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  • 1
    Online Resource
    Online Resource
    The 1994 National Cancer Institute’s strategy to fund multi-institutional, multidisciplinary consortia to design and conduct early phase clinical trials in patients with high grade gliomas.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. 2003-2003
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. 2003-2003
    Abstract: 2003 Background: : In the early 1990’s, the NCI suspended activities of the Brain Tumor Study Group seeking to shift clinical brain tumor research from phase III trials to innovative and correlative rich phase I/II studies. In 1994, NCI funded three early phase brain tumor consortia, later reduced to two consortia in 1999 and one in 2009. In 2020, the NCI announced it would discontinue funding the brain tumor consortium and emphasize pre-clinical glioblastoma drug development (RFA-CA-20-047). Methods: The activities of the New Approaches to Brain Tumor Therapy (NABTT: 1994-2009) and Adult Brain Tumor Consortium (ABTC: 2009-2021) were summarized using data from the Central Operations Office that served the consortia for 27 years. Results: From 1994-2020, 48 consortium meetings were held to discuss, develop, conduct, and evaluate early phase clinical trials. These involved multidisciplinary brain tumor experts (neuro-oncologists, neurosurgeons, radiation oncologists, neuropathologists, statisticians, pharmacologists, imaging experts, immunologists, etc) from 27 US academic centers and hospitals. 85 clinical trials were written, approved by NCI and the Brain Malignancy Steering Committee, and conducted. Most trials evaluated NCI-provided therapeutic agents. 34 trials were conducted in collaboration with 27 pharmaceutical companies eager to develop malignant brain tumor therapeutics; for 9 of these the consortia held the IND. 4870 patients were accrued: 3375 to therapeutic and 1495 to non-therapeutic studies. 49 grant proposals were submitted to fund consortium activities with a 46% approval rate. 91 peer reviewed manuscripts were published, with 174 presentations and abstracts. 18 pharmaceutical symposia were conducted to attract new agents toward early phase brain tumor research. Consortia sponsored 34 Guest Lectureships and multidisciplinary symposia to focus on relevant critical research areas. Additionally, the consortia provided unique opportunities for young faculty to lead multicenter NABTT/ABTC trials with appropriate support and mentorship. Conclusions: Therapeutic progress for high grade gliomas has been slow for many reasons (95% of systemically administered agents do not penetrate the blood-brain barrier, inherent treatment resistance, immunologically “cold” phenotype, etc). NABTT/ABTC focused multidisciplinary, multi-institutional experts on major challenges unique to brain tumor research. The consortia developed innovative early phase clinical studies rich in correlative endpoints, fostered research grants, hosted relevant topical symposia, and provided leadership roles for young investigators while bringing together the NCI, industry, and committed multidisciplinary academicians to explore novel therapeutic options for patients with primary brain tumors.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.2003
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
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  • 2
    Online Resource
    Online Resource
    Working Toward Consensus on Sporadic Vestibular Schwannoma Care: A Modified Delphi Study
    Ovid Technologies (Wolters Kluwer Health) ; 2020
    In:  Otology & Neurotology Vol. 41, No. 10 ( 2020-12), p. e1360-e1371
    Details
    In: Otology & Neurotology, Ovid Technologies (Wolters Kluwer Health), Vol. 41, No. 10 ( 2020-12), p. e1360-e1371
    Abstract: To address variance in clinical care surrounding sporadic vestibular schwannoma, a modified Delphi study was performed to establish a general framework to approach vestibular schwannoma care. A multidisciplinary panel of experts was established with deliberate representation from key stakeholder societies. External validity of the final statements was assessed through an online survey of registered attendees of the 8th Quadrennial International Conference on Vestibular Schwannoma. Study Design: Modified Delphi method. Methods: The panel consisted of 16 vestibular schwannoma experts (8 neurotology and 8 neurosurgery) and included delegates representing the AAOHNSF, AANS/CNS tumor section, ISRS, and NASBS. The modified Delphi method encompassed a four-step process, comprised of one prevoting round to establish a list of focus areas and three subsequent voting rounds to successively refine individual statements and establish levels of consensus. Thresholds for achieving moderate consensus, at ≥67% agreement, and strong consensus, at ≥80% agreement, were determined a priori. All voting was performed anonymously via the Qualtrics online survey tool and full participation from all panel members was required before procession to the next voting round. Results: Through the Delphi process, 103 items were developed encompassing hearing preservation (N = 49), tumor control and imaging surveillance (N = 20), preferred treatment (N = 24), operative considerations (N = 4), and complications (N = 6). As a result of item refinement, moderate (4%) or strong (96%) consensus was achieved in all 103 final statements. Seventy-nine conference registrants participated in the online survey to assess external validity. Among these survey respondents, moderate (N = 21, 20%) or strong (N = 73, 71%) consensus was achieved in 94 of 103 (91%) statements, and no consensus was reached in 9 (9%). Of the four items with moderate consensus by the expert panel, one had moderate consensus by the conference participants and three had no consensus. Conclusion: This modified Delphi study on sporadic vestibular schwannoma codifies 100% consensus within a multidisciplinary expert panel and is further supported by 91% consensus among an external group of clinicians who regularly provide care for patients with vestibular schwannoma. These final 103 statements address clinically pragmatic items that have direct application to everyday patient care. This document is not intended to define standard of care or drive insurance reimbursement, but rather to provide a general framework to approach vestibular schwannoma care for providers and patients.
    Type of Medium: Online Resource
    ISSN: 1531-7129 , 1537-4505
    URL: Article
    DOI: 10.1097/MAO.0000000000002917
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
    detail.hit.zdb_id: 2058738-7
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  • 3
    Online Resource
    Online Resource
    In Vivo 3-T MR Spectroscopy in the Distinction of Recurrent Glioma versus Radiation Effects: Initial Experience
    Radiological Society of North America (RSNA) ; 2002
    In:  Radiology Vol. 225, No. 3 ( 2002-12), p. 871-879
    Details
    In: Radiology, Radiological Society of North America (RSNA), Vol. 225, No. 3 ( 2002-12), p. 871-879
    Type of Medium: Online Resource
    ISSN: 0033-8419 , 1527-1315
    URL: Article
    DOI: 10.1148/radiol.2253010997
    RVK:
    XA 10000
    Language: English
    Publisher: Radiological Society of North America (RSNA)
    Publication Date: 2002
    detail.hit.zdb_id: 80324-8
    detail.hit.zdb_id: 2010588-5
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  • 4
    Online Resource
    Online Resource
    Alliance A071701: Genomically guided treatment trial in brain metastases.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. TPS2573-TPS2573
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. TPS2573-TPS2573
    Abstract: TPS2573 Background: Brain metastases, most commonly derived from melanoma, lung and breast cancers, are the most common brain tumor, with approximately 200,000 cases diagnosed annually in the United States. Median survival is on the order of months. For patients with clinically symptomatic brain metastases, approximately half succumb due to intracranial progression. In preclinical work, we demonstrated that brain metastases and primary tumors are often genetically distinct with frequent alterations in the CDK and PI3K pathway (Brastianos, Carter et al. Cancer Discovery 2015). Methods: We are currently accruing to a prospective multi-arm phase II study of CDK, PI3K/mTOR, and NTRK/ROS1 inhibitors in patients with brain metastases harboring alterations associated with sensitivity to these inhibitors (abemaciclib, paxalisib and entrectinib), respectively. Patients with new, recurrent or progressive brain metastases are eligible for this trial. Previously obtained tissue from brain metastases and extracranial sites (primary or extracranial metastases) are screened for the presence of these alterations, and if present in both tumor sites, patients will receive the appropriate corresponding targeted treatment. Screening is carried out with the SNaPshot NGS assay, which is a fully validated clinical test designed and developed at the MGH Center for Integrated Diagnostics. The primary endpoint of response rate (RR) in the central nervous system as per RANO criteria will be evaluated separately for each inhibitor, stratified by histology within each arm. There will be 21 evaluable patients assigned to each of the CDK and PI3K inhibitor and tumor type cohorts (breast, lung and other) and 10 patients assigned to the NTRK/ROS1 inhibitor cohort (lung) for a total of 136 evaluable patients. Although current systemic therapy for brain metastases is often ineffective, we hypothesize that targeted therapies will demonstrate efficacy in patients harboring the appropriate mutations. This study represents a novel individualized therapeutic approach in brain metastases, a disease with a critical need for effective therapy. Support: U10CA180821, U10CA180882, https://acknowledgments.alliancefound.org ; Genentech, Kazia Therapeutics Limited, Eli Lilly; Clinical trial information: NCT03994796 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.TPS2573
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
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  • 5
    Online Resource
    Online Resource
    Virtual Cisternoscopy: 3D MRI Models of the Cerebellopontine Angle for Lesions Related to the Cranial Nerves
    Georg Thieme Verlag KG ; 2004
    In:  Skull Base Vol. 14, No. 2 ( 2004-05), p. 93-99
    Details
    In: Skull Base, Georg Thieme Verlag KG, Vol. 14, No. 2 ( 2004-05), p. 93-99
    Type of Medium: Online Resource
    ISSN: 1531-5010 , 1532-0065
    URL: Article
    DOI: 10.1055/s-2004-828701
    Language: English
    Publisher: Georg Thieme Verlag KG
    Publication Date: 2004
    detail.hit.zdb_id: 2072466-4
    detail.hit.zdb_id: 2653367-4
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  • 6
    Online Resource
    Online Resource
    Genomic Analysis of Posterior Fossa Meningioma Demonstrates Frequent AKT1 E17K Mutations in Foramen Magnum Meningiomas
    Georg Thieme Verlag KG ; 2019
    In:  Journal of Neurological Surgery Part B: Skull Base Vol. 80, No. 06 ( 2019-12), p. 562-567
    Details
    In: Journal of Neurological Surgery Part B: Skull Base, Georg Thieme Verlag KG, Vol. 80, No. 06 ( 2019-12), p. 562-567
    Abstract: Objective Posterior fossa meningiomas are surgically challenging tumors that are associated with high morbidity and mortality. We sought to investigate the anatomical distribution of clinically actionable mutations in posterior fossa meningioma to facilitate identifying patients amenable for systemic targeted therapy trials. Methods Targeted sequencing of clinically targetable AKT1, SMO, and PIK3CA mutations was performed in 61 posterior fossa meningioma using Illumina NextSeq 500 to a target depth of 〉 500 × . Samples were further interrogated for 53 cancer-relevant RNA fusions by the Archer FusionPlex panel to detect gene rearrangements. Results AKT1 (E17K) mutations were detected in five cases (8.2%), four in the foramen magnum and one in the cerebellopontine angle. In contrast, none of the posterior fossa tumors harbored an SMO (L412F) or a PIK3CA (E545K) mutation. Notably, the majority of foramen magnum meningiomas (4/7, 57%) harbored an AKT1 mutation. In addition, common clinically targetable gene fusions were not detected in any of the cases. Conclusion A large subset of foramen magnum meningiomas harbor AKT1 E17K mutations and are therefore potentially amenable to targeted medical therapy. Genotyping of foramen magnum meningiomas may enable more therapeutic alternatives and guide their treatment decision process.
    Type of Medium: Online Resource
    ISSN: 2193-6331 , 2193-634X
    URL: Article
    DOI: 10.1055/s-0038-1676821
    Language: English
    Publisher: Georg Thieme Verlag KG
    Publication Date: 2019
    detail.hit.zdb_id: 2653367-4
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  • 7
    Online Resource
    Online Resource
    Belzutifan treatment of Von Hippel-Lindau (VHL) related central nervous system (CNS) hemangioblastomas (HBs): A single institution experience.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 2078-2078
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 2078-2078
    Abstract: 2078 Background: Patients with inactivating germline mutations in the VHL gene develop CNS (brain and/or spine) HBs and/or renal cancers, pheochromocytomas and pancreatic neuroendocrine tumors. The oral HIF2a inhibitor belzutifan has been approved by FDA for the treatment of VHL-related HBs. We present here data on a cohort of VHL patients with CNS HBs treated with belzutifan in a single institution. Methods: Adult VHL patients, with radiologically documented CNS (brain and/or spine) HBs that displayed documented growth within the last 6 months prior to therapy, were treated with an initial dose of 120 mg belzutifan orally per day. Target lesions included HBs 〉 0.4cm long in one maximal cross-sectional diameter. Lesions were imaged by MRI at 1.5, 3, 6 months after initiation of treatment and at 6-month intervals thereafter. Solid enhancing lesions, associated cysts and peritumoral edema were recorded and quantified. Tumor sizes were evaluated by RECIST 1.1 criteria and volumetric analysis. All patients were evaluated and treated in the Hemangioblastoma Center and the VHL Clinic of the Massachusetts General Hospital Cancer Center. Results: At the time of analysis, 9 females and ten 10 male VHL patients (n=19) have been treated. Median age at treatment initiation was 36 yo (range 19-59). Median follow up is 12 months (range 1-19.5 months). Two patients were not yet evaluable for response. Of 17 evaluable patients, 8 had a PR (ORR 47%; 95% CI, 34-60), 8 had SD and 1 patient had progression (PD, 5.8%). Two patients had dose reduction to 80 mg/d because of anemia. No patient had grade 3 or greater toxicity and no patient experienced a CNS related toxicity during treatment. Volumetric analysis of solid and cystic components of the lesions, VHL germline mutations and other correlates of response to belzutifan will be presented. Conclusions: Real world data collected at a single institution confirm the high response rate of both solid and cystic components of CNS HBs to the FDA approved HIF2a inhibitor, belzutifan. Belzutifan was well tolerated. Further prospective controlled studies addressing the optimal dose, schedule and duration of treatment of HBs with belzutifan are required.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.2078
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 8
    Online Resource
    Online Resource
    Multi-center, single arm phase II study of the dual mTORC1/mTORC2 inhibitor vistusertib for patients with recurrent or progressive grade II-III meningiomas.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. 2024-2024
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. 2024-2024
    Abstract: 2024 Background: Grade II/III meningiomas represent about 20% of tumors and have increased rates of recurrence with no approved medical therapies. Historically, the progression-free survival at 6 months (PFS-6) for these tumors is 25%. The Response Assessment in Neuro-Oncology (RANO) group identified a PFS-6 rate of 〉 35% to be of interest for trials of grade II/III meningioma. Methods : NF2 gene inactivation occurs in the majority of meningiomas and is associated with mTORC1 activation. Human studies of everolimus for neurofibromatosis 2 patients documented growth arrest in only a minority of tumors. Based on our studies showing mTORC2/SGK1 pathway activation in NF2-deficient meningiomas and the known paradoxical activation of the mTORC2/AKT pathway in meningiomas, we hypothesized that dual inhibition of mTORC1/2 would be superior in meningiomas. Treatment of primary meningioma cells with vistusertib led to decreased cell proliferation and showed greater efficacy than rapamycin, regardless of NF2 expression. We studied the effect of vistusertib in patients with progressive or recurrent grade II/III meningiomas (NCT03071874). Vistusertib was administered orally at 125mg twice daily on two consecutive days each week. MRIs were obtained every 2 cycles (1 cycle = 28 days). Tumor size was defined as the largest cross-sectional area. Progression was defined as ≥25% increase in the sum of products of all measurable lesions over smallest sum observed. The primary endpoint was PFS-6. Secondary endpoints included toxicity, radiographic response, and correlative studies including immunohistochemistry for mTORC1/2 pathway activation and genetic biomarkers. Results: Twenty-eight patients (13 female), with a median age of 58 years (range, 32 to 77 years), were enrolled in this multicenter study. The median Karnofsky performance status was 80. Twenty-five patients have been followed to six months or to tumor progression. The median duration of treatment was 6.5 month (range, 1-18 months). Four patients chose to discontinue treatment, 1 withdrew to intercurrent illness, and 1 was withdrawn due to non-compliance. PFS-6 is 51.5% (CI, 29.3% - 70.0%). Adverse events at least possibly related to vistusertib with frequency 〉 10% include nausea (54%); fatigue (36%); hypophosphatemia (29%); diarrhea, anorexia, dry mouth, and hypertriglyceridemia (all 14%); hypertension, vomiting, increased ALT, constipation, and weight loss (all 11%). Conclusions: Vistusertib treatment was associated with a PFS-6 rate that exceeds the RANO target of 35% for recurrent high-grade meningioma. The follow-up data continue to mature. Adverse events were tolerable in this patient population. Correlative studies to identify biological factors that correlate with response are under way. These data support the initiation of larger randomized studies of vistusertib in this setting. Clinical trial information: NCT03071874.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.2024
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
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  • 9
    Online Resource
    Online Resource
    Lowering the Bar for Mass Spectrometry: A Comparison between Immunoassay and Rapid Time-of-Flight for Presumptive Screening of Drugs in Urine
    Oxford University Press (OUP) ; 2018
    In:  The Journal of Applied Laboratory Medicine Vol. 2, No. 4 ( 2018-01-01), p. 535-542
    Details
    In: The Journal of Applied Laboratory Medicine, Oxford University Press (OUP), Vol. 2, No. 4 ( 2018-01-01), p. 535-542
    Abstract: Immunoassay-based techniques and creatinine quantification have historically been the methods of choice for urine drug screening. Positive presumptive drug screen results are reflexed to more specific, confirmatory testing using gas or liquid chromatography coupled to mass spectrometry. False positives and false negatives with immunoassay techniques are common problems that have substantial down-stream consequences for patient care, laboratory operations, and total costs. Methods The final workflow included rapid enzymatic hydrolysis, rapid liquid chromatographic methods, and time-of-flight mass spectrometry for detection. In total, 84 drugs and metabolites were included and reported qualitatively using 11 isotopically labeled internal standards selected to represent compound classes, retention time, and expected abundances to control for method inefficiencies and matrix suppression/enhancement. The method performance validation included 420 individual urine specimens. Results Of the 420 samples screened by immunoassay, 117 failed to confirm by mass spectrometry and were immunoassay false positives. None of these 117 samples screened positive on the liquid chromatography time-of-flight mass spectrometry (LC-TOF-MS) assay. The LC-TOF-MS method failed to detect 1 sample in each of the following classes: buprenorphine, ethanol markers, and opiates owing to concentrations below the established cutoffs. Out of 579 samples, 275 (47.4%) screened positive by LC-TOF-MS for nicotine and at least 2 of its metabolites. Quantitative creatinine comparison to an existing Jaffe method yielded a slope of 0.91 and a correlation coefficient of 0.96. Conclusions We investigated whether immunoassay-based drug screening and creatinine quantification could be sufficiently replaced by a rapid LC-TOF-MS screen with higher specificity and accuracy than existing methods. The LC-LC-TOF-MS method is a sensitive and more specific way to screen for drugs, providing creatinine quantification and potential novel specimen validity testing with the inclusion of nicotine metabolites.
    Type of Medium: Online Resource
    ISSN: 2475-7241
    URL: Article
    DOI: 10.1373/jalm.2017.024166
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2018
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  • 10
    Online Resource
    Online Resource
    116 Exome Sequencing Uncovers Molecular Determinants of Trigeminal Neuralgia
    Ovid Technologies (Wolters Kluwer Health) ; 2018
    In:  Neurosurgery Vol. 65, No. CN_suppl_1 ( 2018-09-01), p. 85-86
    Details
    In: Neurosurgery, Ovid Technologies (Wolters Kluwer Health), Vol. 65, No. CN_suppl_1 ( 2018-09-01), p. 85-86
    Type of Medium: Online Resource
    ISSN: 0148-396X
    URL: Article
    DOI: 10.1093/neuros/nyy303.116
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2018
    detail.hit.zdb_id: 1491894-8
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