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

Clinical trial: Perfusion Magnetic Resonance Imaging in Measuring the Growth of Blood Vessels in Newly Diagnosed Brain Tumors

Summary: RATIONALE: Perfusion magnetic resonance imaging may be an effective method of measuring the growth of blood vessels in brain tumors. These measurements may help doctors better diagnose and treat brain tumors.
  PURPOSE: Pilot study to determine the effectiveness of perfusion magnetic resonance imaging in measuring the growth of blood vessels in newly diagnosed brain tumors.

Detailed description: OBJECTIVES: I. Correlate the findings of perfusion magnetic resonance imaging with known tissue and serum markers of angiogenesis in patients with newly diagnosed surgically resectable brain tumors.
  OUTLINE: Patients undergo perfusion magnetic resonance imaging (MRI) scanning with contrast in conjunction with preoperative conventional MRI scanning with contrast. Patients receive gadopentetate dimeglumine IV over 5 seconds prior to perfusion MRI. Gadopentetate dimeglumine is administered at a slower rate prior to conventional MRI. Patients undergo blood draw to determine urokinase type plasminogen activator levels. After completion of perfusion and conventional MRI scanning, brain tumor tissue samples are obtained during surgical resection to determine tumor grade and type and urokinase type plasminogen activator and basic fibroblast growth factor levels. If CSF removal is required during surgery, then CSF samples are collected to determine urokinase type plasminogen activator and basic fibroblast growth factor levels.
  PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS: Newly diagnosed surgically resectable brain tumor
  PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Able to tolerate gadopentetate dimeglumine contrast Medically stable
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

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

Clinical trial: Radiation Therapy and Tamoxifen in Treating Children With Newly Diagnosed Brain Stem Glioma

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Tamoxifen may kill tumor cells by blocking the enzymes necessary for cell growth. Combining radiation therapy with tamoxifen may be effective in treating newly diagnosed brain stem glioma.
  PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy and tamoxifen in treating children who have newly diagnosed brain stem glioma.

Detailed description: OBJECTIVES:
  -  Determine whether high-dose tamoxifen with radiotherapy increases the median survival and overall survival of children with newly diagnosed brain stem gliomas.
  -  Determine the time to neurologic or radiographic progression in patients treated with this regimen.
  -  Determine the acute and chronic toxicity of high-dose tamoxifen in these patients.
  OUTLINE: This is a multicenter study.
  Patients undergo radiotherapy once daily 5 days a week for 6 weeks. Within 2 weeks after the initiation of radiotherapy, patients receive oral high-dose tamoxifen once daily. Tamoxifen continues in the absence of disease progression or unacceptable toxicity.
  PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study within 4 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Newly diagnosed tumor of the brain stem (diffuse intrinsic lesion centered on the pons)
  -  Radiological and clinical diagnostic criteria allowed (biopsy not required)
  -  The following astrocytic tumors are allowed if histologically confirmed:
  -  Diffuse astrocytoma (all subtypes)
  -  Anaplastic astrocytoma
  -  Glioblastoma
  -  Pilocytic astrocytoma (grade I)
  -  Less than 6 months since diagnosis
  -  At least 1 of the following signs of brain stem tumor:
  -  Cranial nerve deficit
  -  Long tract signs
  -  Ataxia
  -  No focal lesions of the brain stem (either clearly marginated or cystic), cervicomedullary tumors, tumors predominately exophytic, or pontine tumors diagnosed as pilocytic on biopsy
  PATIENT CHARACTERISTICS:
  Age:
  -  Under 20
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  Not pregnant or nursing
  -  No frequent vomiting or other medical condition that would preclude oral medication intake
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  No prior chemotherapy for brain stem glioma
  Endocrine therapy:
  -  Concurrent steroids allowed
  Radiotherapy:
  -  No prior radiotherapy for brain stem glioma
  Surgery:
  -  Not specified
  Other:
  -  Concurrent anticonvulsants allowed

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

Clinical trial: This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Malignant Glioma.

Summary: Gimatecan® is Sigma-Tau Research's new, potent, oral Topoisomerase I inhibitor. Drugs in this class play a crucial role in destroying DNA replication in tumors. We are conducting this study to determine the Maximum Tolerated Dose of our compound. In addition, we plan to assess the drug's ability to affect the evolution of malignant gliomas, when given as a capsule, rather than by intravenous injection.


Eligibility: Inclusion criteria:
  -  Histologically confirmed diagnosis of a recurrent primary malignant glioma
  -  Life expectancy of at least 3 months with normal hematological, liver and renal function
  Exclusion criteria:
  -  Pregnant and lactating patients
  -  Participation in any investigating drug study within 4 weeks preceding treatment start or concurrent treatment with any other anti-cancer therapy
  -  Gastrointestinal dysfunction that could alter absorption or motility

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

Clinical trial: A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas

Summary: The purpose of this study is to find out about the safety of adding the investigational drug motexafin gadolinium to a standard course of chemotherapy with temozolomide for patients with malignant glioma. Secondly, the study will determine how many patients will respond to this treatment.


Eligibility: Inclusion Criteria:
  -  At least 18 years old
  -  Histologically confirmed diagnosis of malignant gliomas that requires systemic antineoplastic treatment. Malignant glioma is defined as any of the following: Glioblastoma multiforme (GBM); Anaplastic astrocytoma (AA); Anaplastic oligodendroglioma; Anaplastic mixed glioma; Glioma not otherwise specified (except low-grade glioma)
  -  ECOG performance status score of 0, 1, or 2
  -  Each patient must sign a study-specific informed consent form
  Exclusion Criteria:
  Laboratory values of:
  -  Absolute neutrophil count < 2000/µL
  -  Platelet count < 100,000/µL
  -  AST or ALT > 2 x the upper limit of normal (ULN)
  -  Alkaline phosphatase > 5 x ULN
  -  Bilirubin > 2 x ULN
  -  Creatinine > 2.0 mg/µL
  and
  -  Plan to use any additional cancer therapy (e.g., systemic, radiation, surgery) during the study period
  -  Women who are pregnant or lactating

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

Clinical trial: Prolonged Daily Temozolomide for Low-Grade Glioma

Summary: The purpose of this trial is to determine the effects (good and bad) temozolomide has on patients with low-grade glioma. It will also determine whether temozolomide is effective in preventing or delaying future tumor growth.

Detailed description: -  Treatment with temozolomide is based upon an 11-week cycle (7 weeks on the drug and 4 weeks off). Patients will receive temozolomide once daily for 49 days, then have 28 days without taking temozolomide.
  -  Every two to four weeks a physical and neurological examination and blood work will be performed. A magnetic resonance imaging (MRI) scan of the patient's brain will be done approximately every three months (before each cycle of treatment).
  -  Treatment may continue for a maximum of a year and a half based on 6 eleven-week cycles. The actual duration of therapy will depend upon the response to treatment and the development of side effects or toxicity.

Eligibility: Inclusion Criteria:
  -  Histological confirmation of a low-grade glioma (astrocytoma, oligodendroglioma, or mixed oligoastrocytoma)
  -  Measurable disease on MRI
  -  Patients that have undergone recent resection for newly diagnosed or recurrent or progressive tumor are eligible if they have recovered from the effects of surgery.
  -  Patients with recurrent disease my have had one prior chemotherapy regimen
  -  Older than 18 years of age.
  -  Karnofsky performance status (KPS) performance score of > 70%
  -  Adequate hematologic, renal and liver functions,
  -  Life expectancy of greater than 12 weeks.
  -  Negative pregnancy test.
  Exclusion Criteria:
  -  Prior treatment with temozolomide
  -  Patients who are not neurologically stable
  -  Acute infection treated with intravenous antibiotics
  -  Non-malignant systemic disease
  -  Frequent vomiting, inability to swallow or a medical condition that could interfere with oral medication.
  -  Previous or concurrent malignancies at other sites, with the exception of surgically cured carcinoma in-situ of the cervix, and basal or squamous cell carcinoma of the skin.
  -  HIV positive or AIDS-related illness
  -  Pregnant or nursing women
  -  Patients with allergy to decarbazine.

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

Clinical trial: Hereditary Paraganglioma: Evaluation of Screening Methods to Detect Tumors in SDH Positive Carriers

Summary: Hereditary paraganglioma -due to SDH (SDHD, SDHB, SDHC) germline mutations- causes paragangliomas and pheochromocytomas. Presymptomatic genetic testing should be offered to all first-degree relatives if an SDH mutation is detected in an index case with paraganglioma or pheochromocytoma. The main objective of our national clinical research project is to test different screening methods to detect presymptomatic tumors in order to establish guidelines for the work-up and the follow-up of SDH mutation carriers.


Eligibility: Inclusion Criteria: identification of an SDH (SDHD, SDHD, SDHC) germline mutation

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

Clinical trial: The Roles of Tissue Factor in Malignant Gliomas

Summary: To explore the relationship between tissue factor levels, tumour progression, activation of blood coagulation and venous thromboembolism with malignant glioma

Detailed description: To explore the relationship between tissue factor levels, tumour progression, activation of blood coagulation and venous thromboembolism with malignant glioma

Eligibility: Inclusion Criteria:
  -  participation in PRODIGE
  -  adult patients
  -  newly diagnosed, biopsy-confirmed grade III/IV malignant gliomas
  -  undergone craniotomy or stereotactic biopsy > 2 days and < 4 weeks before
  Exclusion Criteria:
  -  have known hereditary thrombophilia
  -  are receiving experimental antiangiogenic therapy

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

Clinical trial: Acute Side Effects in Patients Who Are Undergoing Stereotactic Radiosurgery for Brain Tumors or Other Brain Disorders

Summary: RATIONALE: Learning about the side effects of stereotactic radiosurgery in patients with brain tumors or other brain disorders may help doctors plan treatment and help patients live more comfortably.
  PURPOSE: This clinical trial is studying the acute side effects in patients who are undergoing stereotactic radiosurgery for brain tumors or other brain disorders.

Detailed description: OBJECTIVES:
  -  Determine the incidence and types of acute complications in patients undergoing stereotactic radiosurgery for brain tumors or other brain disorders.
  -  Determine the time frame for development and resolution of these complications in these patients.
  -  Determine the severity of these complications in these patients.
  OUTLINE: Patients undergo stereotactic radiosurgery. Patients also complete questionnaires about the side effects they experience from radiosurgery. The questionnaires are completed at baseline and at 1 week, 1 month, and 2 months after radiosurgery.
  PROJECTED ACCRUAL: A total of 94 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of brain tumor or other brain disorder, including, but not limited to, 1 of the following:
  -  Primary brain tumors
  -  Brain metastases
  -  Acoustic neuromas
  -  Pituitary adenomas
  -  Parkinson's disease
  -  Cluster headaches
  -  Glomus jugulare
  -  Epilepsy
  -  Obsessive compulsive disorder
  -  Arteriovenous malformations
  -  Trigeminal neuralgia
  -  Eligible for and scheduled to undergo stereotactic radiosurgery
  PATIENT CHARACTERISTICS:
  Performance status
  -  Not specified
  Life expectancy
  -  Not specified
  Hematopoietic
  -  Not specified
  Hepatic
  -  Not specified
  Renal
  -  Not specified
  Other
  -  No physical or mental limitation that would preclude study compliance
  PRIOR CONCURRENT THERAPY:
  Endocrine therapy
  -  Concurrent steroids allowed
  Radiotherapy
  -  No prior stereotactic radiosurgery

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

Clinical trial: Genetic Epidemiology of Adult Onset Glioma

Summary: To establish a clinic based case control study for examination of potential risk factors for primary adult brain tumors.

Detailed description: Genetic epidemiology of adult glioma to establish potential risk factors for primary adult brain tumors.

Eligibility: Inclusion Criteria:
  -  primary glioma of any stage
  -  diagnosed within 4 months

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

Clinical trial: Identification of Clinically Occult Glioma Cells and Characterization of Glioma Behavior Through Machine Learning Analysis of Advanced Imaging Technology

Summary: Gliomas are one of the most challenging tumors to treat, because areas of the apparently normal brain contain microscopic deposits of glioma cells; indeed, these occult cells are known to infiltrate several centimeters beyond the clinically apparent lesion visualized on standard computer tomography or magnetic resonance imaging (MR). Since it is not feasible to remove or radiate large volumes of the brain, it is important to target only the visible tumor and the infiltrated regions of the brain. However, due to the limited ability to detect occult glioma cells, clinicians currently add a uniform margin of 2 cm or more beyond the visible abnormality, and irradiate that volume. Evidence, however, suggests that glioma growth is not uniform - growth is favored in certain directions and impeded in others. This means it is important to determine, for each patient, which areas are at high risk of harboring occult cells. We propose to address this task by learning how gliomas grown, by applying Machine Learning algorithms to a database of images (obtained using various advanced imaging technologies: MRI, MRS, DTI, and MET-PET) from previous glioma patients. Advances will directly translate to improvements for patients.

Detailed description: Gliomas are the most common primary brain tumors in adults; most are high-grade and have a high level of mortality. The standard treatment is to kill or remove the cancer cells. Of course, this can only work if the surgeon or radiologist can find these cells. Unfortunately, there are inevitably so-called "occult" cancer cells, which are not found even by today's sophisticated imaging techniques.
  This proposal proposes a technology to predict the locations of these occult cells, by learning the growth patterns exhibited by gliomas in previous patients. We will also develop software tools that help both practitioners and researchers find gliomas similar to a current one, and that can autonomously find the tumor region within a brain image, which can save radiologists time, and perhaps help during surgery.

Eligibility: Inclusion Criteria:
  -  must have histologically proven glioma
  -  the patient or legally authorized representative must fully understand all elements of informed consent, and sign the consent form
  Exclusion Criteria:
  -  psychiatric conditions precluding informed consent
  -  medical or psychiatric condition precluding MRI or PET studies (e.g. pacemaker, aneurysm clips, neurostimulator, cochlear implant, severe claustrophobia/anxiety, pregnancy)

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

Clinical trial: Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma

Summary: RATIONALE: Collecting samples of tumor tissue and blood from patients with cancer to study in the laboratory may help doctors learn how patients respond to treatment.
  PURPOSE: This clinical trial is looking at tumor tissue samples from patients receiving imatinib mesylate for malignant glioma to see how much imatinib mesylate is found in the tumor tissue.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the efficacy, of imatinib mesylate, in terms of achieving a therapeutic tumor:plasma concentration ratio, in patients with primary malignant glioma.
  Secondary
  -  Correlate tumor grade (low vs high) and/or tumor enhancement on MRI with tumor concentration of this drug in these patients.,
  OUTLINE: Patients receive oral imatinib mesylate once daily for 7-12 days. Patients then undergo surgical resection.
  Blood and tissue samples are collected at the time of surgery and analyzed for imatinib mesylate concentration.
  After completion of study treatment, patients are followed for 7 days.
  PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed malignant glioma of 1 of the following subtypes:
  -  Low-grade glioma
  -  Anaplastic astrocytoma
  -  Anaplastic oligodendroglioma
  -  Glioblastoma multiforme
  -  Unifocal disease that is progressive or recurrent after prior radiotherapy and/or chemotherapy
  -  Scheduled to undergo surgical resection
  -  Able to undergo maximal surgical resection of tumor mass
  PATIENT CHARACTERISTICS:
  -  Karnofsky performance status 70-100%
  -  Mini Mental Status Exam ≥ 15
  -  Absolute neutrophil count ≥ 1,500/mm³
  -  Platelet count ≥ 100,000/mm³
  -  Creatinine ≥ 1.7 mg/dL
  -  BUN ≤ 2 times upper limit of normal (ULN)
  -  Transaminases ≤ 4 times ULN
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
  -  No other medical illness that would preclude study treatment, including any of the following:
  -  Serious infection
  -  Uncontrolled hypertension
  -  Unstable angina pectoris
  -  Uncontrolled cardiac dysrhythmia
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  Recovered from all prior therapy
  -  At least 4 weeks since prior investigational drugs
  -  No more than 1 prior chemotherapy regimen
  -  No concurrent chemotherapy, biologic therapy, or radiotherapy
  -  No concurrent medications that may interact with imatinib mesylate or interfere with hepatic cytochrome P450 system

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

Clinical trial: Safety Study of PLX4032 in Patients With Solid Tumors

Summary: The primary objective of this FIH study is to assess the safety and pharmacokinetics of PLX4032 in patients with solid tumors. The secondary objective is to assess the pharmacodynamic activity in paired biopsy specimens obtained from patients with malignant melanoma who have the V600E BRAF oncogenic mutation.

Detailed description: Activating mutations of the BRAF gene have been observed in a variety of cancers, including 55-68% of malignant melanomas. In general, oncogenic mutations of BRAF correlate with a poor outcome. PLX4032 is a compound that selectively inhibits oncogenic B-Raf kinase.
  Two extension cohorts of patients with confirmed V600E mutations will be recruited, consisting of advanced melanoma and metastatic colorectal carcinoma.

Eligibility: Inclusion Criteria:
  -  Solid tumors confirmed histologically whose tumors are refractory to standard therapy, or for whom standard or curative therapy does not exist
  -  Patients from whom paired melanoma biopsies are planned must have a V600E+ BRAF mutation confirmed prior to the administration of PLX4032
  -  Previous chemotherapy, immunotherapy, or radiation therapy must have been completed at least 2 weeks prior to starting PLX4032 therapy, and all associated toxicity must be resolved prior to administration of PLX4032
  -  Patients in the Extension cohorts (melanoma or adenocarcinoma of the colon or rectum) must have both a V600E+ BRAF mutation and measurable disease (by RECIST V 1.0 criteria) prior to the administration of PLX4032. All patients enrolled must provide archival or fresh melanoma tumor biopsy for confirmation of V600E+ BRAF mutation status by TaqMan assay
  -  ECOG performance status 0 or 1
  -  Life expectancy ≥ 3 months
  -  Adequate hematologic, hepatic, and renal function
  Exclusion Criteria:
  -  Brain metastases that are progressing or have been documented to be stable for less than 3 months, or for which systemic corticosteroids are required
  -  Investigational drug use within 28 days of the first dose of PLX4032
  -  Uncontrolled intercurrent illness
  -  Refractory nausea and vomiting, malabsorption, or significant bowel resection that would preclude adequate absorption

Relevance to patient case: possibly relevant