Trametinib and Everolimus for Treatment of Pediatric and Young Adult Patients With Recurrent Gliomas (PNOC021)
NCT ID: NCT04485559
Last Updated: 2025-09-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE1
Total Enrollment
50 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-12-09
Study Completion Date
2027-12-31
Brief Summary
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This phase I trial studies the side effects and best dose of trametinib and everolimus in treating pediatric and young adult patients with gliomas that have come back (recurrent). Trametinib acts by targeting a protein in cells called MEK and disrupting tumor growth. Everolimus is a drug that may block another pathway in tumor cells that can help tumors grow. Giving trametinib and everolimus may work better to treat low and high grade gliomas compared to trametinib or everolimus alone.
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Detailed Description
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PRIMARY OBJECTIVES:
I. To estimate the recommended phase 2 dose (RP2D) of trametinib given orally in combination with everolimus in pediatric and young adult patients with gliomas.
II. To describe the toxicity profile and define the dose limiting toxicities (DLTs) of the combination of trametinib and everolimus in pediatric and young adult patients with recurrent low-grade gliomas (LGG) or high grade glioma (HGG).
III. To characterize the pharmacokinetic profile of trametinib and everolimus when given in combination.
EXPLORATORY OBJECTIVES:
I. To describe the objective response rate and the 2-year progression-free survival (PFS) of LGGs to this therapy in the context of a phase I study.
II. To assess quality of life (QOL) and cognitive measures in pediatric and young adult patients with LGG or HGG.
III. To identify potential predictive biomarkers to targeted therapy in pediatric and young adult patients with LGGs.
IV. To assess endocrine outcomes in pediatric and young adult patients with LGGs.
V. To explore magnetic resonance (MR) quantitative measures of relative cerebral blood volume, permeability and apparent diffusion coefficient within the region of hyperintensity on T2-weighted images as markers of disease response and/or progression in comparison to institutional evaluation of disease response and/or progression and quantitative measures of tumor response as determined by central review (based upon both area and volumetric measures).
OUTLINE: This is a dose-escalation study.
Patients receive a combination of trametinib orally (PO) and everolimus in either of two dosing scheduled (continuous and intermittent). Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, every 3 months for 1 year, then every 6 months for 5 years from the start of therapy.
I. To estimate the recommended phase 2 dose (RP2D) of trametinib given orally in combination with everolimus in pediatric and young adult patients with gliomas.
II. To describe the toxicity profile and define the dose limiting toxicities (DLTs) of the combination of trametinib and everolimus in pediatric and young adult patients with recurrent low-grade gliomas (LGG) or high grade glioma (HGG).
III. To characterize the pharmacokinetic profile of trametinib and everolimus when given in combination.
EXPLORATORY OBJECTIVES:
I. To describe the objective response rate and the 2-year progression-free survival (PFS) of LGGs to this therapy in the context of a phase I study.
II. To assess quality of life (QOL) and cognitive measures in pediatric and young adult patients with LGG or HGG.
III. To identify potential predictive biomarkers to targeted therapy in pediatric and young adult patients with LGGs.
IV. To assess endocrine outcomes in pediatric and young adult patients with LGGs.
V. To explore magnetic resonance (MR) quantitative measures of relative cerebral blood volume, permeability and apparent diffusion coefficient within the region of hyperintensity on T2-weighted images as markers of disease response and/or progression in comparison to institutional evaluation of disease response and/or progression and quantitative measures of tumor response as determined by central review (based upon both area and volumetric measures).
OUTLINE: This is a dose-escalation study.
Patients receive a combination of trametinib orally (PO) and everolimus in either of two dosing scheduled (continuous and intermittent). Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, every 3 months for 1 year, then every 6 months for 5 years from the start of therapy.
Conditions
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Recurrent World Health Organization (WHO) Grade II Glioma
Low-grade Glioma
High Grade Glioma
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Treatment (trametinib, everolimus)
Patients receive dosing per their assigned dose level. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity.
Group Type
EXPERIMENTAL
Everolimus
Intervention Type
DRUG
Given PO
Trametinib
Intervention Type
DRUG
Given PO
Interventions
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Everolimus
Given PO
Intervention Type
DRUG
Trametinib
Given PO
Intervention Type
DRUG
Other Intervention Names
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42-O-(2-Hydroxy)ethyl Rapamycin
Afinitor
Certican
RAD 001
RAD001
Votubia
Zortress
GSK1120212
JTP-74057
MEK Inhibitor GSK1120212
Mekinist
Eligibility Criteria
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Inclusion Criteria
* Participants must have histologically confirmed diagnosis of an LGG (WHO grade I-II) that is recurrent or progressive after prior treatment (biologic, chemotherapy or radiation therapy) or must have a histologically confirmed diagnosis of a high grade glioma (HGG) (WHO grade III-VI)
* Participants with LGG who have had surgery alone are not eligible.
* Participants with neurofibromatosis type 1 (NF-1) are eligible but must have available tissue per study requirements neurofibromatosis (NF) status will be collected
* Participants with spinal cord primaries or disseminated disease are eligible
* For enrollment, snap frozen tissue (150 mg) or 10 unstained 10 um formalin-fixed, paraffin-embedded (FFPE) slides for comprehensive genomic testing or results of prior testing is required
* If clinical comprehensive testing has already been performed, the requirement for submission of tissue may be waived after discussion and review of results with study chairs
* Participants must have evaluable disease
* Prior therapy: Participants must have received prior therapy other than surgery and must have fully recovered from the acute toxic effects of all prior chemotherapy, biologics, immunotherapy, or radiotherapy prior to entering this study
* Myelosuppressive chemotherapy: Participants must have received their last dose of known myelosuppressive anticancer chemotherapy at least three weeks prior to study registration or at least six weeks if they had received nitrosourea. Biologic agents: Participant 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 biologic agents that have a prolonged half-life, at least three half-lives must have elapsed prior to registration
* Participants may have received prior treatment with a mitogen-activated extracellular signal-regulated kinase (MEK) or Mechanistic target of rapamycin (mTOR) inhibitor but must not have developed severe (grade III or IV) clinically significant toxicity. (Participants who developed grade III or IV toxicity which was not presumed by the treating physician to be medically significant should be discussed with the study chair or co-chair)
* Monoclonal antibody treatment: Participants must have received their last dose at least four weeks prior to study registration
* Radiation: Participants must have: had their last fraction of local irradiation to the primary tumor, craniospinal irradiation (\> 24 Gy) or total body irradiation \> 12 weeks prior to registration; investigators are reminded to review potentially eligible cases to confirm disease progression and avoid confusion with pseudo-progression
* Bone marrow transplant: Participants must be: \>= 6 months since allogeneic bone marrow transplant prior to registration; \>= 3 months since autologous bone marrow/stem cell prior to registration
* Corticosteroids: Participants who are receiving steroids must be on a stable or decreasing dose for at least 1 week prior to registration
* Karnofsky \>= 50 for participants \> 16 years of age and Lansky \>= 50 for participants =\< 16 years of age. Participants 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
* Peripheral absolute neutrophil count (ANC) \>= 1000/mm\^3 (unsupported)
* Platelet count \>= 100,000/mm\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
* Hemoglobin \>= 8 m/dL (may be supported)
* International normalized ratio (INR) =\< 1.5
* Creatinine clearance or radioisotope growth factor receptor (rGFR) \>= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/gender as follows:
* 1 to \< 2 years: 0.6 (male), 0.6 (female)
* 2 to \< 6 years: 0.8 (male), 0.8 (female)
* 6 to \< 10 years: 1 (male), 1 (female)
* 10 to \< 13 years: 1.2 (male), 1.2 (female)
* 13 to \< 16 years: 1.5 (male), 1.4 (female)
* \>= 16 years: 1.7 (male), 1.4 (female)
* Bilirubin (sum of conjugated + unconjugated) =\< 1.5 x upper limit of normal (ULN) for age
* Serum glutamate pyruvate transaminase (SGPT) alanine aminotransferase (ALT) =\< 3 x ULN
* Serum albumin \>= 2 g/dL
* Sodium, potassium, calcium and magnesium within 1.5 x institutional lower limit of normal (LLN) or ULN
* Participants must have cholesterol level \< 350 mg/dL and triglycerides \< 400 mg/dL before starting therapy. In case one or both of these are exceeded, the participant can only be included after initiation of appropriate lipid lowering medication and documentation of cholesterol \< 350 mg/dL and triglycerides \< 400mg/dl before start of therapy
* Participants with seizure disorder may be enrolled if well controlled. Participants must be on non-enzyme inducing anticonvulsants which are not excluded on study therapy
* Participants with neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration
* Corrected QT (QTc) interval =\< 450 msecs
* Left ventricular ejection fraction (LVEF) \>= 50%
* Pulse oximeter (Ox) \> 93% on room air
* Hypertension
* Participants 3-17 years of age must have a blood pressure that is =\< 95th percentile for age, height, and gender at the time of registration
* Participants who are \>= 18 years of age must have a blood pressure that is \< 140/90 mm of Hg at the time of registration
* Participants must agree to use adequate contraception: The effects of trametinib and everolimus on the developing human fetus are unknown. For this reason, women of child-bearing potential and males of child fathering potential 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 trametinib and everolimus administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
* A legal parent/guardian or participant must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate per institutional guidelines
* Participants with LGG who have had surgery alone are not eligible.
* Participants with neurofibromatosis type 1 (NF-1) are eligible but must have available tissue per study requirements neurofibromatosis (NF) status will be collected
* Participants with spinal cord primaries or disseminated disease are eligible
* For enrollment, snap frozen tissue (150 mg) or 10 unstained 10 um formalin-fixed, paraffin-embedded (FFPE) slides for comprehensive genomic testing or results of prior testing is required
* If clinical comprehensive testing has already been performed, the requirement for submission of tissue may be waived after discussion and review of results with study chairs
* Participants must have evaluable disease
* Prior therapy: Participants must have received prior therapy other than surgery and must have fully recovered from the acute toxic effects of all prior chemotherapy, biologics, immunotherapy, or radiotherapy prior to entering this study
* Myelosuppressive chemotherapy: Participants must have received their last dose of known myelosuppressive anticancer chemotherapy at least three weeks prior to study registration or at least six weeks if they had received nitrosourea. Biologic agents: Participant 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 biologic agents that have a prolonged half-life, at least three half-lives must have elapsed prior to registration
* Participants may have received prior treatment with a mitogen-activated extracellular signal-regulated kinase (MEK) or Mechanistic target of rapamycin (mTOR) inhibitor but must not have developed severe (grade III or IV) clinically significant toxicity. (Participants who developed grade III or IV toxicity which was not presumed by the treating physician to be medically significant should be discussed with the study chair or co-chair)
* Monoclonal antibody treatment: Participants must have received their last dose at least four weeks prior to study registration
* Radiation: Participants must have: had their last fraction of local irradiation to the primary tumor, craniospinal irradiation (\> 24 Gy) or total body irradiation \> 12 weeks prior to registration; investigators are reminded to review potentially eligible cases to confirm disease progression and avoid confusion with pseudo-progression
* Bone marrow transplant: Participants must be: \>= 6 months since allogeneic bone marrow transplant prior to registration; \>= 3 months since autologous bone marrow/stem cell prior to registration
* Corticosteroids: Participants who are receiving steroids must be on a stable or decreasing dose for at least 1 week prior to registration
* Karnofsky \>= 50 for participants \> 16 years of age and Lansky \>= 50 for participants =\< 16 years of age. Participants 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
* Peripheral absolute neutrophil count (ANC) \>= 1000/mm\^3 (unsupported)
* Platelet count \>= 100,000/mm\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
* Hemoglobin \>= 8 m/dL (may be supported)
* International normalized ratio (INR) =\< 1.5
* Creatinine clearance or radioisotope growth factor receptor (rGFR) \>= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/gender as follows:
* 1 to \< 2 years: 0.6 (male), 0.6 (female)
* 2 to \< 6 years: 0.8 (male), 0.8 (female)
* 6 to \< 10 years: 1 (male), 1 (female)
* 10 to \< 13 years: 1.2 (male), 1.2 (female)
* 13 to \< 16 years: 1.5 (male), 1.4 (female)
* \>= 16 years: 1.7 (male), 1.4 (female)
* Bilirubin (sum of conjugated + unconjugated) =\< 1.5 x upper limit of normal (ULN) for age
* Serum glutamate pyruvate transaminase (SGPT) alanine aminotransferase (ALT) =\< 3 x ULN
* Serum albumin \>= 2 g/dL
* Sodium, potassium, calcium and magnesium within 1.5 x institutional lower limit of normal (LLN) or ULN
* Participants must have cholesterol level \< 350 mg/dL and triglycerides \< 400 mg/dL before starting therapy. In case one or both of these are exceeded, the participant can only be included after initiation of appropriate lipid lowering medication and documentation of cholesterol \< 350 mg/dL and triglycerides \< 400mg/dl before start of therapy
* Participants with seizure disorder may be enrolled if well controlled. Participants must be on non-enzyme inducing anticonvulsants which are not excluded on study therapy
* Participants with neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration
* Corrected QT (QTc) interval =\< 450 msecs
* Left ventricular ejection fraction (LVEF) \>= 50%
* Pulse oximeter (Ox) \> 93% on room air
* Hypertension
* Participants 3-17 years of age must have a blood pressure that is =\< 95th percentile for age, height, and gender at the time of registration
* Participants who are \>= 18 years of age must have a blood pressure that is \< 140/90 mm of Hg at the time of registration
* Participants must agree to use adequate contraception: The effects of trametinib and everolimus on the developing human fetus are unknown. For this reason, women of child-bearing potential and males of child fathering potential 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 trametinib and everolimus administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
* A legal parent/guardian or participant must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate per institutional guidelines
Exclusion Criteria
* Participants who are receiving any other investigational agent for treatment of their tumor
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to everolimus or trametinib
* Participants without available tissue from prior surgery. (If clinical comprehensive testing has already been performed, the requirement for submission of tissue may be waived after discussion and review of results with study chairs)
* Participant is receiving any of the following medications within 7 days prior to enrollment (If participants require (re)initiation of these agents after enrollment and prior to start of therapy they will not be eligible to initiate study therapy):
* Known strong inducers or inhibitors of CYP3A4/5, including enzyme inducing anti-convulsant drugs (EIACDs), grapefruit, grapefruit hybrids, pomelos, starfruit, and Seville oranges
* Substrates of CYP3A4/5 with a narrow therapeutic index
* Herbal preparations/medications (except for vitamins) including, but not limited to: St. John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, black cohosh and ginseng. Participants should stop using all herbal medications at least 7 days prior to enrollment
* As part of the enrollment/informed consent procedures, the participant and/or legal parent or guardian will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product
* Women of childbearing potential who are pregnant or breast-feeding
* Female participants of childbearing potential must have a negative serum or urine pregnancy test within 72 hours of enrollment AND within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* Human immunodeficiency virus (HIV) positive participants will be ineligible if HIV therapy regimen has not been stable for at least 4 weeks or there is intent to change the regimen within 8 weeks following enrollment, or if they are severely immunocompromised
* Participants with known hepatitis B or C are not eligible
* Participants with any clinically significant unrelated systemic illness (serious infectious or significant cardiac, pulmonary, hepatic or other organ dysfunction), which in the opinion of the investigator would interfere with the study procedures or results
* Participants with other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) including heart failure that meets New York Heart Association (NYHA) class II or above are excluded
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to everolimus or trametinib
* Participants without available tissue from prior surgery. (If clinical comprehensive testing has already been performed, the requirement for submission of tissue may be waived after discussion and review of results with study chairs)
* Participant is receiving any of the following medications within 7 days prior to enrollment (If participants require (re)initiation of these agents after enrollment and prior to start of therapy they will not be eligible to initiate study therapy):
* Known strong inducers or inhibitors of CYP3A4/5, including enzyme inducing anti-convulsant drugs (EIACDs), grapefruit, grapefruit hybrids, pomelos, starfruit, and Seville oranges
* Substrates of CYP3A4/5 with a narrow therapeutic index
* Herbal preparations/medications (except for vitamins) including, but not limited to: St. John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, black cohosh and ginseng. Participants should stop using all herbal medications at least 7 days prior to enrollment
* As part of the enrollment/informed consent procedures, the participant and/or legal parent or guardian will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product
* Women of childbearing potential who are pregnant or breast-feeding
* Female participants of childbearing potential must have a negative serum or urine pregnancy test within 72 hours of enrollment AND within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* Human immunodeficiency virus (HIV) positive participants will be ineligible if HIV therapy regimen has not been stable for at least 4 weeks or there is intent to change the regimen within 8 weeks following enrollment, or if they are severely immunocompromised
* Participants with known hepatitis B or C are not eligible
* Participants with any clinically significant unrelated systemic illness (serious infectious or significant cardiac, pulmonary, hepatic or other organ dysfunction), which in the opinion of the investigator would interfere with the study procedures or results
* Participants with other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) including heart failure that meets New York Heart Association (NYHA) class II or above are excluded
Minimum Eligible Age
1 Year
Maximum Eligible Age
25 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Sponsor Role
collaborator
Pediatric Brain Tumor Foundation
UNKNOWN
Sponsor Role
collaborator
The Lilabean Foundation for Pediatric Brain Cancer Research
UNKNOWN
Sponsor Role
collaborator
University of California, San Francisco
OTHER
Sponsor Role
lead
Responsible Party
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Sabine Mueller, MD, PhD
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Sabine Mueller
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of Alabama at Birmingham, Children's of Alabama
Birmingham, Alabama, United States
Site Status
RECRUITING
Children's Hospital Los Angeles
Los Angeles, California, United States
Site Status
RECRUITING
University of California, San Diego Rady Children's Hospital
San Diego, California, United States
Site Status
RECRUITING
University of California, San Francisco
San Francisco, California, United States
Site Status
RECRUITING
Children's National Medical Center
Washington D.C., District of Columbia, United States
Site Status
RECRUITING
University of Florida
Gainesville, Florida, United States
Site Status
RECRUITING
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Site Status
RECRUITING
Riley Hospital for Children
Indianapolis, Indiana, United States
Site Status
RECRUITING
John Hopkins University
Baltimore, Maryland, United States
Site Status
RECRUITING
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Site Status
WITHDRAWN
Children's Minnesota
Minneapolis, Minnesota, United States
Site Status
RECRUITING
Washington University in St. Louis
St Louis, Missouri, United States
Site Status
RECRUITING
Joseph M. Sanzari Children's Hospital at Hackensack University Medical Center
Hackensack, New Jersey, United States
Site Status
RECRUITING
New York University
New York, New York, United States
Site Status
RECRUITING
Doernbecher Children's Hospital Oregon Health & Science University
Portland, Oregon, United States
Site Status
RECRUITING
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Site Status
RECRUITING
University Of Texas Southwestern Medical Center
Dallas, Texas, United States
Site Status
RECRUITING
Texas Children's Hospital
Houston, Texas, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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Elias Sayour, MD, PhD
Role: primary
352-294-8347
Other Identifiers
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NCI-2020-04097
Identifier Type: REGISTRY
Identifier Source: secondary_id
190819
Identifier Type: -
Identifier Source: org_study_id
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