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

Clinical trial: Study to Determine and Evaluate a Safe and Tolerated Dose of HDM201 in Patients With Selected Advanced Tumors That Are TP53wt

Summary: To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with selected advanced tumors characterized by wild-type TP53.


Eligibility: Inclusion Criteria:
  -  Patient with a TP53wt locally advanced or metastatic solid malignancy and with measurable or non-measurable (but evaluable) disease as determined by RECIST 1.1 criteria.
  -  Patients with the TP53wt hematological tumors (AML, ALL, HR-MDS) who have failed prior therapies or who are considered inappropriate candidates for standard induction therapy.
  Other protocol-defined inclusion criteria may apply
  Exclusion Criteria:
  -  Prior treatment with compounds with the same mode of action
  -  Subjects with significant or uncontrolled cardiovascular disease
  -  History of thromboembolic or cerebrovascular events within the last 6 months, including transient ischemic attack, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism
  -  Previous and concomitant therapy that precludes enrollment, as defined in the protocol
  -  Known Human Immunodeficiency Virus (HIV) infection and/or active Hepatitis B or Hepatitis C infection
  -  Patients who have undergone major surgery within the 2 weeks prior to starting study treatment or who have not fully recovered from previous surgery
  -  Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 2 weeks after study drug discontinuation
  -  Pregnant or nursing women
  Other protocol-defined inclusion/exclusion criteria may apply

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

Clinical trial: Window Trial 5-aza in HNSCC, T-tare

Summary: The purpose of this study is to assess the activity of 5-azacitidine in patients with Human Papilloma Virus (HPV)-positive and HPV- negative head and neck squamous cell carcinoma (HNSCC). The response activity will be determined by analyzing your tumor tissue prior to and after treatment with 5-azacitidine. Preliminary studies in mice bearing human head and neck cancers or head and neck cancer cells cultured in laboratories suggest that treatment with 5-azacitidine increases changes in cancer cells that lead to their death. This study is designed to determine if similar changes occur in cancer cells of patients with head and neck cancer.
  The study also aims to determine the amount of a specific type of protein, p53 before and after treatment. Research has shown that the p53 protein is associated with anti-tumor activity.
  Finally, this study is measuring the amount of a specific type of protein called interferon in your tumor tissue. Interferons are proteins made and released by the body in response to pathogens (disease causing agents) such as viruses, bacteria, or tumor cells. Interferons allow for communication between cells to trigger the protective defenses of the immune system that remove pathogens (disease causing agents) or tumors.

Detailed description: Primary Objectives:
  The primary objectives of this study are
  • to investigate response (proliferation, apoptosis), as well as reactivation of p53 pathways in patients treated with 5-azacitadine for HPV-positive and HPV-negative HNSCC.
  Secondary Objectives
  The secondary objectives of this study are:
  -  to investigate response (proliferation, apoptosis), as well as reactivation of IFN pathways in patients treated with 5-azacitadine for HPV-positive and HPV-negative HNSCC.
  -  to investigate the clinical activity of 5-azacitadine in patients with HPV-positive and HPV-negative HNSCC.
  -  to investigate the safety of 5-azacitadine in patients with HPV-positive and HPV-negative HNSCC

Eligibility: Inclusion Criteria:
  1. Histologically confirmed HNSCC with surgically resectable disease
  2. Age ≥18 years of age.
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2
  4. ANC greater than or equal to 1500, Hb greater than or equal to 8, platelet count greater than or equal to 100,000
  Exclusion Criteria:
  1. AST or ALT greater than 2.5 x ULN
  2. Known brain metastases
  3. Women must not be pregnant or breastfeeding
  4. Known allergy to 5-azacitadine
  5. Patients receiving any other investigational agents within 4 weeks of starting the study

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

Clinical trial: Study of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma

Summary: To determine the MTD/RP2D of the HDM201 and LEE011 combination and evaluate whether the combination is safe and has beneficial effects in patients with liposarcoma.


Eligibility: Inclusion Criteria:
  -  Patients with histologically documented, locally advanced or metastatic WD/DD liposarcoma who have received at least one prior systemic therapy
  -  Patients with radiologic progression, defined by RECIST v.1.1, occurring while on/or within 6 months after last systemic treatment, prior to enrollment
  -  ECOG performance status of 0-1
  Exclusion Criteria:
  -  Prior treatment with compounds with the same mode of action
  -  Patients with TP53 mutated tumors, if the molecular status is known
  -  Symptomatic central nervous system metastases
  -  Inadequate organ function
  -  Previous and concomitant therapy that precludes enrollment, as defined by protocol
  Other protocol-defined inclusion/exclusion criteria may apply.

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

Clinical trial: A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Summary: This study is designed to compare Overall Survival (OS) in participants with relapsed or refractory Acute Myeloid Leukemia (AML) treated with idasanutlin in combination with cytarabine versus participants treated with placebo and cytarabine. Participants will receive induction treatment with idasanutlin/placebo and cytarabine (Cycle 1). Responding patients may continue to receive a maximum of further two cycles of consolidation (Cycle 2 and Cycle 3). Complete remission (CR), CR with incomplete platelet count recovery (CRp), overall remission rate (ORR), event-free survival (EFS), leukemia-free survival (LFS) and percentage of participants with an allogeneic hematopoietic stem cell transplant (HSCT) will also be compared between treatment arms. This study will include participants without (TP53 wild-type) and with TP53 mutations.


Eligibility: Inclusion Criteria:
  -  Age >=18 years
  -  Documented/confirmed 1st/2nd refractory/relapsed acute myeloid leukemia (AML) using World Health Organization classification, except acute promyelocytic leukemia.
  -  No more than 2 prior induction regimens (excluding prior hematopoietic stem cell transplant [HSCT]) and one must have included cytarabine with an anthracycline (or anthracenedione)
  -  Eastern Cooperative Oncology Group performance status of 0 to 1
  -  Patient should be a potential candidate for allogeneic HSCT
  -  Adequate hepatic and renal function
  Exclusion Criteria:
  -  Patients with first complete remission (CR1) duration of >1 year AND age <60 years
  -  Patients with AML with myelodysplasia related changes, or AML that has developed as a consequence of an antecedent hematological disorder (AHD)
  -  AML secondary to any prior chemotherapy unrelated to leukemia
  -  Patients who have received more than two prior cytarabine containing induction regimens for AML
  -  Patients who have relapsed within 90 days after therapy with intermediate-dose cytosine arabinoside (IDAC) or high-dose cytosine arabinoside (HiDAC) containing regimens
  -  Patients who have received allogeneic HSCT within 90 days prior to randomization.
  -  Patients who have received immunosuppressive therapy for graft versus host disease (G versus HD) within 2 weeks prior to study start
  -  Prior treatment with a Murine Double Minute 2 (MDM2) antagonist
  -  Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy
  -  Patients with a history of other malignancy within 5 years prior to screening.
  -  Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
  -  Pregnant or breastfeeding patients

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

Clinical trial: Malignant Pediatric Soft Tissue & Bone Tumors of the Extremities: A Retrospective Study

Summary: The aim of this study is to identify demographic & disease characteristics in pediatric oncology patients diagnosed with soft tissue & bone tumors involving the extremities & treatment outcomes in these patients.

Detailed description: Background:
  Sarcomas are a heterogeneous group of rare tumors that arise predominantly from the embryonic mesoderm. The various sarcomas include bone sarcomas (osteosarcomas and chondrosarcomas), Ewing's sarcomas, peripheral primitive neuroectodermal tumors, and soft tissue sarcomas.
  Soft tissue sarcomas account for approximately 1% of adult malignancies and 7% to 15% of pediatric malignancies. Rhabdomyosarcoma is the most common soft tissue sarcoma of childhood.
  There is some confusion within segments of the medical community as to the precise meaning of "soft tissue." The soft tissue of the human body includes all extraskeletal tissue that is neither epithelial, hematopoietic (marrow derived blood elements), nor parenchymal (constituent of a visceral organ). The nervous system is divided such that neither the glial nor the central neuronal elements are considered to be soft tissue, though by convention the peripheral nervous system is. In sum, the soft tissues consist of adipose tissue, fibrous tissue, musculature, vascular structures, and peripheral nerves.
  About 50% to 60% of sarcomas occur in the extremities, and although they are rare, they are responsible for more deaths than testicular cancer, Hodgkin's disease, and thyroid cancer combined.
  Patients & Methods:
  From January 2000 till December 2015, retrieval & analysis of the medical records of pediatric patients with soft tissue & bone tumors involving the extremities will be made at the pediatric oncology department, South Egypt Cancer Institute which represents the largest referral center in Upper Egypt. These data will be categorized according to demographic characteristics, clinico-pathologic features, treatment modalities received, and outcomes of treatments in these patients.

Eligibility: Inclusion Criteria:
  -  Patients whose age less than or equal to 18 years.
  -  Patients diagnosed with bone & soft tissue neoplasms involving the extremities.
  Exclusion Criteria:
  -  Patients whose age more than 18 years.
  -  Patients diagnosed with bone & soft tissue neoplasms not involving the extremities.

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

Clinical trial: A Dose Escalation Study of RO6874813 in Participants With Locally Advanced or Metastatic Solid Tumors

Summary: This first-in-human study consists of three parts. The primary purpose of Part I is to characterize the safety and tolerability of RO6874813 in participants with locally advanced and/or metastatic solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. In addition, the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) will be determined. In Part II the safety and tolerability of RO6874813 will continue to be characterized in participants with locally advanced and/or metastatic solid tumors known to be fibroblast activation protein-alpha positive (FAP+). In addition, treatment-induced efficacy effects of RO6874813 will be assessed by functional imaging and paired tumor biopsies. The primary purpose of Part III is to demonstrate anti-tumor activity of RO6874813 in participants with recurrent or metastatic FAP+ sarcomas.


Eligibility: Inclusion Criteria:
  -  Age >= 18 years
  -  Part I: Patients with histologically/cytologically confirmed locally advanced or metastatic, non-resectable solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists.
  -  Part II: Patients with histologically/ cytologically confirmed locally advanced or metastatic, non-resectable solid tumors known to be fibroblast activation protein-alpha positive (FAP+).
  -  Part III: Patients with histologically confirmed recurrent or metastatic, non-resectable confirmed FAP+ sarcoma with two or fewer prior regimens for advanced disease.
  -  Measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  -  World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 0-1
  -  Recovery from all reversible adverse events (AEs) of previous anti-cancer therapies to baseline or Common Terminology Criteria for Adverse Events (CTCAE) Grade 1, except for alopecia (any grade) and Grade <=2 sensory peripheral neuropathy.
  -  Negative pregnancy test
  Exclusion Criteria:
  -  Primary CNS tumors or CNS tumor involvement.
  -  Major surgery or any other prior anti-cancer treatment within 4 weeks prior to study Day 1.
  -  Received wide-field radiotherapy <= 4 weeks or limited-field radiotherapy <=2 weeks prior to starting study drug.
  -  Known hypersensitivity to any of the components of RO6874813 or to the contrast agents used in the study
  -  Another invasive malignancy in the last 2 years except for those with a minimal risk of metastasis or death.
  -  Any other conditions or diseases that would contraindicate participation in the clinical study because of safety concerns or compliance with clinical study procedures.

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

Clinical trial: SBRT Treatment for Lung Metastasis From Soft Tissue Sarcoma

Summary: In this study the investigators treat PM oligometastatic patients with SBRT. Our objective is to evaluate rate of local control of treated lesions in patients treated with Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT) for lung metastases from STS.

Detailed description: The investigators started to treat PM oligometastatic patients with Stereotactic Body Radiotherapy.
  The investigators objective is to evaluate rate of local control of treated lesions in patients treated with Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT) for lung metastases from soft-tissue sarcomas. Overall and disease free survival will be evaluated as secondary endpoints.

Eligibility: Inclusion Criteria:
  -  Age 18 anni -85 years
  -  PS according to ECOG 0-2
  -  Histopathologically confirmation of soft tissue sarcoma
  -  Metastatic lung lesion less than 4
  -  Controlled primary tumor and other metastatic lesions
  -  Metastatic lesion less than 5 such as the definition of oligometastatic patients
  -  Written informed consent
  -  Contraindication to surgical resection
  -  Estimated survival ≥ 3 months
  -  Absence of progressive disease longer than 6 months
  -  No chemotherapy was given for at least 3 months after SBRT
  -  Maximum diameter ≤ 5 cm
  Exclusion Criteria:
  -  Prior thorax radiation therapy
  -  Age > 85 years
  -  PS according to ECOG >2
  -  Pregnant women
  -  Maximum diameter ≥ 5.1 cm
  -  Total volume of lung lesion greater than 1/3 of the whole pulmonary parenchima

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

Clinical trial: Stereotactic Body Radiotherapy (SBRT) for Pulmonary Metastases in Ewing Sarcoma, Rhabdomyosarcoma, and Wilms Tumors

Summary: This research study is studying stereotactic body radiotherapy (SBRT) as a possible treatment for lung relapse of Ewing Sarcoma, Rhabdomyosarcoma, or Wilms Tumor. SBRT is a form of targeted radiotherapy that can treat very small tumors using a few large doses.

Detailed description: This research study is a Pilot Study, also known as a Phase I-II study, which means it is the first time investigators are examining this study intervention for patients with lung recurrence of Ewing Sarcoma, Rhabdomyosarcoma, or Wilms Tumor. This study tests the most appropriate dose, safety and efficacy of SBRT for the treatment of lung recurrence of Wilms tumor, rhabdomyosarcoma, or Ewing sarcoma in children. Standard radiotherapy is typically used to treat Ewing sarcoma and is used to treat lung recurrence. SBRT is being used to treat adults with small inoperable lung cancers; in such cases, SBRT has been shown to be effective and well-tolerated. SBRT is also used to treat bone metastases in adults and children.

Eligibility: Inclusion Criteria:
  -  Diagnosis of Ewing sarcoma, rhabdomyosarcoma or Wilms tumor or other primary renal tumor
  -  Age 8.0 to age 18.99 years
  -  Must be capable of treatment without general anesthesia
  -  Lesion size 8 mm - 3 cm
  -  Pulmonary metastases found at relapse (does not have to be first relapse); no more than 3 lesions per hemi-thorax
  -  Greater than 5 weeks from doxorubicin at the time of consent, with radiation to be initiated no less than 6 weeks from doxorubicin
  -  Greater than 3 weeks from intravenous chemotherapy except doxorubicin
  -  Informed consent/assent
  -  Life expectancy > 3 months
  -  Pulmonary function FEV1 ≥ 50% of predicted
  -  Females, minorities and other underrepresented populations that are at risk to develop Ewing sarcoma and the other included malignancies
  Exclusion Criteria:
  -  Prior whole-lung or hemi-thorax irradiation of greater than or equal to 12 Gy (focal radiotherapy to the thorax is not an exclusion)
  -  Lesion larger than 3 cm in diameter
  -  Diffuse multiple (> 3 per lung) metastases
  -  Active or new metastatic disease outside of the lung
  -  Lesions within 2 cm of central structures defined as:
  Tumor within or touching the zone of the proximal bronchial tree, defined as a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi).

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

Clinical trial: Advanced MR Imaging in Sarcoma Patients

Summary: We intend to investigate the clinical application of two emerging imaging modalities for which the technical capability is currently in place at Mayo Clinic. The treatment of Ewing Sarcoma (ES), Rhabdomyosarcoma (RMS) and soft tissue sarcoma (STS) patients on this study will involve multi-disciplinary contributions from nationally recognized sarcoma experts in Radiation Oncology, Radiology, Orthopedic Surgery, Pediatric Oncology, Medical Oncology and Pathology.
  Patients will undergo additional magnetic resonance (MR) imaging at the same time as the standard imaging.
  The ability to compare several imaging modalities within a single cohort of patients maximizes the potential of the study to impact the future management of sarcoma patients. The collaborative nature of this study, with essential contributions from many departments will undoubtedly improve the coordinated care of sarcoma patients and naturally disseminate the advanced imaging experience that is acquired.


Eligibility: Inclusion Criteria:
  -  Age ≥ 7 years.
  -  Histological confirmation of newly diagnosed localized or newly diagnosed with metastatic Ewing Sarcoma, Rhabdomyosarcoma or Soft tissue Sarcoma.
  -  Tumors > 5 cm in diameter.
  -  Planning to receive RT or surgery with or without adjuvant radiotherapy (RT) at Mayo Clinic Rochester.
  -  Provide informed written consent if ≥ 18 years. If < 18 years, provide informed written assent and parent or legal guardian provide informed written consent.
  -  Patients must have measurable disease as defined in Section 11.0.
  -  Willingness to participate in mandatory imaging studies at Mayo Clinic Rochester.
  -  Baseline MRE information deemed as acceptable for assessment
  -  Baseline perfusion MRI deemed as acceptable for assessment
  Exclusion Criteria:
  -  Co-morbid conditions that would result in expected survival to be less than 5 years

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

Clinical trial: Characterization of Adipose Derived Regenerative Cells (ADRCs) From Patients With Chronic Heart Disease

Summary: Human adipose tissue is now recognized as an acceptable, highly abundant source of adipose-derived regenerative cells (ADRCs). ADRCs are a heterogeneous or mixed population of cells found in adipose tissue including adult stem cells, leukocytes, connective tissue and vessel-associated cells. Autologous adult regenerative cells are thought to promote healing of scarred or injured tissue. While the investigators are learning more about the exact mechanisms every day, it is believed that this heterogeneous population of cells influences the local environment via cell-to-cell signaling, immune modulation, and differentiation into other cell types. The use of ADRCs in the treatment of many different medical conditions (including cardiovascular disease, soft tissue defects, wound healing, and many more) is being evaluated in numerous clinical and preclinical studies around the world. While there is a considerable amount of information regarding the cellular composition of ADRCs isolated from healthy donors, basically there is no much data regarding the ADRC composition from cardiac patients. In this study, adipose tissue or cells from chronic heart ischemia patients, that would otherwise be thrown away in waste, will be provided to researchers who will study these cells with the objective to characterize ADRCs derived from patients with a heart disease and to compare if a heart disease state does impact ADRC cell composition.


Eligibility: Inclusion Criteria:
  -  Patients enrolled in the ATHENA clinical trial that donated their leftover material to be studied.
  Exclusion Criteria:

Relevance to patient case: not relevant