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

Clinical trial: Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma

Summary: RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
  PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with recurrent glioblastoma multiforme or other malignant glioma.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the progression-free survival rate at 6 months in patients with recurrent glioblastoma multiforme or other malignant glioma treated with temozolomide.
  Secondary
  -  Determine the overall survival of patients treated with this drug.
  OUTLINE: Patients receive oral temozolomide once daily in the absence of disease progression or unacceptable toxicity.
  Blood samples are collected at baseline and every 2 months for 2 years for evaluation of markers of neo-angiogenesis. Samples are analyzed by protein expression, reverse-transcriptase PCR, ELISA, and western blot. (Samples are no longer being collected and tested as of 1/12/09)

Eligibility: DISEASE CHARACTERISTICS:
  -  Pathologically diagnosed glioblastoma multiforme or other malignant glioma
  -  Recurrent disease
  -  Must have received prior temozolomide
  PATIENT CHARACTERISTICS:
  -  Karnofsky performance status 60-100%
  -  Granulocyte count ≥ 1,500/mm³
  -  Platelet count ≥ 100,000/mm³
  -  SGOT ≤ 2.5 times upper limit of normal (ULN)
  -  Creatinine ≤ 2 times ULN
  -  Bilirubin ≤ 2 times ULN
  -  No other active malignancy except for cervical carcinoma in situ or basal cell carcinoma of the skin
  -  No serious medical or psychiatric illness that, in the opinion of the investigator, would preclude study treatment
  -  No medical condition that precludes swallowing pills
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  Recovered from all prior therapy

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

Clinical trial: Changes in Semen or Sperm Caused by Temozolomide in Patients With Newly Diagnosed, Progressive, or Recurrent Primary Malignant Brain Tumors

Summary: RATIONALE: Learning whether temozolomide changes semen or sperm in patients with brain tumors may help doctors learn about the long-term effects of treatment and plan the best treatment.
  PURPOSE: This clinical trial is studying changes in semen or sperm caused by temozolomide in patients with newly diagnosed, progressive, or recurrent primary malignant brain tumors.

Detailed description: OBJECTIVES:
  Primary
  -  Assess if temozolomide induces any changes in standard semen or sperm analysis parameters (i.e., volume, viscosity, pH, forward progression, total count, total motile count, motility, presence of round cells, agglutination, and morphology) in patients with newly diagnosed, recurrent, or progressive primary malignant brain tumors.
  OUTLINE: This is a pilot study.
  During treatment with temozolomide, patients undergo semen or sperm sample collection at baseline, 3 months, and 6 months for semen analysis. Samples are analyzed for volume, viscosity, pH, forward progression, total count, total motile count, motility, presence of round cells, agglutination, and morphology.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed primary malignant brain tumor
  -  Newly diagnosed, progressive, or recurrent disease
  -  May have received prior radiotherapy with or without chemotherapy
  -  Scheduled to begin single-agent temozolomide chemotherapy
  -  Must be able to ejaculate
  -  Must abstain from ejaculating (e.g., not have sex or masturbate) for 2-7 days prior to study
  -  No known abnormal sperm motility and/or morphology
  PATIENT CHARACTERISTICS:
  -  Karnofsky performance status 60-100%
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

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

Clinical trial: A Study of XL765 (SAR245409) in Combination With Temozolomide With and Without Radiation in Adults With Malignant Gliomas

Summary: The purpose of this study is to determine the safety and tolerability of XL765 in combination with Temozolomide in adults with anaplastic gliomas or glioblastoma on a stable Temozolomide maintenance dose. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells, whereas inactivation of mTOR has been shown to inhibit the growth of tumor cells. Temozolomide (TMZ, Temodar®) is an orally administered alkylating agent with activity against malignant gliomas. It is approved by the Food and Drug Administration for the following indications: 1) treatment of newly diagnosed glioblastoma multiforme (GBM) patients when given concomitantly with radiotherapy and then as maintenance treatment; 2) refractory anaplastic astrocytoma (AA), ie, patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. Temozolomide is commonly used in the treatment of other anaplastic gliomas (AG) including oligodendroglial tumors and mixed gliomas.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed intracranial Grade 3 or 4 anaplastic glioma or glioblastoma (astrocytic tumor, anaplastic oligodendroglioma, or oligoastrocytoma)
  -  Received prior standard radiation for a Grade 3 or 4 astrocytic tumor with a minimum cumulative dose of 40 Gy administered
  -  Completed at least one full cycle of temozolomide of 200 mg/m2/day administered on Days 1-5 of a 28-day cycle, without unacceptable toxicity or progression
  -  Karnofsky performance status of 60 or more
  -  Adequate organ and bone marrow function as defined by hematological and serum chemistry limits
  -  At least 18 years old.
  -  Both men and women must practice adequate contraception
  -  Informed consent
  Exclusion Criteria:
  -  Progressed while on temozolomide
  -  Evidence of acute intracranial or intratumoral hemorrhage > Grade 1
  -  Restriction of some therapies/medications within specific timeframes prior to enrollment and during the study including cytotoxic chemotherapy other than temozolomide, biologic agents, nitrosoureas or mitomycin C, small-molecule kinase inhibitors, non-cytotoxic hormonal agents, prior therapy with a PI3K inhibitors, radiation therapy, enzyme-inducing anti-convulsants, valproic acid
  -  Not recovered from the toxic effects of prior therapy
  -  Pregnant or breast feeding
  -  History of diabetes mellitus
  -  Uncontrolled intercurrent illness
  -  Congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study.
  -  HIV positive
  -  Diagnosis of another malignancy may exclude subject from study

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

Clinical trial: Post Marketing Surveillance: Newly Diagnosed Glioblastoma Multiforme Treated With Radiotherapy/Temozolomide and Adjuvant Temozolomide (Study P04739)

Summary: The purpose of this surveillance is to collect more safety and efficacy data in "non-study" patients during concomitant and adjuvant temozolomide therapy.


Eligibility: Inclusion Criteria:
  -  Patients must have newly diagnosed and operated glioblastoma multiforme with postoperative residual tumor <=1.5 cm by magnetic resonance imaging (MRI).
  -  Age >=18 years.
  -  Hemoglobin >=10 g/dL.
  -  White blood cell count >=1.5x10^9/L.
  -  Platelet count >=100x10^9/L.
  -  Blood urea <=1.5 x upper limit of normal values (ULN).
  -  Creatinine <=1.5 x ULN.
  -  Bilirubin <=1.5 x ULN.
  -  Aspartate aminotransferase <=3 x ULN.
  -  Alanine aminotransferase <=3 x ULN.
  -  Alkaline phosphatase <=2 x ULN.
  Exclusion Criteria:
  -  Tumor-specific pretreatment.
  -  Contraindication against radiotherapy and/or chemotherapy.
  -  Malignomas other than basaliomas.
  -  Existing or planned pregnancy or lactation or inadequate contraception.
  -  Psychiatric disease.
  -  Simultaneous participation in another clinical trail or participation in another clinical trail in the last 30 days before recruitment.

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

Clinical trial: Study of Capecitabine to Treat Recurrent High Grade Gliomas

Summary: The purpose of this study is to determine if capecitabine is effective in the treatment of high grade gliomas that have returned after completing treatment.

Detailed description: High grade gliomas (HGGs) represent a heterogenous group of primary brain tumors that share WHO grade III or IV classification (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, and glioblastoma multiforme). Despite the upfront use of surgery, radiation, and chemotherapy, high grade gliomas uniformly result in recurrence and death. Palliative chemotherapy offers an improvement in time to progression, symptom control, quality of life, and potential survival; however, no established chemotherapy regimen for recurrence exists and new treatments are needed. Oral capecitabine is a rationale strategy for therapeutic palliation of recurrent high grade gliomas given its oral administration, its well-known kinetics and toxicities, its non-competitive toxicities to other high grade glioma treatments, its well established management algorithms, its established evidence of entry into the central nervous system, and its evidence of safety and efficacy in malignancies in the central nervous system.

Eligibility: Inclusion Criteria:
  -  Histological confirmation of high grade glioma (WHO grade III or IV: anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, and glioblastoma multiforme)
  -  Male or female 18 years of age or older
  -  Negative pregnancy test (if of childbearing potential)
  -  Any number of previous recurrences will be allowed
  -  Karnofsky Performance Status > 60
  -  Hematocrit > 30,000
  -  White blood cell count > 1,500
  -  Platelet > 100,000
  -  Absolute Neutrophil Count > 1,000
  -  Bilirubin < 1.5 x upper limits of normal
  -  Transaminases (ALT and AST) < 1.5 x upper limits of normal
  -  Creatinine < 1.5 x upper limits of normal
  -  Adequate medical health to participate in this study
  -  Adequate documentation of menopause (natural/surgical) or patient commitment to routine use of reliable birth control (barrier/hormonal)
  -  Ability to read and understand the informed consent document
  -  Ability and willingness to follow all requirements of the study including following all directions, taking medication as prescribed and completing all diaries and forms
  Exclusion Criteria:
  -  Karnofsky Performance Status < 60
  -  Hematocrit < 30,000
  -  White blood cell count < 1,500
  -  Platelet < 100,000
  -  Absolute Neutrophil Count < 1,000
  -  Bilirubin >1.5 x upper limits of normal
  -  Transaminases (ALT and AST) > 1.5 x upper limits of normal
  -  Creatinine > 1.5 x upper limits of normal
  -  Inability to undergo gadolinium-contrasted MRIs, including severe claustrophobia or insufficient allergy prophylaxis

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

Clinical trial: Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2)

Summary: The purpose of this surveillance is to evaluate the postmarketing safety and efficacy of Temodal capsule (temozolomide) under actual conditions of use, and to understand some of the following points that are in question and doubt:
  -  Incidence of adverse events under actual conditions of use (Serious and Nonserious Adverse Events);
  -  Adverse Drug Reactions not shown in the directions for use (will be stated as Unexpected Adverse Reaction);
  -  Adverse Event caused by misuse, abuse, or drug interactions;
  -  Other information concerned with safety or efficacy.


Eligibility: Inclusion Criteria:
  -  Participants who are prescribed with temozolomide by local labeling:
  -  participants with newly diagnosed glioblastoma multiforme;
  -  participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
  Exclusion Criteria:

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

Clinical trial: ADV-TK Improves Outcome of Recurrent High-Grade Glioma

Summary: Malignant gliomas are the most common primary brain tumor in adults, but the prognosis for patients with these tumors remains poor despite advances in diagnosis and standard therapies such as surgery, radiation therapy, and chemotherapy. The advantages of ADV-TK gene therapy highlight its efficacy and safety for glioma patients. This clinical trial was conducted to assess the anti-tumor efficacy and safety of intraarterial cerebral infusion of replication-deficient adenovirus mutant ADV-TK, in combination with systemic intravenous GCV administration in patients with recurrent high-grade glioma.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed WHO grades 3 to 4 malignant glioma
  -  Diagnosed recurrence or progression by clinical or radiological evidence
  -  Fit for intraarterial infusion and intravenous chemotherapy
  -  Adequate hepatic, renal, and hematologic function.
  -  Legal age ≥18 years
  -  Life expectancy ≥12 weeks
  -  Eastern Cooperative Oncology Group performance (ECOG) ≥2
  -  Chemotherapy completion ≥4 weeks prior and recovery from drug induced toxicities.
  Exclusion Criteria:
  -  Active pregnancy
  -  Prior gene therapy
  -  Second primary tumor
  -  Gravidity, lactation, hypersensitivity to antiviral drugs, immunologic deficit, active uncontrolled infections
  -  Requiring treatment with warfarin or any other anticoagulants

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

Clinical trial: Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme

Summary: The purpose of this study is to determine the safety and effectiveness of Azixa in patients with recurrent glioblastoma multiforme


Eligibility: Inclusion Criteria:
  -  Have histologically proven malignant Glioblastoma Multiforme in first or second relapse
  -  Have failed prior Fractionated External Beam Cranial Irradiation or IMRT
  -  Be at least 18 years old and with a life expectancy ≥ 8 weeks or ≥ 4 weeks if failed prior Avastin therapy
  -  Have a Karnofsky performance status of ≥ 60
  -  Have adequate bone marrow function, liver function, and renal function before starting therapy
  Exclusion Criteria:
  -  Have had more than two relapses
  -  Have had radiosurgery
  -  Have a cardiac ejection fraction < 50% by MUGA or ECHO
  -  Have Troponin-I elevated above the normal range
  -  Have an increasing steroid requirement
  -  Have MRI evidence at baseline of enlarging or clinically significant intratumor hemorrhage
  -  Have active stroke and/or transient ischemic attack not optimally managed
  -  Have active cardiovascular disease (e.g. sub-optimally managed angina, impending myocardial infarction, or uncontrolled hypertension)
  -  Be pregnant or breast feeding
  -  Have had prior hypersensitivity reaction to Cremophor EL
  -  Be HIV positive

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

Clinical trial: Improving the Selection of Patients With Glioblastoma Multiforme for Treatment With Epidermal Growth Factor Receptor Inhibitor Therapies

Summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
  PURPOSE: This laboratory study is looking at tissue samples from patients with glioblastoma multiforme to identify biomarkers that may improve the selection of patients for epidermal growth factor receptor inhibitor therapies.

Detailed description: OBJECTIVES:
  Primary
  -  Identify molecular characteristics that predict for overall survival and progression-free survival of patients treated with erlotinib hydrochloride, temozolomide, and radiotherapy on clinical trial NCCTG-N0177.
  Secondary
  -  Identify molecular characteristics that predict for overall survival and progression-free survival of patients treated with gefitinib after radiotherapy on clinical trial NCCTG-N0074.
  OUTLINE: This is a multicenter study.
  Tissue samples from patients enrolled on clinical trials NCCTG-N0177 or NCCTG-N0074 are analyzed by microarray analysis and immunohistochemistry for biological markers predicting progression-free survival and overall survival. Biological markers include epidermal growth factor expression, vIII mutant p53 gene, P-AKT, p7056k, S6, 4EBP1, STAT-3, PLC-g, Erk, ErbB2, ErbB3, ErbB4, platelet-derived growth factor receptor, IGF1R, interleukin-6, FADD, and MGMT.
  PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility: All patients entered onto N0177 and N0074 who have appropriate archived clinical specimens.

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

Clinical trial: Study of NPC-08 is to Treat for Newly-Diagnosed Malignant Glioma and Recurrent Glioblastoma Multiforme

Summary: The purpose of this study is to evaluate whether NPC-08 is safety and efficacy in the treatment of newly-diagnosed malignant glioma and recurrent glioblastoma multiforme.


Eligibility: Inclusion Criteria:
  -  Male or female, aged between 18 and 65 years;
  -  Radiographic evidence on cranial MRI of a single contrast-enhancing unilateral supratentorial cerebral tumor;
  -  Karnofsky Performance Score of 60 or higher;
  -  Willing to practice an effective method of birth control for at least 12 months after wafer implantation surgery;
  Exclusion Criteria:
  -  More than one focus of tumor or tumor crossing the midline, as assessed by coronal cranial MRI scan;
  -  Prior radiotherapy to the brain;
  -  Prior chemotherapy for the malignant glioma before the baseline evaluation, or patients who were being treated with chemotherapeutic agents;
  -  Known hypersensitivity to nitrosoureas;
  -  Participation in any other investigational protocol in the previous 6 months for any type of malignancy;

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

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