araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: Trial of Hu5F9-G4 in Combination With Cetuximab in Patients With Solid Tumors and Advanced Colorectal Cancer

Summary: This trial will evaluate Hu5F9-G4 in combination with cetuximab. Hu5F9-G4 is a monoclonal antibody which is designed to block a protein called CD47, which is widely expressed on human cancer cells. Blocking CD47 with Hu5F9-G4 may enable the body's immune system to find and destroy the cancer cells. Cetuximab is a monoclonal antibody drug that is used for treatment of certain types of colorectal cancer as well as head and neck cancer.
  The major aims of the study are: (Phase 1b) to define the safety profile and to determine a recommended Phase 2 dose for Hu5F9-G4 in combination with cetuximab, and (Phase 2) to evaluate the objective response rate of Hu5F9-G4 in combination with cetuximab in patients with advanced colorectal cancer.


Eligibility: Inclusion Criteria:
  -  Histological Diagnosis
  -  Phase 1b only: Advanced solid malignancy with an emphasis on colorectal, head and neck, breast, pancreatic and ovarian cancers who have been treated with at least one regimen of prior systemic therapy, or who refuse systemic therapy, and for which there is no curative therapy available.
  -  Phase 2:
  -  KRAS Mutant CRC: Advanced KRAS mutant CRC who have progressed or are ineligible for both irinotecan and oxaliplatin based chemotherapy
  -  KRAS Wild Type CRC: Advanced KRAS wild type CRC who have progressed or are ineligible for both irinotecan and oxaliplatin based chemotherapy and who are relapsed or refractory to at least 1 prior systemic therapy that included an anti-EGFR antibody, such as cetuximab, panitumumab or others.
  -  Adequate performance status and hematological, liver, and kidney function
  -  Phase 2 only: Willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor biopsy
  Exclusion Criteria:
  -  Active brain metastases
  -  Prior treatment with CD47 or signal regulatory protein alpha (SIRPα) targeting agents.
  -  Phase 2 only: second malignancy within the last 3 years.
  -  Known active or chronic hepatitis B or C infection or HIV
  -  Pregnancy or active breastfeeding

Relevance to patient case: not relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer.

Summary: Rivaroxaban or placebo for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer: a randomized, double blind, placebo-controlled study.


Eligibility: Inclusion Criteria:
  -  Objective diagnosis of colorectal cancer;
  -  Elective laparoscopic surgery for colorectal cancer
  -  Whatever the stage of cancer
  -  Antithrombotic prophylaxis with LMWH administered for 7±2 days after surgery
  Exclusion Criteria:
  -  Age < 18 years
  -  Surgery for non-cancer disease
  -  Duration of surgery < 45 min
  -  Conversion to open surgery
  -  Other indication for anticoagulant therapy
  -  Known cerebral metastases
  -  Kidney or liver failure
  -  Known hemorrhagic diathesis or high risk for bleeding
  -  History of intracerebral bleeding or neurosurgery within 6 months
  -  History of heparin induced thrombocytopenia
  -  Pregnancy or lactation
  -  Refusal of informed consent.

Relevance to patient case: not relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: Dysplasia in Inflammatory Chronic Idiopathic Colitis Long-standing

Summary: Chronic intestinal inflammation produce dysplasia more frequently than the normal population. The therapies protect against these changes, but do not rule out dysplasia. It is not known the effect of different therapies protection.

Detailed description: The literature data show that the inflammatory bowel diseases (rectal ulcerative colitis and Crohn's disease) determine an increased risk of developing dysplasia and cancer of the colon and rectum, for the chronic inflammation that they fee, with the differences that the two diseases arise. The progression from normal mucosa to dysplasia and then to cancer is more rapid than in the adenoma-carcinoma sequence.
  In patients with idiopathic chronic inflammatory colitis drug therapies in use reduce the incidence of dysplasia.
  A systematic review concluded in favor of a chemo preventive effect of mesalazine. In any case, it has been reported protective association between use of mesalazine and cancer associated with colitis (colitis Associated carcinoma CAC) with an odds ratio of 0.51 per CAC / dysplasia. This data, in subsequent studies, including recent ones, have remained controversial.
  The introduction of biological drugs in the treatment of patients with inflammatory bowel disease (IBD) has changed the quality of life and also the natural history of the disease. It is not known what biological drugs have improved the clinical history of these diseases by changing the incidence of dysplasia and colorectal cancer.
  The treatment of idiopathic inflammatory bowel diseases (IBD), the last decade has seen profound changes and, now, the use of biological drugs is frequent in the moderate-severe forms, especially if extended. Mesalazine has in the indication of mild to moderate forms of therapy.

Eligibility: Inclusion Criteria:
  -  long standing colonic inflammatory bowel disease
  -  clinical, endoscopic and histological remission
  -  completeness of data
  Exclusion Criteria:
  -  important comorbidities
  -  family history of colorectal cancer
  -  insufficient data

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer

Summary: The purpose of this open label, two stage, phase II study is to evaluate the efficacy and tolerability of ZD6474 in patients with locally advanced or metastatic hereditary medullary thyroid carcinoma.


Eligibility: Inclusion Criteria:
  -  Locally advanced or hereditary medullary thyroid cancer
  -  Signed informed consent
  -  One or more measurable lesions
  Exclusion Criteria:
  -  Brain metastases or spinal cord compression
  -  Specific laboratory ranges
  -  Specific heart problems
  -  Prior chemotherapy and/or radiation therapy
  -  Participation in other trials within 30 days

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer

Summary: RATIONALE: Drugs used in chemotherapy, such as irinotecan, 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 irinotecan works in treating patients with metastatic or inoperable thyroid cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the response rate in patients with metastatic or inoperable locoregional medullary thyroid cancer treated with irinotecan.
  Secondary
  -  Determine the safety and tolerability of this drug in these patients.
  OUTLINE: Patients receive irinotecan IV on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Response is assessed after completion of 4 courses. Patients achieving complete response (CR) or partial response (PR) receive 2 additional courses beyond CR or PR. Patients who have stable disease receive up to 12 total courses.
  PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed medullary thyroid cancer
  -  Metastatic or inoperable locoregional disease
  -  Measurable disease by CT scan
  -  Patients with elevated calcitonin levels as the only measurement of disease are not eligible
  PATIENT CHARACTERISTICS:
  Age
  -  18 and over
  Performance status
  -  ECOG 0-1
  Life expectancy
  -  Not specified
  Hematopoietic
  -  Granulocyte count > 1,000/mm^3
  -  Platelet count > 100,000/mm^3
  Hepatic
  -  Bilirubin < 1.5 mg/dL
  -  ALT and AST < 2.5 times upper limit of normal
  -  No unstable or uncompensated hepatic disease
  Renal
  -  Creatinine clearance > 60 mL/min
  -  No unstable or uncompensated renal disease
  Cardiovascular
  -  No unstable or uncompensated cardiovascular disease
  Pulmonary
  -  No unstable or uncompensated respiratory disease
  Other
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  No diarrhea ≥ grade 2 (antidiarrheals allowed)
  -  No other severe or uncontrolled systemic disease
  -  No other malignancy within the past 5 years except squamous cell or basal cell skin cancer or cervical cancer
  -  No other illness that would preclude study participation
  -  No other significant clinical disorder or laboratory finding that would preclude study participation
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  More than 3 months since prior biologic therapy
  Chemotherapy
  -  More than 3 months since prior chemotherapy
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  No prior radiotherapy to > 25% of bone marrow
  -  More than 3 months since prior radiotherapy
  Surgery
  -  Recovered from prior oncologic or other major surgery
  Other
  -  More than 30 days since prior non-approved or investigational drugs

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Study of XL184 (Cabozantinib) in Adults With Advanced Malignancies

Summary: The purpose of this study is to determine the best and safest dose of XL184 administered orally. XL184 is a new chemical entity that inhibits VEGFR2, MET and RET, kinases implicated in tumor formation, growth and migration. To determine the highest safe dose, subjects will receive different amounts of the drug. The first group of subjects will receive the lowest dose of XL184. As long as no medically unacceptable side effects are noted, the dose will be increased for the next group. When the maximum tolerated dose (MTD) is reached, at least 20 subjects with Medullary Thyroid Cancer (MTC) will be enrolled to evaluate the effect of XL184 in this population.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed advanced malignancy (solid tumor or lymphoma) that is metastatic or unresectable for which standard curative measures do not exist or are no longer effective
  -  Eastern Cooperative Oncology Group (ECOG) performance status </= 2
  -  Life expectancy greater than 3 months
  -  Adequate organ and marrow function
  -  Written informed consent
  -  Use of acceptable methods of contraception during the course of the study and for 3 months after completion of study
  -  In the MTD expanded cohort: at least 20 subjects with metastatic and/or advanced/locally recurrent Medullary Thyroid Cancer not appropriate for surgical resection with measurable disease as defined by RECIST
  Exclusion Criteria:
  -  Chemotherapy, immunotherapy or radiation within 4 weeks (or nitrosoureas or mitomycin C within 6 weeks) before the first scheduled dose of XL184
  -  Administration of an investigational drug within 30 days of the first dose of XL184
  -  Subject has not recovered from adverse events due to investigational agents or other medications administered more than 4 weeks before study enrollment
  -  Known brain metastases
  -  Uncontrolled intercurrent illness
  -  Pregnancy or breastfeeding
  -  Known HIV positive
  -  Known allergy or hypersensitivity to any of the components of the XL184 formulation

Relevance to patient case: definitely relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Open-label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind Trial

Summary: The purpose of this study is to evaluate the safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures, who completed the VRX-RET-E22-301 double-blind study. The efficacy of long-term treatment with retigabine and patient quality of life will also be assessed.

Detailed description: This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind VRX-RET-E22-301 trial. Patients who have completed the VRX-RET-E22-301 trial and who meet inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation. Treatment will be continued until retigabine is commercially available, or until the program is discontinued. Patients will be recruited from 45-50 sites in the United States, Canada, Mexico, Brazil, and Argentina. The safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures will be evaluated. In addition, the efficacy of long-term treatment with retigabine and patient quality of life will be assessed.

Eligibility: Inclusion Criteria:
  -  Patient has successfully completed the Maintenance and Transition phases of Study VRX-RET-E22-301 for the treatment of partial-onset seizures
  -  Patient is expected to benefit from participation in the study in the opinion of the Investigator.
  Exclusion Criteria:
  -  Patient meets any of the withdrawal criteria in the previous VRX-RET-E22-301 study or is experiencing an ongoing serious adverse event.
  -  Patient is receiving any investigational drug or using any experimental device in addition to Retigabine for treatment of epilepsy or any other medical condition.
  -  Patient has any other condition that would prevent compliance with the study procedures or proper reporting of adverse events.

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: A Study To Assess ZD6474 (ZACTIMA™) Monotherapy In Locally Advanced or Metastatic Hereditary Medullary Thyroid Cancer

Summary: This will be a Phase II, open label study to establish the effect of once-daily oral doses of ZD6474 100mg in subjects with locally advanced or metastatic hereditary medullary thyroid cancer in whom no standard therapeutic option is available.


Eligibility: Inclusion Criteria:
  -  Provision of written informed consent
  -  Previously confirmed histological diagnosis of locally advanced or metastatic hereditary medullary thyroid carcinoma without standard therapeutic options
  -  Aged 18 or over and a life expectancy of more than 12 weeks
  Exclusion Criteria:
  -  The last dose of prior chemo/radiation received less than 4 weeks before the start of study therapy
  -  Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age, history of arrhythmia

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: A Study of ARQ 171 in Patients With Advanced Solid Tumors

Summary: This is an open label, dose escalation study of ARQ 171 administered via intravenous infusion (IVI) into a peripheral vein weekly.
  Patients with advanced solid tumors, who are refractory to available therapy or for whom no standard systemic therapy exists, will be enrolled.


Eligibility: Inclusion Criteria:
  -  Signed written informed consent must be obtained and documented prior to study-specific screening procedures.
  -  A histologically or cytologically confirmed advanced solid tumor
  -  ≥ 18 years of age
  -  Measurable disease as defined by Response Evaluation Criteria in Solid Tumors
  -  Karnofsky performance status ≥ 70%
  -  Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after participation.
  -  Females of childbearing potential must have a negative serum pregnancy test.
  -  Laboratory results must meet study criteria.
  Exclusion Criteria:
  -  Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first infusion
  -  Surgery within 4 weeks prior to first infusion
  -  Known untreated brain metastases
  -  Pregnant or breastfeeding
  -  Uncontrolled intercurrent illness, or uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements
  -  Other cancer within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma

Summary: Phase II clinical trial assessing efficacy and toxicity of pretargeted radioimmunotherapy using anti-CEAxanti-DTPA bispecific antibody and di-DTPA-131I peptide in patients with reccurrence of medullary thyroid carcinoma (abnormal calcitonin level and biomarkers doubling time lower than 5 years)


Eligibility: Inclusion Criteria:
  -  18 -75 years
  -  Karnofsky ≥ 70%
  -  Histological diagnosis of medullary thyroid carcinoma
  -  Calcitonin serum level Ê 100 pg/ml and Calcitonin or CEA doubling time £ 5 years
  -  Normal liver and renal functions
  -  Granulocytes ≥ 1500/mm3 and platelets ≥ 150 000/mm3
  -  No immunization
  -  Consent form signed

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Elucidating the Genetic Basis of the Pleuropulmonary Blastoma (PPB) Familial Cancer Syndrome

Summary: Pleuropulmonary Blastoma (PPB) is a rare lung tumor which develops in childhood. The underlying genetic factors which contribute to the development and progression of PPB are not defined. We are working to identify the genetic factors which may contribute to the development of this rare tumor.

Detailed description: Studies of inherited cancer syndromes have provided unique opportunities to uncover and explain important cellular pathways with broad relevance to both sporadic cancers and human development. This proposal studies the cancer predisposition syndrome originally described as a familial form of pleuropulmonary blastoma (PPB). PPB is a rare, aggressive lung cancer that affects young children. Children with PPB and/or their family members are at increased risk for a number of rare conditions, including Wilms tumor, rhabdomyosarcoma, brain tumors, ovarian tumors and nodular hyperplasia of the thyroid gland. In 2009, we mapped a PPB locus and identified germline, loss of function mutations in one copy of DICER1 as the genetic basis of this syndrome. DICER1 encodes a protein that performs the final critical step in maturation of microRNAs (miRNAs). miRNAs are an important form of gene regulation. The syndrome's varied nature is likely attributable to the various roles of miRNAs during different developmental and/or functional circumstances. This study focuses on defining the full phenotype of this cancer predisposition syndrome including penetrance, expressivity in children and adults, pathologic classification of disease and spectrum of predisposing DICER1 mutations. Improved understanding of the clinical and genetic features of this cancer predisposition syndrome is essential to facilitate early diagnosis when the diseases are most curable, and to create genetic counseling and educational materials to guide medical care.

Eligibility: Inclusion Criteria:
  -  Child or adult diagnosed with pleuropulmonary blastoma, cystic nephroma, embryonal rhabdomyosarcoma of uterine cervix, ovarian Sertoli-Leydig tumor or gynandroblastoma, pineoblastoma, pituitary blastoma, nasal chondromesenchymal hamartoma, medulloepithelioma, Wilms tumor, germline or mosaic DICER1 mutation
  Exclusion Criteria:
  -  child or adult who does not fit inclusion criteria as listed above

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Sorafenib and Bevacizumab in Combination With Paclitaxel in Patients With Solid Tumors

Summary: The purpose of this study is to evaluate the safety and tolerability and describe the maximum tolerated dose (MTD) of treatment with escalating doses of sorafenib in combination with bevacizumab and paclitaxel for patients with advanced solid tumors.


Eligibility: Inclusion Criteria:
  -  Histological or cytological diagnosis of a solid tumor with evidence of residual, recurrent, or metastatic disease. Patients must be incurable by surgical or other standard available therapy
  -  Measurable or evaluable disease; tumor size of ≥ 2 cm on CT scan
  -  Patients may have received prior standard taxane therapy or anti-VEGF therapy, but may not have progressed on both therapies. Progression on one type therapy (either taxane or anti-VEGF) is allowed
  Exclusion Criteria:
  -  History or presence of central nervous system (CNS) disease (i.e., primary brain tumor, malignant seizures, CNS metastases or carcinomatous meningitis).
  -  Prior chemotherapy ≤ 3 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
  -  Prior biologic or immunotherapy ≤ 3 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
  -  Prior full pelvic field radiotherapy ≤ 4 weeks or limited field radiotherapy ≤ 2 weeks prior to randomization. Patients must have recovered to less than or equal to grade 1 from all therapy-related toxicities except alopecia. The site of previous radiotherapy should have evidence of progressive disease if this is the only site of evaluable disease
  -  Major surgery (i.e., laparotomy) ≤ 4 weeks prior to randomization or anticipation of need for major surgical procedure during the course of the study
  -  Minor surgery ≤ 2 weeks prior to randomization. Insertion of a vascular access device is not considered major or minor surgery in this regard. Patients must have recovered from all surgery-related toxicities
  -  Peripheral neuropathy with functional impairment ≥ Common Terminology Criteria (CTC) grade 2 neuropathy, regardless of causality
  -  Pleural effusion or ascites that causes respiratory compromise (≥ CTC grade 2 dyspnea)
  -  Concurrent severe and/or uncontrolled cardiac, vascular or infectious conditions (as described in the protocol) which could compromise participation in the study
  -  Patients at risk of QT prolongation such as patients with congenital long QT syndrome or with long corrected QT (QTc) at baseline (i.e. QTc greater than 450 msec in males, and greater than 470 msec in females) will be excluded
  -  Lung carcinoma of squamous cell histology (mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible; sputum cytology alone is not acceptable).

Relevance to patient case: not relevant