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

Clinical trial: A Phase 2 Study of PLX3397 in Patients With Recurrent Glioblastoma

Summary: The objective of this study is to evaluate the response of subjects with recurrent glioblastoma to continuous therapy of PLX3397.


Eligibility: Inclusion Criteria:
  -  Male or female patients ≥18 years old with a life expectancy of at least 8 weeks
  -  Radiographically proven recurrent (≥ first relapse), intracranial GBM
  -  For all patients, availability of at least 10 unstained slides (or archival tumor block sufficient to generate at least 10 unstained slides) from any previous GBM surgery
  -  Previous treatment with external beam radiation and temozolomide chemotherapy
  -  Before the first dose of PLX3397,adequate recovery from toxicity of prior therapy as follows:
  >28 days for cytotoxic therapy >42 days for nitrosoureas >28 days for bevacizumab >7 days for non cytotoxic therapy such as interferon, tamoxifen, thalidomide, cis-retinoic acid, or erlotinib
  -  Women of child-bearing potential must have a negative pregnancy test within 7 days of initiation of dosing and must agree to use an acceptable method of birth control while on study drug and for 3 months after the last dose. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year. Men of child-bearing potential must also agree to use an acceptable method of birth control while on study drug.
  -  Karnofsky performance status of ≥60
  -  Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥1.0 x 109/L, Hgb >9 g/dL, platelet count ≥50 x 109/L, AST/ALT ≤2.5x ULN, creatinine ≤1.5x ULN)
  -  Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements
  Exclusion Criteria:
  -  Investigational drug use within 28 days of the first dose of PLX3397
  -  GBM progression within 3 months of previous radiation by RANO criteria
  -  History of Grade 2 (CTCAE v4) or greater acute intracranial hemorrhage
  -  Previous failure of bevacizumab or other VEGF therapy except in a first line setting
  -  History of malignant glioma with co-deletion of 1p/19q
  -  A concurrent active cancer that requires non-surgical therapy (e.g. chemotherapy, radiation, adjuvant therapy). Prior history of other cancer is allowed, as long as there was no active disease within the prior 3 years.
  -  Refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption
  -  Patients with serious illnesses, uncontrolled infection, medical conditions, or other medical history including abnormal laboratory results, which in the investigator's opinion would be likely to interfere with a patient's participation in the study, or with the interpretation of the results
  -  Women of child-bearing potential who are pregnant or breast feeding
  -  QTc ≥450 msec at Screening

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

Clinical trial: Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme

Summary: Glioblastoma multiforme (GBM) is the most common primary brain tumor in adults. The treatment comprises maximal safe resection followed by radiotherapy and chemotherapy. Despite appropriate management, 90% of the patients will develop relapse or progression. After progression, the median survival is 5.2 months (Stupp, 2009).
  The treatment of GBM relapse remains investigational. Reirradiation is an option in selected cases.
  The objective of this study is to compare 2 schemes of stereotactic hypofractionated radiotherapy in the management of recurrent GBM.


Eligibility: Inclusion Criteria:
  -  18 years of age or older
  -  KPS equal or greater than 60
  -  Anatomopathological confirmation of GBM
  -  Previous RT with therapeutic doses
  -  At least 5 months from the end of RT course
  -  Not a candidate to surgical resection
  -  Patients with partial resection after resection of recurrent GBM will be allowed
  -  Patients with local progression after resection of recurrent GBM will be allowed
  -  Lesion with a maximal 150cc volume, as defined by enhancing portion in contrast enhanced MRI
  -  Hemoglobin levels (Hb) equal or greater than 10ng/dl. Blood transfusions to correct the Hb will be allowed.
  Exclusion Criteria:
  -  Important comorbidities
  -  Concomitant chemotherapy
  -  Contraindication to MRI
  -  Brainstem glioma

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

Clinical trial: A Phase 2 Evaluation of TRC105 In Combination With Bevacizumab for the Treatment Of Recurrent or Progressive Glioblastoma That Has Progressed on Bevacizumab

Summary: The purpose of this study is to evaluate the safety and efficacy of TRC105 in patients with recurrent or progressive glioblastoma after prior antiangiogenic therapy (including anti-VEGF therapy)

Detailed description: Angiogenesis plays a central role in the progression of solid cancer. TRC105 is an antibody to CD105, an important non-VEGF angiogenic target on proliferating endothelial cells. TRC105 inhibits angiogenesis, tumor growth and metastases in preclinical models. TRC105 has been well tolerated in patients with glioblastoma (GBM) as a single agent. The combination of TRC105 in combination with bevacizumab has demonstrated activity in bevacizumab refractory cancer patients. We hypothesize that TRC105 when administered with bevacizumab will have activity in GBM patients who progress on bevacizumab. By targeting a non-VEGF pathway, TRC105 has the potential to complement VEGF inhibition by bevacizumab, which could represent a major advance in GBM therapy.

Eligibility: Inclusion Criteria:
  1. Patients with histologically confirmed glioblastoma, recurrent after prior external-beam fractionated radiotherapy and temozolomide chemotherapy.
  2. Patients with documented radiographic progression following bevacizumab therapy for treatment of glioblastoma.
  3. Patients with up to 3 prior recurrences are allowed.
  4. Karnofsky performance status ≥ 70%.
  5. Age ≥ 18 years old.
  6. Normal organ function
  Exclusion Criteria:
  -  Patients who have had previous treatment with TRC105.
  -  Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury
  -  Patients with cirrhosis, or active viral or nonviral hepatitis.
  -  Patients with active bleeding or pathologic conditions that carry a high risk of bleeding,(i.e. hereditary hemorrhagic telangiectasia).
  -  Patients who are currently receiving anticoagulation treatment
  -  Patients unwilling or unable to comply with the protocol

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

Clinical trial: A Phase 3 Study Comparing Dinaciclib Versus Ofatumumab in Patients With Refractory Chronic Lymphocytic Leukemia (P07714)

Summary: This study is being conducted to demonstrate the superiority in progression-free survival (PFS) of dinaciclib compared to ofatumumab in chronic lymphocytic leukemia (CLL) participants with del 17p or in the overall population who are refractory to either fludarabine treatment or chemoimmunotherapy.

Detailed description: Dinaciclib is a cyclin-dependent kinase (CDK) inhibitor, specific for CDK 1, 2, 5 and 9.

Eligibility: Inclusion Criteria:
  -  Aged 18 years or older
  -  Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)
  -  Fludarabine or chemoimmunotherapy refractory disease defined as: failing to respond to or relapsed within 6 months of completing fludarabine or another purine analog alone or in combination regimens, or failing to respond to chemoimmunotherapy or relapsed within 24 months of completing therapy with a combination of chemotherapy plus an anti-CD20 monoclonal antibody
  -  Eastern Cooperative Oncology Group (ECOG) Performance status 0, 1, or 2
  -  Adequate organ function and laboratory parameters
  -  Women of child-bearing potential who are not currently sexually active must
  agree to use a medically accepted method of contraception should they become
  sexually active while participating in the study
  Exclusion Criteria:
  -  Symptomatic brain metastases or primary central nervous system malignancy
  -  Treatment with a CYP3A4 inhibitor or inducer within 1 week prior to randomization, or any chemotherapy or biologic therapy within 4 weeks prior to randomization
  -  Known human immunodeficiency virus (HIV) infection or a known HIV-related
  malignancy
  -  Participants with with clinically active hepatitis B or C defined as disease that requires therapy
  -  Positive test for glucose-6 phosphate dehydrogenase (G6PD) deficiency
  -  Prior allogeneic bone marrow transplant
  -  Presence of Richter's transformation
  -  Indeterminate deletion 17p status
  -  Previous treatment with ofatumumab, dinaciclib, or other CDK inhibitors
  -  Active autoimmune anemia or thrombocytopenia unless stable, which is defined as being responsive to corticosteroids or other standard therapy

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

Clinical trial: Safety and Efficacy Study of Lucanthone When Used in Combination With Temozolomide(TMZ) and Radiation to Treat Glioblastoma Multiforme(GBM)

Summary: The purpose of the study is to determine the effectiveness of an investigational drug called lucanthone, when combined with temozolomide (TMZ) and radiation in the treatment of Glioblastoma Multiforme (GBM).

Detailed description: This is an international, multicenter, randomized, double blind placebo controlled phase II study to evaluate the safety and efficacy of lucanthone administered as an adjunct to patients receiving primary treatment of GBM with temozolomide and radiation. Eligible patients will be randomized to lucanthone or placebo arm in ratio of 1:1. The treatment period will be in two phases ; an initial six weeks of concomitant therapy with temozolomide and radiation, followed by a maintenance phase of six cycles of temozolomide given on Days 1 to 5 of a 28- day cycle (+/- 3 days). Lucanthone / placebo will be given as an add on in both concomitant and maintenance phases.

Eligibility: Main Inclusion Criteria:
  1. 18 and 70 years of age in India, 18 years and above in US
  2. Histologically proven GBM who
  -  May or may not have undergone surgery
  -  Is scheduled to receive treatment with temozolomide and radiation.
  3. Karnofsky score ≥ 70%.
  Main Exclusion Criteria:
  1. Diagnosis of recurrent brain tumor.
  2. Received temozolomide previously.
  3. Absolute neutrophil count ≤ 1.5 X 109/L.
  4. Screening platelet count < 100 K/uL.
  5. Screening bilirubin > 1.6 mg/dL.
  6. Screening creatinine > 2.25 mg/dL in men and 1.8 mg/dL in women.
  7. Screening ALT or AST > 2.5 times the upper limit of the laboratory reference range.
  8. Unstable medical condition or significant comorbid pathophysiology (e.g. active infection, poorly controlled diabetes, unstable angina, severe heart failure) that would interfere with his/her participation in the study.
  9. Enrolled, or plans to enroll, in a concurrent treatment protocol with another investigational product.
  10. Receiving, or plans to receive, an anti-cancer therapy other than temozolomide during the study.
  11. Received prior chemotherapy or radiation therapy within four weeks of enrollment.

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

Clinical trial: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of QGE031 in Japanese Atopic Male Subjects

Summary: This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of QGE031 in Japanese atopic male subjects in order to determine the eligibility of Japanese patients in subsequent clinical studies.


Eligibility: Inclusion Criteria:
  -  Male Japanese subjects who are atopic as determined by an in vitro test (CAP-RAST or MAST test)
  -  Serum IgE level must be equal to or greater than 30 IU/mL at screening.
  Exclusion Criteria:
  -  Poorly controlled asthma i.e. symptoms of asthma (daytime or night-time) or use of short-acting beta agonist for relief of asthma (except with exercise) more than once a week
  -  Worsening of asthma signs and symptoms prompting a medical intervention within 1 year prior to dosing
  -  Severe atopic dermatitis within 1 year prior to dosing, defined by a history of eruption with severe inflammation such as erythema, papule, erosion, infiltration and lichen
  -  Severe allergic rhinitis strongly disturbing daily life within 1 year prior to dosing
  -  Severe allergic conjunctivitis (e.g., episodes of giant papillary, limbal proliferation, shield ulcer) within 1 year prior to dosing
  -  Prior use of Xolair® or other anti-IgE antibodies
  -  Concomitant use of allergy vaccination therapy
  Other protocol-defined inclusion/exclusion criteria may apply.

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

Clinical trial: Resistance Exercise in Rheumatic Disease

Summary: People with rheumatic disease often have decreased strength, muscle mass, and bone mineral density due to repeated bouts of inflammation, normal effects of aging, disuse, and inactivity. The medications used to quell the disease process, such as prednisone, can also have detrimental effects on body composition, strength, and functional capacity. The investigators propose to investigate the feasibility, safety, and effects of resistance exercise in older patients with rheumatoid arthritis (RA) and vasculitis. The unique resistance protocol the investigators propose involves performing movements in a slow and controlled fashion (i.e., no acceleration or use of momentum in the lifting and lowering of the resistance) to minimize force on the joints and connective tissues. This will be conducted in an individually-supervised environment with a new generation of exercise equipment that will accommodate their musculoskeletal capabilities and allow for reproducibility of the exercise protocol. The investigators intend to investigate the feasibility, safety, musculoskeletal, and psychological effects of this resistance exercise protocol in older patients with rheumatoid arthritis and vasculitis by testing their strength, body composition, functional ability, mood, and quality of life before and after this 16-week resistance exercise intervention.


Eligibility: Inclusion Criteria:
  -  diagnosis of rheumatoid arthritis OR systemic vasculitis (defined as granulomatosis with polyangiitis, Churg-Strauss, microscopic polyangiitis, ANCA-associated vasculitis, or giant cell arteritis)
  Exclusion Criteria:
  -  Non-English speaking
  -  Pregnancy
  -  Absolute cardiac or pulmonary contraindication to exercise
  -  pacemaker

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

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

Clinical trial: A Phase 1 Trial of TST of PD 0332991 Followed by Cytarabine and Mitoxantrone for Adults With Relapsed and Refractory Acute Leukemias and High-Risk Myelodysplasia

Summary: 1.1 Primary Objectives
  -  To determine the feasibility, tolerability, and toxicities of administering the selective CDK 4/6 inhibitor PD 0332991 prior to the combination of ara-C and Mitoxantrone for adults with relapsed and refractory acute leukemias and high risk myelodysplasias (MDS), including primary refractory disease
  -  To determine the direct cytotoxic effects of single agent PD 0332991 on malignant blasts
  -  To determine the maximal tolerated dose (MTD) of PD 0332991 in timed sequential combination with ara-C and Mitoxantrone
  -  To determine if the timed sequential combination of PD 0332991 with ara-C and mitoxantrone can induce clinical responses in adults with relapsed or refractory acute leukemias and high-risk MDS
  1.2 Secondary Objectives:
  -  To determine the ability of PD 0332991 to directly induce apoptosis in malignant cell populations in vivo
  -  To obtain pharmacodynamic (PD) data regarding the ability of PD 0332991 to arrest malignant cells in the G 1 phase of cell cycle, followed by synchronized release of those cells into S phase upon discontinuation of PD 0332991 and resultant enhanced ara-C cytotoxicity


Eligibility: Inclusion Criteria:
  -  Adults age ≥ 18 years
  -  Multilineage bone marrow failure
  -  Serum creatinine ≤ 2.0 mg/dl
  -  Hepatic enzymes (AST, ALT) ≤ 3x upper limit of normal (ULN)
  -  Bilirubin ≤ 2.0 mg/dl, unless due to Gilbert's disease, hemolysis or leukemic infiltration
  -  Left ventricular ejection fraction ≥ 45%
  -  QTc ≤ 470 msec
  -  RB expression is required for the action of PD 0332991. Because rb deletions and mutations are rare in acute leukemias and MDS, screening for RB expression will not be required before enrollment. Pretreatment biopsies will be stored and analyzed for RB expression if needed subsequently.
  Exclusion Criteria:
  -  • No more than 5 cytotoxic regimens
  -  Previous allogeneic or autologous stem cell transplantation permitted
  -  ≥ 3 weeks delay from prior cytotoxic chemotherapy or radiation therapy
  -  ≥ 2 week delay from prior biologic therapies including hematopoietic growth factors and vidaza or decitabine
  -  If using Hydroxyurea, steroids, tyrosine kinase/src kinase inhibitors, arsenic, interferon for count control, must be off therapy for ≥ 48 hours prior to beginning PD 0332991
  -  No concomitant use of potent CYP450 3A4 inhibitors (e.g. triazole antifungal agents) or inducers (e.g. omperazole, dilantin, dexamethasone) within 7 days prior to beginning PD 0332991

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

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

Clinical trial: A Phase 1 Study Evaluating AMG 232 in Advanced Solid Tumors or Multiple Myeloma

Summary: First in human, open-label, sequential dose escalation and expansion study of AMG 232 in subjects with advanced solid tumors or multiple myeloma

Detailed description: Study Design: This is an open-label, dose exploration study evaluating AMG 232 in subjects with advanced p53WT solid tumors or multiple myeloma. The study will be conducted in 2 parts: Part 1 - Dose Exploration (parts 1a, 1b and 1c) and Part 2 - Dose Expansion. Part 1a is aimed at evaluating the safety, tolerability, PK and PD of AMG 232 and determining the MTD of a 7-day once daily (QD) dosing schedule in subjects with advanced solid tumors using a practical continuous reassessment method (CRM). Part 1b will evaluate the safety and tolerability of 3-day QD dosing schedule (or alternate dosing schedule based upon emerging data) with a particular emphasis on evaluating the tolerability of daily doses equal to or higher than the part 1a MTD in subjects with solid tumors or multiple myeloma. Part 1c will evaluate the safety and tolerability of 7-day twice daily (BID) dosing schedule with daily cumulative doses equal to or higher than the part 1a MTD in subjects with solid tumors. The dose expansion part of the study (Part 2) can open once the MTD has been determined in Part 1a. Part 2, part 1b and part 1c can be explored in parallel. The dose expansion part will consist of up to 85 additional subjects with specific tumors harboring MDM2 amplification (liposarcoma [LPS], gliobastoma [ GBM ] and all other solid tumors) or potentially harboring MDM2 overexpression (ER+ metastatic breast cancer) and a group of subjects with multiple myeloma.

Eligibility: Inclusion Criteria:
  -  Men or women > 18 years old
  -  Pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, or which no standard therapy is available, or the subject refuses standard therapy or multiple myeloma
  -  Willing to undergo pre-dose core needle tumor biopsies or bone marrow aspirate for subjects with multiple myeloma.
  -  Ability to take oral medications and willing to record daily adherance to investigational product
  -  Adequate hematological, renal, hepatic, and coagulation laboratory assessments
  Exclusion Criteria:
  -  Active brain metastases
  -  For solid tumor-History or presence of hematological malignancies unless curatively treated with no evidence of disease for greater than or equal to 5 years
  -  Active infection requiring intravenous (IV) antibiotics
  -  Anti-tumor therapy
  -  Therapeutic or palliative radiation therapy within 30 days of starting treatment
  -  Currently enrolled in another investigational device or drug study

Relevance to patient case: not relevant