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

Clinical trial: A Study of a Retroviral Replicating Vector Combined With a Prodrug Administered to Patients With Recurrent Malignant Glioma

Summary: This is a multicenter, open-label, ascending-dose trial of the safety and tolerability of increasing doses of Toca 511, a Retroviral Replicating Vector (RRV), administered to patients with recurrent high grade glioma (rHGG) who have undergone surgery followed by adjuvant radiation therapy and chemotherapy. Patients will receive Toca 511 either via stereotactic, transcranial injection into their tumor or as an intravenous injection given daily for 3 & 5 days, depending on cohort. Approximately 3-4 weeks following injection of the RRV, treatment with Toca FC, an antifungal agent, will commence and will be repeated approximately every 6 weeks until study completion. After completion of this study, all patients will be eligible for enrollment and encouraged to enter a long-term continuation protocol that enables additional Toca FC treatment cycles to be given, as well as permits the collection of long-term safety and survival data.


Eligibility: Inclusion Criteria:
  -  at least 18 years of age
  -  for intratumoral cohorts, supratentorial HGG (WHO grade III or IV)
  -  technically unresectable HGG
  -  initial definitive therapy such as surgery with or without adjuvant radiation
  -  subject elected not to undergo treatment with Gliadel wafer
  -  if receiving corticosteroids, dose is stable or decreasing for past 7 days
  -  KPS: at least 70
  -  absolute neutrophil count > 1500/mm^3
  -  absolute lymphocyte count > 500/mm^3
  -  platelet count > 100,000/mm^3
  -  hemoglobin > 10 g/dL
  -  for intratumoral cohort, coagulation profile favorable to surgery
  -  estimated glomerular filtration rate > 50 mL/min
  -  ALT < 3 times ULN and bilirubin < 1.5 mg/dL
  -  negative serum pregnancy test
  Exclusion Criteria:
  -  cytotoxic therapy within the past 4 weeks (6 weeks for BCNU/CCNU)
  -  more than 2 recurrences including present recurrence
  -  Gliadel wafer or wafers implanted within the past 8 weeks
  -  taking more than 8 mg of dexamethasone per day
  -  for intratumoral cohorts, injection of tumor would require violation of ventricular system
  -  any infection requiring antibiotic, anticoagulant, or antiplatelet agents within the past 4 weeks
  -  for intratumoral cohort, bleeding diathesis or use of anticoagulants/antiplatelet agents that cannot be stopped
  -  allergy or intolerance to 5-FC
  -  HIV positive
  -  g.i. condition that would prevent ingestion or absorption of 5-FC
  -  any investigational treatment within the past 30 days
  -  pregnant or breast feeding
  -  received Avastin
  -  history of prior malignancy, excluding basal or squamous cell carcinoma of the skin, with an expected survival of less than 5 years.

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

Clinical trial: A Study of the Effect of Food on the Pharmacokinetics of Single Dose RO5185426 And the Safety And Efficacy of Continuous Administration in Patients With BRAF V600E Mutation-Positive Metastatic Melanoma

Summary: This randomized, open-label, two period crossover study will evaluate the effect of food on the pharmacokinetics of a single dose of RO5185426 and the efficacy and safety of continuous administration in patients with BRAF V600E mutation-positive metastatic melanoma. Patients will be randomized to receive in a crossover design single oral doses of RO5185426 with or without food, with a 10-day washout period between doses. Following the crossover periods, patients will receive RO5185426 orally twice daily on a continuous basis until disease progression or unacceptable toxicity occurs.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/= 18 years of age
  -  Histologically confirmed metastatic melanoma (Stage IV, American Joint Committee on Cancer)
  -  Positive BRAF V600E mutation result determined by Cobas 4800 BRAF V600 Mutation Test
  -  Previously treated patients must have failed at least one prior treatment regimen; if patients have received prior systemic treatments for metastatic melanoma, the time elapsed from previous therapy must be >/= 28 days; patients must have recovered fully from toxicities of all prior therapy
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  -  Evaluable disease (measurable for disease progression according to RECIST criteria)
  -  Adequate hematological, renal and liver function
  Exclusion Criteria:
  -  Active CNS lesions
  -  History of or known spinal cord compression or carcinomatous meningitis
  -  Anticipated or ongoing administration of anti-cancer therapies other than those administered in this study
  -  Previous malignancy within the past 5 years except for basal or squamous cell carcinoma of the skin, melanoma in-situ and carcinoma in-situ of the cervix
  -  Previous treatment with BRAF inhibitor (sorafenib allowed) or MEK inhibitor
  -  Refractory nausea or vomiting, malabsorption, external biliary shunt, or history of any type of gastrointestinal surgery that would preclude adequate absorption of study drug

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

Clinical trial: Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme.

Summary: Investigation on safety, tolerability and efficacy of H-1 parvovirus (H-1PV) in subjects suffering from glioblastoma multiforme.

Detailed description: Investigation on safety, tolerability and efficacy of H-1 parvovirus (H-1PV) in subjects suffering from glioblastoma multiforme.
  H-1PV will primarily be administered either intratumoral or intravenously. Ten days thereafter a complete or a subtotal tumor resection with a subsequent administration of H-1PV into the walls of the resection cavity will be carried out.

Eligibility: Inclusion Criteria:
  -  Age over or equal to 18 years old,
  -  Diagnosis of glioblastoma multiforme,
  -  Written informed consent,
  -  Recurrent or progressive disease despite previous radio- and/or chemotherapy,
  -  Indication for complete or subtotal tumor resection,
  -  Life expectancy of at least 3 months,
  -  Consent for sampling and investigation of biological specimens,
  -  Karnofsky Performance Score over or equal to 60,
  -  Adequate seizure control,
  -  Adequate bone marrow function: neutrophils > 1.5 x 10exp9/L, platelets > 100 x 10exp9/L, hemoglobin > 9.0 g/dL,
  -  Adequate liver function: Bilirubin < 2.0 g/dL, ASAT, ALAT, AP, GGT < 3 x ULN,
  -  Adequate renal function: Creatinine < 1.8 g/dL,
  -  Adequate blood clotting: aPTT < 35 sec, INR < 1.2,
  -  Negative serology for HIV, HBV and HCV,
  -  Negative Beta-HCG test in women of childbearing potential,
  -  Commitment to use adequate contraception (in both genders) for up to six months after study entry,
  -  Commitment to omit exposure to infants < 18 months of age or immunocompromised individuals for up to 28 day after first administration of IMP.
  Exclusion Criteria:
  -  Multifocal disease,
  -  Evidence of distant tumor metastases,
  -  Contraindications for MRI,
  -  Active infection within 5 days prior to the study inclusion,
  -  Chemotherapy within 4 weeks prior to the study inclusion,
  -  Radiotherapy within 6 weeks prior to the study inclusion,
  -  Participation in another interventional trial within the last 30 days,
  -  Treatment with antiangiogenic substances within 21 days prior to therapy.

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

Clinical trial: Imaging Biomarkers of Tissue Microstructure and Vasculature as Predictors of Glioblastoma Multiforme

Summary: This study is for subjects with a diagnosis of a brain tumor called glioblastoma that is being treated with bevacizumab. This study will use a new MRI technique to compare the images of blood vessels and tumor structure to the effectiveness of bevacizumab.

Detailed description: This study is for subjects with a diagnosis of a brain tumor called glioblastoma that is being treated with bevacizumab. Bevacizumab is a drug that your doctor believes is the best treatment option available to subjects at this time for this type of tumor. Bevacizumab affects the growth of blood vessels by tumors such as glioblastoma, thus effectively starving the tumor of oxygen and food.
  Magnetic Resonance Imaging (MRI) is a test done by a machine in the radiology department that takes pictures of your body using special magnets, rather than X-rays. With a new MRI scan technique the investigators can take very, very detailed images of the vessel and tumor structure. This project will allow us to compare the images of vessel and tumor structure to the effectiveness of Bevacizumab as a treatment option. With this project the investigators will hopefully develop an accurate way to predict whether or not Bevacizumab will be an effective treatment option for patients.

Eligibility: Inclusion Criteria:
  -  Age between 18 and 80 years of age
  -  Progressive glioblastoma patients who have been planned to receive bevacizumab
  -  Karnofsky Performance Status 50 or above (vd. Appendix A)
  -  Established pathologic diagnosis of glioblastoma
  -  Prior treatment with radiation and chemotherapy
  -  Neuroimaging progression of glioblastoma
  -  Able and willing to provide informed consent (or consent of a guardian)
  Exclusion Criteria:
  -  Contraindication to MRI
  -  Contraindication to bevacizumab therapy
  -  Concurrent enrollment in other neuroimaging trials
  -  Prior therapy with bevacizumab
  -  Known hypersensitivity to MRI contrast
  -  Females who are nursing or pregnant

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

Clinical trial: Genomic Predictors of Decitabine Response in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

Summary: This clinical trial studies potential genetic markers which might be used to predict which patients with acute myeloid leukemia or myelodysplastic syndromes respond to decitabine. This study will contribute to the efforts to find effective and less toxic therapies to provide durable remissions in a significant proportion of elderly AML patients.


Eligibility: Inclusion Criteria:
  All of the following:
  -  Patient must have non-M3 AML or MDS
  -  An adverse risk karyotype defined by:
  -  Complex karyotype by cytogenetics, or
  -  Deletion of all or part of chromosome 5, 7, 12, or 17 defined by FISH or cytogenetics, or
  -  Somatic TP53 mutation
  All of the following:
  1. Patient must have an ECOG performance status ≤ 2.
  2. Patient must have >10% disease burden measured by cytomorphology, flow cytometry, or cytogenetics.
  3. Patient must have peripheral white blood cell count < 50,000/mcl.
  4. Patient must have adequate organ function, defined as:
  1. Total bilirubin < 1.5 x ULN
  2. AST/ALT < 2.5 x ULN
  3. Serum creatinine < 2.0 x ULN
  5. Patient must have undergone ≤ 2 cycles of prior hypomethylating agent (decitabine or azacitidine).
  6. Patient must be enrolled in HRPO# 201011766 ("Tissue Acquisition for Analysis of Genetic Progression Factors in Hematologic Diseases").
  7. Patient must be > 18 years of age.
  8. Patient must be able to understand and willing to sign an IRB-approved written informed consent document.
  Exclusion Criteria:
  -  Patient must not be pregnant or nursing
  -  Patient must not have acute promyelocytic leukemia or t(15;17) observed by FISH.
  -  Patient must not have known central nervous system (CNS) leukemia
  -  Patient must not have a history of positive human immunodeficiency virus (HIV) serology
  -  Patient must not have a history of positive hepatitis C serology
  -  Patient must not have undergone prior allogeneic stem cell transplant
  -  Patient must not have any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, ongoing or active graft-versus-host disease (GVHD), congestive heart failure of New York Heart Association (NYHA) class 3 or 4, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
  -  Patient must not have had radiation therapy within 14 days of enrollment
  -  Patient must not have received any chemotherapy within 21 days of enrollment and any acute treatment-related toxicities must have returned to baseline. Patients may be receiving hydrea at time of enrollment.

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

Clinical trial: Non Invasive IDentification of Gliomas With IDH1 Mutation

Summary: The recurrent mutation IDH1Arg132His leads to the cellular accumulation of D-2-hydroxyglutarate (2-HG), thus representing a diagnostic marker (this change is almost specific for gliomas) and prognostic (mutated gliomas have longer survival) of interest.
  The main objective is to identify the patients with IDH1 mutated glioma by three complementary approaches -genetic (identification of IDH1 mutation in plasmatic DNA), biochemical (2-HG dosage in the urine of patients) and radiological (2-HG

Detailed description: Our preliminary results indicate an extremely high amount of D-2HG in gliomas and CSF of the patients, and therefore the possibility to detect its presence by spectro-MRI, and to establish a non-invasive diagnosis of glioma with IDH1 mutation. Our goal is to identify and quantify by high-field MRI spectroscopy the presence of D-2HG to identify gliomas with IDH1 mutation. In parallel, we developed a technique for selective amplification of the mutated form of IDH1 (COLD PCR): by combining this technique with digital PCR, we already are able to detect IDH1 mutation from free plasma DNA with a sensitivity of 58% and a specificity of 100%. At the same time we have shown that D-2HG levels in urine of patients correlate with the status of the tumor IDH1.
  The main objective is to identify using this triple approach (detection of the mutation on plasma DNA detection, detection of urinary D-2HG, detection of tumor D-2HG by spectro-MRI) patients with IDH1arg132His mutation, the secondary objective is to evaluate the value of these markers for patients follow-up and for differentiating recurrence from treatment induced damage. 40 patients with grade II and grade III gliomas (20 mutated, 20 non mutated) will be included and followed up for one year (five measurements are planned).
  The first interest is diagnostic: the presence of the IDH1Arg132His mutation allows the diagnosis of glioma. This information is particularly valuable in patients not amenable to biopsy, because of the location of the tumor considered at risk, the general condition of the patient or the co-morbidities and medications. We hope also with these parameters to better monitor patient's follow-up, and to have a new method to differentiate tumor recurrence and radionecrosis or post-radiation leukoencephalopathy.

Eligibility: Inclusion Criteria:
  Inclusion Criteria
  -  Affiliated to Health Insurance regimen (sécurité sociale)
  -  Patient of 18 years or more
  -  written informed consent
  -  Glioma grade II or III histologically proven
  -  Frozen samples available
  -  Known status IDH1/IDH2
  -  Presence of a measurable residual tumor (> 2 cm in diameter FLAIR)
  -  Karnofsky Performance Status (KPS)> 60
  Exclusion Criteria:
  -  Contraindication to MRI *
  -  The rare patients with IDH2 mutation or with non Arg132His IDH1 mutation will be excluded
  -  Inability to provide informed consent
  -  Patient under guardianship or deprived of liberty by court

Relevance to patient case: definitely relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: Curcumin Bioavailability in Glioblastoma Patients

Summary: Measuring the bioavailability of orally administered curcumin in the tumors of glioblastoma patients.


Eligibility: Inclusion Criteria:
  -  Patients harboring Glioblastoma
  -  Patient will undergo surgery
  Exclusion Criteria:
  -  BMI > 30
  -  Liver and Kidney Function so compromised that medication is prescribed

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

Clinical trial: A Pilot Study to Determine Nutrition Status in Glioblastoma Multiforme Patients

Summary: The study is designed to evaluate how the composition of a participant's body, diagnosed with a brain tumor (glioblastoma multiforme) as determined by bioelectrical impedance analysis can predict the progression and outcomes of disease.

Detailed description: The purpose of this study is to monitor the nutritional status of (Glioblastoma Multiforme)GBM patients for one year. We will look at the relationships between phase angle determined by Bioelectrical Impedance Analysis (BIA), nutrition assessment by Subjective Global Assessment and serum albumin, the type of microbes present in the gut, the participant's DNA information, and tumor progression. We will also compare estimated caloric needs determined by BIA and Harris Benedict Equation to Resting Energy Expenditure from Indirect Calorimetry of the people with GBM and the people without.

Eligibility: Inclusion Criteria:
  -  Subjects must be at least 19 years of age.
  -  Subjects must have a histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme).
  -  Women of childbearing potential must have a negative pregnancy test.
  Exclusion Criteria:
  -  Subjects with implanted pacemakers or defibrillators.
  -  Subjects who are pregnant.
  -  Subjects with edema.
  -  Subjects with an amputated extremity.

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

Clinical trial: A Phase III Study of Re-Irradiation in Recurrent Glioblastoma

Summary: The investigators hope to improve overall median survival of patients with recurrent Glioblastoma by investigating continuous low-dose daily Temozolomide plus or minus five treatments of re-irradiation.

Detailed description: This is a stratified study for patients with recurrent intracranial glioblastoma or gliosarcoma previously treated with concurrent chemoradiation presenting radiographic progression or recurrence of tumour. Patients are stratified by extent of resection, time to re-irradiation and re-irradiation volume.

Eligibility: Inclusion Criteria:
  -  histologically-proven intracranial glioblastoma or gliosarcoma previously treated with concurrent chemoradiation
  -  radiographic evidence of tumour progression or recurrence
  -  18 years or older
  -  ECOG 0 - 2
  -  signed informed consent form
  Exclusion Criteria:
  -  tumour progression or recurrence within 3 months of initial concurrent chemoradiation
  -  6 or more cycles of TMZ administered following chemoradiation at initial diagnosis
  -  more than one prior course of salvage chemo for recurrent disease
  -  prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for greater or equal to 3 years
  -  prior head or neck RT except for T1 glottic cancer

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

Clinical trial: Phase 1b Trial of BGJ398/BYL719 in Solid Tumors

Summary: To study the safety and efficacy of the combination of BGJ398 with BYL719 in patients whose tumors express mutations to PIK3CA with or without alterations to FGFR 1-3.

Detailed description: This dose escalation/dose expansion study will evaluate the combination of orally administered BGJ398 in combination with orally administered BYL719. During the dose escalation part, the MTD of the combination will be determined in patients whose advanced or metastatic tumors express mutations to PIK3CA. Once the MTD has been determined, the expansion part will begin. Patients will be addd to one of three arms based on the disease type and genetic changes. Patients with metastatic colorectal cancer are not eligible for participation in the expansion part.

Eligibility: Inclusion Criteria:
  -  Histologically/cytologically confirmed advanced or metastatic solid tumors who have failed standard therapy or for whom no effective standard anti-cancer therapy exists
  -  Documented PIK3CA mutations in all patients in dose escalation and expansion with or without documented genetic alterations in FGFR depending upon dose expansion cohort (either local or central determination)
  -  Measurable disease defined by RECIST v1.1
  -  ECOG performance status of ≤2
  Exclusion Criteria:
  -  Prior PI3Ki or selective FGFR inhibitor treatment (for patients enrolled to expansion part)
  -  Colorectal cancer (for patients enrolled to expansion part)
  -  Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with fasting glucose ≥ 140 mg/dL / 7.8 mmol/L, history of clinically significant gestational diabetes mellitus or documented steroid-induced diabetes mellitus
  -  Use of medications that increase serum levels of phosphorus and/or calcium
  -  Inorganic phosphorus outside of normal limits
  -  Total and ionized serum calcium outside of normal limits

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

Clinical trial: Treatment Response and Prognosis in Glioma Patients: Q Cell and Its Biological Characteristics

Summary: The purpose of this study is to determine whether Q cells separated from the glioma sample are determinants in treatment response and prognosis of glioma patients

Detailed description: The unique markers of Qcell were screened using the method of genomics and
  proteomics, then these markers will be qualitatively and quantitatively evaluated in
  glioblastoma patients by comparing their relationship with overrall
  survival/progression-free survival and treatment response.

Eligibility: Inclusion Criteria:
  1. >=18 years old
  2. Primary Glioblastoma is newly diagnosed and confirmed histologically
  3. Patient is expected to be treated with temozolomide and followed up routinely at the study site.
  4. Willing to sign the informed consent
  Exclusion Criteria:
  1. Currently enrolled in any other clinical study
  2. History of any other malignancies
  3. Refusal to give consent
  4. No available tumor tissue for IDH analysis.

Relevance to patient case: not relevant