araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Study of Tissue and Blood Samples From Patients With Low-Grade Glioma

Summary: RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
  PURPOSE: This research study is looking at tissue and blood samples from patients with low-grade glioma.

Detailed description: OBJECTIVES:
  -  Evaluate the diagnostic and prognostic relevance of alterations of specific chromosomes and chromosomal regions including 7, 9p, 10p, 10q, 13q, 17p, 17q, 19q, 22q, X, and Y, using PCR analysis of microsatellite repeats and FISH.
  -  Evaluate the diagnostic and prognostic relevance of DNA ploidy by flow cytometric analysis; compare with ploidy determination by FISH.
  -  Assess the diagnostic and prognostic relevance of various markers of cellular proliferation and cellular function including flow cytometric determination of %S-phase, %G2M, and immunohistochemical evaluation of PCNA, Ki-67, and p53.

Eligibility: 1. Paraffin-embedded tumor tissue blocks of patients enrolled in NCCTG 86-72-51 or 93-72-02 and who had the diagnosis of low-grade glioma.
  2. Patients who have the diagnosis of low-grade glioma with an available paraffin- embedded tumor tissue block enrolled in prospective NCCTG and Mayo studies.

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Study of Blood and Cheek Cell Samples From Patients With Glioma

Summary: RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
  PURPOSE: This research study is looking at blood and cheek cell samples from patients with glioma.

Detailed description: OBJECTIVES:
  Primary
  -  Determine factors related to glioma survival in patients from two population-based case series collected in the San Francisco Bay Area between August 1991 and April 1994 (series 1) and May 1997 and August 1999 (series 2).
  Secondary
  -  Determine vital status for 879 patients in the two San Francisco Bay Area population-based series through July 2004.
  -  Determine survival as a function of established, potential, and yet unstudied prognostic indicators.
  -  Gather data to validate results from this study with information from adult glioma patients enrolled prospectively at the UCSF-Neuro-Oncology clinic and through series 3 of the San Francisco Bay Area Adult Glioma Study; incorporate results from this study and other components of the SPORE into ongoing clinical investigations at the Brain Tumor Research Center and Neuro-Oncology Service at UCSF.
  -  Using funding from the organization Accelerate Brain Cancer Cure (ABC2), genotype several thousand single nucleotide polymorphisms (SNPs) from some study participants; assess these SNPs for potential relationship to glioma survival.
  OUTLINE: Medical records of patients registered to the California Cancer Registry or the Northern California Cancer Center SEER are reviewed for mortality and treatment information related to the brain tumor. Blood and buccal specimens are collected from patients with newly diagnosed disease who are being seen at the UCSF Neuro-Oncology Service. The specimens are used for polymorphism and tumor marker studies and other pertinent data. Tumor specimens and treatment information related to the brain tumor are also collected from the SPORE Tissue Core.
  Additional tumor makers are studied, including: chromosome 1p/19q, 7q studies; DNA repair and oxidative metabolism polymorphisms; and up to 2 tumor markers and 2 constitutive genotyping studies.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of glioma
  -  Meets 1 of the following criteria:
  -  Participant in the Survival study of San Francisco Bay Area Adult Glioma Study (SFBAAGS) Series 1 and 2
  -  Treated by UCSF Neuro-Oncology Service; diagnosed between Nov. 1, 2001 and June 30, 2006 and seen between Aug. 1, 2002 and June 30, 2006
  -  Participant in SFBAAGS Series 3 (not seen at UCSF Neuro-Oncology Service) diagnosed between Nov. 1, 2001 and Oct. 31, 2004
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Study to Determine the Effectiveness of GSK1120212 in BRAF Mutation-positive Melanoma Previously Treated With or Without a BRAF Inhibitor

Summary: MEK113583 is a Phase II open-label, multi-site study to investigate the objective response rate, safety, and pharmacokinetics of GSK1120212 in subjects with BRAF mutation-positive melanoma who were previously treated with or without a BRAF inhibitor. GSK1120212 is a potent and highly selective inhibitor of MEK activation and kinase activity.


Eligibility: Inclusion Criteria:
  -  Metastatic cutaneous melanoma that was previously treated with: (Cohort A) a BRAF inhibitor either with or without other prior therapy. (Cohort B) at least 1 prior chemotherapy or immunotherapy, without treatment with a BRAF inhibitor.
  -  Documented positive BRAF mutation (V600E, V600K, or V600D).
  -  Subjects must provide archived tumor tissue or undergo fresh tumor biopsy prior to enrollment.
  -  The subject must have a radiographically measurable tumor.
  -  The subject is able to carry out daily life activities without significant difficulty (ECOG performance status score of 0 or 1).
  -  Able to swallow and retain oral medication.
  -  Sexually active subjects must use acceptable methods of contraception during the course of the study.
  -  Adequate organ system function and blood cell counts.
  Exclusion Criteria:
  -  The subject has had major surgery or received certain types of cancer therapy within 21 days before starting the study.
  -  Previous treatment with a MEK inhibitor.
  -  Current use of a prohibited medication listed in the protocol.
  -  Uncontrolled glaucoma.
  -  Brain metastasis, unless previously treated with surgery or stereotactic radiosurgery, and the disease has been stable for at least 2 months prior to enrollment.
  -  Current severe or uncontrolled systemic disease.
  -  History of clinically significant heart, lung, or eye/vision problems.
  -  Significant unresolved side effects from previous anti-cancer therapy.
  -  The subject is pregnant or breastfeeding.

Relevance to patient case: possibly relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: First-Line Chemotherapy and Panitumumab in Advanced Non-Small Cell Lung Cancer

Summary: The purpose of this study is to determine whether the addition of panitumumab to standard chemotherapy in first-line treatment of advanced Non Small Cell Lung Cancer improves the treatment outcome. Patients are selected based on triple mutational status.

Detailed description: Advanced NSCLC holds a very poor prognosis with a moderate response rate to standard chemotherapy. The standard first-line treatment for advanced NSCLC is platinum based combination chemotherapy. The response rates are less than 30% and a substantial amount of patients will experience unnecessary toxicity in terms of e.g. nausea, vomiting, neuropathies or a considerable risk of renal toxicity. The median progression free survival is 3-4 months and consequently, the median overall survival is less than one year (Hotta et al 2007). Addition of new biological agents to standard chemotherapy regimens may improve the outcome for these patients.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed metastatic (stage IV) NSCLC
  -  Measurable disease according to RECIST v.1.0 2009
  -  KRAS, BRAF and PI3K wild type in primary tumor or metastatic tissue.
  -  Age ≥18
  -  PS < 2
  -  Adequate organ function
  Haematology:
  -  Neutrophil count ≥1.5x10^9/L
  -  Platelet count ≥100x10^9/L
  -  Leucocyte count > 3,000/mm
  Hepatic function:
  -  Total bilirubin ≤ 1.5 times the upper normal limit (UNL)
  -  Serum transaminases ≤ 2.5xUNL in absence of liver metastases, or ≤ 5xUNL in presence of liver metastases
  Renal Function:
  -  Creatinine clearance ≥ 50 mL/min and serum creatinine ≤ 1.5xUNL
  Metabolic function:
  -  Magnesium ≥ lower limit of normal.
  -  Calcium ≥ lower limit of normal.
  Consent to translational research studies
  Written informed consent
  Exclusion Criteria:
  -  Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment/randomization, active severe infections or other concurrent disease.
  -  Known CNS metastasis (pretreatment routine assessment not required)
  -  Prior chemotherapy for metastatic disease
  -  Indication for radiation therapy or prior radiotherapy within 30 days before treatment start.
  -  Other malignant diseases within 5 years prior to inclusion in the study, except basal cell squamous carcinoma of the skin and cervical carcinoma-in-situ.
  -  Other experimental therapy within 30 days prior to treatment initiation.
  -  History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
  -  Patients pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
  -  Patients (male or female) not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Hypertension Monitoring in Glioma Patients Treated With Bevacizumab

Summary: Prospective casecontrol study in glioma patients undergoing treatment with bevacizumab (Avastin). At present there are no data on the correlation between occurrence of arterial hypertension and clinical outcome in patients with glioma or anaplastic astrocytoma. We will investigate whether glioma patients developing hypertension under bevacizumab treatment have a better outcome in terms of progression free survival, response rate and overall survival than equally treated patients remaining normotensive. Moreover, we will describe the dynamics of change in blood pressure after administration of bevacizumab in those patients developing hypertension.
  -  Trial with medicinal product


Eligibility: Inclusion criteria: Patients aged 18 or older with histological diagnosis of anaplastic astrocytoma (WHO grade III) or glioma (WHO grade IV) Assigned to bevacizumab treatment (monotherapy or adjunctive to chemotherapy) for therapeutic reasons by an oncologist Patients should be on a stable or decreasing dose of steroids Willingness and ability to comply with the protocol Patient should present with a KPS of >=70 Signed informed consent
  Exclusion criteria: Previous anti-angiogenic drugs other than bevacizumab Allergy or hypersensitivity against bevacizumab Contraindications to bevacizumab according to the Summary of Product of Characteristics Unwillingness to comply with regular assessments of response and performance of study-related procedures Any condition considered relevant for proper performance of the study or risk to the patients, at the discretion of the investigator

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma

Summary: TVI-Brain-1 is an experimental treatment that takes advantage of the fact that your body can produce immune cells, called 'killer' white blood cells that have the ability to kill large numbers of the cancer cells that are present in your body. TVI-Brain-1 is designed to generate large numbers of those 'killer' white blood cells and to deliver those cells into your body so that they can kill your cancer cells.

Detailed description: TVI-Brain-1 involves several steps. First, the patient's cancer will be surgically removed to provide cells for the vaccine. Second, the patient will be vaccinated twice with those cells and GM-CSF. Third, the patient's blood will be filtered for white cells which will then be cultured and stimulated to reach a higher (killer) activity level. Fourth, the activated white blood cells will be infused into the patient's bloodstream so that they will be able to attack the cancer. Finally, the entire process starting with vaccination will be repeated, for a total of two rounds of therapy.

Eligibility: Inclusion Criteria:
  -  Age > 18
  -  Informed consent
  -  Diagnosis of grade IV glioma with progression following standard treatment.
  -  Must be able to tolerate surgery to provide tumor tissue for vaccine.
  -  Must be able to produce viable vaccine from tumor tissue.
  -  Eastern Cooperative Oncology Group (ECOG) performance status must be < 2 or Karnofsky Performance Status must be 70 or greater.
  -  Negative HIV test.
  -  Negative for hepatitis B and C virus.
  -  Respiratory reserve must be reasonable.
  -  Sufficient renal function.
  -  Satisfactory blood counts.
  -  Negative pregnancy test for women of childbearing potential.
  Exclusion Criteria:
  -  Surgically removed cancer reveals that it is not grade IV glioma.
  -  Concomitant life-threatening disease.
  -  Active autoimmune disease.
  -  Currently receiving chemotherapy or biological therapy for the treatment of cancer.
  -  Currently receiving immunosuppressive drugs for any reason.
  -  Prior treatment with Avastin or other anti-angiogenesis treatment within 6 months.
  -  Prior treatment with Gliadel wafers.
  -  Corticosteroids beyond peri-operative period.
  -  Psychological, familial, sociological or geographical conditions that do not permit adequate medical follow-up and compliance with the study protocol.

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: The Effect of Ketogenic Diet on Malignant Tumors- Recurrence and Progress

Summary: The aim of the study is, to study the efficacy of the ketogenic diet in delaying or preventing recurrence and tumor growth progression of patients who have been previously treated by concomitant chemoradiotherapy (6 months) for high-grade glial tumors.
  It will be an open-label trial of nutritional intervention for up to 1 year. An interim analysis of the data will be carried out to assess safety, compliance and efficacy of the diet. This will be reviewed by both SHS and the Clinical trial team.


Eligibility: Inclusion criteria:
  1. Consenting adults aged ≥ 18 years.
  2. Recurrent or progressive high grade glioma after failure of at least one line of standard oncological treatment.
  3. Gliomatosis cerebri, including patients declining radiation treatment.
  Exclusion criteria:
  1. Patients with malignant tumors who are receiving treatment at the time of the recruitment.
  2. Early termination - patients who will wish to stop their participation in the trial will discontinue the ketogenic diet and return to their usual diet.

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Molecular Analysis of Samples From Patients With Diffuse Intrinsic Pontine Glioma and Brainstem Glioma

Summary: The purpose of this study is to prospectively collect specimens from pediatric patients with diffuse intrinsic pontine glioma or brainstem glioma, either during therapy or at autopsy, in order to characterize the molecular abnormalities of this tumor.

Detailed description: High grade diffuse intrinsic pontine glioma (DIPG) accounts for approximately 80% of pediatric brainstem tumors and 10% of pediatric brain tumors, and is the most lethal form of brainstem gliomas in children. There is currently no effective therapy to treat these tumors. We hypothesize that this tumor exhibits unique molecular abnormalities leading to altered RNA and protein expression. The aim of this trial is to collect specimens from pediatric patients with diffuse intrinsic pontine glioma including serum, cerebrospinal fluid, urine, brain tumor and other constitutional tissue, during therapy and/or at autopsy. Our goal is to study this tissue to characterize the genetic abnormalities that lead to tumor formation in order to identify key molecules as biomarkers which we can target to design and test new and more effective treatments.

Eligibility: Inclusion Criteria:
  -  Patients of any age with clinical and radiologic diagnosis of diffuse intrinsic pontine glioma
  -  Patients with other high-grade gliomas originating in the brainstem
  -  Patients with focal gliomas (WHO grade I/II) of the brainstem
  Exclusion Criteria:
  -  Patients with any type of infiltrative low grade (WHO grade I and II) or high grade glioma (WHO grade III and IV) originating outside the brainstem
  -  Patients harboring primary brainstem tumors with other histologic diagnoses (e.g., PNET)

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Neoadjuvant Treatment of Colon Cancer

Summary: This study will investigate
  -  the effect of preoperative combination chemotherapy in patients with locally advanced colon cancer with mutation in the KRAS, BRAF or PIK3CA gene
  -  the effect of preoperative combination chemotherapy in combination with biological treatment in patients without mutation in the KRAS, BRAF or PIK3CA gene.


Eligibility: Inclusion Criteria:
  -  Histologically verified locally advanced T3 or T4 colon cancer assessed by CT scan
  -  Analysis of KRAS, BRAF, PIK3CA
  -  Age ≥18 år
  -  Performance status ≤ 2
  -  Hematology
  -  ANC ≥ 1.5x10^9/l. Thrombocytes ≥ 100x10^9/l.
  -  Biochemistry
  -  Bilirubinaemia ≤ 3 x UNL. ALAT ≤ 5 x UNL
  -  Consent to translational research
  -  Fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment.
  -  Written and orally informed consent.
  Exclusion Criteria:
  -  Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment, active severe infections or other concurrent disease.
  -  Peripheral neuropathy NCI grade >1
  -  Other malignant disease within 5 years prior to enrollment, except basal cell squamous carcinoma of the skin and cervical carcinoma-in-situ
  -  Other investigational treatment within 30 days prior to treatment start
  -  History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
  -  Bleeding tumors
  -  Hypersensitivity to one or more of the substances

Relevance to patient case: possibly relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Biomarkers in Blood Samples From Patients With Refractory Non-Small Cell Lung Cancer Previously Treated With Sorafenib Tosylate

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This research study is studying biomarkers in blood samples from patients with refractory non-small cell lung cancer previously treated with sorafenib tosylate.

Detailed description: OBJECTIVES:
  -  To determine the mutation rates of BRAF, KRAS, and EGFR in patients with non-small cell lung cancer treated with sorafenib tosylate on protocol ECOG-2501.
  -  To determine the association between BRAF, KRAS, or EGFR mutation status and clinical benefits in patients treated with this regimen.
  OUTLINE: This is a multicenter study.
  DNA is isolated from archived plasma samples and analyzed for BRAF, KRAS, and EGFR mutations.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of refractory non-small cell lung cancer
  -  Received sorafenib tosylate on protocol ECOG-E2501
  -  Available blood specimens
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: possibly relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: A Study in Subjects With Recurrent Malignant Glioma

Summary: An open-label phase 2, multicenter study in participants with recurrent malignant glioma.


Eligibility: Inclusion Criteria
  1. Histologically confirmed diagnosis of Grade 3 or 4 malignant glioma.
  2. All subjects who have a first or second recurrence following primary management with surgical resection or biopsy, radiotherapy and up to 2 prior systemic treatments with addition of:
  -  No prior bevacizumab treatment is allowed for Cohort 1 and Cohort 2.
  -  Subjects must have disease progression following prior bevacizumab treatment for Cohort 3.
  -  For all cohorts, no prior anti-vascular endothelial growth factor (VEGF/VEGFR) therapy except for bevacizumab as specified above.
  3. Karnofsky score of 70% or greater.
  4. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than 150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the Screening Visit.
  5. Adequate renal function, adequate bone marrow function, adequate blood coagulation function and adequate liver function, as defined in protocol.
  6. No evidence of hemorrhage on the baseline magnetic resonance imaging (MRI) scan other than in those subjects who are stable grade 1.
  Exclusion criteria:
  1. Females who are pregnant or breastfeeding.
  2. Subjects who received enzyme-inducing anti-epileptic agents within 14 days before the first dose of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone, or oxcarbazepine).
  3. Active infection requiring intravenous antibiotics.
  4. Therapeutic anti-coagulation with warfarin, aspirin, nonsteroidal anti-inflammatory drugs or clopidogrel (low molecular weight heparin is acceptable).
  5. Subjects with 24-hour urine protein greater than or equal to 1 gm.
  6. Prior surgical resection within 4 weeks, or prior stereotactic biopsy within 2 weeks, of Screening Visit.
  7. Prior radiotherapy within 12 weeks unless there is a new area of enhancement consistent with recurrent tumor outside of the radiation field, or there is biopsy-proven unequivocal viable tumor on histopathologic sampling.
  8. Prior chemotherapy (6 weeks for nitrosoureas), or any investigational agent within 4 weeks unless the subject has recovered from all anticipated toxicities associated with that therapy; prior bevacizumab therapy (Cohorts 1 and 2); for Cohort 3, prior bevacizumab therapy within 3 weeks.
  9. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II ; unstable angina; myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment.
  10. Prolongation of QTc interval to greater than 480 msec.
  11. Active hemoptysis (bright red blood of at least 1/2 teaspoon) within 3 weeks prior to the first dose of study drug.

Relevance to patient case: not relevant