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

Recruiting in Palo Alto (17 mi)

+8 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Sabine Mueller, MD, PhD

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a three arm Phase I study within the Pacific Pediatric Neuro-Oncology Consortium (PNOC). This study will look to determine the safety and recommended phase 2 dose of the modified measles virus (MV-NIS) in children and young adults with recurrent medulloblastoma or atypical teratoid rhabdoid tumor (ATRT).

Research Team

Sabine Mueller, MD, PhD, MAS

Principal Investigator

University of California, San Francisco

Eligibility Criteria

Inclusion Criteria

- You must have recovered from any side effects related to biologic medication, and received your last dose at least 7 days before the study starts. - Patients who have received monoclonal antibody treatment should have waited for at least three half-lives before registering. - If you have received bevacizumab, your last dose should have been at least 32 days before the study starts. - If you have had radiation therapy, the last fraction of radiation should have been at least 2 weeks ago for local radiation and at least 12 weeks ago for craniospinal radiation before the study starts. - You must be between the ages of 12 months and 39 years old, and have a good performance score. - You must have adequate bone marrow, renal, and liver function. - You and your partner must use effective contraception during the study and for 4 months after the study ends. - You must be able to understand and sign the informed consent document.

For stratum A, 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. Children 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.

For stratum B, patients must have disseminated recurrent disease (defined as multifocal disease, positive spine MRI including leptomeningeal disease and/or positive cytology within 21 days prior to study registration) and have adequate cerebrospinal fluid (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. Children 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.

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Exclusion Criteria

-Patients who have had chemotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) or radiotherapy within 2 weeks prior to entering the study for local palliative XRT (small port) and within 12 weeks prior for patients that received craniospinal XRT

-Female patients of childbearing potential must not be pregnant or breast-feeding.

You have had an allergic reaction in the past to substances that are similar to the measles virus vaccine.

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Treatment Details

Interventions

Modified Measles Virus (MV-NIS) (Virus Therapy)

Participant Groups

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).