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

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: 82-year-old male with glioma; genetic feature: BRAF

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: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Bevacizumab in Combination With Metronomic Temozolomide for Recurrent Malignant Glioma

Summary: This is a phase II study of the combination of Avastin and metronomic temozolomide in recurrent malignant glioma patients. The primary objective will be to determine the efficacy of Avastin (bevacizumab) and metronomic temozolomide in malignant glioma patients. The secondary objective will be to determine the safety of Avastin, 10 mg/kg every other week, in combination with metronomic temozolomide in terms of progression-free survival.

Detailed description: This is a phase II trial of the combination of Avastin and metronomic temozolomide in recurrent WHO grade IV malignant glioma patients. Patients will receive up to 12 cycles of Avastin and temozolomide and cycles are continuous 28 days. Patients will receive daily temozolomide at a dose of 50mg/m2 and will receive Avastin every other week at a dose of 10mg/kg. Patients will be required to have a baseline MRI within 2 weeks of starting treatment and a repeat MRI every 8 weeks. A total of 32 patients will be enrolled at Duke.
  Patients with recurrent malignant gliomas have a very poor prognosis, so new therapies are needed. Given the activity of metronomic temozolomide and the safety and activity of Avastin against malignant glioma, it is reasonable to study the combination in recurrent malignant glioma patients.

Eligibility: Inclusion Criteria:
  -  Patients must have histologically confirmed diagnosis of WHO grade IV primary malignant glioma
  -  Karnofsy Performance Status (KPS) >/= 60%
  -  Evidence of measurable primary CNS neoplasm on contrast-enhanced MRI.
  -  An interval of at least 4 weeks between prior surgical resection or 1 week from a biopsy and enrollment on this protocol
  -  An interval of at least 4 weeks from the end of prior radiotherapy or one week from the end of a cycle of chemotherapy and enrollment on this protocol.
  -  No evidence of CNS hemorrhage on the baseline MRI or CT scans
  Exclusion Criteria:
  -  Life expectancy < 8 weeks
  -  Pregnancy or breast feeding
  -  Progression to metronomic temozolomide, defined as tumor progression while taking daily temozolomide or progression within 4 weeks of stopping metronomic temozolomide
  -  Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)

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

Clinical trial: Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas

Summary: Objectives:
  -  To determine the maximum tolerated dose of oral topotecan when administered with Temodar to patients with malignant glioma
  -  To characterize any toxicity associated with the combination oral topotecan and Temodar.
  -  To observe patients for clinical antitumor response when treated with oral topotecan and Temodar.

Detailed description: Subjects are patients with glioblastoma (GBM), anaplastic astrocytoma (AA) or grade 3 or greater WHO astrocytic, oligodendroglial or mixed glial tumors, which were initially diagnosed by histologic examination of biopsy/resection. Modified classical "3+3" phase I design used to determine maximum tolerated dose of topotecan in combination with Temodar.

Eligibility: Inclusion Criteria:
  -  Histology: GBM, AA or grade 3 or greater WHO astrocytic, oligodendroglial or mixed glial tumors which were initially diagnosed by histologic exam of biopsy/resection
  -  Age: > or equal to 18 years
  -  Performance Status: Karnofsky Performance Status > or equal to 60% at study entry.
  -  Renal Function: Serum creatinine < 1.5 mg/dl or creatinine clearance > 60 ml/dL.
  -  Hematologic Status: The following baseline studies will be required before entry: total granulocyte count > or equal to 1000/microliter; platelet count > 100,000/microliter
  -  Hepatic Function: Serum SGOT & total bilirubin < or equal to 2.5 times ULN.
  -  Note: All lab parameters must have been obtained within 1 week of registration
  -  Consent: Signed informed consent, approved by IRB, will be obtained prior to initiating treatment
  -  Corticosteroids: For patients currently on corticosteroids, patients should be on stable dose for 1 week prior to study entry, if clinically possible.
  -  Prior Therapy: Interval of at least 2 weeks between prior surgical resection or prior radiotherapy (XRT) or 1 week from completion of chemotherapy and all toxicities are < or equal to grade 1 & enrollment on this protocol unless there is unequivocal evidence of progressive disease.
  -  Patients with Reproductive Potential: Patients must agree to practice effective birth control measures while on study and for 2 months after completing therapy
  Exclusion Criteria:
  -  Pregnant or breast feeding women or women or men with reproductive potential not practicing adequate contraception. This therapy may be associated with potential toxicity to the fetus or child that exceeds minimum risks necessary to meet health needs of mother
  -  Active infection requiring intravenous antibiotics
  -  Prior failure with either topotecan or temozolomide

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

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: 82-year-old male with glioma; genetic feature: BRAF

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: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Assessment of Suspected Intracranial Malignancy Using 3'-Deoxy-3'18 F-flourothymidine PET

Summary: The primary objective of this study is to detect and quantify tumor cells of high grade malignant gliomas and metastatic brain lesions both before and after initial surgical resection in a cohort of newly diagnosed patients.

Detailed description: In this study, 35 patients will be selected to undergoing sequential imaging with FLT-PET. Prior to surgical resection, patients will undergo a preliminary FLT-PET. Additional FLT scans for a maximum of four scans.

Eligibility: Inclusion Criteria:
  -  18 years or older
  -  Women must not be pregnant or breast feeding
  -  Histologic or strong radiologic suspicion of high grade malignant glioma or ogliometastatic tumor(s)
  Exclusion Criteria:
  -  May not have received previous therapy for their malignancy

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

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: 82-year-old male with glioma; genetic feature: BRAF

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: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: 10mg ZD4054 (Zibotentan) PK Study in Male, Elderly Chinese Patients With Advanced Solid Malignancies

Summary: The purpose of this study is to assess the pharmacokinetics of single and multiple doses of 10mg ZD4054 (Zibotentan) in male, elderly Chinese patients with advanced solid malignancies.


Eligibility: Inclusion Criteria:
  -  Provision of informed consent
  -  Histological and/or cytological confirmed advanced solid malignancies
  -  WHO performance status<2
  Exclusion Criteria:
  -  History of significant gastrointestinal impairment, as judged by the investigator, that could significantly affect the absorption of ZD4054 (Zibotentan) , including the ability to swallow the tablet whole.
  -  ALT or AST³2.5 ´ULRR. If liver metastases are present ALT or AST more than 5times ULRR, Serum bilirubin > 1.5 x ULRR, Serum creatinine>1.5 x ULRR or creatinine clearance of <50mL/min calculated by Cockroft-Gault
  -  Recent (<14 days) major surgery prior to entry into the study, or a surgical incision that is not fully healed, Radical radiotherapy within the previous 4 weeks, or unresolved acute or subacute toxicities from prior radiotherapy

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

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