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)

STATUS

Recruiting
End date

May 1, 2024
participants needed

46
sponsor

Sabine Mueller, MD, PhD

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Updated on 25 October 2022

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platelet count

renal function

absolute neutrophil count

monoclonal antibodies

nitrosoureas

glomerular filtration rate

primary tumor

myelosuppressive chemotherapy

biologics

atypical teratoid/rhabdoid tumor

craniospinal irradiation

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).

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.

Details

Condition	Medulloblastoma, Childhood, Recurrent, Atypical Teratoid/Rhabdoid Tumor, Medulloblastoma Recurrent
Treatment	Modified Measles Virus, Modified Measles Virus Lumbar Puncture
Clinical Study Identifier	NCT02962167
Sponsor	Sabine Mueller, MD, PhD
Last Modified on	25 October 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	• 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
	Prior Therapy
	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
	Bone Marrow Transplant: Patient must be
	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
	Radiation
	Children must have undergone what is considered the standard of care as upfront
	Patients must have
	therapy including either surgery followed by high dose chemotherapy with stem cell
	rescue or multi-modality therapy of surgery, radiation and chemotherapy
	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
	o Biologic agent: Patient must have recovered from any acute toxicity potentially
	Adequate Bone Marrow Function Defined as
	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
	Adequate Renal Function Defined as
	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
	A serum creatinine based on age/gender as follows
	study chair
	Maximum Serum/Creatinine (mg/dL)
	For biologic agents that have a prolonged half-life, the appropriate interval since
	Age Male Female
	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 <6 years 0.8 0.8
	to registration. Such patients should be discussed with the study chair prior to
	to <10 years 1 1
	registration. For bevacizumab, patients must have received last dose ≥ 32 days
	to <13 years1.2 1.2
	prior to study registration
	to <16 years1.5 1.4
	≥ 6 months since allogeneic bone marrow transplant prior to registration
	Adequate Liver Function Defined as
	≥ 3 months since autologous bone marrow/stem cell prior to registration
	Serum albumin less than or equal to 2 g/dL
	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
	document
	• Cluster of Differentiation 4 (CD4) (>= 200/microliter)
	• Organ Function Requirements (within 7 days prior to study registration)
	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)
	Creatinine clearance or radioisotope glomerular filtration rate (GFR) greater
	than or equal to 70 milliliters (mL)/min/1.73 m2 or
	- 2 years 0.6 0.6
	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)
	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
	• 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
Exclusion Criteria
	Patients who are receiving any other investigational agents
	Patients with known HIV positivity
	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 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
	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 inability to return for follow-up visits or obtain follow-up
	studies required to assess toxicity to therapy
	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

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platelet count

renal function

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nitrosoureas

glomerular filtration rate

primary tumor

myelosuppressive chemotherapy

biologics

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craniospinal irradiation

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Study Definition

Wikipedia

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)