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New treatment option for Recurrent World Health Organization (WHO) Grade II Glioma
Official title Trametinib and Everolimus for Treatment of Pediatric and Young Adult Patients With Recurrent Gliomas (PNOC021)
ClinicalTrials.gov ID: NCT04485559
What this study is testing
What is Everolimus?
Everolimus is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent world health organization (who) grade ii glioma.
Also referred to as 42-O-(2-Hydroxy)ethyl Rapamycin, Afinitor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 25
You may be able to join if
- Participants must have histologically confirmed diagnosis of an LGG (WHO grade I-II) that is recurrent or progressive after prior treatment...
- 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...
- 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...
You likely can't join if
- 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...
- Participant is receiving any of the following medications within 7 days prior to enrollment (If participants require (re)initiation of these agents...
- Known strong inducers or inhibitors of CYP3A4/5, including enzyme inducing anti-convulsant drugs (EIACDs), grapefruit, grapefruit hybrids, pomelos...
- Substrates of CYP3A4/5 with a narrow therapeutic index
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Washington D.C., District of Columbia, United States
- Gainesville, Florida, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Los Angeles, California, United States; San Diego, California, United States; San Francisco, California, United States; Washington D.C., District of Columbia, United States; Gainesville, Florida, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.