Physician

Neil Belman, DO

Study Coordinator

Angela Rankin
484-658-1792
Angela.Rankin@sluhn.org

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This is a Phase 2 study evaluating the efficacy of a CDK, PI3K, or NTRK/ROS1 inhibitor in patients with progressive brain metastases from solid tumors harboring the alterations predicting sensitivity to each of these inhibitors.

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• Histologically confirmed parenchymal metastatic disease to the brain from any solid tumor

• Tissue must be available for biomarker testing (any brain metastasis tissue and extracranial site from any prior resection or biopsy). If extracranial tissue is not available or there is no evidence of extracrania disease, brain metastasis tissue is sufficient for eligibility

• Measurable CNS disease (≥ 10mm) that is new or progressive after systemic therapy or prior radiotherapy

• Patients must be able to undergo MRI with contrast

• Presence of clinically actionable alteration in NTRK, ROS1, CDK pathway or PI3K pathway in both a brain metastais and extracranial site per central review

• For HER2+ breast cancer, patients must have received prior HER-2 directed therapy in the metastatic setting

• For TNBC, patients must have had at least one chemotherpy in the metastatic setting

• For ER and/or PR+ HER2- breast cancer, patients must have had at least one endocrine therapy in the metastatic setting

• For melanoma, patietnts must have progressed after immunotherapy or after BRAF/MEK inhibitors for BRAF+ disease

• For lung cancer, patients must have failed EGFR therapies for EGFR mutated disease

• No known current diffuse leptomeningeal involvement

• No surgery within 2 weeks prior to or after registration

• No chemotherapy within 14 days prior to registration

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Physician

Hugh Moulding, MD

Study Coordinator

Amy Grossman RN
484-658-1788
Amy.Grossman@sluhn.org

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Synopsis: To determine whether patients who receive radiotherapy with concomitant temozolomide followed by adjuvant temozolomide (RT + TMZ → TMZ) (ARM B) have a marginally better progression free survival (PFS) as compared with patients who receive radiotherapy followed by adjuvant PCV chemotherapy (RT → PCV) (ARM A).

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• Is ≥18 years of age, at the time of signing the informed consent
• Newly diagnosed and ≤ 3 months from surgical diagnosis, or > 3 months for low grade glioma, as long as the patient has not received prior radiation or prior chemotherapy
• Histological evidence of WHO Grade III anaplastic glioma or WHO grade II low grade glioma with locally diagnosed combined 1p/19q loss and the presence of an either IDH1 or IDH2, both as established by a local or referenced laboratory qualified for the study
• Low grade glioma must also be determined as "high risk" defined as age ≥ 40 and any surgery, ≤ 40 with prior subtotal resection or biopsy, or documented growth following prior surgery

Note: Mixed gliomas are eligible, regardless of the degree of astrocytic or oligodendrocytic predominance, as long as the tumor is also co-deleted for 1p an 19q. Surgery (partial or gross total resection or biopsy) must be performed ≥ 2 weeks prior to registration; patient must have recovered adequately from the effects of surgery.

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Physician

Nimisha Deb, MD

Study Coordinator

Amy Grossman RN
484-658-1788
Amy.Grossman@sluhn.org

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Synopsis: This study will evaluate real-world clinical outcomes and patient reported outcomes that measure the effecitveness and safety of GammaTiles™ (GT).

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• Patients must be scheduled to undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles
• Patients must be able to undergo pre- and post-operative imaging for disease implant assessment
• Patients must be fluent in either English or Spanish to allow for informed consent and completion of Quality of Life tests

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Physician

Nimisha Deb, MD

Study Coordinator

Angela Rankin
484-658-1792
Angela.Rankin@sluhn.org

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The purpose of this study is to determine if high dose radiation therapy delivered only to the small areas of brain metastases from small cell lung cancer and avoiding the surrounding normal brain tissue, called stereotactic radiosurgery (SRS), will decrease side effects related to memory and thinking as compared to radiation to the entire brain while avoiding the hippocampus (the memory zone in the brain), called hippocampal-avoidant whole brain radiation therapy (HA-WBRT). The HA-WBRT will be administered in conjunction with memantine, an oral drug that helps preserve memory and thinking.

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• Pathologically proven diagnosis of small cell lung cancer within 5 years of registration (de novo or recurrent small cell lung cancer are permitted)
• 10 or fewer brain metastases ≤ 3 cm in largest diameter and outside of a 5-mm margin around either hippocampus must be visible on contrast-enhanced MRI performed ≤ 21 days prior to study entry. Total tumor volume must be 30 cm3 or less
• Specific criteria related to the MRI imaging for this study must be reviewed with the PI and/or lead CRC
• Karnofsky performance score of ≥ 70
• Patients can initiate treatment with systemic (chemo and/or immunotherapy) before enrollment only if their brain metastases are asymptomatic and not located in eloquent locations (e.g. brainstem, pre-/post-central gyrus, visual cortex)
• Concurrent immunotherapy with brain radiation is permitted on trial
• Patients may have had prior intracranial surgical resection if completed at least 14 days prior to registration
• Patients with intractable seizures while on adequate anticonvulsant therapy are excluded
• Patients with prior allergic reactions to memantine are excluded
• Patients with contraindications to MR imaging are excluded
• Patients with prior radiotherapy to the brain, including SRS, WBRT, or PCI are excluded

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