araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Trial of Therapeutic Vaccine in Patients With Cholangiocarcinoma

Summary: Cholangiocarcinoma (CCA) is a malignant neoplasm originating from the epithelial cells lining the intra- or extrahepatic biliary ducts. It is the second-most common liver cancer, after hepatocellular carcinoma (HCC). About 6,000 people in the United States develop bile duct cancer each year. One-year survival is less than 25% and no effective and safe systemic treatments are currently available. Last year the completion of open-label phase 2 trial (NCT02256514) of hepcortespenlisimut-L (V5) has been reported, which has shown that two-third of Mongolian patients with advanced HCC had a favorable clinical response, including complete remissions and with overall survival over 90% after 1 year. So far a few patients with CCA were treated with V5, but it appeared that their response rate was somewhat inferior to patients with HCC since two (both with hemochromatosis) out six patients died within 6 months. In one patient who had improved clinically, the improvement was correlated with decrease in CA19-9 tumor marker, but no marker profile information is available in regard to other CCA patients. As V5 tablets are made from pooled blood of patients with HCC, in theory, they will be not very useful to patients with CCA. The goal of this project is to manufacture an immunotherapeutic formulation made from pooled heat- and chemically-inactivated blood from donors with CCA and initiate pilot open-label trial in 20 cholangiocarcinoma patients. This clinical trial will be conducted in collaboration with the National Cancer Center.

Detailed description: Upon obtaining regulatory and ethical approvals the Phase II single-arm study will be initiated at the NCC involving 20 patients with confirmed CCA diagnosis. The trial will be short, it will last only 2 months, but this will be sufficient to gauge the safety and efficacy. Only those patients who have higher than normal levels of CA19-9 tumor marker will be enrolled, which will serve as a surrogate marker in a manner alpha fetoprotein (AFP) has been used as a predictor of clinical response in HCC patients. Additional primary endpoints will be overall survival and changes in tumor burden, with secondary endpoints being liver function tests and changes in quality of life.

Eligibility: Inclusion Criteria:
  -  only those positive for CA19.9
  Exclusion Criteria:
  -  pregnant and lactating females

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Exercise Duration Models, in Middle-aged Men

Summary: Duration of exercise is an important factor among the medical guides for weight loss. However, there is still little knowledge about other its models in middle-aged and older men. The present study aimed to determine the effects of the interval training on weight loss and lipid profile, and to compare its efficiency with the continuous training.

Detailed description: Participants included sedentary men (age 45-75 years) with overweight or obesity (n= 82). They were randomly divided into two groups including continuous exercise, and interval exercise. The weight assessment parameters including change in weight and body composition, blood sample tests were performed pre- and three month post-intervention.

Eligibility: Inclusion Criteria:
  -  Sedentary lifestyle
  -  Good Health
  -  Weight stability
  Exclusion Criteria:
  Abnormality or history of Disease

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: A Study of Cisplatin or Carboplatin With Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Patients With Resected or Ablation Intra-Hepatic Cholangiocarcinoma

Summary: Compare the efficacy of adjuvant chemotherapy with Cisplatin or Carboplatin and Gemcitabine versus Gemcitabine in patients with resected or ablated intra-hepatic cholangiocarcinoma.

Detailed description: Phase III, multicenter, open label, randomized study of Cisplatin or Carboplatin with Gemcitabine versus Gemcitabine alone as adjuvant therapy in patients with resected or ablated intra-hepatic cholangiocarcinoma. Subjects will be randomized in a 1:1 fashion to Cisplatin or Carboplatin with Gemcitabine versus Gemcitabine alone.

Eligibility: Inclusion Criteria:
  -  At least 18 years of age, of any race or sex who are eligible to sign written consent and have undergone prior resection of histological evidence of intrahepatic cholangiocarcinoma
  -  Hematologic function: ANC ≥ 1.5 x 10 /L, platelets ≥ 75 x 10 /L, and hemoglobin > 9 g/dL
  -  Adequate liver function as measured by: total bilirubin ≤ 2.0 mg/dl, AST and ALT ≤ 5 ULN, albumin ≥ 2.5 g/dl
  -  Adequate renal function as measured by: creatinine ≤ 2.9 mg/dl, > 50 ml/min calculated by the C-G equation
  -  Non-pregnant women of child bearing potential and fertile men are required to use effective contraception (negative pregnancy test for women of child-bearing age)
  -  ECOG status ≤ 1 at screening
  Exclusion Criteria:
  -  Subjects will be eligible for the study if they meet all inclusion criteria

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Noninvasively Predicting Gene Status of Glioma

Summary: Malignant gliomas are the most common and deadly primary brain tumors in adults. The clinical outcome of patients with glioblastoma depends on key molecular genetic alteration. Specifically, Isocitrate Dehydrogenase Gene Mutation, an independent favorable prognostic factor, serve as diagnostic and prognostic markers of glioma. Thus, accurate grading of a glioma is fundamental in order to determine the treatment strategy. Amide proton transfer (APT) imaging is a noninvasive molecular MRI technique based on chemical exchange saturation transfer mechanism that detects endogenous mobile proteins and peptides in biological tissues. Preliminary studies have shown that APT-weighted (APTw) signal intensity could serve as a new imaging biomarker, by revealing significantly higher signal intensities in the high-grade gliomas compared with the low-grade gliomas. The purpose of this study was to investigate the value of amide proton transfer imaging (APT) in the noninvasive evaluation of isocitrate dehydrogenase (IDH) gene status in glioma.

Detailed description: Materials and Methods:
  The whole brain MRI examinations were performed on a 3.0-T MRI system (Discovery MR750, General Electric Medical System, Milwaukee, WI, USA) with an eight-channel head coil (General Electric Medical System). Conventional MRI, contrast-enhanced MRI, DWI and amide proton transferimaging were performed in regular sequence during the same examination. Finally, contrast-enhanced T1-weighted spin echo sequence was acquired in the transverse, sagittal, and coronal planes after intravenous administration of 0.01 mmol/kg gadodiamide (Omniscan; GE Healthcare, Co. Cork, Ireland).
  MRI data processing and image analysis:
  All data were transferred to a workstation (Advantage Workstation 4.6, General Electric Medical System, Milwaukee, Wisconsin, USA) for processing.The MR imaging of all the patients were assessed independently by two experienced neuroradiologist (HYC and YLF, who have 12 and 6 years of experience, respectively, in neurologic-oncologic imaging) who were blinded to the patient's information. Next, a region of interest (ROI) was drawn manually on the solid part of the tumor with the relatively higher signal intensity on APT image.
  Statistical analysis:
  Categorical data obtained from image were calculated using the Fisher's exact test. Quantitative data were denoted as the mean and standard deviation. The Kolmogorov-Smirnov (K-S) test was used to assess the normality of data distribution.APT-weighted (APTw) signal intensity were tested for differences between the IDH mutation and the IDH wild-type by using independent sample t test.

Eligibility: Inclusion Criteria:
  -  no hypertension or cerebral vascular diseases
  -  no use of corticosteroid drugs
  -  no MRI contraindication
  -  no allergic constitution
  Exclusion Criteria:
  -  pregnant wowan
  -  motion cause poor image quality

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors

Summary: The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors.
  The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas.
  Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarcinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule).
  Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumor's objective response rate. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses.
  Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue may also be collected for review and biomarkers.


Eligibility: Inclusion Criteria:
  -  Availability of tumor tissue for mesothelin expression testing
  -  Histologically-confirmed, mesothelin-expressing metastatic or advanced non-metastatic disease (tumour type specific inclusion criteria)
  -  At least one measurable lesion according to either Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or International Thymic Malignancy Interest Group (ITMIG) modified RECIST 1.1 as applicable
  -  Adequate bone marrow, liver, renal and coagulation function
  -  Left ventricular ejection fraction (LVEF) ≥ 50% of the lower limit of normal (LLN) according to local institutional ranges
  -  Eastern Cooperative Oncology Group (ECOG) 0 or 1
  Exclusion Criteria:
  -  More than one prior anti-tubulin/microtubule agent
  -  Corneal epitheliopathy or any eye disorder that may predispose the patients to this condition
  -  Symptomatic Central nervous system (CNS) metastases and/or carcinomatous meningitis
  -  Contraindication to both CT and MRI contrast agents
  -  Active hepatitis B or C infection
  -  Pregnant or breast-feeding patients
  -  Tumor type specific exclusion criteria

Relevance to patient case: not relevant
Patient case: 18-year-old male with anaplastic large cell lymphoma; genetic feature: ALK

Clinical trial: Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma

Summary: RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
  PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients with refractory anaplastic large cell lymphoma or Hodgkin's lymphoma.

Detailed description: OBJECTIVES:
  -  Determine the safety and tolerability of multiple doses of monoclonal antibody HeFi-1 in patients with CD30+ anaplastic large cell lymphoma or Hodgkin's lymphoma.
  -  Determine the pharmacokinetics of this drug in this patient population.
  -  Evaluate the efficacy, in terms of correlating immunologic parameters and immunogenicity, of this drug in these patients.
  OUTLINE: This is an open-label, dose-escalation study.
  Patients receive monoclonal antibody HeFi-1 IV over 30 minutes 3 times a week for 2 weeks. Treatment may continue for 2 additional weeks in the absence of anti-HeFi-1 response. Responding patients may continue treatment at monthly intervals for one year.
  Cohorts of 3-4 patients receive escalating doses of monoclonal antibody HeFi-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4 patients experience dose-limiting toxicity.
  Patients are followed monthly.
  PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed CD30+ anaplastic large cell lymphoma (ALCL) or Hodgkin's lymphoma
  -  At least 50% of malignant cells must react with HeFi-1
  -  HIV positive or HIV negative
  -  Measurable disease
  -  No symptomatic CNS disease
  -  Must have failed or be ineligible for standard chemotherapy regimen
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  Not specified
  Life expectancy:
  -  More than 2 months
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  No significant hepatic disease
  -  Bilirubin no greater than 2 mg/dL
  Renal:
  -  No significant renal disease
  -  Creatinine no greater than 3 mg/dL
  Cardiovascular:
  -  No significant cardiovascular disease
  Pulmonary:
  -  No significant pulmonary disease
  Other:
  -  No significant endocrine, rheumatologic, or allergic disease
  -  No active clinical disease caused by cytomegalovirus (CMV), herpes simplex virus (HSV) I, HSV II, hepatitis B, or tuberculosis
  -  Not pregnant
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No prior murine antibody therapy
  Chemotherapy:
  -  See Disease Characteristics
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  At least 4 weeks since prior radiotherapy to measurable disease
  Surgery:
  -  Not specified
  Other
  -  At least 4 weeks since prior cytotoxic therapy to measurable disease

Relevance to patient case: not relevant
Patient case: 18-year-old male with anaplastic large cell lymphoma; genetic feature: ALK

Clinical trial: Bone Marrow and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

Summary: RATIONALE: Bone marrow and peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells.
  PURPOSE: Phase I trial to study the effectiveness of bone marrow and peripheral stem cell transplantation in treating patients who have hematologic cancer.

Detailed description: OBJECTIVES:
  -  Determine the toxicity of unmanipulated bone marrow augmented with CD34+ enriched peripheral blood stem cells in patients with hematologic malignancies undergoing allogeneic transplantation.
  -  Evaluate this treatment regimen in terms of kinetics of hematopoietic engraftment, infection, severity of graft-vs-host disease, relapse rate, and cost effectiveness in this patient population.
  OUTLINE: Patients undergo allogeneic transplantation comprising unmanipulated bone marrow with filgrastim (G-CSF)-mobilized, CD34+ enriched peripheral blood stem cells on day 0.
  Patients receive graft-vs-host disease prophylaxis comprising cyclosporine IV over 24 hours on day -1 and methylprednisolone IV or oral prednisone daily on days 7-65. Patients also receive G-CSF subcutaneously daily until blood counts recover.
  Patients are followed weekly for 3 months, at 6 months and 1 year, and then annually for 5 years.
  PROJECTED ACCRUAL: A total of 30-60 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosed hematologic malignancy that is eligible for an active allogeneic bone marrow transplantation protocol and leukemia, lymphoma, myeloma, and aplastic anemia treatment protocols
  -  HLA-identical or one antigen-mismatched related donor
  PATIENT CHARACTERISTICS:
  Age:
  -  10 to 65
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  No known sensitivity to E. coli derivatives
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 18-year-old male with anaplastic large cell lymphoma; genetic feature: ALK

Clinical trial: Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies

Summary: Phase I study to define the safety profile and pharmacokinetic parameters of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies. This is a single-arm, open-label, Phase I dose escalation study designed to define the MTD, PK, immunogenicity and anti-tumor activity of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies.


Eligibility: Inclusion Criteria:
  -  Patients must have histologically confirmed CD30-positive hematologic malignancy.
  -  Patients with HL must have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy after initial radiotherapy for early stage disease and were ineligible for, refused treatment by, or previously received stem cell transplant.
  -  Patients must have measurable disease of at least 10mm as documented by radiographic technique.
  -  Must be at least 18 years of age.
  Exclusion Criteria:
  -  Patients with current diagnosis of pcALCL (systemic ALCL eligible).
  -  Patients with history of allogeneic stem cell transplant.
  -  Patients who have had previous treatment with any anti-CD30 antibody.

Relevance to patient case: not relevant
Patient case: 18-year-old male with anaplastic large cell lymphoma; genetic feature: ALK

Clinical trial: A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer

Summary: PF-02341066 may work in cancer by blocking the cell growth, migration and invasion of tumor cells. PF-02341066 is a new class of drugs called c-Met/Hepatocyte growth factor receptor tyrosine kinase inhibitors. This compound is also an inhibitor of the anaplastic lymphoma kinase (called ALK) tyrosine kinase and ROS receptor tyrosine kinases. This research study is the first time PF-02341066 will be given to people. PF-02341066 is taken by mouth daily.


Eligibility: Inclusion Criteria:
  -  Advanced malignancies (except leukemias), histologically proven at diagnosis; Histologically confirmed advanced malignancies that are known to be sensitive to PF-03241066 inhibition, e.g. ALK, c-MET and ROS
  -  Solid tumors must have measurable disease (Recommended Phase 2 Dose Cohort patients with non-measurable disease may enter on a case-by-case basis); not required for DDI sub-studies.
  -  Adequate blood cell counts, kidney function, liver function and Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 (for the Recommended Phase 2 Cohort, a ECOG score of 2 may be allowed on a case-by-case basis)
  Exclusion Criteria:
  -  Major surgery, radiation therapy or anti-cancer therapy within 2 to 4 weeks of starting study treatment, depending on the patient cohort
  -  Prior stem cell transplant except of patients with neuroblastoma, lymphoma or myeloma
  -  Active or unstable cardiac disease or heart attack within 3 months of starting study treatment

Relevance to patient case: not relevant
Patient case: 18-year-old male with anaplastic large cell lymphoma; genetic feature: ALK

Clinical trial: Phase 1 Study of MDX-1401 in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma

Summary: To establish the safety and tolerability profile of MDX-1401 in patients with relapsed or refractory Hodgkin's Lymphoma (HL).


Eligibility: Inclusion Criteria:
  -  Diagnosis of CD30-positive HL by immunohistochemistry or flow cytometry
  -  Must have failed or relapsed following second line chemotherapy or radiation or failed/relapsed following autologous stem cell transplant
  -  Bi-measurable disease
  -  ECOG Performance Status of 0 - 2
  -  Meet all screening laboratory values
  Exclusion Criteria:
  -  Previous treatment with any other anti-CD30 antibody
  -  History of allogeneic transplant
  -  Any tumor lesion greater than or equal to 10 cm in diameter
  -  Any active or chronic significant infection
  -  Underlying medical condition which will make the administration of MDX- 1401 hazardous
  -  Concomitant corticosteroids, chemotherapy, investigational agents, other anti-HL biologics, or radiation therapy

Relevance to patient case: not relevant
Patient case: 18-year-old male with anaplastic large cell lymphoma; genetic feature: ALK

Clinical trial: Pilot Study of dMRI as a Tool for Early Evaluation of Tumor Response in Diffuse Large B-cell Lymphoma

Summary: This research study is designed to test whether the results of a diffusion MRI scan performed after one cycle of chemotherapy for lymphoma can accurately predict the outcome of treatment for individual patients.

Detailed description: Different types of functional imaging are under investigation as a tool to predict response to treatment, as imaging soon after starting therapy might be able to better define the likelihood of response. Functional imaging refers to scans that measure characteristics other than size and shape (anatomic imaging), as measured by CT scans. We are interested in evaluating the potential value of diffusion Magnetic Resonance Imaging (dMRI), which in some settings can be used very early in treatment in predicting patients' response to treatment.
  Diffusion MRI (dMRI) detects changes in cell structure, and has the potential to detect and measure cell changes that occur in response to treatment. Several groups are investigating the use of dMRI to monitor treatment responses. This strategy has been most frequently explored in humans in patients with brain tumors, where dMRI has been demonstrated to predict response to treatment early after starting treatment. A few studies have looked at response in other cancers. These studies showed early changes in patients who later responded to treatment, with changes seen within one to 2 weeks.
  Although diffusion MRI has been shown to be useful in several cancer types, it has not been explored in the evaluation of lymphoma. This pilot study will evaluate the imaging characteristics of Diffuse Large B-Cell Lymphoma (DLBCL) by dMRI prior to treatment and 7 days after initial chemotherapy in order to explore whether dMRI is useful in evaluating the response of lymphoma to chemotherapy.

Eligibility: Inclusion Criteria:
  -  Patients with a new diagnosis of CD20 Positive diffuse large B cell lymphoma (LBCL) of any stage, including subtypes mediastinal large B cell, centroblastic, immunoblastic, T cell rich B cell and anaplastic B cell lymphoma, who will receive standard R/CHOP as first line chemotherapy will be included.
  -  Patients must be age 18 or older.
  -  No selection will be made on the basis of gender, race or ethnicity.
  Exclusion Criteria:
  -  Patients will be excluded if the diagnosis of diffuse large B cell lymphoma cannot be confirmed.
  -  Patients receiving treatment other than R/CHOP or R/CHOP followed by radiotherapy or who have previously been treated for DLBCL will be excluded. - Patients with HIV infection will also be excluded. No selection will be made based on other medical problems or laboratory values, except as they affect the patient's eligibility to receive standard R/CHOP chemotherapy as determined by the treating physician.
  -  Patients who have magnetic metal implants or fragments in their body that are incompatible with MRI will be excluded.

Relevance to patient case: not relevant