?

"Our team at Power assesses the safety of Modified Measles Virus Lumbar Puncture to be a 1 due to its Phase 1 status, indicating limited evidence in favour of both efficacy and security."

Answered by AI

Does this research endeavor currently have openings for new participants?

"The trial, which was uploaded to clinicaltrials.gov on February 22nd 2017 and last amended on October 5th 2022, is presently searching for participants."

Answered by AI

To what extent is this research open to prospective participants?

"This medical trial is recruiting 46 patients between the ages of 12 months and 39 with a diagnosis of medulloblastoma. To be eligible, individuals must have received their last dose of biologic agent at least seven days prior to registration, had surgery followed by high-dose chemotherapy or multi-modality therapy as upfront treatment, failed one previous anticancer therapy before study commencement and not recently undergone myelosuppressive chemotherapy or monoclonal antibody treatments. Furthermore, those who underwent allogeneic bone marrow transplantation should wait for more than 6 months after the procedure to register for this clinical trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Modified Measles Virus (MV-NIS) for Children and Young Adults With Recurrent Medulloblastoma or Recurrent ATRT

Sabine Mueller, MD, PhD 2017. "Modified Measles Virus (MV-NIS) for Children and Young Adults With Recurrent Medulloblastoma or Recurrent ATRT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02962167.