araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: Enzastaurin Versus Lomustine in Glioblastoma

Summary: This protocol will test the activity of Enzastaurin vs. Lomustine in the treatment of recurrent brain cancer (specifically intracranial glioblastoma multiforme).


Eligibility: Inclusion Criteria:
  1. Patient presents with histologically confirmed diagnosis of brain cancer (specifically glioblastoma multiforme).
  2. Your cancer has returned following therapy.
  3. Patient may have undergone prior surgery to remove cancer.
  4. Patient must be able to care for self.
  Exclusion Criteria:
  1. Have a second type of cancer (except adequately treated basal cell carcinoma of the skin). Patient who has had another cancer in the past, must be free of cancer for more than 2 years.
  2. Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of entry.
  3. Patients receiving medication for seizures must discontinue 14 days prior to enrolling.
  4. Cannot be on blood thinning medication at study enrollment.
  5. Cannot be on other medicines to prevent cancer at study enrollment.
  6. Patients are not allowed to enter the study if they have previously taken Enzastaurin, Lomustine and/or Bevacizumab.

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: Phase II Feasibility Study of Dendritic Cell Vaccination for Newly Diagnosed Glioblastoma Multiforme

Summary: Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme will be treated with radiotherapy/chemotherapy followed by dendritic cell vaccine. Chemotherapy will be administered after three vaccinations for one year or until progression of disease.

Detailed description: Two to six weeks after surgery, patients with newly diagnosed glioblastoma multiforme (GBM) will undergo a six-week course of radiotherapy with concurrent chemotherapy (temozolomide). Between three and seven weeks after completing radiotherapy/chemotherapy, patients will undergo leukapheresis to collect white blood cells. These cells will be grown into dendritic cells, and cultured with tumor cells from the individual patient. Vaccinations will be given every two weeks for a total of three vaccinations. Four weeks after the third vaccination patients will resume chemotherapy for one year or until disease progression.

Eligibility: Inclusion Criteria:
  -  Histologically proven GBM with central pathology review at Dartmouth-Hitchcock Medical Center (DHMC)
  -  Tumor specimen obtained at the time of surgery adequate for vaccination
  -  18 years of age or older
  -  Karnofsky Performance Status 60% or greater
  -  Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10 9th/L
  -  Platelets greater than or equal to 100 x 10 9th/L
  -  Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) less than or equal to 5 times the upper limits of normal (ULN)
  -  Total bilirubin less than or equal to 1.5 times ULN
  -  Serum creatinine less than or equal to 1.5 times ULN, OR estimated creatinine clearance greater than or equal to 60 mL/min
  -  No known immunosuppression other than chemo-related
  -  Negative HIV serologies
  -  No evidence of acute or chronic hepatitis on standard hepatitis C and B screening tests
  -  No chemotherapy within four weeks prior to leukapheresis
  -  Radiotherapy at outside institution is permitted if tissue was obtained at time of surgery at DHMC and patient is willing to follow-up per protocol
  -  Off steroids for at least two weeks before leukapheresis
  -  No second malignancies except non-melanoma skin cancer, and non-invasive cancer such at cervical CIS, superficial bladder cancer or breast CIS
  -  Negative serum or urine pregnancy test for women of childbearing potential
  -  No serious uncontrolled medical disorder or active infection
  -  All patients must give informed consent
  -  No history of clinical evidence of active autoimmune disease
  Exclusion Criteria:
  -  Invasive cancers in the past 5 years
  -  Rheumatologic/autoimmune disease
  -  Pregnancy or unwillingness to remain on acceptable form of birth control during study
  -  Major cardiac, pulmonary, or other systemic disease; viral hepatitis; HIV infection

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: Study of XL647 in Subjects With Non-Small-Cell Lung Cancer

Summary: The purpose of this phase II study is to determine the safety, tolerability, and activity of XL647 in previously untreated subjects with non-small cell lung cancer (NSCLC). XL647 is a small molecule that potently inhibits multiple receptor kinases, including EGFR, VEGFR2 (KDR), ErbB2, and EphB4. Sensitivity to EGFR inhibitors has been linked to specific EGFR mutations and associated with certain clinical characteristics in patients with NSCLC (eg, female, minimal and remote smoking history, and adenocarcinoma histology).


Eligibility: Inclusion Criteria:
  -  Subject has NSCLC with a histologically confirmed diagnosis of adenocarcinoma with measurable disease (stage IIIB, with malignant pleural effusion, and stage IV) and either has a demonstrated activating mutation of the EGF receptor in tumor tissue or meets one of three criteria: asian, female, and minimal or no smoking history.
  -  Measurable disease defined according to RECIST
  -  ECOG performance status of 0 or 1
  -  Normal organ and marrow function
  -  No other malignancies within 5 years, except for non-melanoma skin cancer
  Exclusion Criteria:
  -  Radiation to ≥25% of bone marrow within 30 days of XL647 treatment
  -  Prior systemic anticancer therapy, including cytotoxic chemotherapy, anti-VEGF, anti-VEGFR, or anti-EGFR agents or investigational drug
  -  Subject has not recovered to ≤ grade 1 or to within 10% of baseline values from adverse events due to other medications administered > 30 days before study enrollment
  -  Receiving anticoagulation therapy with warfarin (low-dose warfarin < 1 mg/day, heparin and low molecular weight heparins are permitted)
  -  The subject meets any of the following cardiac criteria:
  -  Corrected QT interval (QTc) of > 460 msec
  -  Family history of congenital long QT syndrome or unexplained sudden death
  -  History of sustained ventricular arrhythmias
  -  Has a finding of left bundle branch block
  -  Has an obligate pacemaker
  -  Has important bradycardia defined as a heart rate of < 50 bpm due to sinus node dysfunction
  -  Has uncontrolled hypertension
  -  Has symptomatic congestive heart failure, unstable angina, or a myocardial infarction within the past 3 months
  -  Has a serum potassium or serum magnesium level that falls outside the normal range
  -  The subject has progressive symptomatic or hemorrhagic brain or leptomeningeal metastases
  -  Uncontrolled intercurrent illness
  -  Subject is pregnant or breastfeeding
  -  Known HIV

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: Study of Everolimus (RAD001) in Patients With Recurrent Glioblastoma Multiforme (GBM)

Summary: This study will define the safety and efficacy of Everolimus (RAD001) administered daily in patients with glioblastoma multiforme (GBM)

Detailed description: This was a multicenter, open label, randomized study of RAD001 dosed daily in patients with recurrent GBM. The study was conducted with 2 parallel groups of patients. Group 1 was designed to study the biological effects of RAD001 in patients scheduled to undergo salvage surgical resection, and Group 2 was to enroll patients who were not scheduled for surgery. Patients in Group 1 were randomly assigned to one of three pre-surgery treatment groups (0, 5 or 10 mg/day RAD001 for 7 days). All patients in Group 2 were to receive a fixed daily dose of 10 mg/day oral RAD001.

Eligibility: Inclusion Criteria:
  -  Age 18 years of age or older
  -  Histologically confirmed Glioblastoma Multiforme (GBM)
  -  Radiographic evidence of disease progression
  -  Patients must have evaluable contrast enhancing tumor
  -  Availability of paraffin blocks or unstained pathology slides for biomarker studies
  -  Karnofsky Performance Status of greater than or equal to 60%
  Exclusion Criteria:
  -  Prior treatment with Mammalian target of rapamycin (mTOR) inhibitor
  -  History of another malignancy within 3 years
  -  Cardiac pacemaker
  -  Ferromagnetic metal implants other than those approves as safe for use in Magnetic resonance imaging (MRI) scanners
  -  Claustrophobia
  -  Obesity
  -  Unstable systemic diseases
  -  Elevated cholesterol or triglycerides
  -  Radiation therapy or cytotoxic chemotherapy <=4 weeks prior to study enrollment. Patient must have recovered from the toxic effects of a prior chemotherapy.
  -  Patients must be off all enzyme inducing anticonvulsants for at least 2 week before study enrollment can occur
  -  Need for increasing dose of steroids. Patients on a stable or tapering dose of steroids >=7 days were permitted.

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: Nimotuzumab in Adults With Glioblastoma Multiforma

Summary: Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma

Detailed description: The objective of the present study is a comparison of treatment of patients with newly diagnosed glioblastoma multiforme grade IV. Patients will be randomized in one of two arms when included. Patients randomly assigned to arm A will receive Nimotuzumab (OSAG 101) plus Temozolomide concomitant with standard radiotherapy. Patients randomised in arm B will receive standard radiotherapy plus Temozolomide treatment.

Eligibility: Inclusion Criteria:
  -  Patient signed informed consent
  -  Newly diagnosed, histologically confirmed glioblastoma multiforme grade IV
  -  Condition is measurable by MRI in at least one dimension
  -  Age 18-70
  -  Karnofsky-Index > 40
  -  Treatment in a study center
  -  Female patients with a childbearing potential must have a negative pregnancy test within one week before inclusion in the trial. Those female and male patients admitted in the study must use a reliable method of contraception.
  -  Adequate haematological, renal and hepatic function:
  -  Leucocytes >2.0x10^9/l
  -  Hb> 10g/dl
  -  Billirubin total < 2.5x upper limit of normal (ULN)
  -  Creatinin i.S. < 1.5x ULN
  -  AST (GOT)/ALT (GPT) < 5x ULN
  Exclusion Criteria:
  -  Patients with history of anaphylactic reaction to murine or humanized antibody
  -  Patients with evidence second malignancy
  -  Patients who are pregnant or patients who refused adequate contraceptive precaution (female and male) during the trial
  -  Pregnancy and lactation
  -  Other conditions considered by investigators as sound reasons for disqualification from enrolment into the study such as: potential non compliance with protocol requirement
  -  No MRI for tumour evaluation

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: A Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Gliomas

Summary: To assess the efficacy and safety of bevacizumab plus irinotecan for the patients with recurrent anaplastic astrocytoma or with recurrent glioblastoma multiforme


Eligibility: Inclusion Criteria:
  -  Histologically diagnosed recurrent anaplastic astrocytoma or recurrent glioblastoma multiforme
  -  At least 18 years of age
  -  Performance status of 0 and 1 on the Eastern Cooperative Oncology Group (ECOG) criteria
  -  One or more measurable disease
  -  Adequate hematologic (neutrophil count >= 1500/uL, platelets >= 100,000/uL), hepatic (transaminase =< upper normal limit (UNL)x2.5, bilirubin level =< UNLx1.5, alkaline phosphatase =< UNLx2.5), and renal (creatinine clearance >= 30mL/min)
  -  Expected life time more than at least 2 months
  -  A patients who signed the informed consent prior to the participation in the study
  Exclusion Criteria:
  -  A pregnant or lactating patient
  -  A patient of childbearing potential without being tested for pregnancy at baseline or with a positive test. (A premenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
  -  A man or woman of childbearing potential without the willingness to use a contraceptive measures during the study
  -  A patient with history of another malignant disease within past 3 years, except curatively treated basal cell carcinoma of the skin, cervical carcinoma in situ, and early gastric cancer
  -  Medically uncontrolled serious heart, lung, neurological, psychological, or metabolic disease
  -  Uncontrolled serious infection
  -  Enrollment in other study within 30 days
  -  Hemorrhage on baseline radiologic examination
  -  A patient who refused to sign the informed consent

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma

Summary: This 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide) as compared to the current standard of care alone. Participants were randomly assigned to either the bevacizumab (10 milligrams per kilogram (mg/kg) intravenously [IV] once every 2 week [q2w]) or the placebo arm, in combination with radiation therapy (total dose 60 Gray [Gy], administered as 2 Gy fractions, 5 days/week) plus temozolomide (75 milligrams per meter squared [mg/m^2] oral administration [po] daily) for 6 weeks. After a 4 week treatment break, participants continued to receive bevacizumab (10 mg/kg IV q2w) or placebo, plus temozolomide (150-200 mg/m^2 po daily on days 1-5 of each 4 week cycle) for 6 cycles of maintenance treatment or until disease progression or unacceptable toxicity, whichever occured first. Following the maintenance phase, bevacizumab (15 mg/kg iv every 3 weeks [q3w]) or placebo monotherapy continued. The time on study treatment was until disease progression.


Eligibility: Key Inclusion Criteria:
  -  newly diagnosed glioblastoma
  -  World Health Organization (WHO) performance status less than or equal to (<=2)
  -  stable or decreasing corticosteroid dose within 5 days prior to randomization
  Key Exclusion Criteria:
  -  evidence of recent hemorrhage on postoperative magnetic resonance imaging (MRI) of brain
  -  any prior chemotherapy or immunotherapy for glioblastomas and low grade astrocytomas
  -  any prior radiotherapy to brain
  -  clinically significant cardiovascular disease
  -  history of greater than or equal to (>=) grade 2 hemoptysis within 1 month prior to randomization
  -  previous centralized screening for Methylguanine-DNA methyltransferase (MGMT) status for enrollment into a clinical trial

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: Study of CCNU (Lomustine) Plus Dasatinib in Recurrent Glioblastoma (GBM)

Summary: To determine whether dasatinib plus lomustine are effective for treatment of recurrent glioblastoma


Eligibility: Inclusion Criteria:
  -  Patients with histological or cytological proven glioblastoma multiforme
  -  Recurrent or progressive disease documented by magnetic resonance imaging (MRI)
  -  World Health Organization (WHO) Performance status 0 - 2
  -  Patient may have been operated for recurrence
  -  For non operated patients, recurrent disease must be at least one bidimensionally measurable target lesion with one diameter of at least 2cm
  -  Patients must be on a stable or decreasing dose of corticosteroids for at least 1 week prior to baseline MRI
  Exclusion Criteria:
  -  Patients with histological or cytological proven glioblastoma multiforme
  -  Completion of radiotherapy to the brain less than 3 months prior to registration/randomization
  -  Prior treatment with high dose radiotherapy, stereotactic radiosurgery or internal radiation therapy
  -  Previous or current malignancy at other sites within prior 3 years

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery

Summary: A one time oral dose of ALA is taken before surgery. The medication makes the tumor visible under ultraviolet light which allow the surgeon to see more of the tumor for a more complete removal.

Detailed description: Patients with primary neoplastic brain tumors (Grades II-IV) will participate in this trial. Each patient will have been evaluated and found to have such a tumor by history and recent imaging studies (MRI) and deemed a surgical candidate based on current neurosurgical standards of care.

Eligibility: Inclusion Criteria:
  -  Suspected primary brain tumor
  -  18 years of age or more
  -  Normal marrow and organ function
  -  Eastern Cooperative Group performance status ≤ 2
  -  Women of childbearing potential must use adequate birth control
  -  Ability to understand and willingness to sign a written informed consent form
  -  Life expectancy not a consideration
  Exclusion Criteria:
  -  Receiving any other investigational agents
  -  History of allergic reactions to ALA
  -  Personal or family history of porphyrias
  -  Liver disease in the past year
  -  Uncontrolled intercurrent illness
  -  Pregnant or lactating women
  -  Inability to undergo MRI with contrast

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: P1/2 of Temozolomide and Hypofractionated Radiotherapy in Tx of Supratentorial Glioblastoma Multiform

Summary: The purpose of this study is to investigate the safety and effectiveness of a combination treatment for glioblastoma multiforme utilizing radiotherapy with the FDA approved chemotherapy drug temozolomide

Detailed description: To determine the maximum tolerated dose (MTD) of hypofractionated (5 fractions) radiotherapy with temozolomide for the treatment of glioblastoma multiforme, patients will be evaluated by a multi-disciplinary team composed of radiation oncologists, neurosurgeons, and neuro-oncologists to assess for their eligibility. Patient's oncologic history, presenting symptoms, physical examination, pathology, and imaging studies will be reviewed. Patients will be evaluated for surgical candidacy and resectability. Patients who are surgical candidates will undergo a surgical resection prior to radiotherapy. Patients whose tumors are unresectable or are not good surgical candidates will undergo a biopsy for tissue diagnosis. Radiation will be delivered in five fractions.

Eligibility: Inclusion Criteria:
  -  Histopathologically confirmed newly diagnosed glioblastoma multiforme. Diagnosis must be made by surgical biopsy or excision
  -  The tumor must be supratentorial in location
  -  The planning target volume (tumor plus margin) must measure ≤ 150 cm^3 in volume
  -  Age ≥ 18 years
  -  Life expectancy of at least 12 weeks
  -  Patient must have adequate organ function to tolerate temozolomide (details in the protocol)
  Exclusion Criteria:
  -  Patients who have previously been treated with brain irradiation to the region that would result in overlap of the radiation fields
  -  Tumor foci detected below the tentorium
  -  Multifocal disease or leptomeningeal spread
  -  Prior allergic reaction to the study drugs involved in this protocol
  -  Patients with pacemaker will be allowed to undergo CT instead of MRI
  -  Pediatric patients (age < 18), pregnant women, and nursing patients will be excluded

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: KRAS Mutation and Incidence of the Colorectal Carcinoma in Martinique Between 2007 and 2009

Summary: -  There is no data at present concerning the KRAS mutation in patients from Martinique with colorectal cancer. Despite the fact that the incidence of this disease continues to increase there is no recent data to confirm it. This study has a descriptive purpose, allowing a comparison of the population from Martinique to other populations.
  -  A study of incidence of colorectal cancer, overseen by the Association from Martinique for the Epidemiological Search on Cancer (AMREC), also leads to a better knowledge of the local characteristics of the colorectal cancer.
  -  These two descriptive characteristics of colorectal cancer in Martinique will be useful data for the health professionals to provide their patients better care.

Detailed description: -  The colorectal carcinogenesis is complex. It influences among others, the EGFR (Epidermal Growth Factor Receptor) which activation leads to tumoral proliferation, differentiation and invasion. The binding of the EGF (Epidermal Growth Factor) or of another ligand to the EGFR is responsible for the activation of the Ras- Raf and Pi3k pathways.
  -  The mutation of the genes KRAS, BRAF or PIK3CA results in their continuous activation, independently of the activation or of the pharmacological blocking of EGFR. The most frequently found mutation affects the KRAS gene (20 to 50 % of the cases). 90 % of these mutations are situated on codons 12 and 13 of this gene (70 % codon 12 and 30 % codon 13). These mutations are responsible for a decrease of the GTPase activity of the ras protein, which stays then in active conformation bound to the GTP. This leads to the blocking of the pathway and to the inactivity of the pharmacological blocking of EGFR.

Eligibility: Inclusion Criteria:
  -  for the study of the KRAS mutation: 250 patients drawn by lots among the cases of colorectal carcinoma diagnosed between January 1st, 2007 and December 31st, 2009 in Martinique
  -  for the study of incidence: patient for whom was diagnosed a colorectal carcinoma between January 1st, 2007 and December 31st, 2009
  -  patient unopposed and in free agreement to participate in this study
  -  patient having his main home in Martinique at the time of the diagnosis
  -  patient 18 years old and over
  Exclusion Criteria:
  -  patient whose diagnosis is prior to 2007 and later in 2009
  -  patient having shown opposition to the participation in this study
  -  patient minor or under guardianship
  -  patient not having his main home in Martinique at the time of the diagnosis

Relevance to patient case: not relevant