araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 26-year-old male with Liposarcoma. Genetic variant: MDM2 Amplification. Other conditions: None.

Clinical trial: A Safety Study of SGN-CD33A in AML Patients

Summary: This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) administered as a single agent and in combination with a hypomethylating agent (HMA). The main purpose of the study is to find the maximum tolerated dose (MTD, which is the highest dose that does not cause unacceptable side effects) of SGN-CD33A in patients with acute myeloid leukemia (AML). The MTD will be determined by observing the dose-limiting toxicities (the side effects that prevent further increases in dose) of SGN-CD33A. In addition, the pharmacokinetic profile and anti-leukemia activity of SGN-CD33A will be assessed.

Detailed description: This study will explore SGN-CD33A as a monotherapy and in combination with a hypomethylating agent (HMA; i.e., azacitidine or decitabine). Initial study treatment with SGN-CD33A includes a maximum of 2 cycles of treatment for monotherapy and 4 cycles for combination cohorts. Patients who achieve documented CR or CRi (Monotherapy) or clinical benefit (Combination) during the first part of the study are eligible to continue treatment.
  Additional monotherapy cohorts may include patients with relapsed acute promyelocytic leukemia, relapsed patients with nucleophosmin-1 gene mutation (absence of fms-like tyrosine kinase 3 mutation) (NPM1-mutated, FLT-3 wild type), alternate dosing schedules (fractionated dosing on Days 1 and 4), treatment naive patients with AML who declined intensive therapy, and patients who have relapsed after post-allogeneic stem cell transplant.
  Patients in the combination cohort will be treated with azacitidine or decitabine per institutional practice prior to SGN-CD33A dosing. Expansion cohorts may be added for further evaluation of safety, pharmacokinetics, pharmacodynamics, and antitumor activity.

Eligibility: Inclusion Criteria:
  -  Acute myeloid leukemia, positive for CD33
  -  Eastern Cooperative Oncology Group status of 0 or 1
  -  Adequate baseline renal and hepatic function
  -  Central venous access
  -  Either achieved complete remission (greater than 12 weeks in duration) with initial induction/consolidation and have experienced relapse of disease or declined treatment with high-dose induction/consolidation
  -  Bone marrow blasts greater than or equal to 5% for relapsed patients, or greater than or equal to 20% for untreated patients
  Exclusion Criteria:
  -  Inadequate lung function
  -  Prior allogeneic stem cell transplant, except for a specific cohort
  -  High-dose chemotherapy within 4 weeks of study drug
  -  Antileukemia treatment within 14 days of study drug (other than hydroxyurea or 6-mercaptopurine)

Relevance to patient case: not relevant
Patient case: 26-year-old male with Liposarcoma. Genetic variant: MDM2 Amplification. Other conditions: None.

Clinical trial: Ph II Cabazitaxel DD Liposarcoma

Summary: Soft tissue sarcomas (STS) are a rare group of malignant heterogenous tumors (> 50 histological subtypes, including liposarcoma, the commonest subtype of STS) with distinct genetic, pathological and clinical profiles, and varying patterns of tumor spread. The optimal cytotoxic treatment for this group of patients remains uncertain. Single agents which are most effective include doxorubicin and ifosfamide, but objective response rates and progression-free survival times remain modest. There is clearly a need to improve treatment options for liposarcoma. Eribulin, a antimicrotubule agent that targets the protein tubulin in cells, interfering with cancer cell division and growth , has demonstrated activity in STS. Therefore, it is reasonable to explore whether other anti-microtubule agent like cabazitaxel have a role in STS. Cabazitaxel has been shown to be a relatively safe, effective and tolerated. This drug has been approved by FDA for prostate cancer. The main objective of this trial is to determine whether cabazitaxel or prolonged infusional ifosfamide demonstrate sufficient antitumor activity for liposarcoma.


Eligibility: Inclusion Criteria:
  -  Local diagnosis of dedifferentiated liposarcoma
  -  Age 18-70 yrs
  -  WHO performance status 0-1
  -  Radiological or histological diagnosis of inoperable locally advanced or metastatic disease, with evidence of disease progression within the past 6 months
  -  Clinically and/or radiographically documented measurable disease within 21 days prior to randomization.At least one site of disease must be unidimensionally measurable according to RECIST 1.1.
  -  One previous chemotherapy regimen for locally advanced or metastatic dedifferentiated liposarcoma (this could include pre-operative chemotherapy for primary disease if subsequent complete resection was not achieved).
  -  Adequate organ functions
  -  Birth control measures
  -  Written informed consent
  Exclusion Criteria:
  -  More than 1 prior molecularly targeted therapy (e.g. CDK4 inhibitor). Any prior such therapy must be completed at least 4 weeks before randomization.
  -  Symptomatic CNS metastases
  -  Previous encephalopathy of any cause or other significant neurological condition
  -  Concurrent or planned treatment with strong inhibitors or inducers of cytochrome P450 3A4/5
  -  Pregnancy

Relevance to patient case: not relevant
Patient case: 26-year-old male with Liposarcoma. Genetic variant: MDM2 Amplification. Other conditions: None.

Clinical trial: Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas

Summary: To study the feasibility of reducing the dose of preoperative radiotherapy in MLS (Myxoid Liposarcomas) from 50 Gy to 36 Gy while maintaining comparable clinicopathological responses.

Detailed description: -  A Bayesian approach is considered for the analysis of this trial. The aim is to provide a stopping rule for inefficacy of the new dose.
  -  Two aspects are important to elucidate the mechanism of this treatment: dynamic investigations of perfusion and vasculature. Apart from participation to the dose reduction paragraphs of this study, patients will be also asked to undergo, at clinically relevant dose points, dynamic contrast enhanced (DEC) MRI scans and separately tumor biopsies.

Eligibility: Inclusion Criteria:
  1. Age above or equal to 18 years
  2. Biopsy proven MLS (including the reciprocal chromosomal translocation t(12;16)(q13;p11); A the primary sarcoma in case of non-metastatic disease for management is with curative intent (regimen to be chosen = 18 x 2 GY) B in case of oligometastatic patients, the metastasis may also be irradiated to a dose of 36 GY in order to postpone the time interval to next systemic chemotherapy. These patients are usually not operated upon and the total dose may also be reached in 12 times 3 Gy, for convenience purposes (see paragraph 10 for radiobiological considerations).
  3. ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) 0-2
  4. Patients must be able (physically, mentally and socially) to complete a series of RT, followed by an observation period of 4-6 weeks and undergo surgery.
  5. Written informed consent
  Exclusion Criteria:
  1. Prior radiotherapy to the target area.
  2. Anticoagulant medication of any kind; especially Ascal®(and derivates), coumarines (Sintrom® and Marcoumar®), all heparin and heparin-like formulations. (Note: this exclusion criterion only applies for patients consenting to the translational research part of the study; patients on anticoagulant medication as described above may take part in the dose reduction part of the study, but the repeat biopsies may not be taken.)
  3. Pregnancy -

Relevance to patient case: not relevant
Patient case: 26-year-old male with Liposarcoma. Genetic variant: MDM2 Amplification. Other conditions: None.

Clinical trial: Study of Doxorubicin and Trabectedin in First Line Treatment on Patients With Metastatic Leiomyosarcoma

Summary: Uterine leiomyosarcomas and soft tissues are rare tumors with a poor prognosis when metastatic or locally advanced. They have an average chemosensitivity mainly to doxorubicin, ifosfamide, cisplatin, gemcitabine and trabectedin but response rates in combination in first line does not exceed 55% for uterine leiomyosarcomas and 35% for leiomyosarcomas of soft tissue.
  The trabectedin is a new cancer drug that has obtained marketing authorization after failure of anthracyclines and ifosfamide in the treatment of soft tissue sarcomas (STM) in Europe. It has especially shown efficacy in myxoid liposarcomas, leiomyosarcomas and synoviosarcoma.
  This study aims to evaluate the usefulness of the combination of trabectedin with doxorubicin in first-line treatment of uterine or soft tissue leiomyosarcoma.


Eligibility: Inclusion Criteria:
  -  Metastatic leiomyosarcoma (uterus or soft tissue) in inoperable relapse with no previous chemotherapy
  -  At least one measurable lesion according to RECIST criteria before inclusion. At least one of the target is in a none irradiated area
  -  Aged >/= 18 years and physiological age </= 70 years
  -  PS </= 2
  -  Normal hematological function (Polymorphonuclear Neutrophils >/= 1500/mm3, platelets >/= 100 000/mm3)
  -  Normal kidney function (creatinine < 1.5xN)
  -  Creatinine phosphokinase </= 2.5xN
  -  Normal hepatic function (total bilirubin </= 1xN; transaminase </= 2.5xN and alkaline phosphatase </= 1.5xN)
  -  Cardiac function: normal echography and/or isotopic ventriculography (FR>30%, FEVG > 50%)
  -  Patients able to procreate must use a birth control device during treatment and during 3 months after treatment for women; 5 months for men
  -  Signed informed consent
  -  Patient under affiliated to a system of care
  Exclusion Criteria:
  -  Any other histological type of uterus sarcoma (carcinosarcoma...) or soft tissue
  -  Specific contraindication to the treatment
  -  Previous or evolutive mental disease
  -  Previous cancer
  -  Symptomatic or known brain metastasis
  -  Previous radiotherapy ont he only measurable lesion
  -  Previous allograft or autograft
  -  Known positive serology (HIV, HbC, HbS)
  -  Pregnant or breastfeeding women
  -  Impossibility to follow the treatment for geographical, social or mental reason
  -  Patients under legal protection

Relevance to patient case: not relevant
Patient case: 26-year-old male with Liposarcoma. Genetic variant: MDM2 Amplification. Other conditions: None.

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: 26-year-old male with Liposarcoma. Genetic variant: MDM2 Amplification. Other conditions: None.

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: 26-year-old male with Liposarcoma. Genetic variant: MDM2 Amplification. Other conditions: None.

Clinical trial: Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE)

Summary: The purpose of this signal seeking study is to determine whether treatment with ceritinib demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.


Eligibility: Inclusion Criteria:
  -  Patient has a confirmed diagnosis of a select solid tumor (except ALK+ NSCLC) or hematological malignancy and is in need of treatment because of radiologic progression or relapse.
  -  Patient must have been pre-identified as having a tumor with an ALK or ROS1 positive mutation, translocation, rearrangement or amplification. The qualifying alteration must be assessed and reported by a CLIA-certified laboratory. ALK positivity as assessed by IHC or FISH are allowed.
  -  Patient must have received at least one prior treatment for recurrent, metastatic and/or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.
  -  Patient has progressive and measurable disease as per RECIST 1.1 or other appropriate hematological guidelines.
  -  Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  Exclusion Criteria:
  -  Patient has received prior treatment with ceritinib.
  -  Patients with symptomatic CNS metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
  -  Patient has received chemotherapy or anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, monoclonal antibodies or mitomycin-C) prior to starting study drug.

Relevance to patient case: not relevant
Patient case: 26-year-old male with Liposarcoma. Genetic variant: MDM2 Amplification. Other conditions: None.

Clinical trial: LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)

Summary: The purpose of this signal seeking study is to determine whether treatment with LEE011 demonstrates sufficient efficacy in CDK4/6 pathway activated solid tumors and/or hematologic malignancies to warrant further study.


Eligibility: Inclusion Criteria:
  -  Patient has a confirmed diagnosis of a select solid tumor (except breast cancer (however, triple negative will be included), liposarcoma, CRPC, melanoma and teratoma) or hematological malignancy (except mantle cell lymphoma).
  -  Patient must have been pre-identified as having a tumor with CDK4 amplification or mutation, CDK6 amplification or mutation, Cyclin D1 (CCND1) amplification, Cyclin D3 (CCND3) amplification, or p16 (CDKN2A) mutation
  -  Patient has received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.
  -  Patient has progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines.
  -  Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  Exclusion Criteria:
  -  Patients has received prior treatment with LEE011.
  -  Patient has clinically significant resting bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval > 109 msec, or QTcF > 450 msec.
  -  Patients has primary CNS tumor or CNS tumor involvement
  -  Patient has received chemotherapy or anticancer therapy ≤ 4 weeks prior to starting study drug

Relevance to patient case: not relevant
Patient case: 26-year-old male with Liposarcoma. Genetic variant: MDM2 Amplification. Other conditions: None.

Clinical trial: PET Imaging of Solid Tumors Using 124I-Humanized 3F8: A Pilot Study

Summary: The purpose of this study is to find out how an antibody called Hu3F8 travels through the body and to tumors. Antibodies, like Hu3F8, are proteins that help attack tumors or fight infections. Antibodies can be made by your own body or in a laboratory. The target of an antibody is called an antigen; antibodies fit their antigen like a lock fits a key.


Eligibility: Inclusion Criteria:
  -  Patients with the diagnosis of neuroblastoma must meet both of the following criteria:
  -  Diagnosis confirmed by histological assessment by MSKCC Department of pathology or by the presence of BM metastases PLUS elevated urinary catecholamines
  -  Relapsed or refractory stage 4 disease or relapsed or refractory stage MYCN-amplified 2B or 3 disease.
  -  Patients with tumors other than neuroblastoma must meet both the following criteria:
  -  Have one of the following diagnoses (these tumors are known to express GD2 on cell surface):
  -  Melanoma
  -  Osteogenic sarcoma
  -  Leiomyosarcoma
  -  Ewing sarcoma
  -  Liposarcoma
  -  Fibrosarcoma
  -  Malignant fibrous histiocytoma
  -  Spindle cell sarcoma
  -  Small cell lung cancer
  -  Medulloblastoma metastatic to extracranial sites
  -  Paraganglioma
  -  Have refractory or relapsed or metastatic disease
  -  Patients with solid tumors with diagnoses OTHER than neuroblastoma or those listed above will be eligible if they meet both of the following criteria:
  -  Immunohistochemical demonstration of GD2 expression on cell surface (Tumor assessment by immunohistochemistry is required for this group of patients)
  -  Have refractory or relapsed disease or metastatic disease. All patients must have measurable or evaluable disease
  -  Age 3-90 years
  -  Prior treatment with anti-GD2 monoclonal antibody is permitted only if human anti-human antibody titer is ≤1300 assay developed by Dr. Nai-Kong Cheung.
  -  Negative serum pregnancy test in women of childbearing potential
  -  Women of child-bearing potential must be willing to practice an effective method of birth control while on study
  -  Signed informed consent indicating awareness of the investigational nature of this study.
  Exclusion Criteria:
  -  Existing major organ dysfunction > grade 2, with the exception of myelosuppression (neutrophil count > or = 500/μl and platelet count > or = 25,000/μl are acceptable) and hearing loss.
  -  Acute life threatening infection
  -  Requirement for sedation for PET/CT scans
  -  Pregnant women or women who are breast-feeding.
  -  Inability to comply with protocol requirements.
  -  Hypersensitivity to potassium iodide or Lugols products
  -  Prior development of positive human antimouse antibody response (HAMA) or human antihuman antibody response (HAHA)
  -  Positive human anti-hu3F8 antibody titer.

Relevance to patient case: not relevant
Patient case: 26-year-old male with Liposarcoma. Genetic variant: MDM2 Amplification. Other conditions: None.

Clinical trial: Safety and Clinical Activity of Lapatinib in Patients With HER2-positive Refractory Advanced Cancer

Summary: Although anti-HER2 (human epidermal growth factor receptor 2) therapy is currently approved for breast, gastric, and gastroesophageal cancers overexpressing the HER2 protein or amplified for the HER2 gene, HER2 aberrations (gene amplification, gene mutations, and protein overexpression) are reported in other diverse malignancies. Indeed, about 1-37% of tumors of the following types harbor HER2 aberrations: bladder, cervix, colon, endometrium, germ cell, glioblastoma, head and neck, liver, lung, ovarian, pancreas, and salivary duct.
  Lapatinib is an orally active, reversible, small molecule TKI that potently inhibits both ErbB1 and ErbB2 tyrosine kinase activity. Data suggest that a dual ErbB1 and ErbB2 inhibitor may provide improved therapeutic benefit compared with inhibitors that target only one or the other receptor.
  Therefore, this phase 2 study is designed to evaluated the activity of lapatinib in patients with HER2-positive refractory cancer.


Eligibility: Inclusion Criteria:
  -  Age > 19
  -  Written informed consent
  -  ECOG 0-2,
  -  Histologically confirmed HER2-positive Refractory solid tumor(IHC 3+ alone, or IHC 2+ with FISH amplification) and/or specific sensitivity to Lapatinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  -  The presence of measurable disease as defined by the Response (Evaluation Criteria in Solid Tumors (RECIST) version 1.1)
  -  Adequate organ function
  Exclusion Criteria:
  -  Uncontrolled symptomatic brain metastasis,Uncontrolled active infection
  -  Uncontrolled systemic illness (DM, CHF, unstable angina, hypertension or arrhythmia)
  -  Prolonged QT interval in ECG (QTc >450 msec)
  -  Pregnant, lactating women
  -  Prior treatment with lapatinib,Malabsorption syndrome, any disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or persons unable to swallow oral medication
  -  Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer

Relevance to patient case: not relevant