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Medulloblastoma, Childhood, RecurrentPhase 1NCT02962167

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

A Phase 1 study testing Modified Measles Virus and Modified Measles Virus Lumbar Puncture in people with Medulloblastoma, Childhood, Recurrent and Atypical Teratoid/Rhabdoid Tumor, run by Sabine Mueller, MD, PhD at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 12 months to 39 years
What is being tested?
Modified Measles Virus and Modified Measles Virus Lumbar Puncture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
8 sitesUnited States
Study dates
22 Feb 2017to 10 May 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 months to 39 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
  • For stratum C, 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.
  • Prior Therapy:
  • The patient must have failed at least one prior therapy - surgery followed by high dose chemotherapy with stem cell rescue or multi-modality therapy of surgery, radiation and chemotherapy - prior to study registration. Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
  • o Myelosuppressive chemotherapy: Patients must have received their last dose of known myelosuppressive anticancer chemotherapy at least three weeks prior to study registration or at least six weeks prior if nitrosourea.
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  • o Biologic agent: Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the biologic agent ≥ 7 days prior to study registration.
  • For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended to beyond the time during which adverse events are known to occur. The duration of this interval should be discussed with the study chair.
  • For biologic agents that have a prolonged half-life, the appropriate interval since last treatment should be discussed with the Study Chair prior to registration.
  • Monoclonal antibody treatment: At least three half-lives must have elapsed prior to registration. Such patients should be discussed with the study chair prior to registration. For bevacizumab, patients must have received last dose ≥ 32 days prior to study registration.
  • Bone Marrow Transplant: Patient must be:
  • ≥ 6 months since allogeneic bone marrow transplant prior to registration
  • ≥ 3 months since autologous bone marrow/stem cell prior to registration
  • Radiation:
  • Patients must have:
  • Had their last fraction of local irradiation to primary tumor ≥2 weeks prior to registration for local palliative radiation therapy (XRT) (small port)
  • Had their last fraction of craniospinal irradiation ≥ 12 weeks prior to registration
  • Age ≥ 12 months to less than or equal to 39 years of age
  • Karnofsky ≥ 50 for patients ≥ 16 years of age, and Lansky ≥ 50 for patients < 16 years of age (See Appendix A). Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. Patients with pre-existing neurological deficits need to be stable prior to surgery or LP as determined by the investigator.
  • Cluster of Differentiation 4 (CD4) (>= 200/microliter)
  • Organ Function Requirements (within 7 days prior to study registration)
  • Adequate Bone Marrow Function Defined as:
  • Peripheral absolute neutrophil count (ANC) ≥ 1000/mm3 and
  • Platelet count ≥ 100,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).
  • Adequate Renal Function Defined as:
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) greater than or equal to 70 milliliters (mL)/min/1.73 m2 or
  • A serum creatinine based on age/gender as follows:
  • Maximum Serum/Creatinine (mg/dL)
  • Age Male Female
  • - 2 years 0.6 0.6
  • to <6 years 0.8 0.8
  • 6 to <10 years 1 1
  • 10 to <13 years1.2 1.2
  • 13 to <16 years1.5 1.4
  • 16 years 1.7 1.4 The threshold creatinine values in this table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Centers for Disease Control and Prevention (CDC).
  • Adequate Liver Function Defined as:
  • Bilirubin (sum of conjugated + unconjugated) less than or equal to 1.5 x upper limit of normal (ULN) for age and
  • serum glutamic-pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) less than or equal to 110 U/L and
  • Serum albumin less than or equal to 2 g/dL.
  • The effects of MV-NIS on the developing human fetus are unknown. For this reason, females of child-bearing potential and males must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and 4 months after completion of MV-NIS administration. Should a female become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.
  • -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
  • Patients who have not recovered from acute adverse events due to agents administered more than 4 weeks earlier
  • -Patients who are receiving any other investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to measles virus vaccination
  • -Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • -Female patients of childbearing potential must not be pregnant or breast-feeding.
  • -Female patients of childbearing potential must have a negative serum or urine pregnancy test (within 7 days prior to study registration)
  • -Patients with known HIV positivity
  • Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy
  • Exposure to household contact with known immunodeficiency
  • History of chronic hepatitis B or C infection
  • History of organ transplantation
  • Patients with evidence of extraneural disease
  • Patients on chronic steroids or other immunosuppressive agents. Note: Patients that are currently using inhaled, intranasal, ocular, topical or other non-oral or non-IV steroids may be eligible.
  • Inability to undergo magnetic resonance (MR) imaging to assess disease status

Who cannot join

None listed.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • University of Utah

    Salt Lake City, Utah, 84112

  • University of California, San Francisco

    San Francisco, California, 94143

  • Seattle Children's Hospital

    Seattle, Washington, 98105

  • Washington University in St. Louis

    St Louis, Missouri, 63130

Other trials in United States

About this study

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)

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).

Read the detailed description

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 (patients in the first arm) MV-NIS will be directly administered into the tumor bed following a standard of care surgical resection. For patients with disseminated recurrence (patients in the second or third arm), MV-NIS will be injected via lumbar puncture (LP).

Patients in the second arm will receive a one-time administration of MV-NIS. 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.

Patients in the third arm will receive two administrations of MV-NIS. Patients will be closely monitored for 56 days after injection, and then followed for evaluation of 4 month progressive free survival.

Being tested
Modified Measles Virus, Modified Measles Virus Lumbar Puncture
Keywords
measles virus, recurrent medulloblastoma, recurrent ATRT
Medical subject headings
Medulloblastoma, Recurrence, Rhabdoid Tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified Measles VirusBiological

    Also called MV-NIS

    Administration of MV-NIS either into the tumor bed, if surgery to remove local tumor

  • Modified Measles Virus Lumbar PunctureBiological

    Also called MV-NIS LP

    Administration of MV-NIS into the cerebrospinal fluid via lumbar puncture

Study groups in NCT02962167
Study groupRoleWhat they receive
Locally Recurrent Medulloblastoma/ATRTExperimentalPatients 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.
Receives: Biological: Modified Measles Virus
Disseminated Recurrent MB/ATRTExperimentalPatients 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).
Receives: Biological: Modified Measles Virus Lumbar Puncture
Disseminated Recurrent MedulloblastomaExperimentalPatients 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).
Receives: Biological: Modified Measles Virus Lumbar Puncture

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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 v5.0. We will aggregate this information into the number of subjects with adverse events that are related to study treatment.

    Measured: 12 months

  2. Recommended Phase 2 Dose.

    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.

    Measured: 12 months

Secondary outcomes (2)

  1. Objective Response Rate (ORR)

    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.

    Measured: 24 months

  2. Progression Free Survival (PFS)

    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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2016 (estimated)
  2. Study start22 Feb 2017
  3. Primary completion10 May 2023
  4. Study completion10 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02962167
Sponsor's protocol ID
PNOC 005
Other IDs
150812, NCI-2017-01831
Status last verified
Mar 2024
First submitted
2 Nov 2016
Last updated
20 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Modified Measles Virus and Modified Measles Virus Lumbar Puncture in people with Medulloblastoma, Childhood, Recurrent and Atypical Teratoid/Rhabdoid Tumor, run by Sabine Mueller, MD, PhD at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 57 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events as Assessed by CTCAE v5. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02962167.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.

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