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

Clinical trial: A Pilot Study for the Treatment of Patients With Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors

Summary: This protocol is designed to test the feasibility of the administration of vincristine, adriamycin and cytoxan, alternating with the newly developed regimen ifosfamide VP-16 as well as the efficacy of this therapy in addition to radiotherapy in producing complete responses and disease-free survival in patients with Ewing's sarcoma, primitive sarcoma of bone, peripheral neuroepithelioma, and soft tissue sarcoma. This will not be a randomized study but will be comparable to the large data base of similar patients treated on successive Pediatric Branch studies.

Detailed description: This protocol is designed to test the feasibility of the administration of vincristine, adriamycin and cytoxan, alternating with the newly developed regimen ifosfamide VP-16 as well as the efficacy of this therapy in addition to radiotherapy in producing complete responses and disease-free survival in patients with Ewing's sarcoma, primitive sarcoma of bone, peripheral neuroepithelioma, and soft tissue sarcoma. This will not be a randomized study but will be comparable to the large data base of similar patients treated on successive Pediatric Branch studies.

Eligibility: Patients with high grade soft tissue sarcomas and either metastatic disease or stage III tumors including synovial sarcoma, malignant fibrous histiocytoma, hemangiopericytoma, malignant schwannoma (neurofibrosarcoma).
  Patients must not have been previously treated with chemotherapy or radiation therapy.
  The patients age must be less than or equal to 25 years.
  The patient (or their guardian if under 18 years of age) must sign a document indicating that he/she is aware of the investigational nature of this treatment protocol and the potential risks and benefits that may be expected.
  Patients must have a direct bilirubin of less than 4.0 mg/dl.
  Patients must not have abnormal cardiac function (ejection fraction greater than 45% on MUGA scan with confirmation of shortening-fraction greater than 25% on echocardiography).

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

Clinical trial: Microarray Analysis for Human Genetic Disease

Summary: This study will look at genetic changes which occur in the development of male and female breast cancer and other cancer. It will use a new technology called DNA microarray hybridization that looks at a wide array of genes to identify disease-associated patterns in the human genome (complete set of human genes). Numerous studies have linked particular genes to a given disease, but there is very little information on patterns of gene expression (production of proteins from genetic coding) in the entire human genome.
  Pinpointing genetic abnormalities in disease may help classify different forms of cancer and perhaps lead to new avenues of treatment or prevention. A primary goal of this study will be to create a database of gene expression for human cancers and other disorders that will provide the basis for finding genetic abnormalities in disease.
  Tumors specimens used in this study will be taken from tissues biopsied from patients with breast, colon cancer, sarcomas or melanoma as part of their routine care. Patients in the study will be among those receiving care at the: Department of Oncology, University Hospital, University of Lund, Sweden (breast cancer); Department of Medicine, University of Michigan, Ann Arbor, Michigan (breast cancer); Surgery Branch, National Cancer Institute, Bethesda, Maryland (melanoma), Johns Hopkins Univ. (colon cancer), Memorial Sloan Kettering (sarcoma).
  Patients in the study will have a family history taken and will complete a questionnaire. Some patients will be asked to have a blood test. Breast cancer patients will have a mammogram if one has not been done within the last year.

Detailed description: The purpose of our study is to make use of a novel technology that the Cancer Genetics Branch of the NHGRI has been a leader in developing. This technology for genome-wide expression analysis, DNA microarray hybridization, is the focus of our protocol. We will access tissue banks collected by our collaborators that contain excess tissues obtained during routine clinical care. Specimens will be processed for large-scale gene expression analysis and DNA copy number determination using DNA microarrays. The development and analysis of this gene expression and gene copy number database are the primary purpose of this study. Currently available and new bioinformatics tools will be applied to the data for the characterization of disease subsets (e.g., early vs. advanced stage cancer) as well as to mine the data for specific genes which are linked to given disease states.

Eligibility: -  Clinical inclusion/exclusion criteria will be dependent upon the collaborating Institutions' requirements.

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

Clinical trial: Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether receiving radiation therapy or no further therapy after surgery is more effective for cancer of the uterus.
  PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of no further therapy in treating patients who have stage I or stage II cancer of the uterus that has been surgically removed.

Detailed description: OBJECTIVES: I. Compare the rates of pelvic recurrence and development of distant metastases in patients with completely resected, stage I or II, high-grade uterine sarcoma treated with adjuvant pelvic radiotherapy vs observation alone.
  OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, tumor histology (leiomyosarcoma vs mixed mesodermal sarcoma vs endometrial stromal sarcoma), and surgical procedure (total abdominal hysterectomy (TAH) with or without bilateral salpingo-oophorectomy (BSO) vs TAH and BSO with pelvic and para-aortic node sampling and random biopsies). Patients are randomized to 1 of 2 treatment arms. Arm I: Beginning within 6 weeks after surgery, patients undergo pelvic radiotherapy 5 days a week for 5.6 weeks. Arm II: Patients undergo observation alone. Patients are followed every 2 months for 1 year, every 3 months for 2 years, and then every 6 months thereafter.
  PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study within 3 years.

Eligibility: DISEASE CHARACTERISTICS: Histologically proven high-grade uterine sarcoma Eligible subtypes: Leiomyosarcoma Mixed mesodermal (mullerian) sarcoma Endometrial sarcoma Surgically proven stage I or II (T1-2, N0, M0) disease No leiomyoma with a high mitotic activity index after hormonal therapy (especially estrogen) Mixoid leiomyosarcoma with a low mitotic activity index allowed Completely resected disease Prior abdominal hysterectomy as minimal surgical procedure required
  PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix No serious mental disorder
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

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

Clinical trial: Laparoscopic Surgery or Standard Surgery in Treating Patients With Endometrial Cancer or Cancer of the Uterus

Summary: This randomized phase III trial is studying laparoscopic surgery to see how well it works compared to standard surgery in treating patients with endometrial cancer or cancer of the uterus. Laparoscopic surgery is a less invasive type of surgery for cancer of the uterus and may have fewer side effects and improve recovery. It is not known whether laparoscopic surgery is more effective than standard surgery in treating endometrial cancer.

Detailed description: OBJECTIVES:
  I. Compare the incidence of surgical complications, peri-operative morbidity, and mortality in patients with stage I or IIa, grade I-III endometrial cancer or uterine cancer undergoing surgical staging through laparoscopic assisted vaginal hysterectomy vs total abdominal hysterectomy.
  II. Compare the length of hospital stay after surgery in patients receiving these treatments.
  III. Compare the quality of life of patients receiving these treatments. IV. Compare the incidence and location of disease recurrence in patients receiving these treatments.
  OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
  ARM I: Patients undergo vaginal hysterectomy and bilateral salpingo-oophorectomy (BSO) via laparoscopy.
  ARM II: Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy.
  Patients in both arms also undergo pelvic and para-aortic lymph node sampling. Quality of life is assessed at baseline, at 1, 3, and 6 weeks, and then at 6 months.
  Patients are followed at 6 weeks, every 3 months for 2 years, and then every 6 months for 3 years.

Eligibility: Inclusion Criteria:
  -  Diagnosis of stage I or IIA, grade I-III endometrial adenocarcinoma or uterine sarcoma
  -  Must be considered a candidate for surgery
  -  No contraindication to laparoscopy
  -  No clinical or chest x-ray evidence of metastasis beyond the uterine corpus or macroscopic involvement of the endocervix
  -  Performance status - GOG 0-3
  -  WBC at least 3,000/mm^3
  -  Platelet count at least 100,000/mm^3
  -  Bilirubin no greater than 1.5 times normal
  -  SGOT no greater than 3 times normal
  -  Creatinine no greater than 2.0 mg/dL
  -  Prior malignancy allowed if no current evidence of disease
  -  Not pregnant
  -  No prior pelvic or abdominal radiotherapy
  -  See Disease Characteristics
  -  No prior retroperitoneal surgery

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

Clinical trial: Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia, Osteosarcoma, or Non-Hodgkin's Lymphoma

Summary: RATIONALE: Drugs used in chemotherapy, such as trimetrexate glucuronate and leucovorin, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
  PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating children with recurrent acute lymphoblastic leukemia, recurrent osteosarcoma, or refractory non-Hodgkin's lymphoma.

Detailed description: OBJECTIVES:
  -  Determine the efficacy of trimetrexate glucuronate with leucovorin calcium rescue in children with recurrent acute lymphoblastic leukemia, recurrent osteogenic sarcoma, or refractory non-Hodgkin's lymphoma resistant to methotrexate.
  -  Evaluate the toxicity of this treatment regimen in this patient population.
  OUTLINE: Patients are stratified according to disease (acute lymphocytic leukemia, non-Hodgkin's lymphoma vs osteogenic sarcoma).
  Patients receive trimetrexate glucuronate orally or IV every 12 hours on days 1-21 and oral leucovorin calcium every 12 hours on days 1-24. Treatment repeats every 4 weeks. Patients with stable or responsive disease may receive up to 4 courses of therapy.
  PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologic evidence of one of the following malignancies that has failed conventional therapy:
  -  Acute lymphoblastic leukemia
  -  Non-Hodgkin's lymphoma with bone marrow involvement
  -  Osteogenic sarcoma
  -  In vitro transport resistance to methotrexate demonstrated by bone marrow aspirate assay
  PATIENT CHARACTERISTICS:
  Age:
  -  21 and under at diagnosis
  Performance status:
  -  ECOG 0-2
  Life expectancy:
  -  At least 8 weeks
  Hematopoietic:
  -  Granulocytopenia allowed with bone marrow involvement
  -  Thrombocytopenia allowed with bone marrow involvement
  -  Anemia allowed with bone marrow involvement
  Hepatic:
  -  (unless due to disease)
  -  Bilirubin no greater than 2.0 mg/dL
  -  AST no greater than 100
  Renal:
  -  Creatinine less than 1.5 mg/dL OR
  -  Creatinine clearance at least 60 mL/min
  Other:
  -  No other serious medical illness
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Prior bone marrow transplantation allowed
  Chemotherapy:
  -  At least 1 week since prior intrathecal treatment
  -  At least 2 weeks since prior systemic chemotherapy and recovered
  -  At least 10 days for rapidly proliferating leukemia (i.e., WBC greater than 50,000)
  -  No concurrent chemotherapy
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  Prior radiotherapy allowed and recovered
  -  No concurrent radiotherapy
  Surgery:
  -  Not specified

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

Clinical trial: Combination Chemotherapy in Treating Patients With Recurrent or Advanced Cancer of the Uterus

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
  PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with mitomycin, doxorubicin, and cisplatin in treating patients with recurrent or advanced cancer of the uterus.

Detailed description: OBJECTIVES: I. Estimate the antitumor activity of the combination of mitomycin, doxorubicin, and cisplatin (MAP) in patients with recurrent or advanced uterine sarcomas. II. Determine the nature and degree of toxicity of MAP chemotherapy in this cohort of patients.
  OUTLINE: Patients receive IV doxorubicin, mitomycin, and cisplatin over 3 hours once every 3 weeks, for a minimum of 1 course. Patients who have complete response, partial response, or stable disease will continue for at least 3 courses. If side effects are not severe, patients may remain on the study regimen at the investigator's discretion for a maximum of 6 courses. All patients are followed until death.
  PROJECTED ACCRUAL: The first stage of accrual is anticipated to accrue 20 evaluable patients in approximately 12 months. If indicated, a second stage will accrue approximately 10 evaluable patients.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed advanced, persistent, or recurrent uterine sarcoma Documented disease progression after local therapy Measurable disease consisting of abdominal, pelvic, chest, or other masses that can be defined in at least two dimensions by palpation, x-ray, computed tomography or ultrasound
  PATIENT CHARACTERISTICS: Age: No age specified Performance status: Karnofsky 50%-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 1.5 times normal Cardiovascular: Ejection fraction within institutional normal limits Pulmonary: Not specified Other: No active infection No concurrent second malignancy other than nonmelanoma skin cancer Must be disease free of any prior malignancy for at least 5 years and not received any treatments with chemotherapy or radiation therapy for that malignancy
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 6 weeks since radiotherapy Recovered from effects of radiotherapy Surgery: Recovered from effects of surgery

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

Clinical trial: Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the Uterus

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients with recurrent or refractory cancer of the uterus.

Detailed description: OBJECTIVES: I. Determine the antitumor activity of gemcitabine in patients with recurrent or persistent leiomyosarcoma of the uterus who failed higher priority treatment protocols. II. Determine the toxicity of gemcitabine in these patients.
  OUTLINE: Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat every 4 weeks in the absence of unacceptable toxicity and disease progression. Patients with partial response, complete response, or stable disease receive at least 3 courses of therapy. Patients are followed every 3 months for 2 years, then every 6 months for 3 years.
  PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed recurrent or persistent uterine leiomyosarcoma that is refractory to curative therapy or standard treatments Failed local therapeutic measures and considered incurable Measurable disease Not eligible for a higher priority GOG protocol
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 1.5 mg/dL Other: No significant infection At least 5 years since any other invasive malignancy except nonmelanoma skin cancer
  PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No prior gemcitabine No more than 1 prior chemotherapy regimen (single agent or combination therapy) Endocrine therapy: At least 3 weeks since prior endocrine therapy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: At least 3 weeks since prior surgery and recovered

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

Clinical trial: Antiviral Therapy in Treating Patients With Slowly Progressing HIV-Related Kaposi's Sarcoma

Summary: RATIONALE: HIV virus is found in the lesions of most patients with Kaposi's sarcoma, and may have a role in causing Kaposi's sarcoma. Antiviral therapy acts against the HIV virus and may be an effective treatment for Kaposi's sarcoma.
  PURPOSE: This phase II trial is studying how well antiviral therapy works in treating patients with slowly progressing HIV-related Kaposi's sarcoma.

Detailed description: OBJECTIVES:
  -  Determine the efficacy of highly active antiretroviral therapy (HAART) in treating patients with HIV-related stage I-III nonaggressive epidemic Kaposi's sarcoma.
  OUTLINE: Patients receive therapy consisting of nucleoside analogues (RTI) and protease inhibitors (PI). Patients may receive either 2 RTIs or 2 RTIs plus 2 PIs. Treatment continues for 12 weeks, then progression is assessed.
  Patients with stable or regressing Kaposi's sarcoma (KS) with a viral load of greater than 500 copies of RNA/mL may continue with the therapy (if the viral load has decreased by greater than 2 logs) or may modify therapy (if the viral load has decreased less than 2 logs). Patients with progressive disease may begin chemotherapy but continue to receive the antiretroviral therapy. Treatment continues for at least 48 weeks.
  Patients are followed every 8 weeks until week 48.
  PROJECTED ACCRUAL: This study will accrue a total of 14-25 patients.

Eligibility: DISEASE CHARACTERISTICS:
  -  Stage I-III (NYU) Kaposi's sarcoma that is slowly progressive
  -  Stable disease without progression in diameter of tumor or in number of lesions (less than 50% increase in 3 months)
  -  No progressive disease during or after treatment for Kaposi's sarcoma
  -  Level of viral load detectable independently from CD4+ cells
  -  No other active AIDS pathologies
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  ECOG 0-3
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  WBC greater than 1500/mm3
  -  Hemoglobin greater than 8 mg/dL
  Hepatic:
  -  Bilirubin less than 2.5 times normal
  -  AST and ALT less than 5 times normal
  -  Alkaline phosphatase less than 2.5 times normal
  Renal:
  -  Creatinine less than 2.5 times normal
  Other:
  -  No prior malignancy except carcinoma in situ of the cervix or nonmelanomatous skin cancer
  -  No active cytomegalovirus, herpes simplex 1 or 2, or herpes zoster infection requiring treatment
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  Not specified
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  Not specified
  Surgery:
  -  Not specified
  Other
  -  No prior antiretroviral therapy OR
  -  No prior highly active antiretroviral therapy (HAART)
  -  No concurrent acyclovir, ganciclovir, foscarnet, or cidofovir

Relevance to patient case: not relevant