araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Comparison of Two Dosing Regimens of Temozolomide in Patients With Progressive or Recurrent Glioblastoma

Summary: For patients with progressive or recurrent glioblastoma there is no standard therapy. One strategy is re-exposure to temozolomide in a higher dose. This increase in dosing can be done by 2 regimens. Aim of this study is to compare these 2 dosing regimens concerning toxicity. In study arm A patients receive temozolomide for one week, followed by a week without temozolomide. In study arm B patients receive temozolomide for three weeks, followed by a week without temozolomide. The regimen that is less toxic will be selected for further evaluations.


Eligibility: Inclusion Criteria:
  -  Progressive or recurrent glioblastoma documented by MRI no earlier than 180 days after first surgery for glioblastoma and no earlier than 90 days after completion of radiotherapy.
  -  Histological diagnosis of glioblastoma
  -  Tissue available for the determination of MGMT promoter methylation in the primary tumor or from the recurrent tumor if a patient undergoes a surgical procedure at recurrence prior to study entry.
  -  Prior treatment with temozolomide administered concomitantly with radiotherapy and at least for two cycles (5/28) as an adjuvant treatment
  -  Informed consent
  -  Age 18-80 years
  -  Karnofsky performance score > 50%
  -  Neutrophil counts > 1 500/µl
  -  Platelet counts > 100 000/µl
  -  Hemoglobin > 10 g/dl
  -  Serum creatinin < 1.5-fold upper normal range
  -  ASAT or ALAT < 3-fold upper normal range unless attributed to anticonvulsants
  -  Alkaline phosphatase < 3-fold upper normal range
  -  Women with childbearing potential must have a negative serum pregnancy test ≤14 days prior to study enrollment
  -  Willingness to apply contraception according to local requirements (as stated in patient information)
  Exclusion Criteria:
  -  Progressive or recurrent glioblastoma documented by MRI earlier than 180 days after first surgery for glioblastoma and earlier than 90 days after completion of radiotherapy.
  -  Treatment with any chemotherapy other than temozolomide according to the schedule of the EORTC NCIC trial (Stupp et al. N Engl J Med 2005;352:987-996) except that an adjuvant starting dose of 200 mg/m2 and more than 6 cycles of adjuvant temozolomide are allowed
  -  Prior systemic or local treatment with DNA-damaging agents, tyrosine kinase inhibitors or anti-angiogenic agents for any cancer
  -  Allergy to or other intolerability of temozolomide
  -  Unable to undergo MRI
  -  Past medical history of diseases with poor prognosis, e.g. severe coronary heart disease, severe diabetes, immune deficiency, residual deficits after stroke, severe mental retardation
  -  HIV infection
  -  Pregnancy
  -  Breast feeding
  -  Treatment within in any other clinical trial parallel to the treatment phase of the current study

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Study of 18F-FEC for Positron Emission Tomography-Computed Tomography (PET-CT) Imaging of GBM

Summary: Positron Emission Tomography-Computed Tomography (PET-CT) with injection of 18F-fluoroethylcholine (FEC) could be a useful tool in the evaluation and follow-up of patients who have been diagnosed with glioblastoma multiforme (GBM) and who are treated with radiotherapy and temozolomide by allowing, for example, the distinction of necrosis from tumour tissue. This tool could help the clinician in making therapeutic decisions for GBM patients.


Eligibility: Inclusion criteria:
  -  Age between 18 and 70 years of age
  -  Histological diagnosis of GBM (grade IV astrocytoma based on the World Health Organization [WHO] classification)
  -  No previous radiotherapy or chemotherapy
  -  No history of previous neoplasms
  -  Inoperable patients (tumour in place, biopsy only)
  -  KPS ≥ 70
  -  Adequate hematological, renal and hepatic function
  -  Absolute neutrophil count ≥ 1,500/mm3
  -  Platelets ≥ 100,000 per mm3
  -  Serum creatinine ≤ 1.5 times the upper limit of normal of the laboratory where it is measured
  -  Total bilirubin ≤ 1.5 times the upper limit of normal of the laboratory where it is measured
  -  Liver enzymes < 3 times the upper limit of normal of the laboratory where they are measured
  -  Patients under corticosteroids must have received a stable or decreasing dose in the 14 days preceding randomization
  -  Consent form signed by the patients

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Study of Tissue Samples From Patients With Glioma or Other Brain Tumors

Summary: RATIONALE: Studying the genes expressed in samples of 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 tissue samples from patients with glioma or other brain tumors.

Detailed description: OBJECTIVES:
  Primary
  -  To better understand the pathophysiology of gliomas and identify molecular markers that may predict prognosis and progression or that could identify new therapeutic approaches.
  Secondary
  -  To compare gene expression profiles, in terms of response to treatment, and attempt to isolate subgroups of patients with objective response to certain types of chemotherapy or radiotherapy.
  OUTLINE: This is a multicenter study.
  Biological samples are collected from patients at time of surgery for diagnostic and/or treatment purposes.

Eligibility: Inclusion Histologically confirmed glioma of any grade or rare primary brain tumor No urgent situation No known or suspected active infection Must not be deprived of liberty or protected by law Not pregnant or nursing
  Exclusion :
  No concurrent participation in other trials that require a period of exclusion

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: A Study of Avastin (Bevacizumab) and Irinotecan Versus Temozolomide Radiochemistry in Patients With Glioblastoma

Summary: This 2 arm study will compare the effect of Avastin + irinotecan versus temozolomide, in combination with conventional involved field radiotherapy, in patients with newly diagnosed glioblastoma and a non-methylated MGMT promoter. Patients will be randomized 3:1 to receive Avastin 10mg/kg iv every 2 weeks + irinotecan 125mg/m2 iv every 2 weeks, or temozolomide 75mg/m2 po daily during radiotherapy followed by 6 cycles of temozolomide 150-200mg/m2 po daily on days 1-5 of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility: Inclusion Criteria:
  -  adult patients, 18-70 years of age;
  -  glioblastoma, confirmed histologically;
  -  no previous chemotherapy or radiotherapy for glioblastoma;
  -  non-methylated MGMT promoter in the tumor.
  Exclusion Criteria:
  -  prior systemic treatment for glioblastoma multiforme;
  -  prior treatment with Avastin;
  -  significant cardiovascular disease;
  -  other active malignant disease.

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Study of Blood Samples and Risk of Infection in Patients With Newly Diagnosed Malignant Supratentorial Astrocytoma

Summary: RATIONALE: Gathering information over time from laboratory tests of patients with newly diagnosed malignant supratentorial astrocytoma may help doctors learn more about the effect of treatment on white blood cell count and the risk of infection.
  PURPOSE: This clinical trial is studying blood samples and risk of infection in patients with newly diagnosed malignant supratentorial astrocytoma.

Detailed description: OBJECTIVES:
  -  Determine the frequency and severity of decreases in CD4 counts as a function of therapy in patients with newly diagnosed malignant astrocytoma.
  -  Determine whether the decrease in CD4 counts is a significant predictor of infections or adverse outcomes in these patients.
  OUTLINE: This is a multicenter study.
  Patients undergo monthly collection of blood for serial CD4 counts and heme-8 with differential for 1 year for quantitative analysis. Patients also complete a monthly questionnaire about infections and antibiotic use.
  Patients are followed every 2 months.
  PROJECTED ACCRUAL: A total of 125 patients (100 with high-grade disease and 25 with low-grade disease) will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed primary malignant brain tumor in 1 of the following groups:
  -  High grade (grade III or IV) supratentorial glioma receiving antineoplastic treatment and with 1 of the following histologies:
  -  Anaplastic astrocytoma
  -  Glioblastoma multiforme (giant cell glioblastoma or gliosarcoma)
  -  Anaplastic oligodendroma
  -  Low grade (grade I or II) supratentorial glioma not planning to receive treatment of any kind (including steroids) and with 1 of the following histologies:
  -  Astrocytoma
  -  Oligodendroglioma
  PATIENT CHARACTERISTICS:
  -  Karnofsky performance status 60-100%
  -  No HIV positivity
  PRIOR CONCURRENT THERAPY:
  -  No prior chemotherapy for brain tumor except polifeprosan 20 with carmustine implant (Gliadel® wafer)
  -  No prior cranial radiotherapy or radiotherapy for brain tumor
  -  No prior immunotherapy or biologic agents for brain tumor, including any of the following:
  -  Immunotoxins
  -  Immunoconjugates
  -  Peptide receptor antagonists
  -  Interleukins
  -  Interferons
  -  Tumor-infiltrating lymphocytes
  -  Lymphokine-activated killer cell therapy
  -  Gene therapy
  -  Antisense therapy
  -  No prior hormonal therapy for brain tumor
  -  More than 14 days since prior and no concurrent steroid therapy for patients with low-grade (grade I or II) astrocytoma
  -  Prior glucocorticoid therapy allowed

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Exploratory Study of the Modulation of the Immune System by VEGF Blockade in Patients With Glioblastoma Multiforme (GBM)

Summary: Blood samples will be obtained from newly diagnosed GBM patients treated with combined radiotherapy (RT), temozolomide (TMZ) and bevacizumab (BEV) at specific time points. The primary outcome is the shift in T reg cell fraction a defined by determining the proportion of CD4 cells that are CD4+ CD25.

Detailed description: Glioblastoma multiforme (GBM) is the most frequent malignant brain tumor and it remains a lethal disease. Approximately 4 weeks post surgery for tumor resection, patients will proceed to standard of care treatment which currently consists of temozolomide (TMZ) with concurrent radiation therapy (RT) for 6 weeks. This study will add bevacizumab (BEV) to the standard of care regimen in newly diagnosed patients. The Bevacizumab will be added 2 weeks post start of RT/TMZ. Administration of bevacizumab will continue concurrently with TMZ every 2 weeks for 12 months. Blood samples will be obtained from these patients at 3 different time points during this study.

Eligibility: Inclusion Criteria:
  -  Histologically proven GBM
  -  Karnofsky status equal to or greater than 60%
  Exclusion Criteria:
  -  Inadequately controlled hypertension
  -  Prior history of hypertension crisis or hypertensive encephalopathy
  -  History of stroke or transient ischemic attach within 12 months

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Laboratory Study of Early Tumor Markers in the Peripheral Blood of Glioblastoma Multiforme Patients

Summary: The purpose of this study is to determine if tumor cells can be detected in the blood of patients diagnosed with a brain tumor.

Detailed description: Despite aggressive therapies, Glioblastoma Multiforme (GBM) is rapidly fatal. GBMs are increasingly recognized for occasionally metastasizing through the peripheral blood to distant locations. This research study involves the detection and novel characterization of human GBM (hGBM) circulating tumor cells (CTCs) within the peripheral blood of brain tumor patients by identifying their unique cell surface antigen profile, determining an optimal isolation protocol, and quantitatively and qualitatively reporting the yield and characteristics.

Eligibility: Inclusion Criteria:
  -  18 to 89 years of age
  -  Weight of at least 110 pounds
  -  Able to provide informed consent for self
  Exclusion Criteria:
  -  Patients with active malignant tumors other than GBM

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Single-Arm Open-Label Multicenter Study of VB-111 in Patients With Recurrent Glioblastoma Multiforme

Summary: The purpose of this study is to evaluate the safety, tolerability and efficacy of VB-111 in patients with Relapsed Glioblastoma Multiforme.


Eligibility: Inclusion Criteria:
  1. Subjects must have a histologically confirmed diagnosis of glioblastoma multiforme or gliosarcoma;
  2. Measurable disease by RANO criteria;
  3. Disease progression or recurrence following standard of care treatment with temozolomide and radiation;
  4. An interval of at least 4 weeks between prior surgical resection and study enrollment;
  5. An interval of at least 12 weeks between prior radiotherapy or at least 4 weeks from prior chemotherapy, and enrollment in this protocol;
  6. Recovered to Grade 1 or less from the toxic effects of any earlier intervention;
  7. Karnofsky performance status > 60%
  Exclusion Criteria:
  1. Prior anti-angiogenic therapy including VEGF sequestering agents (ie bevacizumab, aflibercept, etc) or VEGFR inhibitors (cediranib, pazopanib, sunitinib, sorafenib, etc);
  2. Prior stereotactic radiotherapy;
  3. Active infection;
  4. Evidence of CNS haemorrhage CTCAE grade 2 or above on baseline MRI;
  5. Subjects who suffered from an acute cardiac event within the last 12 months;
  6. Subjects with active vascular disease, either myocardial or peripheral;
  7. Subjects with proliferative and/or vascular retinopathy;
  8. Subjects with known active second malignancy;

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Cyclin Dependent Kinase (CDK)4/6 Inhibitor, PD0332991 in Advanced Non-small Cell Lung Cancer NSCLC.

Summary: The purpose of this study is to determine the efficacy and the toxicities of the study drug PD0332991 in the treatment of patients with Stage IV non-small cell lung cancer with wildtype retinoblastoma protein (RB) and inactivated cyclin dependent kinase (CDK) N2A in the tumor.

Detailed description: The oral drug PD0332991 is a highly selective reversible inhibitor of cyclin-dependent kinases 4 & 6 that is being studied for use in the treatment of advanced non-small cell lung cancer.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically proven non small cell lung cancer
  -  Stage IV (M1a or M1b) disease. Patients may also have recurrence of early-stage disease or locally advanced disease with the presence of new distant metastases.
  -  Cyclin dependent kinase (CDK)N2a (p16) protein absent or expressed at a low level in tumor biopsy specimen
  -  Failed or intolerant of at least one prior systemic chemotherapy regimen (there is no maximum number of prior chemotherapy regimens)
  -  Eastern cooperative oncology group (ECOG) performance status 0-2
  -  Age >18 years.
  -  Adequate organ and bone marrow function
  -  Measurable disease by standard RECIST v1.1 criteria
  -  Life expectancy of greater than 3 months
  Exclusion Criteria:
  -  Inability to understand or sign the informed consent document
  -  Inability or unwillingness to take oral medications
  -  No available tissue specimen for p16 analysis
  -  Chemotherapy or radiotherapy within 3 weeks prior to beginning the study drug
  -  Other investigational agents within 4 weeks prior to beginning the study drug
  -  All side effects from previous chemotherapy, radiotherapy or investigational agents not resolved, returned to baseline or returned to Grade 1 toxicity (exceptions are grade 2 alopecia and grade 2 peripheral neuropathy)
  -  Major surgery within 4 weeks prior to beginning the study drug
  -  Surgical scar from previous surgery not healed prior to beginning the study drug
  -  High-dose or chronic steroid use
  -  High-dose statins within 7 days
  -  History of rhabdomyolysis
  -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes, stroke or myocardial infarction within 3 months, or psychiatric illness/social situations that would limit compliance with study requirements.
  -  Baseline corrected QT interval (QTc) >470ms
  -  Pre-existing clinically significant cardiac, hepatic or renal dysfunction at the discretion of the treating physician
  -  Untreated or uncontrolled (symptomatic or asymptomatic) brain metastases
  -  Leptomeningeal carcinomatosis
  -  Inability or unwillingness to use contraception during the treatment period by patients with reproductive potential.
  -  Pregnant or breastfeeding women
  -  HIV-positive patients on combination antiretroviral therapy

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

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: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: A Dose- and Efficacy-Finding Study of RO5323441 in Combination With Avastin (Bevacizumab) in Patients With Recurrent Glioblastoma

Summary: This open-label, multicenter study will evaluate the safety and efficacy of RO5323441 in combination with Avastin (bevacizumab) in patients with recurrent glioblastoma. In the dose-finding part, patients will receive intravenous escalating doses of RO5323441 in combination with 10 mg/kg Avastin once every two weeks. In the efficacy-finding part, patients will be randomized to receive the established dose (from the dose-finding part) of RO5323441 plus Avastin or Avastin alone. Patients in the dose-finding part may continue treatment with RO5323441 and Avastin on the study until evidence of progressive disease or unacceptable adverse events happen. In the efficacy-finding part, patients will receive study treatment until disease progression or death.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/=18 years of age
  -  Histologically confirmed glioblastoma
  -  Radiographic demonstration of disease progression by Response Assessment in Neurooncology (RANO) criteria following prior therapy
  -  Availability of at least 1 formalin-fixed paraffin-embedded tumor tissue sample
  -  If receiving corticosteroids, patients must have been on a stable or decreasing dose of corticosteroids
  -  Prior standard radiotherapy for glioblastoma
  -  Karnofsky Performance status >/=70
  -  Over 4 weeks since prior surgical resection
  -  Over 12 weeks from radiotherapy
  -  Over 4 weeks from anticancer agents
  Exclusion Criteria:
  -  Patients had second or later glioblastoma relapse
  -  Patients received more than one systemic treatment regimen for glioblastoma
  -  Patients have secondary glioblastoma
  -  Prior treatment with Avastin
  -  Patients unable to undergo Magnetic Resonance Imaging (MRI)

Relevance to patient case: not relevant