Is NCT06955169 recruiting in Irvine, CA?

Yes, NCT06955169 is currently enrolling participants at its Irvine, CA location. This intracranial meningioma clinical trial is accepting qualified participants.

How do I join the intracranial meningioma clinical trial in Irvine?

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

Is participation in this Irvine 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.

Intracranial Meningioma Clinical Trial in Irvine, CA: [177Lu]Lu-DOTATATE

Who Can Participate

Inclusion Criteria

STEP 1 REGISTRATION

Aged \>= 18 years

Histologically confirmed diagnosis of WHO grade 1-3 meningioma

Disease progression following at least one prior surgical intervention (biopsy or resection) and at least one prior course of radiation.

The patient is not considered a candidate for additional surgery and/or radiation or the patient has declined additional surgery and/or radiation.

Presence of measurable contrast-enhancing disease on gadolinium-enhanced MRI brain scan defined as at least one lesion with two perpendicular diameters measuring ≥10 mm on two or more axial slices (≤ 5 mm interslice thickness, ≤ 1 mm interslice gap) per current RANO meningioma criteria

Progression of disease determined by local radiology review per current RANO meningioma criteria, defined as:

≥ 15% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 6 months (196 days), or

≥ 25% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 12 months (379 days), or

Development of a new measurable lesion

The following scans must be available for submission for central radiology review:

Pre-progression gadolinium-enhanced MRI brain scan no older than 12 months (379 days) that serves as a reference for evaluation of radiographic disease progression

Progression gadolinium-enhanced MRI brain scan STEP 2 REGISTRATION

Progression of disease determined by central radiology review per current RANO meningioma criteria, defined as:

≥ 15% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 6 months (196 days), or

≥ 25% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 12 months (379 days), or

Development of a new measurable lesion.

\[68Ga\]Ga-DOTATATE uptake on PET-CT. Positive uptake is defined as uptake at least as high as liver, based on the uptake in at least one target lesion.

Both the patient and investigator must agree that the patient will NOT receive SSTR2-targeted therapy, surgical resection, or radiation therapy until progression of disease while on study treatment.

Patients must be willing and able to undergo regular MRI scans of the brain and \[68Ga\]Ga-DOTATATE PET-CT imaging during the study.

Patients must have recovered to CTCAE grade ≤1 or pretreatment baseline from clinically significant adverse events related to prior therapy (

Exclusion Criteria

include alopecia, lymphopenia, sensory neuropathy ≤ grade 2, or other ≤ grade 2 not constituting a safety risk based on the investigator's judgment).

Adequate organ and bone marrow function as defined below (within 28 days prior to step 2 registration):

Absolute neutrophil count (ANC) ≥ 1500/mm3

Platelet count ≥ 75,000/mm3

Hemoglobin ≥ 8 g/dL

Creatinine clearance (calculated by the Cockroft-Gault method) ≥40mL/min

AST (SGOT) and ALT (SGPT) ≤ 3 x the laboratory upper limit of normal (ULN)

Total serum bilirubin ≤ 3 x ULN (except participants with Gilbert's Syndrome, who can have a total bilirubin ≤ 5 x ULN)

Potassium within normal limits. Exclusion Criteria:

Patients with a clinical diagnosis of NF2-related schwannomatosis or with a known molecular diagnosis of NF2-related schwannomatosis.

Patients with radiation-associated meningiomas.

Patients with known intraspinal meningiomas or meningioma metastases outside the skull/spinal column. Meningiomas invading the skull base or orbits are not excluded.

Prior SSTR2-targeted therapy, e.g. Somatostatin LAR or short-acting Octreotide. No limit on number of prior non-SSTR2-tartgeted systemic therapies.

Unstable neurological symptoms requiring steroids to control symptoms at a dose of \>2 mg of dexamethasone (or equivalent) daily within 28 days prior to step 2 registration.

Patients requiring immediate local therapy (e.g. surgical resection).

Surgical procedure within the timeframes listed below, prior to step 2 registration.

28 days from any prior craniotomy

7 days from stereotactic biopsy Note: There is no limit to the number of prior surgical interventions

Treatment within the timeframes specified below, prior to step 2 registration.

28 days (or 5 half-lives, whichever is longer) for cytotoxic chemotherapy, biologic agent, investigational agent or any other systemic agent prescribed for the purpose of treating meningioma

6 weeks from nitrosoureas Note: There is no limit to the number of prior systemically administered therapeutic agents.

A target lesion is excluded if it has received any of the following:

More than 2 total prior courses of radiation

More than 1 prior course of standard fractionated external beam radiation therapy (EBRT)

Radiation treatment to the target lesion completed \<24 weeks (168 days) before Step 2 registration. For purposes of this criterion, one course of EBRT counts as one course regardless of duration, and each course of stereotactic radiation (1-5 fractions) counts as one course. Accordingly, a target lesion may have received at most one prior course of EBRT plus one prior course of stereotactic radiation, or two prior courses of stereotactic radiation. Prior radiation history must be evaluated on a lesion-by-lesion basis, including radiation delivered before any subsequent surgical resection.

All types of radioligand therapy at any time prior to registration. Radioligands received for diagnostic purposes are not exclusionary.

Known hypersensitivity to somatostatin analogues or any component of the \[68Ga\]Ga- DOTATATE or \[177Lu\]Lu-DOTATATE formulations.

Active infection requiring current use of intravenous therapy with antibiotics.

Active cardiovascular disease: cerebral vascular accident/stroke (≤ 6 months prior to registration), myocardial infarction (≤ 6 months prior to registration), congestive heart failure (≥ NYHA class II), unstable angina pectoris, or serious cardiac arrhythmia requiring medication.

An active malignancy ≤ 3 years. Note: Patients with a malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

Pregnant and/or breastfeeding patients who are unwilling to discontinue breast feeding.

Participants of childbearing potential must have a negative pregnancy test within 14 days of study entry.

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 Irvine?

Yes, this clinical trial (NCT06955169) has an active research site in Irvine, CA 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.

Intracranial Meningioma Treatment Options in Irvine, CA

If you're searching for intracranial meningioma treatment options in Irvine, CA, this clinical trial (NCT06955169) 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 Irvine research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced intracranial meningioma 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 intracranial meningioma clinical trials near you to find additional studies recruiting in your area.

Intracranial Meningioma Clinical Trial in Irvine, CA

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IRB Approved

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About This Intracranial Meningioma Study in Irvine