araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Decitabine in Treating Patients With Melanoma or Other Advanced Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: Phase I trial to study the effectiveness of decitabine in treating patients with stage III or stage IV melanoma or other advanced cancer that has not responded to previous therapy.

Detailed description: OBJECTIVES: I. Identify dosage level(s) of decitabine (DAC) that show biologic activity and acceptable side effects. II. Describe the side effects and toxicity of DAC at the doses studied. III. Determine the steady state DAC serum levels at the doses studied. IV. Document any clinical responses to DAC.
  OUTLINE: A dose escalation schedule for the administration of decitabine (DAC) is being used to determine the MTD and biologically active dose. Patients are given two 12 hour continuous infusions per day, for 3 days at each dose level. A minimum of 3 patients are enrolled at each dose level until dose limiting toxicity (DLT) or biologic activity is observed. If DLT or biologic activity is observed at a particular dose level, an additional 3 patients are enrolled, for a total of 6. If 2 or more patients experience DLT, dose escalation is ceased.
  PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS: Stage III (nonresectable) and IV melanoma, or any other advanced metastatic malignancy for which all standard therapy has failed Must have at least two cutaneous, mucosal or lymph nodal lesions that can be biopsied or one lesion large enough to be biopsied twice
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Hemoglobin at least 9.0 g/dL Platelet count at least 100,000/mm3 WBC at least 3500/mm3 Absolute granulocyte count at least 1500/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT less than 2.5 times normal Renal: Creatinine no greater than 1.8 mg/dL Other: Not pregnant Not HIV or hepatitis BsAg positive No major systemic infections No coagulation disorders No major illness of cardiovascular or respiratory systems No symptomatic CNS disease or evidence of cerebral edema
  PRIOR CONCURRENT THERAPY: No therapy for cancer within the past month

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Vaccine Therapy in Treating Patients With Stage II Melanoma That Can Be Removed by Surgery

Summary: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known what preparation of vaccine therapy is most effective for treating melanoma.
  PURPOSE: Randomized phase II trial to study the effectiveness of tyrosinase/gp100 peptide vaccine in treating patients who have stage II melanoma that can be removed by surgery.

Detailed description: OBJECTIVES: I. Determine immune reactivity in HLA-A2 positive patients with resectable stage IIA or IIB melanoma treated with vaccine comprising tyrosinase peptide and gp100 antigen emulsified in Montanide ISA-51 (ISA-51) alone or in combination with sargramostim (GM-CSF).
  OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage (IIA vs IIB). Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive vaccine comprising tyrosinase peptide and gp100 antigen emulsified in Montanide ISA-51 (ISA-51) alone subcutaneously (SQ) once a week on weeks 0, 2, 4, 6, 10, 14, 18, and 26. Arm II: Patients receive treatment as in arm I followed by sargramostim (GM-CSF) SQ for 5 days after each vaccination. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
  PROJECTED ACCRUAL: A total of 50 patients (25 per arm) will be accrued for this study within 3 years.

Eligibility: DISEASE CHARACTERISTICS: Histologically proven stage IIA or stage IIB resectable cutaneous melanoma rendered disease free Clinically uninvolved lymph nodes by physical examination OR Pathologically uninvolved lymph nodes or sentinel lymph nodes after either complete node dissection or selective lymphadenectomy, respectively No evidence of metastatic disease within 28 days prior to definitive surgery HLA-A2 positive
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Hematopoietic: No coagulation disorders No significant hematologic abnormality Hepatic: Bilirubin no greater than 2.0 mg/dL No significant liver abnormality Renal: Creatinine no greater than 2.0 mg/dL No significant kidney abnormality Cardiovascular: No major medical illness of the cardiovascular system Pulmonary: No major medical illness of the respiratory system Other: No known allergic reaction to Montanide ISA-51 or sargramostim (GM-CSF) No major systemic infections Not pregnant or nursing HIV negative Hepatitis B surface antigen negative Hepatitis C antibody negative No prior uveitis or autoimmune inflammatory eye disease No active autoimmune disease No other malignancy within past 5 years
  PRIOR CONCURRENT THERAPY: At least 1 month since prior adjuvant therapy or any other therapy for cancer Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No concurrent steroid therapy Radiotherapy: At least 1 month since prior radiotherapy Surgery: See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Vaccine Therapy in Treating Patients With Melanoma

Summary: Phase I trial to study the effectiveness of vaccine therapy in treating patients with melanoma that cannot be treated with surgery. Vaccines may make the body build an immune response that may kill tumor cells. Combining more than one vaccine may kill more tumor cells.

Detailed description: OBJECTIVES:
  I. Determine the toxic effects associated with ALVAC-hB7.1 alone or combined with ALVAC-hIL-12 in patients with surgically incurable melanoma.
  II. Characterize the inflammatory and lymphokine response to this regimen in these patients.
  III. Examine the extent of nodule regression, humoral immune response, and cytolytic T cell activity with this regimen in these patients.
  OUTLINE: This is a dose escalation study of ALVAC-hB7.1
  Patients receive ALVAC-hB7.1 alone or combined with ALVAC-hIL-12 intratumorally on days 1, 4, 8, and 11. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated at each dose level of ALVAC-hB7.1. The maximum tolerated dose is defined as the dose of ALVAC-hB7.1 at which no more than 1 of 5 patients experiences dose limiting toxicity.
  Patients are followed at 1, 2, 4, 8, 11, 15, 22, and 43 days after the first vaccination.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed melanoma that is surgically incurable
  -  At least one dermal, subcutaneous or lymph node metastasis that is evaluable for local response and accessible for injection
  -  If only one accessible lesion is available, it must be at least 2 cm
  -  If two or more accessible lesions exist, then none of them are required to be at least 2 cm
  PATIENT CHARACTERISTICS:
  -  Age: Over 18
  -  Performance status: ECOG 0-2
  -  Life expectancy: Greater than 3 months
  -  Leukocyte count at least 3,000/mm3
  -  Platelet count at least 120,000/mm3
  -  SGOT and alkaline phosphatase less than 5 times normal
  -  Bilirubin less than 1.5 mg/dL (unless secondary to hepatic metastasis)
  -  BUN less than 40 mg/dL
  -  Creatinine less than 2.5 mg/dL
  -  No evidence of congestive heart failure, unstable angina, or serious cardiac arrhythmias
  -  Not positive for hepatitis B virus
  -  Not positive for HIV
  -  No history of allergy to vaccinia virus
  -  No evidence of other primary tumors except for basal cell carcinoma, squamous cell skin carcinoma, or carcinoma in situ of the cervix
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  -  No underlying immunodeficiency disorder
  PRIOR CONCURRENT THERAPY:
  -  At least 30 days since prior biologic therapy (e.g., interferon or IL-2)
  -  At least 30 days since prior chemotherapy
  -  No concurrent steroids
  -  At least 30 days since prior radiotherapy
  -  Prior radiotherapy to no greater than 50% of nodal groups
  -  No prior splenectomy
  -  No concurrent drugs which affect immune function (e.g., glucocorticoids or cimetidine)

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Diagnostic Study of Patients With Aggressive Non-Hodgkin's Lymphoma

Summary: RATIONALE: Determination of genetic markers for aggressive non-Hodgkin's lymphoma may help identify patients with this disease and help predict the outcome of treatment.
  PURPOSE: Diagnostic study to determine the genetic markers in patients who have aggressive non-Hodgkin's lymphoma.

Detailed description: OBJECTIVES:
  -  Estimate the proportions of patients with diffuse aggressive non-Hodgkin's lymphoma who have rearrangements affecting the MYC, BCL2, and BCL6 genes (determined by fluorescent in situ hybridization), overtly amplified chromosomal regions, and nonrandom copy number changes of chromosomal regions (determined by comparative genomic hybridization).
  -  Investigate the prognostic importance of these genetic markers by studying their relationships with clinical outcomes (e.g., response to therapy, failure-free survival, and overall survival) in these patients.
  -  Investigate the interrelationships among these genetic and biological markers and their relationships with clinical features of the disease, such as disease site (nodal vs extranodal) and stage, in these patients.
  OUTLINE: This is a multicenter study.
  Tissue samples are obtained before treatment and at the time of documentation of refractory disease in patients who do not achieve complete remission after induction therapy or at the time of first relapse in patients who achieve a complete remission.
  Samples are examined for rearrangements in the MYC, BCL2, BCL6, and IGH genes using fluorescent in situ hybridization. DNA is examined by comparative genomic hybridization, which allows cytogenetic detection of losses and gains of chromosomal regions in tumor cells.
  Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically proven aggressive non-Hodgkin's lymphoma and registered to front-line CALGB protocols (e.g, CLB-59903, 59909, 10002, and 50103)
  -  Diffuse small cleaved cell lymphoma
  -  Diffuse mixed small and large cell lymphoma
  -  Diffuse large cell lymphoma
  -  Diffuse large cell immunoblastic lymphoma
  -  Small noncleaved cell lymphoma
  -  Mantle cell lymphoma OR
  -  Previously entered on similar curative CALGB protocols (CLB-8852, CLB-8854, and CLB-9351) with blocks or unstained slides of initial diagnosis available
  PATIENT CHARACTERISTICS:
  Age:
  -  18 years and older

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Randomized Study of Human Parathyroid Hormone in Middle-Aged Men With Idiopathic Osteoporosis

Summary: OBJECTIVES:
  I. Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men with idiopathic osteoporosis.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. All patients self-administer daily subcutaneous injections of human parathyroid hormone (1-34) or placebo for a period of 2.5 years.
  Patients are followed regularly for unacceptable toxicities.
  Completion date provided represents the completion date of the grant per OOPD records

Eligibility: PROTOCOL ENTRY CRITERIA:
  --Disease Characteristics--
  Osteoporosis as defined by: Bone mineral density at the lumbar spine or femoral neck that is 2.5 standard deviations below peak bone mass reference value (T score less than -2.5)
  No family history of male osteoporosis
  No other metabolic bone disease
  --Prior/Concurrent Therapy--
  Endocrine therapy:
  -  No concurrent glucocorticoid therapy
  -  No prior steroid use
  Surgery: No prior gastrointestinal tract surgery
  Other: No prior or concurrent anticonvulsant therapy
  --Patient Characteristics--
  Hematopoietic: Normal CBC
  Hepatic: Normal liver function
  Renal: Normal renal function
  Other:
  -  Normal thyroid function
  -  Normal adrenal function
  -  Normal gonadal status
  -  No myeloma or other malignancy
  -  No alcoholism, hypercortisolism or diabetes mellitus
  -  No gastrointestinal tract disease or disorder associated with malabsorption

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Assessment of Digital Imaging as a Tool for Diagnosing Psoriasis, Hand Rashes and Unusual Moles

Summary: This study will evaluate whether digital photography is a reliable tool for diagnosing hand rashes, psoriasis and unusual moles. The findings will help determine if this method can be used in the National Health and Nutrition Examination survey (NHANES), which monitors disease in the United States.
  Employees of the National Institutes of Health 19 years and older may enroll in this study. Participants will complete a brief questionnaire that includes information on skin type, history of skin conditions (moles, cancer, rashes, psoriasis), and demographic information such as name, age and sex. They will be examined by a dermatologist, who will note in writing the appearance of any hand rashes, unusual moles, or psoriasis. If any areas suspicious for skin cancer are found, the participant will receive this information in writing, along with advice about where to go for treatment.
  A total of six photographs will then be taken of the participant's arms, legs, hands and back. The face will not be photographed, and the participants will not be identifiable.

Detailed description: This validation study is designed to evaluate the sensitivity, specificity, validity and reliability of digital photography of the skin as a prevalence assessment tool in preparation for the National Health and Nutrition Examination Survey, 2001 (NHANES IV). NHANES is charged with monitoring disease in the U.S. population, which is affected frequently by skin disorders and disease. The three skin disorders proposed for study in NHANES IV are atypical nevi, psoriasis, and hand dermatitis. This selection is based on the expected impact of these diseases on the U.S. population, including a prevalence of 3-10%, associated risk of melanoma in the case of atypical nevi, and associated disability in the cases of psoriasis and hand dermatitis.
  This skin disease section of NHANES, as currently planned for 2001, includes an imaging component with four standardized photographs to be obtained from each survey participant (SP). The selection of the regions to be photographed is designed to maximize the information obtained, while preserving patient privacy and is based on the known distribution of clinical findings of the three conditions, as well as NHANES logistical limitations. This validation study is a cooperative effort between the NIAMS extramural programs, the NCI intramural program, and the National Center for Health Statistics.

Eligibility: Must have employee status at the National Institutes of Health.
  Age greater than 18 years.
  Able to understand and sign consent.
  Patients who are wheelchair bound and are unable to have images of their back and lower extremities taken safely will be excluded from photography since this portion of the examination requires an ability to stand. However, they will still be eligible to participate in the skin cancer screening.

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Nitrocamptothecin in Treating Patients With Metastatic Melanoma

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 nitrocamptothecin in treating patients who have metastatic melanoma.

Detailed description: OBJECTIVES: I. Assess the efficacy and toxicity of nitrocamptothecin in patients with metastatic melanoma.
  OUTLINE: Patients are stratified according to disease (choroidal vs nonchoroidal). Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly for at least 8 weeks (2 courses) in the absence of disease progression or unacceptable toxicity.
  PROJECTED ACCRUAL: A total of 28-74 patients (14-37 per stratum) will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic melanoma Choroidal (no prior chemotherapy required) OR Nonchoroidal No more than 3 chemotherapy regimens Bidimensionally measurable disease No symptomatic uncontrolled CNS involvement including extensive brain metastases, spinal cord compression, or meningeal carcinomatosis Not eligible for treatment protocol of higher priority
  PATIENT CHARACTERISTICS: Age: Over 16 Performance status: Zubrod 0-2 Life expectancy: Greater than 8 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Transaminase no greater than 3 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 year after study No serious concurrent illness
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: Not specified

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Genetic Study in Patients Receiving Treatment for Hodgkin's Disease or Childhood Brain Tumor

Summary: RATIONALE: Determination of genetic markers for leukemia or non-Hodgkin's lymphoma that is secondary to Hodgkin's disease and childhood brain tumors may help doctors to identify patients who are at risk for these cancers.
  PURPOSE: Clinical trial to determine the presence of certain genes in patients who are receiving treatment for Hodgkin's disease or childhood brain tumors.

Detailed description: OBJECTIVES: I. Determine the frequency of chromosome 3, 11, and 21 aberrations in peripheral blood lymphocytes (PBL) specifically associated with acute myelogenous leukemia in patients with adult or pediatric Hodgkin's disease treated with radiotherapy and/or chemotherapy. II. Determine the frequency of these aberrations in patients with pediatric central nervous system tumors treated with radiotherapy and/or chemotherapy. III. Determine the glutathione-S-transferase allotype, associated with human toxicological response to carcinogen exposure, for these patients. IV. Determine the frequency of t(14;18) gene rearrangement, associated with deregulation of the bcl-2 proto-oncogene in non-Hodgkin's lymphoma, in PBL of these patients.
  OUTLINE: An extra tube of blood is collected before, every 4 weeks during, and every 3 months after radiotherapy and/or chemotherapy. DNA is isolated from the blood sample and the GSTM1, GSTT1, and various cytochrome P (CYP) 450 genotypes are determined by polymerase chain reaction (PCR). Mononuclear leukocytes are analyzed for chromosome aberrations on chromosome numbers 3, 11, and 21. Pretreatment karyotype and frequency of translocations are determined for each patient. Peripheral blood lymphocyte DNA is also examined for t(14;18) gene rearrangements.
  PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 2 years.

Eligibility: DISEASE CHARACTERISTICS: Diagnosis of Hodgkin's disease Adult or child OR Diagnosis of primary central nervous system (CNS) malignancy 16 and under Medulloblastoma Ependymoma Brain stem glioma Astrocytoma Primitive neuroectodermal tumor (PNET) Proposed therapy must include external beam radiotherapy and/or chemotherapy
  PATIENT CHARACTERISTICS: Age: See Disease Characteristics Any age 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: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: EPO906 Therapy in Patients With Advanced Melanoma

Summary: This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause melanoma.


Eligibility: Inclusion Criteria
  The following patients may be eligible for this study:
  -  Patients with advanced metastatic melanoma defined as poor prognosis Stage III melanoma and Stage IV disease, which has been histologically or cytologically confirmed with at least one measurable lesion not including bone metastases (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
  -  Patients with poor prognosis Stage III melanoma must have locally advanced unresectable disease that is measurable (repeat histological or cytological confirmation is not necessary at the time of study entry if previous results are available and there is no question in the investigator's opinion as to the diagnosis)
  -  Must have a life expectancy of greater than three (3) months
  -  Prior immunotherapy with interferon alpha in the adjuvant setting is permitted, but must have been completed > 4 weeks prior to treatment
  -  Prior vaccine therapy is permitted, but must have been completed > 4 weeks prior to treatment
  -  Patient has no major impairment of hematological function (red blood cell transfusions and repeat evaluations for study entry are allowed).
  Exclusion Criteria
  The following patients are not eligible for this study:
  -  Patients with choroidal ocular melanoma
  -  Patients with symptomatic CNS metastases or leptomeningeal involvement
  -  Patients with renal or hepatic dysfunction
  -  Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
  -  Patients with severe cardiac insufficiency
  -  Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports
  -  Patients who have received any investigational compound or anti-melanoma vaccine within the past 28 days or those who are planning to receive other investigational drugs while participating in the study
  -  Patients who had received radiotherapy within the last 4 weeks to a site which will be the reference for disease assessment (however, new or progressive lesions in the previously irradiated fields of these patients may be used for disease assessment and patients must have recovered from the side effects of radiotherapy)
  -  Patients receiving chemotherapy within the last four weeks
  -  History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer or cervical cancer in situ
  -  Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
  -  HIV+ patients
  -  Pregnant or lactating females.

Relevance to patient case: not relevant