araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Evaluation for NCI Surgery Branch Clinical Studies

Summary: Background:
  The NCI Surgery Branch has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient.
  Objective:
  This study will allow patients to under screening and evaluation for participation in NCI Surgery Branch Protocols
  Eligibility:
  Patients must meet the minimum eligibility criteria for an NCI surgery Branch Treatment Protocol
  Design
  Patients will undergo testing and evaluations as required by the appropriate NCI Surgery Branch Treatment protocol

Detailed description: Background:
  Potential research candidates undergo thorough screening including laboratory tests, scans, x-rays and review of pathology slides to determine initial eligibility for Surgery Branch research protocols.
  Objectives:
  To permit evaluation of patients referred to the NCI Surgery Branch in order to identify individuals who will be suitable candidates for Surgery Branch clinical research protocols.
  To assess frequency of HLA type and expression of neo antigens in malignant tumors across the population of cancer patients undergoing screening for NCI Surgery Branch Protocols.
  Eligibility:
  Patient suspected of having, or with biopsy proven malignant disease.
  Patient, parent or guardian (if a minor), is able to provide informed consent.
  Design:
  Patients enrolled on this protocol will be evaluated by NCI Surgery Branch physicians to determine the individual's suitability for participation in a clinical research protocol. An accrual ceiling of 6000 patients has been set to meet the screening needs of the Surgery Branch.

Eligibility: -  INCLUSION CRITERIA:
  Patients suspected of having, or with biopsy proven malignant disease.
  Patient, or their legal guardians (if the patient is less than 18 years of age), is able to provide informed consent.
  EXCLUSION CRITERIA:

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Immunotherapy After Surgery in Treating Patients With Breast Cancer, Colon Cancer, or Melanoma

Summary: RATIONALE: Immunotherapy uses different ways to stimulate the immune system and stop cancer cells from growing. Immunotherapy biological extracts may be useful as adjuvant therapy in treating patients who have had surgery for breast cancer, colon cancer, or melanoma.
  PURPOSE: Phase III trial to study the effectiveness of Corynebacterium granulosum extract as maintenance immunotherapy following surgery in treating patients with breast cancer, colon cancer, or melanoma.

Detailed description: OBJECTIVES:
  -  Determine the survival of patients with colon cancer, breast cancer, or melanoma with minimal residual disease after surgical resection treated with maintenance immunotherapy using Corynebacterium granulosum P40.
  -  Determine leucocyte adherence inhibition, an indication of metastases, over time in patients treated with this regimen.
  OUTLINE: This is a multicenter study. Patients are stratified by center and are matched with case-controls by disease type and stage.
  Beginning 2 weeks after surgical resection, patients receive Corynebacterium granulosum P40 subcutaneously weekly for 6 weeks, followed by rest for 3 months. Treatment continues for life.
  Patients are followed for survival.
  PROJECTED ACCRUAL: Not specified

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of colon cancer, breast cancer, or melanoma with minimal residual disease (at least 90% of tumor mass resected) after surgical resection
  -  Hormone receptor status:
  -  Not specified
  PATIENT CHARACTERISTICS:
  Age:
  -  20 to 80
  Sex:
  -  Not specified
  Menopausal status:
  -  Not specified
  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
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  Not specified
  Surgery
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Interleukin-2 in Treating Patients With Metastatic Melanoma

Summary: RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.
  PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients who have metastatic melanoma.

Detailed description: OBJECTIVES: I. Evaluate the response and survival rates of patients with metastatic melanoma following induction with high-dose and maintenance with low-dose interleukin-2. II. Assess the toxicity of this regimen.
  OUTLINE: All patients receive high-dose interleukin-2 over 24 hours, followed by low-dose interleukin-2 for 4 days in the absence of toxicity. Patients receive a second cycle beginning 9-13 days after completion of the first cycle, with response assessed approximately 2 months after initiating therapy. Patients with stable or responding disease receive a second course as above; those with a continued response may receive additional courses provided toxicity is limited. Patients are followed for survival.
  PROJECTED ACCRUAL: 20 patients will be entered.

Eligibility: DISEASE CHARACTERISTICS: Histologically proven melanoma that is metastatic No tumor replacement of 25% or more of liver on CT or MRI No involvement of the CNS or a major nerve Measurable disease required
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80%-100% Life expectancy: More than 3 months Hematopoietic: No coagulopathy (i.e., platelets less than 80,000) Hepatic: Bilirubin normal Renal: Creatinine normal Cardiovascular: No abnormal cardiac stress test in patients over 50 years of age or with possible cardiac disease suggested by history, physical exam, or EKG Pulmonary: FEV1 or VC greater than 65% of predicted in patients with significant smoking history or with suspected pulmonary disease by history, physical exam, or x-ray Other: No site of ongoing bleeding No systemic infection No HIV antibody No HBsAg No requirement for steroids No psychiatric disease that precludes informed consent or protocol treatment No second malignancy except: Basal cell skin carcinoma Carcinoma in situ of the cervix No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile women
  PRIOR CONCURRENT THERAPY: No prior interleukin-2 At least 28 days since treatment for melanoma

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer

Summary: RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
  PURPOSE: Phase I trial to study the effectiveness of indium In 111 pentetreotide in treating patients who have refractory cancer.

Detailed description: OBJECTIVES: I. Determine the maximum tolerated dose (MTD), toxic effects, and the preliminary antitumor activity of indium In 111 pentetreotide.
  OUTLINE: This is a dose escalation study. Patients receive indium In III pentetreotide (OctreoScan) IV on day 1. Imaging is conducted on days 3 and 6. Treatment continues weekly for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of at least 3 patients receive escalating doses of OctreoScan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicities. Patients are followed every 3 months for the first year, then every 6 months thereafter.
  PROJECTED ACCRUAL: Up to 35 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS: Histologically proven malignancy with no alternate treatments available Measurable or evaluable progressive disease Somatostatin receptors present on tumor and uptake demonstrated on diagnostic scan with OctreoScan
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil count at least 1,500/mm3 Hepatic: Total bilirubin no greater than 2.0 mg/dL Renal: Creatinine clearance at least 40 mL/min Other: No active infections Not HIV positive No coexisting medical condition Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior wide field radiation therapy Surgery: Recovery from prior surgery

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

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: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy following surgery may be effective in treating patients with phyllodes tumor of the breast.
  PURPOSE: This phase II trial is studying how well radiation therapy works after surgery in treating women with phyllodes tumor of the breast.

Detailed description: OBJECTIVES:
  -  Determine the local recurrence rate in women with phyllodes tumors of the breast previously treated with local excision with negative margins and are now treated with adjuvant radiotherapy.
  -  Determine the survival rate in patients treated with this regimen.
  OUTLINE: Within 12 weeks after prior local excision or breast reexcision, patients undergo adjuvant radiotherapy 5 days a week for a total of 28 treatments.
  Patients are followed every 6 months for 10 years.
  PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within approximately 6-7 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically proven phyllodes tumors of the breast with borderline or malignant grade, defined as 1 of the following:
  -  Borderline, defined as 5-9 mitoses/10 high power fields (HPF), pushing or infiltrating margins, 2+ atypia
  -  Malignant, defined as 10 or more mitoses/10 HPF, predominantly infiltrating margins, usually 3+ atypia with occasional 2+ atypia
  -  Must have been excised with breast-conserving resection
  -  No positive margins
  -  Local recurrence of a previously excised phyllodes tumor allowed if the recurrence is in the area of the prior excision
  -  No prior breast carcinoma or ductal carcinoma in situ in the ipsilateral breast
  -  Hormone receptor status:
  -  Not specified
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Sex:
  -  Female
  Menopausal status:
  -  Not specified
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  Not pregnant
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  No prior radiotherapy to the ipsilateral breast
  Surgery
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

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: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma

Summary: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
  PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or stage IV melanoma.

Detailed description: OBJECTIVES:
  -  Determine the immune response in patients with stage IIIB, IIIC, or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF).
  OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.
  -  Arm I: Patients receive vaccine comprising low-dose multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) on days 1, 8, 15, 29, 36, and 43.
  -  Arm II: Patients receive vaccine comprising medium-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.
  -  Arm III: Patients receive vaccine comprising high-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.
  On day 22, the lymph node draining the vaccination site is removed to determine whether the immune system is responding to the vaccine.
  PROJECTED ACCRUAL: A maximum of 38 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of stage IIIB, IIIC, or IV melanoma
  -  HLA-DR1, -DR4, -DR11, -DR13, or -DR15 positive
  -  Brain metastases allowed at the discretion of the principle investigator
  PATIENT CHARACTERISTICS:
  Age
  -  18 and over
  Performance status
  -  ECOG 0-1
  Life expectancy
  -  Not specified
  Hematopoietic
  -  Absolute neutrophil count > 1,000/mm^3
  -  Platelet count > 100,000/mm ^3
  -  Hemoglobin > 9 g/dL
  Hepatic
  -  Liver function tests ≤ 2.5 times upper limit of normal (ULN)
  Renal
  -  Creatinine ≤ 1.5 times ULN
  Cardiovascular
  -  No New York Heart Association class III or IV heart disease
  Other
  -  Prior diagnosis of other cancer allowed
  -  Not pregnant or nursing
  -  Weight ≥ 110 pounds
  -  No uncontrolled diabetes
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  More than 4 weeks since prior growth factors
  -  More than 4 weeks since prior allergy shots
  -  More than 12 weeks since prior melanoma vaccine therapy* NOTE: *Prior melanoma vaccine allowed only for patients with disease progression during or after administration of the vaccine
  -  No prior vaccination with any of the peptides used in this study
  Chemotherapy
  -  More than 4 weeks since prior chemotherapy
  Endocrine therapy
  -  More than 4 weeks since prior steroids
  Radiotherapy
  -  More than 4 weeks since prior radiotherapy
  Surgery
  -  Not specified
  Other
  -  More than 1 month since prior investigational drugs or therapies
  -  No other concurrent investigational drugs or therapies

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Anti-Tumor Activity Of SB-485232 In Patients With Previously Untreated Metastatic Melanoma

Summary: This Phase II study is designed to evaluate the anti-tumor activity of three dose groups of SB-485232 (0.01, 0.1, and 1.0 mg/kg/day) administered intravenously as a single agent in subjects with previously untreated metastatic melanoma.


Eligibility: Inclusion criteria:
  -  Patients must have melanoma that has spread beyond the original location and has not yet been treated.
  -  Tissue from the spreading melanoma should have been tested to confirm it is melanoma.
  Exclusion criteria:
  -  Patients having hepatitis or HIV infection.
  -  Taking corticosteroids.
  -  Patients with the primary site being occular melanoma or patients with melanoma of the brain.

Relevance to patient case: not relevant