araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 4-year-old female with neuroblastoma; genetic feature: ALK

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: 4-year-old female with neuroblastoma; genetic feature: ALK

Clinical trial: Genetic Study of Newly Diagnosed Central Nervous System Tumors in Young Children

Summary: RATIONALE: Genetic studies may help in understanding the genetic processes involved in the development of some types of cancer.
  PURPOSE: Genetic study to learn more about genes involved in the development of central nervous system tumors in young children.

Detailed description: OBJECTIVES:
  -  Identify known genes that have significantly different levels of expression, using microarray gene chip analysis, in infants with newly diagnosed metastatic vs non-metastatic embryonal central nervous system tumors.
  -  Determine the protein expression of genes identified by microarray analysis that are involved in cellular functions that regulate angiogenesis, invasion, or metastasis in this patient population.
  -  Determine the quantity of gene expression of the confirmed translationally expressed genes using semi-quantitative polymerase chain reaction.
  OUTLINE: This is a multicenter study.
  Tumor samples are analyzed using microarray gene chip analysis. Differentially expressed genes are evaluated for protein expression by standard immunohistochemistry and/or Western blot analysis, and gene expression is further quantified by semi-quantitative polymerase chain reaction.
  PROJECTED ACCRUAL: Approximately 80-100 patients (20-25 with metastatic disease and 60-75 with non-metastatic disease) will be accrued for this study within 4-5 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed, newly diagnosed, primary intracranial embryonal central nervous system tumor
  -  Medulloblastoma
  -  Primitive neuroectodermal tumor
  -  Medulloepithelioma
  -  Ependymoblastoma
  -  Neuroblastoma
  -  Pineoblastoma
  -  Atypical teratoid/rhabdoid tumor
  -  Intracranial germ cell tumor
  -  Choroid plexus carcinoma
  -  M positive ependymoma
  -  Potential enrollment on PBTC-001 therapeutic protocol
  PATIENT CHARACTERISTICS:
  Age:
  -  Under 3
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  No prior chemotherapy
  Endocrine therapy:
  -  Prior steroids allowed
  Radiotherapy:
  -  No prior radiotherapy
  Surgery:
  -  Not specified
  Other:
  -  No concurrent investigational agents

Relevance to patient case: not relevant
Patient case: 4-year-old female with neuroblastoma; genetic feature: ALK

Clinical trial: Treatment of Attention Deficit Hyperactivity Disorder in Preschool-Age Children (PATS)

Summary: This research focuses on the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in very young children. The medication being used is methylphenidate (Ritalin); it is being studied to determine its safety and how well it works to treat ADHD in preschool-age children (3-5.5 year olds).

Detailed description: Young children age 3-5.5 years will be studied. The study includes treatment with different doses of methylphenidate and placebo; all children will receive active medication during the study. Prior to treatment, each child will receive a thorough psychiatric evaluation and each guardian will complete a 10-week workshop (2 hours/week). Throughout the study, parents and teachers will complete forms that report on the child's behavior and possible side effects. Participants will be monitored by regular visits with a study physician. Most participants will be involved in the study for up to 16 months to ensure optimal evaluation, dosing, and monitoring

Eligibility: Boys and girls who are:
  -  Between the ages of 3-5.5 years
  -  Qualified as having ADHD by our diagnostic evaluations and clinical staff
  -  Otherwise generally healthy
  -  Willing, and have parents that are willing, to attend all visits required by the study
  -  Enrolled in some type of day-program: day care, preschool, nursery school, kindergarten, for at least 2 half days/week
  -  In classrooms with teachers that are willing to participate by completing rating scale

Relevance to patient case: not relevant
Patient case: 4-year-old female with neuroblastoma; genetic feature: ALK

Clinical trial: Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors

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 arsenic trioxide in treating children who have advanced neuroblastoma or other solid tumors.

Detailed description: OBJECTIVES:
  -  Determine the response rates of patients with advanced neuroblastoma or other pediatric solid tumors treated with arsenic trioxide.
  -  Determine the toxicity of this drug in these patients.
  OUTLINE: Patients are stratified according to type of disease (neuroblastoma with progressive disease vs neuroblastoma with stable refractory disease vs other solid tumor).
  Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
  Patients are followed every 2-3 months for 1 year and then annually thereafter.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed neuroblastoma or other pediatric solid tumor (nonmyeloid and nonlymphoid) including the following:
  -  Ewing's family of tumors/primitive neuroectodermal tumor
  -  Retinoblastoma
  -  Nephroblastoma
  -  Osteosarcoma
  -  Rhabdomyosarcoma
  -  Desmoplastic small round-cell tumor
  -  Hepatoblastoma
  -  Germ cell tumors
  -  Medulloblastoma
  -  Relapsed from or resistant to prior standard anticancer therapy and/or no known standard therapy available
  -  Measurable disease (e.g., solid mass with definable dimensions) OR
  -  Evaluable disease (e.g., bone marrow involvement or malignant pleural effusion)
  PATIENT CHARACTERISTICS:
  Age:
  -  40 and under
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Bilirubin no greater than 2.5 times upper limit of normal (ULN)
  Renal:
  -  Creatinine no greater than 2.5 times ULN
  Cardiovascular:
  -  Absolute QT interval no greater than 460 msec in the presence of adequate potassium and magnesium levels
  Other:
  -  No pre-existing neurotoxicity/neuropathy grade 2 or greater
  -  No pre-existing convulsive disorder
  -  No active serious infections uncontrolled by antibiotics
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  More than 3 weeks since prior cytotoxic chemotherapy
  -  No other concurrent cytotoxic chemotherapy
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  Concurrent radiotherapy allowed provided measurable or evaluable disease exists outside radiation field
  Surgery:
  -  Not specified
  Other:
  -  No other concurrent investigational agents

Relevance to patient case: not relevant
Patient case: 4-year-old female with neuroblastoma; genetic feature: ALK

Clinical trial: Iressa/Docetaxel in Non-Small-Cell Lung Cancer

Summary: Patients will receive 250 mg Iressa by mouth daily each day while on this study. Patients will also receive docetaxel 30 mg/m2 by by vein (IV) on day 1 weekly for the first 3 weeks of each course of therapy. A course of therapy is 4 weeks. Patients will not receive docetaxel during week 4. A maximum of 8 full cycles of docetaxel plus Iressa are planned. Patients may continue on daily Iressa until progressive disease and/or unacceptable toxicity.


Eligibility: Inclusion Criteria:
  -  Pathologically confirmed non-small cell lung cancer.
  -  Measurable, evaluable disease outside of a radiation port.
  -  ECOG performance status 0-2.
  -  Adequate hematologic function as defined by an absolute neutrophil count >= 1,500/mm3, a platelet count >= 100,000/mm3, a WBC >= 3,000/ mm3, and a hemoglobin level of >= 9 g/dl.
  -  One prior chemotherapy regimen. This may include chemoradiation treatment.
  -  Disease progression or recurrence within 6 months of last dose of chemotherapy in first chemotherapy regimen.
  -  At least a 2-week recovery from prior therapy toxicity.
  -  Signed informed consent.
  -  Prior CNS involvement by tumor are eligible if previously treated and clinically stable for two weeks after completion of treatment.
  Exclusion Criteria:
  -  Prior Iressa or other EGFR inhibiting agents
  -  Prior docetaxel therapy
  -  Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
  -  Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy.
  -  Incomplete healing from previous oncologic or other major surgery.
  -  Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, St John's Wort, anti-coagulants.
  -  Absolute neutrophil counts less than 1500 x 109/liter (L) or platelets less than 100,000x 109/liter (L).
  -  Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR).
  -  In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease, (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
  -  A serum creatinine >= 1.5 mg/dl and calculated creatinine clearance <= 60 cc/minute.
  -  Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2.5 times the ULRR if no demonstrable liver metastases or greater than 5 times the ULRR in the presence of liver metastases.
  -  Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial.
  -  Pregnancy or breast feeding
  -  The patient has uncontrolled seizure disorder, active neurological disease, or Grade >= 2 neuropathy
  -  The patient has received any investigational agent(s) within 30 days of study entry.
  -  The patient has signs and symptoms of keratoconjunctivitis sicca or incompletely treated eye infection.

Relevance to patient case: not relevant
Patient case: 4-year-old female with neuroblastoma; genetic feature: ALK

Clinical trial: Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Refractory, Recurrent, or Advanced CNS or Leptomeningeal Cancer

Summary: The purpose of this study is to find a safe dose of a new medicine called antibody 8H9. Antibodies are made by the body to fight infections and in some cases, to fight tumors. The antibody 8H9 is made by mice and can attack many kinds of tumors. 8H9 antibody can have a dose of radiation attached to it called 131-I. 131I-8H9 has been given in the vein to patients to find cancer cells. This is the first study using 131I-8H9 in the fluid in the spine to kill cancer cells. 131-I is a beta emitting isotope used extensively for radiation targeted therapies.


Eligibility: Subject Inclusion Criteria:
  -  Patients must have a histologically confirmed diagnosis of a malignancy known to be 8H9 reactive. 8H9 expression must be confirmed by immunohistochemical staining of tumor and assessed by the Department of Pathology or by immunofluorescence of bone marrow except for patients confirmed to have neuroblastoma.
  -  Patients must have CNS/ leptomeningeal disease which is refractory to conventional therapies or for which no conventional therapy exists OR a recurrent brain tumors with a predilection for leptomeningeal dissemination (medulloblastoma, PNET, rhabdoid tumor).
  -  Patients must have no rapidly progressing or deteriorating neurologic examination.
  -  Patients must have an absolute neutrophil count (ANC) > 1000/ul and a platelet count > 50,000/ul.
  -  Patients may have active malignancy outside the central nervous system.
  -  Both pediatric and adult patients of any age are eligible.
  -  Patients or a legal guardian will sign an informed consent form approved by the IRB and obtained by the Principal or a Co- Investigator before patient entry. Minors will provide assent.
  -  Patients with stored stem cells will be treated at the escalating dose while patients with no stem cells will be treated at the 50 mCi dose. Neuroblastoma patients can be treated at the 50 mCi dose with or without stored stem cells.
  Subject Exclusion Criteria:
  -  Patients with obstructive or symptomatic communicating hydrocephalus.
  -  Patients with an uncontrolled life-threatening infection.
  -  Patients who are pregnant: Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is required during the study period.
  -  Patients who have received cranial or spinal irradiation less than 3 weeks prior to the start of this protocol.
  -  Patients who have received systemic chemotherapy (corticosteroids not included) less than 3 weeks prior to the start of this protocol.
  -  Severe major organ toxicity. Specifically, renal, cardiac, hepatic, pulmonary, and gastrointestinal system toxicity should all be less than grade 2. Patients with stable neurological deficits (because of their brain tumor) are not excluded. Patients with <= 3 hearing loss are not excluded.

Relevance to patient case: not relevant
Patient case: 4-year-old female with neuroblastoma; genetic feature: ALK

Clinical trial: Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma

Summary: The purpose of this research study is to find how active and safe 131 I-MIBG is in patients with resistant neuroblastoma, malignant pheochromocytoma and malignant paraganglioma.


Eligibility: Inclusion criteria for NB:
  -  Patients must have the diagnosis of NB in accordance with the International Criteria, i.e., either histopathology (confirmed by the MSKCC Department of Pathology) or BM involvement plus elevated urinary catecholamines.
  -  Must have a history of tumor progression or recurrence or failure to achieve complete response with standard therapy.
  -  Patients must have MIBG-avid NB and evaluable disease on MIBG scan at time of enrollment on protocol
  -  Prior Therapy: At least 2 weeks should have elapsed since any biologic therapy. Three weeks should have elapsed since last dose of chemotherapy.
  -  Age >1 year with a determination that radiation safety restrictions during therapy period can be implemented.
  -  Stem cells: Patients must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after MIBG treatment. The minimum dose for peripheral blood stem cells is 2 X106 CD34+ cells/kg.
  -  Minimum life expectancy of eight weeks
  -  Signed informed consent indicating awareness of the investigational nature of this program.
  Inclusion criteria for malignant CCT:
  -  Patients must have the diagnosis of malignant CCT i.e. malignant pheochromocytoma or malignant paraganglioma
  -  Patients must have MIBG-avid malignant CCT and evaluable disease on MIBG scan at time of enrollment on protocol
  -  Prior Therapy: At least 2 weeks should have elapsed since any biologic therapy. Three weeks should have elapsed since last dose of chemotherapy.
  -  Age between 1 and 21 years and able to cooperate with radiation safety restrictions during therapy period
  -  Stem cells: Patients must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after MIBG treatment. The minimum dose for peripheral blood stem cells is 2 X106 CD34+ cells/kg.
  -  Minimum life expectancy of eight weeks.
  -  Signed informed consent indicating awareness of the investigational nature of this program.
  Exclusion Criteria:
  -  Severe major organ toxicity. Specifically, renal, cardiac, hepatic, pulmonary, gastrointestinal and neurologic toxicity should all be grade 2 or less. A grade 3 hearing deficit is acceptable.
  -  Active serious infections not controlled by antibiotics.
  -  Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period.
  -  Inability or unwillingness to comply with radiation safety procedures or protocol requirements.

Relevance to patient case: not relevant
Patient case: 4-year-old female with neuroblastoma; genetic feature: ALK

Clinical trial: Child-Parent Psychotherapy for Preschooler Witnesses of Domestic Violence Program

Summary: This study will examine the efficacy of Child-Parent Psychotherapy (CPP) for the treatment of preschoolers exposed to marital violence.

Detailed description: This study examines the efficacy of Child-Parent Psychotherapy (CPP) for the treatment of preschoolers exposed to marital violence. Multi-ethnic preschool-mother dyads from diverse socioeconomic backgrounds were randomly assigned to CPP or to a case management plus community referral for individual treatment comparison group. It was hypothesized the children who received CPP treatment would show significantly greater improvement in general symptomatology and in traumatic stress symptoms than those in the comparison group.
  There is growing recognition that, contrary to the long-standing assumption that young children are impervious to environmental stresses, preschoolers exposed to violence show increased rates of disturbances in self-regulation and in emotional, social and cognitive functioning (Osofsky, 2004; Pynoos et al., 1999; van der Kolk, 2003). The present study examines the efficacy of a relationship-based treatment approach involving the child and the mother. Dyads were randomly assigned to either the Child-Parent Psychotherapy (CPP) treatment group or to a comparison group that consisted of monthly case management by an experienced Ph.D.-level clinician plus referrals for individual treatment in the community for mothers and child. We hypothesized that Child-Parent Psychotherapy would be more effective in alleviating children's traumatic stress symptoms and behavior problems because it focuses on improving the quality of the child-mother relationship and engages the mother as the child's ally in coping with the trauma. Treatment was offered for 50 weeks.

Eligibility: Inclusion Criteria:
  -  child 3-5 years old
  -  child exposed to marital violence as confirmed by mother's report on the Conflict Tactics Scale 2 (Straus et al., 1996)
  -  perpetrator was not living in the home.
  Exclusion Criteria:
  -  mother's documented abuse of the target child
  -  current maternal substance abuse
  -  homelessness
  -  maternal mental retardation
  -  maternal psychosis
  -  child mental retardation or autistic-spectrum disorder

Relevance to patient case: not relevant