Modified Measles Virus (MV-NIS) for Children and Young Adults With Recurrent Medulloblastoma or Recurrent ATRT
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|ClinicalTrials.gov Identifier: NCT02962167|
Recruitment Status : Recruiting
First Posted : November 11, 2016
Last Update Posted : December 19, 2018
This is a two 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).
|Condition or disease||Intervention/treatment||Phase|
|Medulloblastoma, Childhood, Recurrent Atypical Teratoid/Rhabdoid Tumor Medulloblastoma Recurrent||Biological: Modified Measles Virus Biological: Modified Measles Virus Lumbar Puncture||Phase 1|
This is an open label, multi-center, Phase I study to assess the safety of administering MV-NIS directly into the tumor bed (for locally recurrent medulloblastoma or ATRT patients) or into the subarachnoid space (for disseminated recurrent medulloblastoma or ATRT patients).
For locally recurrent patients, MV-NIS will be directly administered into the tumor bed following a standard of care surgical resection. For patients with disseminated recurrence, MV-NIS will be injected via lumbar puncture (LP). This is a one-time administration for either locally or disseminated recurrence.
Patients will be closely monitored for 30 days after injection, and then followed for evaluation of 6 month progressive free survival and overall response rate.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Modified Measles Virus (MV-NIS) for the Treatment of Children and Young Adults With Recurrent Medulloblastoma or Recurrent Atypical Teratoid Rhabdoid Tumors (ATRT)|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||February 2020|
Experimental: Locally Recurrent Medulloblastoma/ATRT
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.
Biological: Modified Measles Virus
Administration of MV-NIS either into the tumor bed, if surgery to remove local tumor
Other Name: MV-NIS
Experimental: Disseminated Recurrent MB/ATRT
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).
Biological: Modified Measles Virus Lumbar Puncture
Administration of MV-NIS into the cerebrospinal fluid via lumbar puncture
Other Name: MV-NIS LP
- Number of Participants with Adverse Events as Assessed by CTCAE v4. [ Time Frame: 12 months ]The safety of the modified measles virus will be assessed by monitoring for adverse events. Subjects will be monitored for adverse events via scheduled laboratory assessments, vital sign measurements, and physical examinations. The severity of any toxicity will be graded according to the NCI CTCAE v4.0. We will aggregate this information into the number of subjects with adverse events that are related to study treatment.
- Recommended Phase 2 Dose. [ Time Frame: 12 months ]The maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) will be the dose level at which 6 evaluable patients have been treated and at most 1 patient experienced a dose limiting toxicity (DLT) and the next highest dose level is too toxic or we have reached the protocol defined highest dose level.
- Objective Response Rate (ORR) [ Time Frame: 24 months ]Any eligible patient that receives MV-NIS will be considered evaluable for clinical efficacy. The objective response criteria is that partial response (PR) and complete response (CR) must be confirmed at least 8 weeks after the initial PR or CR criteria is met.
- Progression Free Survival (PFS) [ Time Frame: 24 months ]For patients who are still progression free at the time of analysis, PFS will be censored at the last contact date. PFS will be estimated using the Kaplan-Meier method.
- The distribution of MV-NIS [ Time Frame: 12 months ]Subjects who consent to this optional study will receive an injection of technetium-99m (TC-99m) (pertechnetate) and then undergo SPECT imaging to determine MV-NIS distribution after local injection or after administration into the subarachnoid space.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962167
|Contact: Sabine Mueller, MD, PhD, MAS||(415) firstname.lastname@example.org|
|Contact: Lajhem Cambridge, MS||(415) email@example.com|
|United States, California|
|Children's Hospital Los Angeles||Recruiting|
|Los Angeles, California, United States, 90027|
|Contact: Ashley Margol, MD 323-361-5642 firstname.lastname@example.org|
|Contact: Girish Dhall, MD (323) 361-4629 email@example.com|
|UCSF Helen Diller Family Comprehensive Cancer Center||Recruiting|
|San Francisco, California, United States, 94158|
|Contact: Sabine Mueller, MD 415-476-3831 firstname.lastname@example.org|
|United States, Florida|
|University of Florida||Recruiting|
|Gainesville, Florida, United States, 32610|
|Contact: Sridharan Gururangan, FRCP 352-294-8347 Sridharan.Gururangan@neurosurgery.ufl.edu|
|Contact: Duane Mitchell, MD, PhD 352-294-5232 Duane.Mitchell@neurosurgery.ufl.edu|
|United States, Illinois|
|Ann & Robert H. Lurie Children's Hospital of Chicago||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Stewart Goldman, MD 312-227-4873 email@example.com|
|Contact: Rishi Lulla, MD 312-227-4874 firstname.lastname@example.org|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215-5450|
|Contact: Susan Chi, MD 617-632-4386 Susan_Chi@dfci.harvard.edu|
|Contact: Daphne Haas-Kogan, MD 617-632-2291 Dhaasemail@example.com|
|United States, Missouri|
|Washington University in St. Louis||Recruiting|
|Saint Louis, Missouri, United States, 63130|
|Contact: Karen Gauvain, MD 314-454-2002 firstname.lastname@example.org|
|Contact: Josh Rubin, MD 314-286-2790 email@example.com|
|United States, Ohio|
|Nationwide Children's Hospital||Recruiting|
|Columbus, Ohio, United States, 43205|
|Contact: Mohamed AbdelBaki, MD 614-722-4087 Mohamed.AbdelBaki@NationwideChildrens.org|
|Contact: Johnathan Finlay, MD, MB, ChB, FRCP 614-722-4087 Jonathan.Finlay@nationwidechildrens.org|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Jane Minturn, MD, PhD 267-426-5026 MINTURN@email.chop.edu|
|Contact: Angela Waanders, MD 1-800-879-2467 firstname.lastname@example.org|
|United States, Washington|
|Seattle Children's Hospital||Recruiting|
|Seattle, Washington, United States, 98105|
|Contact: Sarah Leary, MD 206-987-2106 email@example.com|
|Contact: Nicholas Vitanza, MD 206-987-2106 firstname.lastname@example.org|
|Study Chair:||Sabine Mueller, MD, PhD, MAS||University of California, San Francisco|