araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 49-year-old male with melanoma; genetic feature: extensive tumor infiltrating lymphocytes

Clinical trial: Lucentis as an Adjuvant Therapy With TTT-ICG Based in Choroidal Melanoma

Summary: To report preliminary results on safety and tolerability of intravitreal injection of Ranibizumab (Lucentis) combined with Transpupillary Thermotherapy (TTT)+ Indocyanine Green (ICG)-based photodynamic therapy (PDT) in the treatment of choroidal melanoma.


Eligibility: Inclusion Criteria:
  -  Age > 18 yo.
  -  Primary pigmented or amelanotic choroidal melanoma measurement of 16 mm or less in the largest vessel diameter and 6 mm or less in the apical height.
  -  Location of the tumor posterior to the equator.
  -  Documented growth by A/B scan.
  -  Risk factor for metastasis (thickness greater than 2 mm, symptoms, tumor margin at the optic disc)
  -  Ability to provide inform consent.
  -  Comply with the study assessment for the cooperation of the study.
  Exclusion Criteria:
  -  Pregnancy or lactation.
  -  Premenopausal women not using adequate contraception; surgical sterilization or use of oral contraception, barrier contraception with either a condom or diaphragm or in conjunction with spermicidal gel, an IUD or contraceptive hormon implant or patch.
  -  Current infection or inflammation in either eye.
  -  Extension of tumor into the orbit.
  -  Retinal spread or metastatic disease.
  -  Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
  -  Any known allergy to any of the components to be used in the study.
  -  Participation in another simultaneous medical investigation or trial.

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

Clinical trial: Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer

Summary: Feasibility and efficacy of combined modality intervention using chemotherapeutic agent gemcitabine with anti-angiogenic peptide vaccination targeting VRGFR1 should be determined in case of advanced/inoperable or therapy-resistant pancreatic cancer patients.
  Gemcitabine 1,000mg/m2 BSA will be administered on day1, day8, day15, day29, day36, day43, respectively.
  HLA-A*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084; SYGVLLWEI) emulsified with Montanide ISA51 will be subcutaneously injected twice weekly for 8weeks (total 16 doses).

Detailed description: HLA-A*2402-restricted cytotoxic T lymphocyte (CTL) clones were obtained from healthy volunteer donor peripheral blood.
  These CTL clones showed potent cytotoxicities selectively against VEGFR1-expressing target cells in HLA-class I-restricted manner.

Eligibility: Inclusion Criteria:
  -  Heterozygote or homozygote of HLA-A*2402 allele
  -  Inoperable or recurrent pancreatic cancer with or without any prior therapy
  -  Difficult to continue the prior therapy due to treatment-related toxicities
  -  ECOG performance status 0-2
  -  Evaluable primary or metastatic lesion with RECIST criteria
  -  Clearance period from prior therapy more than 4 weeks
  -  Life expectancy more than 3 months
  -  Laboratory values as follows 2,000/μL<WBC<15,000/μL Platelet count>100,000/μL AST<150IU/L ALT<150IU/L Total bilirubin<3.0mg/dl Serum creatinine<3.0mg/dl
  Exclusion Criteria:
  -  Pregnancy (refusal or inability to use effective contraceptives)
  -  Breastfeeding
  -  Active or uncontrolled infection
  -  Systemic use of corticosteroids or immunosuppressants
  -  Uncontrollable brain metastasis and/or meningeal infiltration
  -  Unhealed external wound
  -  Possibilities of complicated paralytic ileus or interstitial pneumonitis
  -  Decision of not eligible determined by principal investigator or attending doctor

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

Clinical trial: A Phase II Study of an Anti-Tumor Immunotherapy Regimen Comprised of Pegylated Interferon-Alpha 2b and HyperAcute Melanoma Vaccine for Subjects With Advanced Melanoma

Summary: The purpose of this study is to determine the safety of giving subjects with advanced, recurrent or refractory melanoma the HyperAcute® Melanoma vaccine with a variant of a drug, called Interferon (PEG-Intron®) that is specially formulated to be given on a weekly basis (instead of daily). The study vaccine (HyperAcute®-Melanoma) is made from three types of human melanoma cell lines (grown in the laboratory) in which the genes have been slightly changed. This clinical study will try to discover the safety of the study vaccine combined with PEG-Intron®, its side effects and the potential benefits, if any.

Detailed description: This study will look at the anti-tumor vaccine effect, side effects and toxicity of the HyperAcute® Vaccine with PEG-Intron®. It is hoped that the immune system's response to these genetically engineered melanoma cells and PEG-Intron® will cause a reaction that will make it react to and attack and kill the melanoma cells and keep it from growing, possibly causing the tumors to shrink.
  Patients that are eligible are 19 years or older and have been diagnosed with advanced, treatment resistant or recurrent melanoma, an aggressive usually pigmented form of skin cancer.

Eligibility: Inclusion Criteria:
  -  19 years or older
  -  Histological diagnosis of melanoma
  -  AJCC Stage IIIC (any T, N1b, N2b, N3, M0) or Stage IV (any T, and N, M1), metastatic, progressive, refractory, recurrent or high risk of recurrence melanoma.
  -  Expected survival of more than 6 months
  -  Adequate organ function
  -  Measurable or non-measurable disease
  -  Must have negative serologies for Hepatitis B and C and HIV prior to entering study
  -  Must be more than 4 weeks since major surgery, radiotherapy, chemotherapy or biotherapy/targeted therapies
  -  Male and female subjects of child producing potential must agree to use contraception or avoidance pregnancy measures while enrolled on the study and for one month after the last immunization.
  Exclusion Criteria:
  -  Active CNS metastases or carcinomatous meningitis
  -  Hypercalcemia
  -  Pregnant or nursing women
  -  Other malignancy within five years
  -  History of organ transplant or current active immunosuppressive therapy
  -  Subjects taking systemic corticosteroid therapy
  -  Active infection or antibiotics within 1-week prior to study
  -  Uncontrolled or significant congestive heart failure, myocardial infarction, ventricular arrhythmias or pulmonary dysfunction
  -  Autoimmune disease
  -  A known allergy to any component of the HyperAcute vaccine or PEG-Intron
  -  Patients having undergone splenectomy
  -  Patients with sickle-cell anemia or thalassemia major.

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

Clinical trial: A Dose-Escalation Study of RO5126766 in Patients With Advanced Solid Tumors.

Summary: This study will determine the maximum tolerated dose and the dose limiting toxicities (Part 1 of study) and the activity (Part 2 of study) of RO5126766 in patients with metastatic or advanced solid tumors. In the first part of the study, groups of patients will by sequentially enrolled to receive ascending oral doses of RO5126766 daily for 28 days. The starting dose of 0.1mg will be escalated in subsequent groups of patients after a successful assessment of the safety and tolerability of the previous dose. In Part 2 of the study, patients with selected tumor types will be randomized to receive either the optimal biological dose or the maximum tolerated dose of RO5126766 daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.


Eligibility: Inclusion Criteria:
  -  adult patients, >=18 years of age;
  -  advanced and/or metastatic cancer not amenable to standard therapy;
  -  any solid tumor type (Part 1); malignant melanoma, pancreatic cancer or non-small cell lung cancer (Part 2);
  -  measurable and/or evaluable disease (Part 1), >=1 measurable lesion (Part 2);
  -  ECOG performance status 0-1.
  Exclusion Criteria:
  -  prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;
  -  prior corticosteroids as anti-cancer therapy within 14 days of first receipt of study drug;
  -  known past or present CNS metastases;
  -  acute or chronic infection.

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

Clinical trial: Feasibility and Functionality of fPAM Imaging in Melanoma

Summary: Melanoma is a cutaneous malignancy that has the potential for local (skin) and regional (lymph node) recurrence. These recurrences may be difficult to detect in their earliest stages. We are attempting to use novel form of skin imaging that uses ultrasound combined with laser to identify these recurrences early, when they may be most amenable to treatment. This imaging will detect melanoma pigment below the surface of the skin and in the draining lymph nodes, as well as new blood vessel formation that occurs with these loco-regional metastases.

Detailed description: recruiting healthy individuals with pigmented lesions and individuals with melanoma and pigmented lesions

Eligibility: Inclusion Criteria:
  -  Adult patients (> 18 yrs of age) with recently diagnosed or a history of, Stage I - III melanoma who are able to give informed consent.
  Exclusion Criteria:
  -  Patients with melanomas < 1mm.
  -  Pregnant females.
  -  Children and young adults < 18 yrs of age and patients who are unable to give informed consent.

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

Clinical trial: Tailored Intervention for Melanoma Patient's Families

Summary: The purpose of the investigators' study is to find the best way to provide information about sun protection and skin cancer detection. The investigators want to see which of two methods most improves sun protection and screening attitudes and practices. The investigators hope to improve these attitudes and practices among people who are at higher risk for melanoma. People at higher risk for melanoma are first degree relatives (mother, father, sibling or child) of people diagnosed with melanoma.

Detailed description: Eligible patients will be contacted to find out whether they have any living first degree relatives that we may contact to discuss their participation in our study.
  Eligible first degree relatives (FDRs) will participate in our study as outlined under Interventions.

Eligibility: Inclusion Criteria - Patients (for referral of FDRs):
  -  Newly diagnosed with cutaneous malignant melanoma (CMM) within the past 2 years but more than 3 months prior to being approached
  -  Seen at FCCC, FCCC Network, Temple, MCC, or HUP patient clinics
  -  Greater than 18 years of age
  -  English speaking
  -  Able to give meaningful informed consent
  -  Does NOT have a first-degree relative with CMM
  Inclusion Criteria - FDR (First Degree Relative):
  -  Current age of at least 21 years
  -  One or more of the following additional risk factors; blonde or red hair; marked freckling on the upper back; history of 3 or more blistering sunburns prior to age 20; 3 or more years of an outdoor summer job as a teenager; Actinic keratosis
  -  Able to give informed consent
  -  English speaking
  -  Has residential phone service
  -  No personal history of CMM or non-melanoma skin cancer
  -  No personal history of dysplastic nevi
  Exclusion Criteria - FDR:
  -  2 or more first degree relatives with CMM
  -  Has had a total cutaneous examination (TCE) in the past 3 years AND has done skin self-examination (SSE) more than once in the past year AND has a sun protection habits mean score greater than or equal to 4 (often). We are selecting a set participants who are NOT compliant with TCE and are inconsistent/minimal performers of SSE and sun protection practices.

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

Clinical trial: Comparison of Video-Based Versus Written Patient Education on Melanoma

Summary: The purpose of this study is to compare the effect of video-based patient education with written instruction on subjects' understanding of melanoma.

Detailed description: We plan to conduct a randomized, controlled trial comparing the effect of video-based patient education with written instruction on subjects' understanding of melanoma.
  Subjects randomized to the video-based education arm will be instructed to watch a video on the definition of melanoma, risk factors associated with the development of melanoma, and signs that should prompt an evaluation for melanoma. Subjects randomized to the written education arm will receive written information on the definition of melanoma, risk factors associated with the development of melanoma, and signs that should prompt an evaluation for melanoma. The contents of the video and the written educational materials will be comparable.
  At the end of the study period 1 month later, subjects will be interviewed via telephone regarding their understanding of melanoma. Subjects will also be interviewed regarding their comprehension and attitude towards video-based and written education materials.

Eligibility: Inclusion Criteria:
  -  18 years of age or older at time of consent, may be men or women.
  -  Able to adhere to the study visit schedule and other protocol requirements.
  -  Capable of giving informed consent.
  Exclusion Criteria:
  -  Non-English speaking individuals.

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

Clinical trial: Studying Tumor Tissue Samples From Patients With Melanoma Who Have Undergone Sentinel Lymph Node Biopsy

Summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help the study of cancer in the future.
  PURPOSE: This laboratory study is looking at tumor tissue samples from patients with melanoma who have undergone sentinel lymph node biopsy.

Detailed description: OBJECTIVES:
  -  Develop a predictive model for sentinel lymph node biopsy positivity in patients with melanoma who have undergone sentinel lymph node biopsy.
  -  Develop a survival model for relapse based on sentinel lymph node biopsy positivity.
  -  Assess the genetic determinants in primary melanomas that predict a metastatic phenotype and thereby improve understanding of the biology of the metastases in melanoma.
  OUTLINE: This is a retrospective, case-controlled, multicenter study. Patients are stratified according to Breslow thickness of the tumor (0.75-1.50 mm vs 1.51- 4 mm vs > 4 mm) and gender.
  Archived tumor tissue is analyzed by immunohistochemistry (IHC) for AP2, vascular endothelial growth factor, MMP 2, MCM4, and others, if feasible. Sentinel node biopsies are analyzed by IHC for CD31, LYVE-1, and D2-40 expression. RNA and DNA are also extracted for genetic expression studies and mutation analysis (e.g., BRAF, NRAS, PTEN, CDKN2A).
  Patient data related to relapse and recurrence is collected, if available.
  Peer reviewed and funded or endorsed by Cancer Research UK
  PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Confirmed diagnosis of cutaneous melanoma
  -  Breslow thickness > 0.75 mm
  -  Has undergone sentinel lymph node biopsy
  -  No primary melanoma that has not originated in the skin
  -  No multiple primary melanomas
  -  Currently under clinical followup OR discharged from follow up within the past 3 months
  PATIENT CHARACTERISTICS:
  -  No other malignancy except for nonmelanoma skin cancer or cervical carcinoma in situ
  PRIOR CONCURRENT THERAPY:
  -  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: Biomarkers to Predict Response to Interferon Therapy in Patients With Melanoma

Summary: RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer, and may help doctors learn how well patients will respond to treatment.
  PURPOSE: This laboratory study is looking at biomarkers to predict the response to interferon therapy in patients with melanoma.

Detailed description: OBJECTIVES:
  -  Generate a comprehensive multiplexed array of melanoma-associated serological markers and validate it using serum samples from patients with melanoma and healthy control participants.
  -  Determine changes in the profile of serological markers induced by interferon-alfa 2b (IFN-α2b) therapy.
  -  Define panels of serological markers with prognostic and predictive power for IFN-α2b therapy responses in patients with melanoma.
  OUTLINE: This is a multicenter study.
  Serum samples are used for multiplex analyses. Biomarkers to be assessed include cytokines, chemokines, growth factors, angiogenic and antiangiogenic molecules, matrix metalloproteases (MMPs), tissue inhibitors of MMPs (TIMPs), melanoma-associated antigens, basic fibroblast growth factor, insulin-like growth factor I and II, thrombospondin, endostatin, angiostatin, vasostatin, and vascular endothelial growth factor inhibitor.
  PROJECTED ACCRUAL: A total of 1,716 samples will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of melanoma OR healthy volunteer (control)
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

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

Clinical trial: T-cell Based Immunotherapy for Head and Neck Cancer

Summary: The aim of this study is to investigate the toxicity and immune response of therapy with tumor infiltrating lymphocytes as adjuvant treatment for head and neck cancer after primary operation and radiotherapy.
  Patient will receive a single treatment consisting of conditioning chemotherapy for seven days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with daily low-dose interleukine-2. Patients will be evaluated for toxicity and immune response.


Eligibility: Inclusion Criteria:
  -  Patients with histological proven squamous cell carcinoma T3 or more in the oral cavity planned for primary surgery. Performance Status 0 to 1. Acceptable CBC and blood chemistry results. Acceptable organ functions.
  Exclusion Criteria:
  -  Patients with a history of any other malignancies less than five years ago. Brain metastases. Other significant illness including severe allergy, asthma, DM, angina pectoris, congestive heart failure, chronic infections, or active autoimmune disease. Treatment with immune suppressive drugs, experimental drugs, or antineoplastic drugs.

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

Clinical trial: T-cell Based Immunotherapy for of Melanoma

Summary: The aim of this study is to investigate the toxicity and clinical response of therapy with tumor infiltrating lymphocytes as treatment for advanced melanoma.
  Patient will receive a single treatment consisting of conditioning chemotherapy for seven days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with daily low-dose interleukine-2. Patients will be evaluated for toxicity, tumor response, and immune response.
  After the first 6 patients the treatment with IL-2 has been changed to include higher doses of IL-2 (see intervention)


Eligibility: Inclusion Criteria:
  -  Patients with histological proven skin derived progressive metastatic or locally advanced malignant melanoma. Further inclusion criteria: Performance Status 0 to 1, surgical available metastasis, at least one measurable lesion, acceptable CBC and blood chemistry results. Acceptable organ functions.
  Exclusion Criteria:
  -  Patients with a history of any other malignancies less than five years ago. Brain metastases. Other significant illness including severe allergy, asthma, DM, angina pectoris, congestive heart failure, chronic infections, or active autoimmune disease. Treatment with immune suppressive drugs, experimental drugs, or antineoplastic drugs.

Relevance to patient case: possibly relevant
Patient case: 49-year-old male with melanoma; genetic feature: extensive tumor infiltrating lymphocytes

Clinical trial: Study of Tumor Samples in Patients Undergoing Radiation Therapy or Surgery For Primary Melanoma of the Eye

Summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This clinical trial is studying tumor samples in patients undergoing surgery or radiation therapy for primary melanoma of the eye.

Detailed description: OBJECTIVES:
  Primary
  -  To establish the feasibility of using fine needle aspiration (FNA) and FISH to determine tumor genotype in patients with primary uveal melanoma.
  Secondary
  -  To characterize ophthalmic complication rate of FNA for FISH analysis in patients undergoing plaque radiotherapy.
  -  To estimate disease-free survival in patients with and without tumor monosomy 3 and/or 8q amplification.
  -  To explore the relationship between tumor monosomy 3 and 8q amplification and plasma levels of tumor immune escape and invasion biomarkers (e.g., circulating granulysin, beta2-microglobulin, autotoxin, lysophosphatidic acid, matrix metalloproteinase-7, tissue inhibitor of matrix metalloproteinase, and soluble E- cadherin).
  -  To explore the psychological impact of prognostication in uveal melanoma.
  OUTLINE: Patients undergo plaque radiotherapy, enucleation, or tumor resection based upon standard of care guidelines.
  Trans-scleral fine needle aspiration (FNA) is performed at the time of plaque radiotherapy and ex vivo FNA is performed on enucleation and tumor resection specimens. Tissue samples are analyzed by fluorescence in situ hybridization (FISH). Blood samples are also collected for further analysis.
  After completion of study therapy, patients are followed up periodically.

Eligibility: Inclusion Criteria
  -  Patients must have a clinical diagnosis of melanoma of the iris, ciliary body and/or choroids
  -  Patients must have had a hepatic ultrasound and/or other suitable imaging studies to eliminate metastatic disease
  -  Patients must not have received any local or systemic therapy for uveal melanoma
  -  All patients must be informed of the investigational nature of this study and must provide written informed consent in accordance with institutional and federal guidelines. A copy of the informed consent document signed by the patient must be given to the patient
  -  Patients must have the following pretreatment laboratory findings:
  -  Bilirubin (total) </= 1.5 ml/dl
  -  AST </= 2 x normal
  -  ALT </= 2 x normal
  -  Alkaline phosphatase </= 2 x normal
  Exclusion Criteria
  -  Patients with metastasis
  -  Patients under the age of 18

Relevance to patient case: not relevant