araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Once or Twice Daily Administration of BIIB021 to Subjects With Advanced Solid Tumors

Summary: The purpose of the study is to see if daily and twice daily administration of BIIB021 is tolerated in patients with advanced solid tumors.

Detailed description: Heat shock protein 90 (HSP90) inhibitors are anticipated to have clinical activity in solid tumors because Hsp90 is required for the folding, activation, and assembly of many proteins involved in cancer cell survival, proliferation, and metastasis. The maximum tolerated dose (MTX) for BIIB021 administered twice weekly in a phase I study in subjects with advanced solid tumors have been defined at 600mg. It is now reasonable from a safety perspective and desirable from a pharmacokinetic perspective to evaluate more frequent dosing intervals in solid tumors with the goal of providing more sustained and completed inhibition of Hsp90.

Eligibility: Inclusion Criteria:
  Subjects with histologically or cytologically confirmed solid tumor who have failed or refused standard therapies or for which no approved therapy is available.
  Age greater than or equal to 18 years at the time of informed consent. ECOG performance status of less than or equal to 2. Lab values consistent with adequate renal, hepatic, and bone marrow functions.
  Exclusion Criteria:
  Prior antitumor therapies, including prior experimental agents or approved antitumor small molecules and biologics within 28 days and all associated toxicities resolved to eligibility levels.
  Subjects with known brain metastases. Concurrent severe or uncontrolled medical disease. Must utilize effective contraception.

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Study of Denosumab in Subjects With Giant Cell Tumor of Bone

Summary: To determine how safe denosumab is in treating subjects with giant cell tumor of bone (GCTB)

Detailed description: To determine how safe denosumab is in treating subjects with GCTB

Eligibility: Inclusion criteria:
  -  Pathologically confirmed GCTB within 1 year before study enrollment
  -  Measurable evidence of active disease within 1 year before study enrollment
  -  Subjects with surgically unsalvageable disease (eg, sacral, spinal GCTB, or multiple lesions including pulmonary metastases) OR subjects whose planned surgery includes joint resection, limb amputation, hemipelvectomy or surgical procedure resulting in severe morbidity
  -  Karnofsky performance status equal or greater than 50% (ie, Eastern Cooperative Oncology Group status 0, 1, or 2)
  -  Adults or skeletally mature adolescents (ie, radiographic evidence of at least 1 mature long bone [eg, humerus with closed growth epiphyseal plate]) equal or greater than 12 years of age
  -  Skeletally mature adolescents must weigh at least 45 kg
  -  Before any study-specific procedure is performed, the appropriate written informed consent must be obtained
  Exclusion criteria:
  -  Currently receiving other GCTB specific treatment (eg, radiation, chemotherapy, or embolization)
  -  Concurrent bisphosphonate treatment
  -  Known or suspected current diagnosis of underlying malignancy including high grade sarcoma, osteosarcoma, fibrosarcoma, malignant giant cell sarcoma
  -  Known or suspected current diagnosis of non GCTB giant cell-rich tumors
  -  Known or suspected current diagnosis of brown cell tumor of bone or Paget's disease
  -  Known diagnosis of second malignancy within the past 5 years (subjects with definitively treated basal cell carcinoma and cervical carcinoma in situ are permitted)
  -  Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
  -  Active dental or jaw condition which requires oral surgery, including tooth extraction
  -  Non-healed dental/oral surgery
  -  Planned invasive dental procedure for the course of the study
  -  Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
  -  Subject has known sensitivity to any of the products to be administered during dosing
  -  Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before enrollment
  -  Subject is pregnant or breast feeding, or planning to become pregnant within 5 months after the end of treatment
  -  Female subject of child bearing potential is not willing to use two methods of highly effective contraception during treatment and for 5 months after the end of treatment
  -  Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Treatment of Patients With RAD001 With Progressive Sarcoma

Summary: The purpose of this multicenter, three-arm, exact binomial single-stage, phase II trial is to determine the preliminary efficacy and safety of RAD001 in patients with histological evidence of progressive or metastatic bone or soft tissue sarcoma.


Eligibility: Inclusion Criteria:
  Histological evidence of progressive or metastatic bone or soft tissue sarcoma.
  The following tumor types are included:
  -  malignant fibrous histiocytoma
  -  liposarcoma
  -  synovial sarcoma
  -  malignant paraganglioma
  -  fibrosarcoma
  -  leiomyosarcoma
  -  angiosarcoma including haemangiopericytoma
  -  malignant peripheral nerve sheath tumor
  -  STS, not otherwise specified
  -  miscellaneous sarcoma including mixed mesodermal tumors of the uterus
  -  osteosarcoma
  -  Ewing's sarcoma
  -  rhabdomyosarcoma
  -  gastrointestinal stromal tumor (only after failure or intolerance of imatinib or sunitinib in 1st and 2nd line)
  -  alveolar soft part sarcoma (ASPS)
  -  Objective progression of disease may be documented by RECIST criteria. Any of the following would be sufficient according to RECIST:
  -  a 20% increase in the sum of unidimensionally measured target lesions
  -  a new lesion
  -  unequivocal increase in non-measurable disease.
  -  Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent.
  -  ECOG performance status 0 - 2.
  Exclusion Criteria:
  Anticancer therapy within 3 weeks of enrollment including chemotherapy, hormonal therapy, immunotherapy, or radiotherapy.
  -  The following tumor types will not be included:
  -  gastrointestinal stromal tumor (except for patients after treatment with imatinib or sunitinib in 1st and 2nd line)
  -  chondrosarcoma
  -  malignant mesothelioma
  -  neuroblastoma.
  -  Prior therapy with RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus).
  -  Neurotoxicity > grade 2 CTC.
  -  Radiation of the lung.
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Proton Therapy for Chordomas and/or Chondrosarcomas

Summary: The purpose of this study is to collect information from medical records to see what effects proton beam radiation has on cancer and analyze possible side effects.

Detailed description: Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

Eligibility: Inclusion Criteria:
  -  Histologically proven chordoma or chondrosarcoma.
  -  Sites: base of skull and/or spine.
  -  Age 18 years or older.
  Exclusion Criteria:
  -  Previous radiation to the head and neck or brain.
  -  Evidence of metastatic disease.

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Magnetic Resonance (MR) Imaging to Determine High Risk Areas in Patients With Malignant Gliomas and to Design Potential Radiation Plans and to Examine Metabolite Changes in Gliomas and Other Solid Tumors

Summary: The purpose of this study is to assess the ability of these advanced MRI scans in predicting areas within a malignant glioma (brain tumor) that are at a high risk of recurring. If these advanced MRI scans are able to identify the cancerous part of the tumor, then radiation therapy can be targeted to those sites and possibly improve patient survival.


Eligibility: Inclusion Criteria:
  -  Suspected or Histopathologically proven diagnosis of high grade or low glioma or tumor is suspected to harbor an isocitrate dehydrogenase (IDH) mutation
  -  May undergo radiation therapy
  -  Patient and/or guardian is able to provide written informed consent prior to study registration
  -  Age ≥ 18 years old
  Exclusion Criteria:
  -  Extreme claustrophobia that precludes MRI scan
  -  Known allergic reaction to Gd-DTPA
  -  Any contraindication to gadolinium intravenous contrast as per standard Department of Radiology contrast guidelines
  -  Any absolute contraindication to MRI (e.g., pacemaker, aneurysm clip, tissue expander).
  -  Pregnant or nursing female
  -  Unable to cooperate for MRI and/or radiation therapy planning

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Imatinib in Patients With Desmoid Tumor and Chondrosarcoma

Summary: The purpose of this study is to determine whether Imatinib Mesylate is active in diseases - such as Desmoid Tumor and Chondrosarcoma - expressing the receptor for the platelet-derived growth factor (PDGF) both in its isoform alpha and beta


Eligibility: Inclusion Criteria:
  -  Histological diagnosis of DT or CDS.
  -  Biomolecular or immunohistochemical evidence of Imatinib mesylate target (KIT, PDGFRα PDGFRβ activation and/or presence of PDGFα or PDGFβ)
  -  Measurable or evaluable disease
  -  Surgical resection of local disease unfeasible radically (or unaccepted by the patient, or amenable to become less demolitive, or easier, or likely more feasible, after cytoreduction) and/or metastatic disease.
  -  ECOG Performance status 0, 1, 2 or 3
  -  Adequate bone marrow, liver and renal function
  -  Female patients of child-bearing potential must have negative pregnancy test.
  -  Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study.
  -  Written, voluntary, informed consent.
  Exclusion Criteria:
  -  Previous treatment with any other investigational or not investigational agents within 28 days of first day of study drug dosing
  -  Other primary malignancy with <5 years clinically assessed disease-free interval, except basal cell skin cancer or cervical carcinoma in situ.
  -  Grade III/IV cardiac problems as defined by the New York Heart Association Criteria
  -  Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection)
  -  Known brain metastasis.
  -  Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
  -  Known diagnosis of human immunodeficiency virus (HIV) infection.
  -  Previous radiotherapy to >/=25% of the bone marrow or within the previous 2 months on target lesion.
  -  Major surgery within 2 weeks prior to study entry.
  -  Expected non-compliance to medical regimens (e.g. psychiatric diseases).

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant

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 chronic graft-versus-host disease in patients who have undergone donor stem cell transplant.
  PURPOSE: This phase I trial is studying chronic graft-versus-host disease in patients who have undergone donor stem cell transplant.

Detailed description: OBJECTIVES:
  -  To determine and define the biological basis of different subtypes of chronic graft-vs-host disease using a targeted single nucleotide polymorphisms approach in patients who have undergone allogeneic stem cell transplantation.
  OUTLINE: Two important aspects of the methodologies that will be employed for the analysis of SNPs associated with GVHD are throughput efficiency to be able to perform the assays on a reasonable number of samples as well as having the ability to add or remove SNPs to the assay panel. While a genome-wide association study to identify variants associated with GVHD would offer an unbiased approach, our patient cohort size would not allow significant statistical power in the study. Therefore, a more targeted approach using two established technologies is proposed.
  The Sequenome assay uses the unique combination of a single-base primer extension assay incorporating one of four modified nucleotides. The four modified nucleotides each have a unique mass that allows them to be distinguished from one another using mass spectrometry. Each SNP is determined analyzing the primer extension product from a PCR amplicon that surrounds the SNP of interest. The development of each assay involves designing flanking PCR primers and an internal extension assay using web-based software provided by Sequenome. The assays can be designed to analyze up to 30 SNPs in a single reaction, providing a customizable, efficient and high-throughput assay for SNPs of interest.

Eligibility: DISEASE CHARACTERISTICS:
  -  Underwent prior matched related or unrelated allogeneic stem cell transplantation (SCT)
  -  Presence OR absence of chronic graft-vs-host disease after day 100 and alive after day 180 post-transplantation
  -  No T-cell depleted SCT, cord blood transplantation, mismatched allogeneic transplantation, or autologous transplantation
  -  Available recipient and donor DNA (samples collected from the Vanderbilt University or the Fred Hutchinson Cancer Center tissue bank)
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds

Summary: The purpose of this study is to determine whether the use of a bioelectric wound dressing is effective in the healing of skin graft donor site wounds.


Eligibility: Inclusion Criteria:
  -  Wounds resulting from skin graft
  -  Split thickness wound
  -  Wound size greater than 2x2 cm
  -  Wounds must be ≥5 cm away from all other wounds
  -  Participant agrees to participate in follow-up evaluation
  -  Participant must be able to read and understand informed consent, and sign the informed consent
  Exclusion Criteria:
  -  Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study
  -  Participant is to receive another topical antimicrobial agent other than the study dressing
  -  Participant with sensitivity or adverse reactions to silver or zinc
  -  Pregnancy or nursing an infant or child
  -  Immunosuppression
  -  Active or systemic infection
  -  Peripheral vascular occlusive disease
  -  Collagen vascular disease
  -  Connective tissue disease
  -  Participant undergoing active cancer chemotherapy
  -  Chronic steroid use
  -  Decision impairment

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Trial of Proton Versus Carbon Ion Radiation Therapy in Patients With Low and Inter-mediate Grade Chondrosarcoma of the Skull Base

Summary: The study is a prospective randomised clinical phase III trial. Proton therapy is the gold standard in the treatment of low and intermediate grad chondrosarcomas of the skull base. However, high-LET beams such as carbon ions theoretically offer biologic advantages by enhanced biologic effectiveness in slow-growing tumors. Up until now it was impossible to compare two different particle therapies, i.e. proton and carbon ion therapy directly with each other. The aim of this study is to find out, whether the biological advantages of carbon ion therapy mentioned above can also be clinically confirmed.

Detailed description: The study is a prospective randomised clinical phase III trial. The trial will be carried out at Heidelberger Ionenstrahl-Therapie (HIT) centre as monocentric trial.
  Proton therapy is the gold standard in the treatment of low and intermediate grad chondrosarcomas of the skull base. However, high-LET beams such as carbon ions theoretically offer biologic advantages by enhanced biologic effectiveness in slow-growing tumors. Up until now it was impossible to compare two different particle therapies, i.e. proton and carbon ion therapy directly with each other. The aim of this study is to find out, whether the biological advantages of carbon ion therapy mentioned above can also be clinically confirmed.
  Patients with skull base chondrosarcomas will be randomised to either proton or carbon ion radiation therapy. As a standard, patients will undergo non-invasive, rigid immobilization and target volume definition will be carried out based on CT and MRI data. The biologically isoeffective target dose to the PTV in carbon ion treatment will be 60 Gy E ± 5% and 70 Gy E ± 5% (standard dose) in proton therapy respectively. The 5 year local-progression free survival (LPFS) rate will be analysed as primary end point. Overall survival, progression free and metastasis free survival, patterns of recurrence, local control rate and morbidity are the secondary end points. Plan quality is also a matter of interest.

Eligibility: Inclusion Criteria:
  -  Karnofsky Performance Score ≥60%
  -  Age >18 years and <80 years
  -  Informed consent signed by the patient
  -  Histological confirmation of low/ intermediate grade chondrosarcoma with infiltration of the skull base.
  Exclusion Criteria:
  -  Inability to understand the aims of the study, no informed consent
  -  Prior RT of skull base region
  -  Other malignancies with disease-free interval < 5 years (excepting pre-cancerous lesions)
  -  Participation in another trial
  -  Pregnancy
  -  Simultaneous CHT or Immunotherapy.

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI

Summary: This pilot trial studies the differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced magnetic resonance imaging (MRI). Imaging procedures that allow doctors to more accurately differentiate between malignant bone sarcomas and osteomyelitis may help in diagnosing patients correctly and may result in more timely treatment.

Detailed description: PRIMARY OBJECTIVES:
  I. Establish magnetic resonance (MR) imaging characteristics of bone sarcomas and osteomyelitis based on their ferumoxytol-enhancement on relatively early postcontrast T1-weighted images.
  II. Establish MR imaging characteristics of bone sarcomas and osteomyelitis based on their ferumoxytol-enhancement on delayed postcontrast T2-weighted images.
  III. Establish T2-weighted MR imaging characteristics of iron labeled mesenchymal stem cell (MSC) in osteonecrotic bone over time, before and after surgical core decompression and bone marrow implantation.
  IV. Adding a second branch for patients who can not receive ferumoxytol but still getting the MRI exam.
  OUTLINE:
  Patients receive ferumoxytol intravenously (IV) and then undergo ferumoxytol-enhanced MRI up to 1 hour after infusion and up to 24 hours post-infusion.

Eligibility: Inclusion Criteria:
  -  Suspected or confirmed diagnosis of a bone sarcoma or osteomyelitis
  -  Symptomatic osteonecrosis (ON) of the femur or proximal tibia with MR signal abnormalities that involve more than 50% of the respective joint surface, but no evidence of epiphyseal collapse
  -  There will be no gender/race-ethnic restrictions
  -  In this pediatric & adult study, the participant or parent/guardian is consented, and the patient when a minor is given an assent form and involved in the discussion as appropriate
  Exclusion Criteria:
  -  Contraindication to MRI
  -  Presence of metal implants
  -  Need for sedation or anesthesia
  -  Claustrophobia
  -  Hemosiderosis/hemochromatosis (patients can still be included in the 2nd branch without receiving ferumoxytol)
  -  There will be no restrictions regarding use of other investigational agents
  -  Patients with evidence of iron overload, hemosiderosis/hemochromatosis will be excluded for the bone sarcoma study; however, they can undergo MRI exam without ferumoxytol enhancement for the ON study
  -  History of allergic reactions to similar compounds will be obtained and patients with positive history of allergic reactions will be excluded from the study
  -  Pregnancy or nursing patients will be excluded from the study; a pregnancy test will be done prior to the MR examination for postmenarchal teenage girls, in whom pregnancy may be possible; only patients with a negative pregnancy test will be included in the study

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Proton Radiation for Chordomas and Chondrosarcomas

Summary: The objectives of this study are 1) To evaluate the feasibility and acute side effects of proton therapy for chordomas and chondrosarcomas and 2) To evaluate clinical outcomes and long term side effects of proton beam radiation for treatment of chordomas and chondrosarcomas.

Detailed description: This trial will be conducted in two phases: a feasibility then a phase II trial. Once feasibility and safety are established in the first 12 pts. the phase II study will begin. Proton therapy at standard doses is not known to improve clinical outcome but will likely reduce fatigue and toxicity.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed diagnosis of chordoma or chondrosarcoma.
  -  Patients must have no evidence of metastatic disease based on routine imaging (CT or MRI of the chest/abdomen/pelvis, bone scan, etc.)
  -  Patients must have an ECOG score equal to or less than 2.
  -  Age ≥ 18 years.
  -  Patients must be able to provide informed consent.
  -  Adequate bone marrow function: WBC ≥ 4000/mm3, platelets ≥ 100, 000mm3
  -  Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive , IUD, condoms or other barrier methods etc.) Hysterectomy or menopause must be clinically documented.
  -  Tumors arising in the skull and spine.
  Exclusion Criteria:
  -  Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
  -  Patients with the following histologies are excluded: melanoma , other soft tissue or bony sarcomas, giant cell tumor aneurismal bone cyst or metastatic lesions from other histologies.
  -  Pregnant women.
  -  Actively being treated on any other therapeutic research study.
  -  Tumors arising outside of the CNS.

Relevance to patient case: not relevant