araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 86-year-old female with melanoma; genetic feature: high tumor mutational burden

Clinical trial: Risk Stratification Among Individuals Who Have Many Moles on Their Skin

Summary: The investigators are doing this study to improve our ability to identify which people with many moles on their skin are most likely to develop skin melanoma. The investigators hope to identify features of moles that are associated with melanoma risk. The investigators hope to use this information to customize and tailor melanoma screening to the individual patient based on a better estimate of their individual risk.


Eligibility: Inclusion Criteria:
  -  Patients ≥ 18 years of age
  -  High-risk nevus phenotype (≥ 50 nevi and ≥ 1 atypical nevus)
  -  First presented to MSKCC for cutaneous melanoma-related care within the past 12 months
  -  Cases: recent diagnosis (≤ 12 months) of unequivocal invasive cutaneous melanomas (AJCC Stages I-IV) confirmed by MSKCC pathology
  -  Cases: completion of surgical treatment of primary melanoma
  -  Ability to sign informed consent
  Exclusion Criteria:
  -  Known germline high-penetrance melanoma predisposition mutation (that is, CDKN2A and CDK4)
  -  Cases: history of invasive cutaneous melanoma (AJCC Stages I-IV) not confirmed by MSKCC pathology, history of acrolentiginous type of cutaneous melanoma
  -  Cases: history of systemic adjuvant therapy or treatment of metastatic melanoma, including: MEK inhibitors (trametinib, cobimetinib, etc.), BRAF inhibitors (vemurafenib, dabrafenib, etc.), and immunotherapy (pembrolizumab, nivolumab, atezolizumab, ipilimumab, etc.). Controls: history of Stage 0-IV melanoma confirmed by MSKCC pathology
  -  History of limb amputation or other condition (e.g., tattoos, burns) per investigator discretion that would modify nevus phenotype
  -  Physical inability to undergo total body photography or reflectance confocal microscopy imaging (that is, remain relatively still for durations of 3-5 minutes)
  -  Known hypersensitivity to adhesive rings used for reflectance confocal microscopy
  -  Inability to give informed consent
  -  Have skin afflicted with anther skin condition (for example, psoriasis) that would affect ability to characterize nevus phenotype (per investigator discretion)
  -  Familial cutaneous melanoma history (families with at least one invasive melanoma and two or more other diagnoses of invasive melanoma or pancreatic cancer among first- or second-degree relatives on the same side of the family). We will confirm melanoma family history via medical record documentation, whenever possible, as recommended by previous studies that disproved about half of the reported family histories of melanoma among first-degree relatives in case-control studies.

Relevance to patient case: not relevant
Patient case: 49-year-old male with melanoma; genetic feature: extensive tumor infiltrating lymphocytes

Clinical trial: A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion With Melphalan, Tumor Necrosis Factor, and Interferon-Gamma in Patients With Locally Advanced Extremity Melanoma

Summary: Randomized study. Initially, 3 patients will be entered on Arm I as a pilot feasibility study and to standardize the technical aspects of the study. Subsequently, all patients are randomized to Arms I and II.
  Arm I: Regional Hyperthermia plus Regional Single-Agent Chemotherapy. Hyperthermic intravenous limb perfusion, HILP; plus Melphalan, L-PAM, NSC-8806.
  Arm II: Regional Hyperthermia plus Regional Single-Agent Chemotherapy and Biological Response Modifier Therapy. HILP as in Arm I; plus L-PAM; and Tumor Necrosis Factor (Knoll), TNF, NSC-635257; Interferon gamma (Genentech), IFN-G, NSC-600662.

Detailed description: Patients with locally advanced melanoma confined to an extremity (Stage IIIA or Stage IIIAB) will be treated in a randomized Phase III study with hyperthermic isolated limb perfusion. One arm of the study will be a standard 60 minute perfusion with melphalan as a single agent. The second arm of the study will combine melphalan, tumor necrosis factor, and interferon-gamma in the isolated limb perfusion reproducing a regimen shown to have 100% response rates in a Phase II European trial. Patients will be followed for local response rates, duration of response, treatment toxicity, and disease-free survival.

Eligibility: DISEASE CHARACTERISTICS:
  Biopsy-proven Stage IIIA or IIIAB melanoma (M.D. Anderson staging system) of an extremity, as follows:
  Advanced local disease indicated by 2 or more satellite or in-transit metastases.
  Lower limb regional metastases must be distal to the apex of the femoral triangle except inguinal lymph node metastases.
  Upper limb regional metastases must be distal to the deltoid insertion except axillary lymph node metastases.
  No evidence of systemic disease outside the involved extremity.
  Recurrent disease subsequent to prior successful limb perfusion allowed.
  Bidimensional directly measurable dermal or subcutaneous lesion required.
  PRIOR/CONCURRENT THERAPY:
  No prior isolated limb perfusion.
  Biologic Therapy: At least 1 month since Biologic Therapy.
  At least 3 months since regional therapy of the extremity.
  Chemotherapy: At least 1 month since chemotherap.y
  At least 3 months since regional therapy of the extremity.
  Endocrine Therapy: Not specified.
  Radiotherapy: At least 1 month since radiotherapy.
  Surgery: Not specified.
  PATIENT CHARACTERISTICS:
  Age: 18 and over.
  Performance status: ECOG 0 or 1.
  Hematopoietic: Platelets greater than 150,000.
  Hepatic: Bilirubin less than 1.5 mg/dl; Coagulation profile normal.
  Renal: Creatinine less than 2.0 mg/dl.
  Cardiovascular: No evidence of peripheral vascular disease, e.g.:
  No history of claudication.
  OTHER:
  HIV negative.
  No pregnant or nursing women.

Relevance to patient case: not relevant
Patient case: 49-year-old male with melanoma; genetic feature: extensive tumor infiltrating lymphocytes

Clinical trial: A Phase I Study of gp100 Human Melanoma Peptide Vaccine With Incomplete Freund's Adjuvant

Summary: This is a phase I study of melanoma tumor antigen peptide vaccines. The nine amino acid peptides representing HLA-A2 restricted T cell epitope of the melanoma antigen, gp100 will be administered to patients emulsified in Incomplete Freund's Adjuvant, (IFA). The study is designed to evaluate the toxicity, immunologic effects and potential therapeutic role of repeated doses of gp100 peptide vaccines administered subcutaneously.
  Immune reactivity to the gp100 epitope peptides will be monitored in all patients by analysis of melanoma-specific T cell precursor frequency prior to and after immunization.

Detailed description: This is a phase I study of melanoma tumor antigen peptide vaccines. The nine amino acid peptides representing HLA-A2 restricted T cell epitope of the melanoma antigen, gp100 will be administered to patients emulsified in Incomplete Freund's Adjuvant, (IFA). The study is designed to evaluate the toxicity, immunologic effects and potential therapeutic role of repeated doses of gp100 peptide vaccines administered subcutaneously.
  Immune reactivity to the gp100 epitope peptides will be monitored in all patients by analysis of melanoma-specific T cell precursor frequency prior to and after immunization.

Eligibility: DISEASE CHARACTERISTICS:
  Metastatic melanoma that is HLA-A2 positive.
  No primary melanoma of ocular or mucosal origin.
  Measurable or resected metastatic disease required.
  PRIOR/CONCURRENT THERAPY:
  BIOLOGIC THERAPY: No prior (greater than 30 days) or concurrent Biologic Therapy.
  CHEMOTHERAPY: No prior (greater than 30 days) or concurrent chemotherapy.
  ENDOCRINE THERAPY: No prior (greater than 30 days) or concurrent hormone therapy.
  No requirement for steroids.
  RADIOTHERAPY: No prior (greater than 30 days) or concurrent radiotherapy.
  SURGERY: Not specified.
  PATIENT CHARACTERISTICS:
  Age: 18 and over.
  Performance Status: ECOG 0 or 1.
  Life Expectancy: More than 3 months.
  HEMATOPOIETIC: No coagulation disorder.
  HEPATIC:
  Bilirubin no greater than 2.0 mg/dL.
  No Hepatitis BsAg antibody.
  RENAL: Creatinine no greater than 2.0 mg/dL.
  CARDIOVASCULAR: No major cardiovascular illness.
  PULMONARY: No major respiratory illness.
  OTHER:
  No previous allergic reaction to incomplete Freund's adjuvant.
  HIV negative.
  No active systemic infection.
  Not pregnant or lactating.

Relevance to patient case: not relevant
Patient case: 49-year-old male with melanoma; genetic feature: extensive tumor infiltrating lymphocytes

Clinical trial: Follow-up Protocol for Patients With Cancer/AIDS/Skin Disease

Summary: This protocol is to provide follow-up medical/surgical visits for DCS patients who are long term survivors and may not currently be a participant entered on an active research protocol. No investigational treatments or standard treatments will be administered on this protocol.

Detailed description: Background:
  -  Patients enrolled on CCR clinical protocols may require long term follow-up to assess outcome (e.g., survival) or the effects of prior therapy.
  -  Keeping the primary treatment protocols open after accrual is complete in order to follow patients for long term outcome is an administrative burden on investigators and the IRB.
  Objectives:
  -To provide follow-up for patients who are long term survivors previously enrolled Center for Cancer Research (CCR) trial but who may not currently be enrolled on a research protocol.
  Eligibility:
  -Patients who were previously enrolled on a CCR protocol and who are not eligible for an active NCI intramural primary research protocol.
  Design:
  -  The medical procedures/tests will be based on the patient's diagnosis, treatment and supporting clinical information. This is a follow-up study in which only standard tests and procedures are to be performed.
  -  Clinical information that is relevant to the patients prior protocols will be collected for research purposes.
  -  Procedures that entail more than minimal risk to the patient should not be performed for research purposes on this protocol.

Eligibility: -  ELIGIBILITY CRITERIA:
  Patients of any age who were previously enrolled on a CCR protocol.
  Not eligible for or unwilling to participate in an active NCI intramural primary research protocol.
  CCR investigator decides it is in the best interests of the patient and the CC for the patient to be seen in follow-up visits at the NIH.
  Patient or guardian is able to provide informed consent.

Relevance to patient case: not relevant
Patient case: 49-year-old male with melanoma; genetic feature: extensive tumor infiltrating lymphocytes

Clinical trial: Immunization of HLA-A201 Patients With Metastatic Melanoma Using a Combination of Immunodominant Peptides From Three Melanoma Antigens, MART-1, GP100 and Tyrosinase

Summary: This is a study of a melanoma tumor antigen peptide vaccine. Peptides representing HLA-A201 restricted T cell epitopes of the melanoma antigens, MART-1, gp100 and tyrosinase will be administered emulsified in Incomplete Freund's Adjuvant, (IFA) to HLA-A201 patients with melanoma. The study is designed to evaluate the potential therapeutic role, immunologic effects and toxicity of repeated doses of this peptide vaccine administered subcutaneously.
  Immune reactivity to the peptide epitope will be monitored in all patients by analysis of melanoma-specific T cell precursors prior to and after immunization.

Detailed description: This is a study of a melanoma tumor antigen peptide vaccine. Peptides representing HLA-A201 restricted T cell epitopes of the melanoma antigens, MART-1, gp100 and tyrosinase will be administered emulsified in Incomplete Freund's Adjuvant, (IFA) to HLA-A201 patients with melanoma. The study is designed to evaluate the potential therapeutic role, immunologic effects and toxicity of repeated doses of this peptide vaccine administered subcutaneously.
  Immune reactivity to the peptide epitope will be monitored in all patients by analysis of melanoma-specific T cell precursors prior to and after immunization.

Eligibility: Any patient 16 years of age or older with measurable metastatic melanoma who has failed standard treatment and has an expected survival of greater than three months.
  Must be HLA-A0201.
  Serum creatinine of 2.0 mg/dl or less.
  Bilirubin 1.6 mg/dl or less.
  WBC 3000/mm(3) or greater.
  Platelet count 90,000 mm(3) or greater.
  Serum AST/ALT less then two times normal.
  ECOG performance status of 0 or 1.
  Patients of both genders must be willing to practice effective birth control during the trial.
  Must not be undergoing or have undergone in the past 3 weeks any other form of therapy except surgery for their cancer.
  Must not have active systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular or respiratory systems or any known immunodeficiency disease.
  Must not require steroid therapy.
  Must not be pregnant.
  Must not be positive for hepatitis B(s)AG or HIV antibody.
  Must not have had a known allergic reaction to Incomplete Freund's Adjuvant (IFA).

Relevance to patient case: not relevant
Patient case: 49-year-old male with melanoma; genetic feature: extensive tumor infiltrating lymphocytes

Clinical trial: Immunization of Patients With Metastatic Melanoma Using the GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence

Summary: Patients with metastatic melanoma who are HLA-A201+ will be immunized with a modified peptide from the gp100 molecule that contains a signal sequence designed to improve peptide presentation by antigen presenting cells. This peptide called gp100:ES209-217 (210M) will be administered either alone or in combination with high or low dose IL-2. Patients will be evaluated for clinical response, as well as undergo studies of the immunologic response to the peptide immunization.

Detailed description: Patients with metastatic melanoma who are HLA-A201+ will be immunized with a modified peptide from the gp100 molecule that contains a signal sequence designed to improve peptide presentation by antigen presenting cells. This peptide called gp100:ES209-217 (210M) will be administered either alone or in combination with high or low dose IL-2. Patients will be evaluated for clinical response, as well as undergo studies of the immunologic response to the peptide immunization.

Eligibility: Any patient age greater than or equal to 18 with measurable metastatic melanoma who has failed standard treatment and has an expected survival of greater than three months will be considered.
  Serum creatinine of 2.0 mg/dl or less.
  Bilirubin 1.6 mg/dl or less.
  WBC 3000/mm(3) or greater.
  Platelet count 90,000 mm(3) or greater.
  Serum AST/ALT less then two times normal.
  ECOG performance status of 0 or 1 or 2.
  Patients of both genders must be willing to practice effective birth control during this trial.
  No patients who are undergoing or have undergone in the past 3 weeks any other form of therapy except surgery for their cancer.
  No patients who have active systemic infections, coagulation disorders, autoimmune disease or other major medical illnesses of the cardiovascular or respiratory systems or any known immunodeficiency disease. Patients with cardiovascular disease will be eligible to receive peptide in IFA alone.
  No patients who require steroid therapy.
  No patients who are pregnant (because of possible side effects on the fetus).
  No patients who are known to be positive for hepatitis BsAG or HIV antibody (because of possible immune effects of these conditions).
  No patients who have any form of primary or secondary immunodeficiency. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).

Relevance to patient case: not relevant
Patient case: 49-year-old male with melanoma; genetic feature: extensive 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: 49-year-old male with melanoma; genetic feature: extensive 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: 49-year-old male with melanoma; genetic feature: extensive 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: possibly relevant