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

Clinical trial: Diagnostic Study of Tumor Characteristics in Patients With Ewing's Sarcoma

Summary: Diagnostic trial to study genetic differences in patients who have Ewing's sarcoma. Genetic testing may help predict how cancer will respond to treatment and allow doctors to plan more effective therapy.

Detailed description: PRIMARY OBJECTIVES:
  I. To develop a mechanism to collect and distribute tumor specimens to various investigators, and a system to prioritize and develop quality-control measures for central data reporting of studies undertaken.
  II. To determine the prognostic significance of translocation subtype in Ewing sarcoma; to determine the prognostic significance of translocation negative Ewing sarcoma.
  III. To determine the prognostic significance of MRD detection in bone marrow specimens by RT-PCR determination of EWS-ETS fusion genes.
  IV. To determine whether serum levels of IGF1, IGFBP3 are of significance in the outcome of patients with Ewing sarcoma.
  V. To determine whether RNA expression profiles performed on diagnostic specimens will allow for the identification of newer prognostic categories and potentially new molecular targets for treatment in Ewing sarcoma.
  VI. To identify new treatment targets for therapy. Further testing of these potential targets will be carried out in hopes of expediting translation of these findings to the clinic.
  VII. To establish a bank of Ewing sarcoma xenografts in SCID/Beige mice. VIII. To establish clinical proteomics as a resource for investigations of altered signaling molecules in the pathogenesis of Ewing sarcoma.
  OUTLINE: This is a multicenter study.
  Patients undergo various specimen collections, including bone marrow aspirate, paraffin-embedded blocks of tumor tissue or slides of tumor tissue, and blood specimens. These specimens are collected before, during, and after any chemotherapy regimens, during follow-up, and at time of recurrence. Translocation studies are performed on specimens to identify fusion genes, specifically EWS-ETS. Serum IGF1 and IFGBP3 levels are determined. Bone marrow is assessed for minimal residual disease using reverse-transcriptase polymerase chain reaction.

Eligibility: Inclusion Criteria:
  -  Newly diagnosed or recurrent Ewing's sarcoma
  -  Availability of the following specimens:
  -  Paraffin-embedded block or 20 unstained slides and 1-3 thick (50 micron) sections from initial biopsy
  -  Pretreatment serum and whole blood
  -  Concurrent therapy is not required

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

Clinical trial: a Multicenter Clinical Trial for the Treatment of Children and Adolescents With Soft Tissue Sarcoma Stage 4

Summary: Phase II Study to evaluate the response on two blocks of topotecan and carboplatin

Detailed description: Phase II study for patients with chemosensible soft tissue sarcoma stage IV in children and adolescents ; response according to RECIST criteria following two blocks of combination therapy consisting of Topotecan and carboplatin

Eligibility: Inclusion Criteria:
  -  Soft tissue sarcoma chemosensible, stage IV
  -  age < 21
  -  measurable tumor lesions
  Exclusion Criteria:
  -  Lack of cooperation by the patient
  -  no willingness of follow-up examinations
  -  participation on another clinical trial at the same time
  -  death due to the sickness within four weeks

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

Clinical trial: Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas

Summary: The purpose of this study is to determine if the combination of gemcitabine and vinorelbine is effective in treating patients with advanced soft tissue sarcoma.

Detailed description: Patients will receive both gemcitabine and vinorelbine once a week for two weeks and then one week with no chemotherapy (1 cycle equals 21 days). Gemcitabine and vinorelbine will be administered on day 1 and day 8 of each cycle.
  Blood tests will be performed on each day chemotherapy is administered. A CT scan will be done after every 2 cycles (approximately every 6 weeks) to determine the effects of the chemotherapy on the sarcoma.
  A physical exam will be performed at the start of chemotherapy and at least every three weeks thereafter.
  Patients will remain on this study as long as the disease does not progress or there are no unacceptable side effects.

Eligibility: Inclusion Criteria:
  -  Histologic diagnosis of unresectable or metastatic soft tissue sarcoma
  -  Measurable disease outside of a prior irradiated area
  -  ECOG performance status 0,1, or 2.
  -  0 or 1 prior regimens for advanced disease.
  -  Adequate end organ function, defined as bilirubin < 1.8; SGOT/SGPT < 2.5 x upper limit of normal (ULN); creatinine < 1.5 x ULN.
  -  Negative pregnancy test
  -  Life expectancy of greater than 3 months
  Exclusion Criteria:
  -  Patient has received any investigational agents within 28 days of first day of study drug dosing
  -  Two or more prior regimens for advanced disease
  -  Prior gemcitabine or vinorelbine
  -  Another primary malignancy
  -  Grade III/IV cardia dysfunction
  -  Female patients who are pregnant or breast-feeding
  -  Severe and/or life-threatening medical disease
  -  Known diagnosis of HIV infection
  -  Prior chemotherapy within 4 weeks prior to study entry
  -  Major surgery within 2 weeks prior to study entry
  -  Known hypersensitivity to either gemcitabine or vinorelbine

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

Clinical trial: Isolated Pelvic and Limb Perfusion in the Treatment of Locally Advanced Sarcoma of Pelvis and Limbs’ Girdle

Summary: This study looks at isolated pelvic perfusion and limbs' girdle with 1 mg tumor necrosis factor alpha (TNFa) in the treatment of locally advanced sarcoma of the pelvis and limbs’ girdle.


Eligibility: Inclusion Criteria:
  -  Soft tissue or bone sarcomas locally advanced of the pelvis or limbs’ girdle
  Exclusion Criteria:
  -  Resectable tumor without mutilation

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

Clinical trial: Evaluation of Side Effects and Relative Activity of Two Chemotherapy Regimens in the Treatment Soft Tissue Sarcoma

Summary: The purpose of this study is to explore how a sarcoma is affected by and the side effects of a newer combination of chemotherapy drugs(gemcitabine and docetaxel)as compared to a standard combination of chemotherapy drugs, ifosfamide and doxorubicin.

Detailed description: The purpose of this study is to explore the relative activity and toxicity of a newer combination of chemotherapy drugs, gemcitabine and docetaxel, as compared to a standard combination of chemotherapy drugs, ifosfamide and doxorubicin.
  Ifosfamide and Doxorubicin, given in combination, are recognized as a standard of care for some types of sarcoma. Both gemcitabine and docetaxel are approved by the US Food and Drug Administration (FDA) for the treatment of some cancers (cancers of the pancreas, lung) because patients with those cancers treated with either gemcitabine or docetaxel experienced shrinkage of their tumor or improvement in their symptoms. However, neither gemcitabine or docetaxel is approved for sarcoma, but the combination of gemcitabine and docetaxel is a standard treatment for advanced sarcoma.

Eligibility: Inclusion Criteria:
  -  no evidence of metastasis
  -  soft tissue sarcoma
  -  intermediate or high histologic grade
  -  greater than 5 cm
  -  Zubrod performance status 1 or better
  -  age 10 or older
  Exclusion Criteria:
  -  clear cell, alveolar soft part, Ewing's rhabdosarcoma, undifferentiated small cell or Kaposi's
  -  prior chemotherapy
  -  nephrectomy
  -  active unstable angina pectoris
  -  concurrent therapy

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

Clinical trial: Chart Review of Treatments Received by Patients Diagnosed With Soft Tissue Sarcoma

Summary: To review the outcome of patients with soft tissue sarcoma treated with chemotherapy from 2004 and 2005.

Detailed description: Chart review of patients with soft tissue sarcoma treated with chemotherapy from 2004 and 2005 to determine outcome

Eligibility: Inclusion Criteria:
  -  Patients diagnosed with soft tissue sarcoma treated with chemotherapy form 2004 and 2005.
  Exclusion Criteria:
  -  Not Specified

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

Clinical trial: PET Scan Combined With CT Scan in Evaluating Treatment Response in Patients Undergoing Treatment for Bone Cancer or Soft Tissue Sarcoma

Summary: RATIONALE: Diagnostic procedures, such as PET scan and CT scan, may help doctors determine the extent of cancer and predict a patient's response to treatment and help plan the best treatment.
  PURPOSE: This clinical trial is studying how well PET scan combined with CT scan evaluates treatment response in patients undergoing treatment for bone cancer or soft tissue sarcoma.

Detailed description: OBJECTIVES:
  -  Determine whether an FDA-approved device that combines fludeoxyglucose ^18F positron-emission tomography (FDG-PET) and CT scanning (FDG-PET/CT) can accurately locate and determine the extent of disease in patients who are undergoing treatment for bone or soft tissue sarcoma.
  -  Determine whether FDG-PET/CT scanning is effective in evaluating the response of sarcoma to treatment.
  -  Determine whether the new FDG-PET/CT device improves the ability to evaluate treatment response early and accurately.
  -  Correlate changes in glucose metabolic activity early and late after treatment with overall and progression-free survival.
  -  Correlate changes in glucose metabolic activity early and late after treatment with degree of tumor necrosis at the time of surgery.
  OUTLINE: This is a prospective, pilot study. Patients are stratified according to disease (high-grade soft tissue sarcoma vs low-grade soft tissue sarcoma vs osteosarcoma).
  Patients undergo fludeoxyglucose ^18F positron-emission tomography (FDG-PET)/CT scanning at baseline and then within 2 weeks and 12 weeks after the start of treatment (total of 3 scans).
  PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed bone or soft tissue sarcoma
  -  Scheduled to undergo treatment (i.e., chemotherapy and/or radiotherapy) for sarcoma
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  Not claustrophobic
  -  Able to lie supine for 1 hour
  -  Patients with diabetes mellitus allowed provided serum glucose levels ≤ 200 mg/dL
  Exclusion Criteria:
  -  pregnant
  -  other malignancies within the past 5 years (except completely resected cervical or nonmelanoma skin cancer) unless the malignancy was curatively treated and is at low risk for recurrence

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

Clinical trial: Improving Employment in Patients Who Have Survived Cervical Cancer, Uterine Cancer, or Ovarian Cancer

Summary: RATIONALE: Finding out which problems affect employment in survivors of gynecologic cancer may help in planning cancer treatment and improve the quality of life of future cancer survivors.
  PURPOSE: This research study is looking at ways to improve employment in patients who have survived cervical cancer, uterine cancer, or ovarian cancer.

Detailed description: OBJECTIVES:
  -  Conduct formative work, including 4 to 5 focus groups, leading to development of a structured interview instrument assessing factors related to employment outcomes among women with gynecologic cancers.
  -  Pilot a recruitment strategy and administer the interview among a sample of 60 to 70 gynecologic cancer survivors; and, with each woman's permission, a family member, a key health care provider, and her supervisor will be interviewed.
  OUTLINE: This is a multicenter, pilot study.
  Patients complete a survey, meet with a focus group, and undergo a short interview. Patient-designated participants are also interviewed; these individuals may include a health care provider, a significant other, and/or a work supervisor.
  PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of 1 of the following invasive cancers:
  -  Cervical cancer
  -  Uterine cancer
  -  Ovarian cancer
  -  Diagnosed ≥ 6 months ago
  -  Any stage disease
  -  Employed at the time of diagnosis, defined as working for pay ≥ 20 hours/week
  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: Development of Serologic Assays for Human Herpes Virus-8

Summary: Dr. Burbelo and colleagues have developed a technique for rapidly and quantitatively detecting antibody responses in sera to a variety of pathogens using recombinant proteins. We would like to apply this technique to develop an assay for detecting antibodies to HHV-8 (KSHV, the etiologic agents of Kaposi's sarcoma, an AIDS-defining condition). We initially plan to examine samples from patients with Kaposi's sarcoma, since all those patients are almost certainly infected with HHV-8. We are thus using samples from patients with previously diagnosed Kaposi's sarcoma. The samples in question are stored at the NCI FCRF repository operated by SAIC Frederick or in Rockville, MD.

Detailed description: Our colleagues have developed a technique for rapidly and quantitatively detecting antibody responses in sera to a variety of antigens using recombinant proteins. We would like to apply this technique to develop an assay for detecting antibodies to HHV- 8 (KSHV, the etiologic agent of Kaposi s sarcoma, an AIDS-defining condition). In addition we would like to potentially measure antibody responses to HIV, other infectious agents, and human antigens, to see if antibodies (or high antibody titers) to these antigens are associated with Kaposi s sarcoma or HIV infection. We initially plan to examine samples from patients with Kaposi s sarcoma, since all those patients are almost certainly infected with HHV-8. We would subsequently plan to examine samples from HIV positive and HIV negative patients without known Kaposi s sarcoma. We are thus requesting permission to use samples from patients with and without previously diagnosed Kaposi's Sarcoma. In addition to antibody testing, we would also like to examine these samples for evidence of infection with other infectious agents, such as newly identified or unknown viruses, using techniques such as PCR or deep
  sequencing.

Eligibility: -  Data analysis only

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

Clinical trial: Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors

Summary: This is a study to assess the combination of PXD101 and 5-Fluorouracil (5-FU)in patients with advanced solid tumors. The primary goal of the study is to understand the safety, anti-tumor activity, and how the study drug behaves within the body when given with 5-Fluorouracil (5-FU).


Eligibility: Inclusion Criteria:
  -  Histologically confirmed solid tumors
  -  Advanced colorectal cancer or other adenocarcinomas
  -  Tumor progression after standard chemotherapy, or where none yet approved
  -  At least one unidimensionally measurable lesion
  -  Karnofsky performance >= 70%
  -  Life expectancy of at least 3 months
  -  Age >= 18 years
  -  Signed, written Institutional Review Board (IRB)-approved informed consent
  -  Acceptable liver function:
  -  Bilirubin <= 1.5 x upper limit of normal (ULN)
  -  AST (SGOT) and ALT (SGPT) <= 2.5 x ULN, OR
  -  AST (SGOT) and ALT (SGPT) <= 5 x ULN if liver metastasis
  -  Acceptable renal function:
  -  Serum creatinine within normal limits, OR
  -  Calculated creatinine clearance of >= 60 mL/min/1.73 m2 for certain patients
  -  Acceptable hematologic status:
  -  Absolute neutrophil count (ANC) >= 1500 cells/mm3
  -  Platelet count >= 100,000 (plt/mm3)
  -  Hemoglobin >= 9 g/dL
  -  Urinalysis: No clinically significant abnormalities
  -  Acceptable coagulation status:
  -  Prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits, OR
  -  For patients on anticoagulation therapy, status within therapeutic range
  -  For men and women of child-producing potential, use of effective contraception
  -  Tumors accessible for needle biopsy
  Exclusion Criteria:
  -  Significant cardiovascular disease.
  -  A marked baseline prolongation of QT/QTc interval
  -  Long QT syndrome
  -  Required use of medication on dosing days that may cause torsade de pointes.
  -  Infections requiring intravenous (IV) systemic therapy
  -  Pregnant or nursing women
  -  Treatment with chemotherapy or investigational therapy < 4 weeks (28 days) prior to study entry (6 weeks for nitrosoureas, mitomycin C, or Avastin).
  -  Treatment with radiation therapy or surgery either within 2 weeks prior to study entry, or not yet recovered if 2-4 weeks prior to study entry.
  -  Unwillingness or inability to comply with protocol procedures.
  -  Known active uncontrolled infection with HIV, hepatitis B, or hepatitis C
  -  Serious nonmalignant disease (e.g. hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
  -  Concurrent use of other investigational agent(s)
  -  Serious concurrent medical illness

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

Clinical trial: Study Of Anti-IGF-IR CP-751,871 In Patients With Solid Tumors

Summary: This is a phase 1 study of anti-IGF-IR CP-751,871 in patients with solid tumors currently enrolling patients 9 years old and older with Ewing's sarcoma family of tumors (Ewing's, PNET and Askin's).


Eligibility: Inclusion Criteria:
  -  Diagnosis of Ewing's sarcoma family tumors
  Exclusion Criteria:
  -  Concurrent treatment with any other anti tumor agents

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

Clinical trial: A Study of LY573636-Sodium in the Treatment of Patients With Metastatic Soft Tissue Sarcoma

Summary: The primary purpose of the study is to estimate the time from the first dose of LY573636 to the date your physician determines that your disease has progressed or worsened.

Detailed description: Patients will receive a 2-hour intravenous infusion of study drug (LY573636) once every 21 days or 28 days depending on their target dose. Radiological imaging scans will be performed before the first dose of study drug and then after every other treatment. Patients will be assessed for clinical progression at every visit and for response approximately every 42 days or 56 days (every other cycle).

Eligibility: Inclusion Criteria:
  -  Diagnosis of soft tissue sarcoma that is unresectable or metastatic
  -  Have received one or two (but no more than two) prior treatment regimens for metastatic soft tissue sarcoma, one of which must have included doxorubicin (adriamycin).
  -  Must have stopped all previous treatments for cancer, including chemotherapy, radiation therapy or other investigational treatments for cancer for at least 30 days
  Exclusion Criteria:
  -  Patients with primary bone sarcoma (e.g. osteosarcoma, Ewing's sarcoma, chondrosarcoma), gastrointestinal stromal tumor (GIST) and Kaposi's sarcoma
  -  Serious pre-existing medical problems (as determined by your doctor)
  -  Have received more that two previous systemic treatment regimens for unresectable or metastatic soft tissue sarcoma
  -  Have a second primary cancer (unless cancer-free for more than 2 years)
  -  Active treatment with Warfarin (Coumadin)

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

Clinical trial: Ridaforolimus in Treatment of Sarcoma-SUCCEED (Sarcoma Multi-Center Clinical Evaluation of the Efficacy of Ridaforolimus)(8669-011 AM6)

Summary: The purpose of this study is to determine whether maintenance therapy with oral AP23573 (ridaforolimus), by preventing and controlling tumor growth for a prolonged period of time in patients with metastatic soft-tissue or bone sarcomas responding to chemotherapy, will result in clinically significant improvement in progression-free survival as compared to oral placebo.


Eligibility: Inclusion Criteria:
  -  Confirmed diagnosis of metastatic soft-tissue or bone sarcoma
  -  Ongoing complete response, partial response, or stable disease (RECIST) after a minimum of 4 cycles (and maximum of 12 months) of any one first, second, or third line of prior cytotoxic chemotherapy for metastatic disease
  -  Eastern Cooperative Oncology Group performance status of 0 or 1
  -  Adequate organ and bone marrow function
  -  Completed prior chemotherapy with last dose received at least 3 and up to 12 weeks prior to randomization
  Exclusion Criteria:
  -  Prior therapy with rapamycin or rapamycin analogs
  -  Ongoing toxicity associated with prior anticancer therapy
  -  Another primary malignancy within the past three years
  -  Concomitant medications that induce or inhibit CYP3A
  -  Significant, uncontrolled cardiovascular disease

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

Clinical trial: Phase II Pilot Study of Vincristine, Adriamycin, Actinomycin D, Ifosfamide Combination Chemotherapy in Ewing's Sarcoma

Summary: Phase II Pilot Study of Vincristine, Adriamycin, Actinomycin D, Ifosfamide combination chemotherapy in Ewing's Sarcoma


Eligibility: Inclusion Criteria:
  -  Patients with Ewing's Sarcoma

Relevance to patient case: not relevant