araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells

Summary: Mesenchymal stem cells have the capability to differentiate into hepatocytes and will be useful for liver regeneration. Adipose tissue is relatively enriched with mesenchymal stem cells compared to bone marrow tissue. In this trial, eligible liver cirrhosis patients will receive autologous adipose tissue derived stromal cells which include such mesenchymal stem cells.

Detailed description: The population of the liver cirrhosis patients is enormous in Japan and the only radical treatment for them is liver transplantation. However, the number of giving donors is extremely limited. Mesenchymal stem cells have been capable to differentiate into mesodermal-lineage cells as well as endodermal-lineage cells such as hepatocytes. They reside in the mesenchymal tissues such as bone marrows as well as adipose tissues. The latter tissues are relatively enriched with mesenchymal stem cells compared to bone marrow cells. In this study, the cirrhotic patients will receive autologous adipose tissue derived stromal cells which contains substantial number of mesenchymal stem cells.

Eligibility: Inclusion Criteria:
  -  Liver cirrhosis patients
  -  Platelets count in peripheral blood: over 7.0x10^4/microliter
  -  Serum creatinine: less than 1.5 mg/dl
  -  Capable of understanding the features of this clinical trial
  Exclusion Criteria:
  -  Associated with risky gastroesophageal varices for bleeding
  -  Severe portal hypertension
  -  Complicated with severe heart failure
  -  Renal disease
  -  Respiratory disease
  -  Hematological disease
  -  Coagulation disturbance and judged to be excluded by doctors
  -  Associated with malignancy
  -  Past history of the following:
  -  malignancy
  -  ischemic heart disease
  -  cerebrovascular disease (cerebral infarction, cerebral hemorrhage)
  -  decompensated status of liver cirrhosis
  -  Pregnant, or possibility of pregnancy
  -  Infected with HIV
  -  Under mediation with adrenal corticoid steroid, anti-histamine drug
  -  Anticipated with difficulty of follow-up observation
  -  Anticipated with inconsistency of following the protocol
  -  Addiction of alcohol drinking and unable to stop drinking
  -  Other candidates who are judged to be not applicable to this study by doctors

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Liver Regeneration Therapy by Intrahepatic Arterial Administration of Autologous Adipose Tissue Derived Stromal Cells

Summary: Mesenchymal stem cells have capability to differentiate into hepatocyte and will be useful for liver regeneration. Adipose tissue is relatively enriched with mesenchymal stem cell compared to bone marrow tissue. In this trial, eligible liver cirrhosis patients will receive autologous adipose tissue derived stromal cells through intrahepatic arterial catheterization.

Detailed description: The population of the liver cirrhosis patients is enormous in Japan and the only radical treatment for them is liver transplantation: however, the number of giving donor is extremely limited. Mesenchymal stem cells have been capable to differentiate into mesodermal-lineage cells as well as endodermal-lineage cells such as hepatocytes. They reside in the mesenchymal tissues such as bone marrows as well as adipose tissues. The latter tissues are relatively enriched with mesenchymal stem cells compared to bone marrow cells. In this study, the cirrhotic patients will undergo intrahepatic arterial administration of autologous adipose tissue derived stromal cells through catheter.

Eligibility: Criteria defined in the implementation protocol

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: A Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery

Summary: This open-label study will evaluate efficacy, safety and tolerability of RO5045337 in patients with liposarcoma who are eligible for debulking surgery. Prior to surgery, patients will receive 2-3 cycles of RO5045337, orally for 10 days followed by 18 days of rest per cycle. Anticipated time on study treatment is 3 months. Patients with an incomplete resection may be treated for an additional 3 cycles with RO5045337.


Eligibility: Inclusion Criteria:
  -  adult patients, >/=18 years of age
  -  well differentiated and/or dedifferentiated liposarcoma eligible for tumor debulking surgery
  -  willing to undergo tumor biopsies before, during and after treatment
  -  ECOG performance status 0-1
  Exclusion Criteria:
  -  previous chemotherapy and/or radiation for liposarcoma; previous debulking surgery is acceptable
  -  patients receiving any other agent or therapy to treat their malignancy
  -  patients requiring anticoagulant therapy and/or anti-platelet therapy
  -  pre-existing gastrointestinal disorders which may interfere with absorption of drugs
  -  history of seizure disorders or unstable CNS metastases
  -  clinically significant cardiovascular disease
  -  history of long QT syndrome

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: A Study of BIBW 2992 (Afatinib) in Patients With Metastatic Colorectal Cancer

Summary: This Phase II study is open to patients with metastatic colorectal cancer who have tried but failed chemotherapy regimens containing oxaliplatin and irinotecan. Patients must not have received anti-EGFR (Epidermal Growth Factor Receptor) treatment (for example, cetuximab, panitumumab) in the past. Patients with wild-type KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) colorectal cancer will be randomised to receive either BIBW 2992 or cetuximab. Patients with KRAS mutated colorectal cancer will not be randomised, but will all receive BIBW 2992. The main objectives of the study are: to compare the effectiveness of BIBW 2992 with that of cetuximab in patients with KRAS wild type cancer, and to assess the effectiveness of BIBW 2992 in patients with KRAS mutated cancer.


Eligibility: Inclusion criteria:
  1. Patients with metastatic colorectal cancer who have failed both oxaliplatin- and irinotecan-based regimens
  2. Tumour sample available for KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) mutation testing and other biomarker analyses.
  Exclusion criteria:
  1. Prior treatment with Epidermal Growth Factor Receptor (EGFR) targeting small molecules or antibodies.
  2. Biological treatment (including Bevacizumab or any other antiangiogenic agents) during the trial is not allowed.
  3. Known pre-existing interstitial lung disease.
  4. Planned major surgical procedures during the trial period.

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Study of Blood Samples From Patients With Ewing Sarcoma and Their Relatives

Summary: RATIONALE: Studying samples of blood in the laboratory from patients with cancer and their relatives may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This research study is looking at blood samples collected from patients with Ewing sarcoma and their relatives.

Detailed description: OBJECTIVES:
  -  To identify and characterize a genetic susceptibility factor to Ewing's sarcoma by performing a Genome-Wide Association Study with as many as possible Ewing sarcoma patients.
  OUTLINE: This is a multicenter study.
  Blood samples are collected from patients and their relatives. Blood DNA samples are analyzed for susceptibility genes of Ewing Sarcoma.

Eligibility: DISEASE CHARACTERISTICS:
  -  Patients with Ewing sarcoma
  -  Relatives of Ewing sarcoma patients
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Decitabine Followed by a Cancer Antigen Vaccine for Patients With Neuroblastoma and Sarcoma

Summary: This treatment study for relapsed high-risk neuroblastoma, Ewings sarcoma, osteogenic sarcoma, rhabdomyosarcoma or synovial sarcoma involves an autologous cancer testis (CT) antigen specific dendritic cell (DC) vaccine preceded by decitabine as a demethylating chemotherapy.

Detailed description: For vaccine production, mature DC will be pulsed with overlapping peptides mixes derived from full-length NY-ESO-1, MAGE-A1, and MAGE-A3.

Eligibility: Inclusion Criteria:
  -  Confirmed diagnosis of relapsed high-risk neuroblastoma,Ewings sarcoma, osteogenic sarcoma, rhabdomyosarcoma, synovial sarcoma
  -  Patient may have gross tumor that has been treated with multi-agent chemotherapy prior study entry, but does not need to have gross tumor prior to study entry.
  -  Patients must have had a diagnosis of neuroblastoma or sarcoma either by histological verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines.
  -  Have received standard chemotherapy and/or SCT, and are at least 6 months post-transplant.
  -  Age: Patients must be 1 - < 25 years of age when registered on study.
  -  Organ Function Requirements: All patients must have adequate organ function defined as:
  -  Hematological Function: ANC ≥ 500; Platelet count ≥ 75.
  -  Renal Function: Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 OR A maximum serum creatinine (mg/dL) based on age/gender as follows: 1YO M&F = 0.6, 2-5YO M&F = 0.8, 6-9YO M&F = 1, 10-12YO M&F = 1.2, 13-15YO M = 1.5, 13-15YO F = 1.4, 16+ M = 1.7, 16+ F = 1.4
  -  Cardiac Function: Patient must have normal cardiac function documented by Ejection fraction (> 55%) documented by echocardiogram or radionuclide MUGA evaluation OR Fractional shortening (≥ 28%) documented by echocardiogram
  -  Liver Function: Total bilirubin ≤ 1.5 x normal for age, AND SGPT (ALT) and SGOT (AST) ≤ 3 x normal for age.
  -  Room air pulse oximetry >94%.
  -  Male and female sexually active patients of reproductive age who wish to participate must agree to use acceptable contraception.
  -  Lansky performance scale > 70, ECOG < 2 (Appendix I).
  Exclusion Criteria:
  -  Patient is pregnant.
  -  Patients with a positive result for any of the following diagnostic tests: Hep B Ag, Hep B Core Ab, Hep C Ab, HIV-1 Ab, HIV-2 Ab, HTLV-1 Ab, HTLV-2 Ab, RPR.
  -  Patient has a history of autoimmune disease, specifically inflammatory bowel disease, systemic lupus erythematosis, or rheumatoid arthritis.
  -  Patient is receiving concurrent systemic steroid therapy.
  -  Patient has a known systemic hypersensitivity to DAC, Hiltonol, or any vaccine component.

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Study of Oral Ridaforolimus in Combination With Standard Chemotherapy for Soft Tissue Sarcoma

Summary: Ridaforolimus has been tested in almost 2 dozen studies; however, it has not previously been tested in combination with the standard of care chemotherapy for sarcoma as this study will. We will be looking to see if Ridaforolimus given with SOC chemo (AIM or TG) is well tolerated and to determine a Phase 2 dose.


Eligibility: Inclusion Criteria:
  -  Advanced or metastatic soft tissue sarcoma with histological or cytological proven disease. No more than 2 lines of chemotherapy in the metastatic setting in the dose escalation phase, and no more than one line of prior therapy in the expansion phase.
  -  ECOG performance status of ≤ 1
  -  A minimum life expectancy > 3 months
  -  At least 4 weeks must have elapsed between prior investigational therapy, chemotherapy or radiotherapy and the first dose of ridaforolimus
  -  Adequate hematological, hepatic and renal function (hemoglobin ≥ 9g/dl, absolute neutrophil count [ANC] ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; bilirubin ≤ ULN; alkaline phosphatase ≤ 2.5 x ULN; AST, ALT ≤ 2.5 x ULN; albumin ≥ 2.5mg/dL; creatinine ≤ 1.5 x ULN)
  -  Serum cholesterol ≤ 350 mg/dL and triglycerides ≤400 mg/dL
  -  Signed informed consent
  -  Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to start of therapy and must use an approved contraceptive method as appropriate from the time of screening until 30 days after the last dose of study drug.
  Exclusion Criteria:
  -  Uncontrolled brain metastases, spinal cord compression, or carcinomatous meningitis.
  -  Clinically significant unexplained bleeding within 28 days prior to entering the trial
  -  Uncontrolled systemic vascular hypertension
  -  Clinically significant cardiovascular disease
  -  Newly diagnosed (within 3 months of enrollment) or poorly controlled type 1 or 2 diabetes
  -  Have received >350 mg/m2 total dose of Doxorubicin
  -  Active infection requiring prescribed intervention
  -  Other concurrent illness
  -  Major surgery within 28 days before trial entry, or incompletely healed surgical incision; minor surgery or procedures within 7 days
  -  Previous anthracycline lifetime exposure more than 350 mg/m2 would exclude patient form AIM Arm enrollment
  -  Pregnant or breastfeeding
  -  Known allergy to macrolide antibiotics
  -  Concurrent treatment with medications that induce or inhibit cytochrome P450 (CYP3A).
  -  Known history of HIV sero-positivity

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Biomarkers in Samples From Young Patients With Soft Tissue Sarcoma

Summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
  PURPOSE: This research trial is studying biomarkers in samples from young patients with soft tissue sarcoma.

Detailed description: OBJECTIVES:
  -  To identify the key components of driver pathways of primary and secondary soft tissue sarcomas.
  -  To perform the next-generation sequencing on primary versus normal on undifferentiated sarcomas.
  OUTLINE: Genomic DNA and RNA samples from undifferentiated sarcoma tumors are analyzed by next-generation sequencing for somatic mutations. Normal matched lymphocytes and tissue are also analyzed.

Eligibility: DISEASE CHARACTERISTICS:
  -  Banked childhood samples from the COG-D9902 soft tissue sarcoma biology and banking study
  -  Rhabdomyosarcoma, NOS
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Biomarker in Tissue Samples From Patients With Ewing Sarcoma

Summary: RATIONALE: Studying 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.
  PURPOSE: This research trial studies biomarkers in tissue samples from patients with Ewing sarcoma.

Detailed description: OBJECTIVES:
  -  To determine the frequency of INI-1 protein loss in Ewing Sarcoma.
  OUTLINE: Previously collected tissue samples are analyzed for INI-1 protein loss by IHC and tissue microarray.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of Ewing sarcoma
  -  Prepared tissue microarray with Ewing sarcoma samples available
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Studying Genes in Samples From Younger Patients With Desmoplastic Small Round Cell Tumor Registered on COG-D9902 or COG-ABTR01B1

Summary: RATIONALE: Studying samples of blood and tumor 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.
  PURPOSE: This research study is studying genes in samples from younger patients with desmoplastic small round cell tumor registered on COG-D9902 or COG-ABTR01B1.

Detailed description: OBJECTIVES:
  -  To perform whole-exome sequencing on desmoplastic small round cell tumor (DSRCT) samples and their available matched normal samples to identify novel mutations, single nucleotide polymorphisms, or copy number changes associated with these tumors.
  -  To identify regions of interest that may be involved in the pathogenesis (including the region of EWSR1-WT1 translocation) from the whole-exome sequencing and perform detailed resequencing and transcriptone sequencing to further define the molecular aberrations at the RNA level.
  OUTLINE: This is a multicenter study.
  Archived tumor tissue samples are analyzed for DNA sequencing, effects of RNA on gene expression levels, novel RNA isoforms, splice variants, and translocations.

Eligibility: DISEASE CHARACTERISTICS:
  -  Tumor and blood samples from patients registered on COG-D9902 or COG-ABTR01B1 obtained from the Cooperative Human Tissue Network (CHTN) and the Children's Oncology Group (COG) tumor banks
  -  Matched normal samples
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Phase 1 Study of Pazopanib With GSK1120212 in Advanced Solid Tumors, Enriched With Patients With Differentiated Thyroid Cancer, Soft-tissue Sarcoma, and Cholangiocarcinoma

Summary: The purpose of this study is to determine the safety and toxicity of the combination of pazopanib and GSK1120212 in patients with solid tumors and identify the maximum tolerated dose (MTD) of this combination for phase II study.


Eligibility: Inclusion Criteria:
  -  Dose escalation cohort for all solid tumors is closed to enrollment.
  -  Expansion cohorts: Soft-tissue sarcoma, cholangiocarcinoma, and differentiated thyroid cancer (DTC) cohorts are closed to enrollment. Patients in the DTC cohort must have disease that is able to be biopsied.
  -  Must have measurable disease.
  -  Tumor progression in the 6-month period prior to study drug initiation.
  -  DTC patients: must have radioiodine non-avid lesions, OR radioiodine avid lesions that have not responded to treatment with radioactive iodine.
  -  ECOG performance status less than or equal to 1.
  -  Life expectancy >3 months.
  -  Blood pressure <140 mmHg and <90 mmHg.
  -  LVEF is >= 50%
  -  Must be able to swallow pills.
  Exclusion Criteria:
  -  Chemotherapy, radiotherapy, other investigational therapy, or major surgery within 4 weeks.
  -  Sarcoma and cholangiocarcinoma ONLY: Prior VEGF-targeted TKI therapy.
  -  Pregnant or currently breastfeeding.
  -  Unresolved toxicity greater than grade 1.
  -  Evidence of active hepatitis or HIV.
  -  Significant cardiovascular disease.
  -  Taking medications known to be strong inducers or inhibitors of CYP3A enzymes.
  -  Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding.
  -  History of gastrointestinal condition causing malabsorption or obstruction.
  -  Cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep vein thrombosis (DVT) within past 6 months.
  -  Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase risk of pulmonary hemorrhage.
  -  Hemoptysis within 6 months of starting treatment.
  -  History of retinal vein occlusion (RVO) or central serous retinopathy (CSR), or predisposing factors to RVO or CSR as assessed by ophthalmic exam.
  -  Known brain mets that are not stable for at least 8 weeks prior to treatment, or patient is on glucocorticoids for brain mets.

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: A First-In-Human Study of RO5503781 in Participants With Advanced Malignancies Except Leukemia

Summary: This multicenter, open label, dose-escalating study will evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of RO5503781, administered once daily (QD) or once weekly (QW) in participants with advanced malignancies except leukemia. Participants will receive multiple escalating oral doses in two different dosing schedules (Sch) until disease progression or unacceptable toxicity occurs.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed advanced malignancies, except all forms of leukemia, for which standard curative or palliative measures do not exist, are no longer effective, or are not acceptable to the participants
  -  Measurable disease (according to RECIST or Cheson criteria) or evaluable disease prior to administration of study drug
  -  Minimum weight of 35 kg and life expectancy of greater than or equal to (>=) 12 weeks
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  -  Acute toxicities from any prior anti-tumor therapy, surgery, or radiotherapy must have resolved to NCT-CTCAE Grade less than or equal to (<=) 1
  -  Adequate renal, hepatic and bone marrow function
  -  Participants with stable Central Nervous System (CNS) metastasis and with chronic, stable and rate controlled atrial fibrillation
  -  Participants in consideration for the biomarker cohorts or apoptosis imaging cohort must consent and be able to undergo paired biopsies for tumor biomarker analyses
  -  Able to participate and willing to give written informed consent and to comply with the study restrictions
  Exclusion Criteria:
  -  History of any form of leukemia except for Stage 0 and 1 chronic lymphocytic leukemia (CLL) not requiring treatment in addition to the underlying solid tumor
  -  Use of hormonal therapy within 2 weeks and use of other investigational agents or having received investigational drugs <= 4 weeks prior to study treatment start
  -  History of seizure disorders or unstable CNS metastases
  -  Severe and/or uncontrolled cardiovascular disease or disorder
  -  Active (acute or chronic) or uncontrolled infection
  -  Pregnant or breastfeeding women
  -  HIV-positive participants who are currently receiving anti-retroviral treatment
  -  Known coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia
  -  Participants receiving oral or parenteral anticoagulants/antiplatelet agents; anticoagulant flushes for maintenance of indwelling catheters are allowed
  -  Participants with known bone marrow disorder which may interfere with bone marrow recovery
  -  Participants with hypersensitivity reaction to 18Fluorothymidine (FLT or 18F) compounds

Relevance to patient case: possibly relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Sarcoma Database at KFSH&RC

Summary: Sarcoma Database

Detailed description: Sarcoma Database

Eligibility: Inclusion Criteria:
  -  Patients with diagnosed Sarcoma
  Exclusion Criteria:
  -  Patients with diagnosis other than Sarcoma

Relevance to patient case: not relevant