- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03971461
Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma
A Single Arm, Open-label, Multicenter Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Rebecca Rastall, RN, BSc, MSc
- Phone Number: (212) 263-3668
- Email: Rebecca.Rastall@nyulangone.org
Study Contact Backup
- Name: Erika Waalkes
- Email: Erika.Waalkes@nyulangone.org
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- Recruiting
- NYU Langone Health
-
Contact:
- Vivian Chan
- Phone Number: 212-263-4436
- Email: Vivian.Chan@nyulangone.org
-
Principal Investigator:
- Erik Sulman, MD
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Recruiting
- Cleveland Clinic
-
Contact:
- David Peereboom, MD
- Email: PEEREBD@ccf.org
-
Principal Investigator:
- David Peereboom, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female subjects aged ≥ 18 years.
- Karnofsky Performance Status ≥ 60.
Histologically confirmed diagnosis WHO grade I-III meningioma:
a. For grade I meningioma, subjects must have: i. Progressive disease after at least surgical resection and radiotherapy, as defined as an increase in size of the measurable primary lesion (bidirectional area) on imaging by 25% or more between scans separated by no more than 12 months.
or ii. Progressive residual tumor after maximal safe resection, be located at or near critical organs at-risk and considered to be high-risk for radiation injury by the treating investigator. Prior external beam radiotherapy is not required for these subjects.
b. For Grade II or III meningioma, subjects must have either: i. Progressive disease after at least surgical resection and radiotherapy, as defined as an increase in size of the measurable primary lesion (bi-directional area) on imaging by 25% or more between scans separated by no more than 12 months or ii. Residual measurable disease after surgery without requirement of progression.
Positive 68Ga-DOTATATE uptake on PET-MRI.
- Positive uptake is defined as uptake higher than the background and SUV ratios adjusted to the liver and spleen uptake (adopted from Krenning score).
- 68Ga-DOTATATE uptake in target lesions should be Krenning score ≥ 2.
- Presence of measurable disease defined as at least one lesion measuring ≥10 mm in at least one dimension by contrast-enhanced MRI performed within 30 days prior to study registration.
- Multifocal disease is allowed but is limited to ≤ 3 measurable intracranial mass lesions on the most recent post-contrast MRI.
- Any neurological symptoms must be stable for at least 28 days prior to enrollment and patients should not require steroids to control neurological symptoms.
- There is no limit on the number of prior surgeries, radiation therapy, radiosurgery treatments or systemically administered therapeutic agents.
- For patients treated with external beam radiation, interstitial brachytherapy or radiosurgery, an interval ≥24 weeks must have elapsed from completion from these therapies to registration unless there is histopathologic confirmation of recurrent tumor or there is new enhancing tumor outside the radiation field (beyond the high dose region or the 80% isodose line).
- An interval of ≥28 days (or 5 half-lives, whichever is shorter) from prior cytotoxic chemotherapy (6 weeks from nitrosoureas), biologic agent, investigational agent or any other systemic agent prescribed for the purpose of treating meningioma.
- An interval of ≥28 days from craniotomy and ≥7 days from stereotactic biopsy.
Availability of a paraffin-embedded archival tumor block from most recent tumor resection sufficient to generate at minimum 8 unstained slides but preferably up to 25 unstained slides; or, if a paraffin tumor block is unavailable, at minimum 8 unstained slides but preferably up to 25 unstained slides.
a. Positive SSTR2 expression in the most recent tumor specimen must be confirmed by central pathology review.
- Patients must be willing and able to undergo regular MRI scans of the brain.
- Patients must have recovered to CTCAE grade ≤1 or pretreatment baseline from clinically significant adverse events related to prior therapy (exclusions include alopecia, laboratory values listed per inclusion criteria, 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 21 days of treatment initiation):
- White blood cell (WBC) ≥ 2,000/mm3
- Absolute neutrophil count (ANC) ≥ 1,000/mm3
- Platelet count ≥ 75,000/mm3
- Hemoglobin ≥ 8 gm/dL
- AST(SGOT)/ALT(SGPT) ≤ 3 x laboratory upper limit of normal (ULN)
- Creatinine clearance (measured or calculated) ≥ 50 mL/min OR creatinine levels > 150 μMol/L (1.7 mg/dL)
- Total serum bilirubin ≤ 3 X ULN (except participants with Gilbert's Syndrome, who can have a total bilirubin ≤ 5 X ULN)
- Serum albumin level of more than 3.0 g/dL, unless the prothrombin time value was within the normal range
- Women of childbearing potential (WOCBP) and men able to father a child must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in the study, she must inform her treating physician immediately.
- Able to understand and willing to sign an IRB approved written informed consent document.
Exclusion Criteria
- Patients with a clinical diagnosis of NF2 (either by NIH or Manchester criteria) or with a molecular diagnosis of NF2.
- Patients with radiation-associated meningiomas.
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm. This includes treatment with Somatostatin LAR within 4 weeks prior to treatment, or any patient receiving treatment with short-acting Octreotide that cannot be interrupted for greater than 24 hours before treatment.
- Peptide receptor radionuclide therapy at any time prior to registration.
- Known hypersensitivity to somatostatin analogues or any component of the 68Ga- DOTATATE or 177Lu-DOTATATE formulations.
- Known additional malignancy that is progressing or requires active treatment within 2 years of start of study drug. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and in situ cervical cancer that has undergone potentially curative therapy.
- Current or planned participation in another study of an investigational agent or investigational device.
- Active infection requiring intravenous therapy with antibiotics.
- Uncontrolled intercurrent illness including, but not limited to, clinically significant (i.e. active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), congestive heart failure (≥ NYHA class II), unstable angina pectoris, or serious cardiac arrhythmia requiring medication.
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Active Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test is positive).
- Other severe acute or chronic medical or psychiatric conditions (within the past year) including recent or active suicidal ideation or behavior, or laboratory abnormalities that may increase the risk associated with study participation or treatment on study or may interfere with the interpretation of study results.
- Pregnant and/or breastfeeding patients. Women of childbearing potential (WOCBP) must have a negative pregnancy test within 14 days of study entry.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lutathera
|
administered intravenously every 8 weeks for a total of 4 doses
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival at 6 months (PFS-6)
Time Frame: 6 Months
|
proportion of subjects who achieve a complete response (CR), partial response (PR), or stable disease (SD) at 6 months from start of Lutathera treatment.
Radiographic treatment response will be assessed by measuring the bidirectional tumor diameters on contrast-enhanced MRI in patients who received at least one dose of Lutathera compared to baseline measurements at time of study enrollment
|
6 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: 12 months
|
defined as the best response [Complete Response (CR) + Partial Response (PR) + stable disease (SD)] recorded from the start of the study until the end of study in patients who received at least one dose of Lutathera.
|
12 months
|
Overall Survival at 12 months (OS-12)
Time Frame: 12 months
|
proportion of subjects who are alive at 12 months from start of Lutathera treatment.
Survival data will be captured by clinical follow-up every 8 weeks during treatment with Lutathera and by follow-up phone calls every 12 weeks for up to 2 years after completion of treatment with Lutathera.
|
12 months
|
Progression Free Survival (PFS)
Time Frame: 2 Years Post Treatment
|
defined as the number of days from the treatment start date to the date of documented disease progression or death due to any cause.
|
2 Years Post Treatment
|
Overall Survival (OS)
Time Frame: 2 Years Post Treatment
|
defined as the number of days from the treatment start date to the date of death due to any cause.
|
2 Years Post Treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Erik Sulman, MD, New York Langone Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Nerve Tissue
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Neoplasms, Vascular Tissue
- Meningeal Neoplasms
- Meningioma
- Molecular Mechanisms of Pharmacological Action
- Radiopharmaceuticals
- Lutetium Lu 177 dotatate
Other Study ID Numbers
- 18-00719
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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