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Feasibility and clinical impact of next generation genomic sequencing in selected solid tumor patients
|Head & Neck
|High Grade Glioma
- To evaluate the feasibility of conducting genomic analyses on tumor tissues collected from solid tumor patients seen at the Taussig Cancer Institute. Feasibility will be defined as the proportion of patients signing consent who are able to have tumor tissue shipped to Foundation Medicine within 14 days of patient consent.
- To evaluate the time it takes for Foundation Medicine to provide results. We will evaluate what proportion of patients have a result delivered from Foundation Medicine within 21 days of shipment of sample to them.
- To analyze what proportion of genomic analyses yield actionable genetic aberrations, and what proportion lead to change in patient management plan. Actionable will be defined as a mutation linked to an approved therapy in the solid tumor under study or another solid tumor, a known or suspected contraindication to a given therapy, or a clinical trial linked to the alteration.
- To evaluate clinical outcomes of specific therapies chosen to target these aberrations. Standard clinical outcome measures (objective response rate, progression-free survival) will be captured.
- To evaluate the cost implications associated with this testing and subsequent treatment selection, compared with non-genomic-directed standard of care therapy.
- Solid tumor with a confirmed histopathologic diagnosis falling into one of the following categories and without a known curative therapeutic option:
- Metastatic/locally-advanced carcinoma of unknown primary- this includes tumors in which the pathology reads poorly differentiated (adeno)carcinoma in which the primary organ site cannot be discerned with certainty despite adequate clinical, laboratory and radiologic investigations
- Metastatic/locally-advanced bladder cancer after failure of at least one platinum-based systemic chemotherapy
- Metastatic/locally-advanced adrenocortical cancer
- Metastatic/locally-advanced non-clear cell renal cell carcinoma
- Metastatic/locally-advanced non-small cell lung cancer in a non/light/distant smoker without known EGFR or EML4-ALK mutation in the tumor
- Unresectable pancreatobiliary cancer
- Head and neck squamous cell carcinoma, after failure of primary therapy
- Metastatic/unresectable pleural mesothelioma
- Metastatic triple-negative- defined as ER-negative (<5%), PR-negative (<5%), HER2 non-amplified (FISH ratio <2.0)- breast cancer who have received 0-1 prior regimens for advanced disease
- Anaplastic and atypical meningioma
- Metastatic uveal melanoma
- Metastatic castrate-resistant prostate adenocarcinoma
- Grade III Gliomas (anaplastic oligodendroglioma, anaplastic astrocytoma and mixed anaplastic glioma)
- Metastatic colorectal cancer
- Age ≥ 18 years
- ECOG performance status 0, 1 or 2
- Measurable and/or evaluable disease per RECIST version 1.1
- Patient not currently enrolled or being enrolled in another clinical trial of cancer-specific therapeutic agent(s)
- Prior therapies (e.g. chemotherapy, targeted therapy, surgery, radiation) are permitted but not required
Exclusion Criteria Not Available
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