Is NCT04485559 recruiting in Baltimore, MD?

Yes, NCT04485559 is currently recruiting participants at its Baltimore, MD location. This recurrent world health organization (who) grade ii glioma clinical trial is actively enrolling qualified participants.

Is participation in this Baltimore clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Recurrent World Health Organization (WHO) Grade II Glioma Clinical Trial in Baltimore, MD

Q: How do I join the recurrent world health organization (who) grade ii glioma clinical trial in Baltimore?

To join this clinical trial in Baltimore, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Recurrent World Health Organization (WHO) Grade II Glioma Study in Baltimore

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.

Sponsor: University of California, San Francisco

Who Can Participate

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

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Baltimore?

Yes, this clinical trial (NCT04485559) has an active research site in Baltimore, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Recurrent World Health Organization (WHO) Grade II Glioma Treatment Options in Baltimore, MD

If you're searching for recurrent world health organization (who) grade ii glioma treatment options in Baltimore, MD, this clinical trial (NCT04485559) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Baltimore research site is actively enrolling participants for this clinical trial. You'll receive care from experienced recurrent world health organization (who) grade ii glioma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all recurrent world health organization (who) grade ii glioma clinical trials near you to find additional studies recruiting in your area.

Recurrent World Health Organization (WHO) Grade II Glioma Clinical Trial in Baltimore, MD

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