araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

Clinical trial: Interferon Alfa or No Further Therapy Following Surgery in Treating Patients With Stage II, Stage III, or Recurrent Melanoma

Summary: RATIONALE: Interferon alfa may interfere with the growth of the cancer cells. It is not yet known whether interferon alfa following surgery is more effective than surgery alone in treating patients with melanoma.
  PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with no further therapy following surgery in treating patients with stage II, stage III, or recurrent melanoma.

Detailed description: OBJECTIVES: I. Determine the effects of adjuvant low-dose extended-duration interferon alfa on disease-free and overall survival in patients with completely resected malignant melanoma at high risk of recurrence. II. Determine any correlation between patient age or sex and the effects of interferon therapy on disease-free and overall survival. III. Describe the toxic effects of this treatment. IV. Evaluate the economic implications of implementing effective interferon therapy in these patients.
  OUTLINE: This is a randomized study. Patients will be stratified by age, sex, disease status at entry, and participating institution. Patients are randomized to observation only or to receive interferon alfa by subcutaneous injections 3 times weekly for 2 years, or until disease progression or toxicity intervenes. Patients are followed monthly for 6 months, quarterly for 18 months, and every 6 months thereafter.
  PROJECTED ACCRUAL: A total of 1,000 patients will be entered over 5 years.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma definitively resected within 12 weeks prior to entry One of the following categories: Stage II disease (greater than 4 mm Breslow thickness) Stage III disease (regional lymph node involvement) Recurrent non-nodal superficial regional disease (local or in transit) Recurrent regional nodal involvement
  PATIENT CHARACTERISTICS: Able to tolerate interferon No second malignancy except curatively treated: Carcinoma of the cervix Nonmelanomatous skin cancer No pregnant or nursing women
  PRIOR CONCURRENT THERAPY: No prior immunosuppressive therapy, including systemic steroids No prior biologic therapy Recovered from surgery

Relevance to patient case: not relevant
Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

Clinical trial: S9903: Whole Brain Radiotherapy Followed By Stereotactic Radiosurgery for Limited Malignant Melanoma Brain Metastases

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Stereotactic radiosurgery may kill more tumor cells.
  PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by stereotactic radiosurgery in treating patients who have brain metastases from malignant melanoma.

Detailed description: OBJECTIVES: I. Estimate the 6 month intracranial progression rate and 6 month overall survival rate in patients with limited brain metastases from malignant melanoma undergoing whole brain radiotherapy followed by stereotactic radiosurgery boost. II. Evaluate the qualitative and quantitative toxic effects of this regimen in these patients.
  OUTLINE: Patients undergo whole brain radiotherapy 5 days a week for 3 weeks, followed 3-5 weeks later by stereotactic radiosurgery. Patients are followed every 3 months until death.
  PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.

Eligibility: DISEASE CHARACTERISTICS: Histologically proven malignant melanoma at primary or any metastatic site Bidimensionally measurable disease by MRI scan Must have 1-6 enhancing brain metastases If at least 2 lesions are present, only 1 lesion may be greater than 3 cm in maximum diameter
  PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic response modifier or immunotherapy Chemotherapy: No concurrent chemotherapy with whole brain radiotherapy Prior systemic chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: No prior stereotactic or conventional radiotherapy to any field of the brain Surgery: Prior surgical resection of brain metastases allowed (provided 1 or 2 measurable brain metastases remain)

Relevance to patient case: not relevant
Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

Clinical trial: Detection of Melanoma Markers in Lymph Nodes or Peripheral Blood of Patients With Melanoma

Summary: RATIONALE: Diagnostic procedures may improve the ability to detect the presence or recurrence of disease.
  PURPOSE: Diagnostic trial to detect melanoma markers in the lymph nodes or peripheral blood of patients who have melanoma.

Detailed description: OBJECTIVES:
  -  Determine the feasibility of performing reverse transcriptase-polymerase chain reaction (RT-PCR) for five different tumor antigen genes using lymph node samples or peripheral blood from patients with melanoma.
  -  Determine the ability of PCR-positive lymph nodes or peripheral blood to predict relapse of disease in these patients.
  -  Determine the correlation of positive PCR results from peripheral blood with disease stage.
  OUTLINE: Lymph node biopsies or peripheral blood are obtained from patients. These specimens are examined by nested reverse transcriptase-polymerase chain reaction (RT-PCR) and analyzed for various tumor antigens.
  Patients may choose to be told the results of this testing, but the results do not influence or change the planned therapy. Brief counseling is required to discuss the results and their potential implications.
  Patients are followed for at least 2 years.
  PROJECTED ACCRUAL: A total of 30 patients for the lymph node portion and 80 patients (20 per stage of disease) for the peripheral blood portion will be accrued for this study within 3 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Clinically proven melanoma with indication to perform sentinel lymph node biopsy or elective lymph node dissection OR
  -  Histologically proven or diagnosis highly suspicious for melanoma
  PATIENT CHARACTERISTICS:
  Age:
  -  Any age
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Platelet count greater than 50,000/mm^3
  -  Hemoglobin greater than 7 g/dL
  Hepatic:
  -  PT less than 15 sec
  -  PTT less than 30 sec
  Renal:
  -  Not specified
  Other:
  -  No psychiatric illness that precludes compliance
  -  No other concurrent malignancy
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  Not specified
  Surgery
  -  Not specified

Relevance to patient case: not relevant
Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

Clinical trial: ADI-PEG in Patients With Metastatic Melanoma

Summary: This is a study to determine the safety and toxicity of increasing doses of arginine deiminase combined to polyethylene glycol (ADI-PEG) in patients with nonresectable metastatic melanoma.

Detailed description: The use of amino acid degrading enzymes derived from microbial sources has proven to be an effective means of controlling some forms of cancer auxotrophic for nonessential amino acids. Recently it has been shown that human melanomas are auxotrophic for arginine. As arginine is a nonessential amino acid for humans, elimination of it may prove to be an effective method for controlling cancer. Laboratory studies have provided promising results with the arginine-degrading enzyme arginine deiminase (ADI) coupled to polyethylene glycol (PEG) to enhance its circulating half-life.
  In this study, patients each receive 3 intramuscular treatments of ADI-SS PEG over a 4-week period. There are 4 cohorts of patients each receiving a different dose level. Pharmacokinetics, pharmacodynamics, safety and toxicity, and immunogenicity studies will be performed.

Eligibility: Inclusion criteria:
  -  Histologically confirmed metastatic melanoma
  -  Nonresectable disease
  -  Measurable or evaluable disease
  -  Progressive disease following standard chemotherapy, radiotherapy, surgery, or immunotherapy; and no longer responding to therapy
  -  Recovered from prior surgery
  -  Karnofsky performance status 70 or higher
  -  Expected survival of at least 12 weeks
  -  Bilirubin less than 2.0 mg/dL
  -  Albumin greater than 3.0 g/dL
  -  SGOT less than 5 times upper limit of normal (ULN)
  -  Alkaline phosphatase less than 5 times ULN
  -  Ammonia less than 55 microg/dL
  -  Glucose greater than 60 mg/dL
  -  Amylase less than 1.5 times ULN
  -  Absolute neutrophil count greater than 1,500/mm3
  -  Platelet count greater than 100,000/mm3
  -  Patients must use 2 forms of effective contraception
  Exclusion criteria:
  -  Prior therapy within the past 4 weeks
  -  Ascites or pleural effusion
  -  Significant cardiac disease (i.e., New York Heart Association class III or IV heart disease)
  -  Pregnant or nursing
  -  Concurrent enrollment in another IND study
  -  Serious infection requiring antibiotics

Relevance to patient case: not relevant
Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

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
Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

Clinical trial: Comparison Study of MDX-010 (CTLA-4) Alone and Combined With DTIC in the Treatment of Metastatic Melanoma

Summary: The objectives of this study are to determine the safety and activity profile of multiple doses of MDX-010, and to determine the whether the addition of cytotoxic chemotherapy (decarbazine [DTIC]) can augment the effects of MDX-010 in patients with chemotherapy naïve metastatic melanoma with a tolerable toxicity profile.


Eligibility: Inclusion Criteria
  -  Clinical diagnosis of unresectable metastatic melanoma.
  -  No prior chemotherapy for melanoma, and no chemotherapy for other malignancies within 5 years and at least 4 weeks since treatment (surgery, radiation, or immunotherapy) for melanoma.
  Exclusion Criteria
  Patients who exhibit any of the following conditions at screening will not be eligible for admission into the study:
  -  Any other prior malignancy, except for the following: adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the patient has been disease-free for >=5 years.
  -  Active autoimmune disease.
  -  Active infection requiring therapy, or chronic active HBV or HCV, or confirmed reactivity with HIV tests.

Relevance to patient case: not relevant
Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

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
Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

Clinical trial: Immunotherapy of Melanoma Patients

Summary: The purpose of this study is to test whether vaccination with antigenic peptides induces an immune response in the vaccine site sentinel lymph node of patients with microscopically detectable lymph node melanoma metastases.

Detailed description: The study is designed for patients with skin melanoma and lymph node micrometastasis previously diagnosed by a sentinel node procedure. As a result of their diagnosis, the patients are scheduled for lymph node dissection. Before this is done, patients are vaccinated with antigenic peptides. The peptides are mixed with the adjuvant SB AS-2 or Montanide and injected in a lower limb not affected by the disease. The skin site of vaccine injection is marked with a permanent pen where, two weeks later, patent blue and 99technetium is injected. These markers allow one to locate the vaccine site sentinel node (VSSN) which will be removed during the lymph node dissection at the diseased limb.
  The aim of the study is to test whether the vaccine has induced an immune response in the lymph node that drains the vaccine site.

Eligibility: Inclusion Criteria:
  -  Patients with microscopically detectable lymph node metastases
  -  Positive detection of the Melan-A gene +/- MAGE-10 in positive sentinel node or primary tumor tissue by polymerase chain reaction (PCR) analysis of mRNA and/or by immunohistochemistry using monoclonal antibodies
  -  Human leukocyte antigen-A2 (HLA-A2) positive
  Exclusion Criteria:
  -  Previous splenectomy or radiotherapy to the spleen
  -  Treatment with systemic antihistamines, corticosteroids, or non-steroidal anti-inflammatory drugs (except occasional or low dose non-steroidal anti-inflammatory drugs such as 100 mg aspirin/day) within 4 weeks of entry into the study
  -  Heart disease (New York Heart Association [NYHA] Class III or IV)
  -  Serious illness, e.g. active infections requiring antibiotics, bleeding disorders or other diseases considered by the investigator to have potential for interfering with obtaining accurate results from this study

Relevance to patient case: not relevant
Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

Clinical trial: Immunotherapy of Stage III/IV Melanoma Patients

Summary: The purpose of this study is to determine whether vaccination with melanoma antigen peptides [Melan-A/Mart-1 (both EAA and ELA), NY-ESO-1b analog, Long NY-ESO-1 LP and MAGE-A10] and Montanide, CpG adjuvants and low dose rIL-2 can induce an immune response in melanoma patients and to assess the safety of this vaccination.

Detailed description: Current peptide vaccines suffer from low efficiency, since they induce only weak immune activation. We have recently confirmed that in humans the immune response was readily detectable in local lymph nodes while no or only weak activation could be identified in circulating lymphocytes. Increased doses of antigen and adjuvant allow a better extension from local to systemic immune responses.
  -  Group 1 : vaccination with Melan-A analog (ELA) peptide + Montanide
  -  Group 2 : vaccination with Melan-A analog (ELA), NY-ESO-1b analog and MAGE-A10 peptides + Montanide
  -  Group 3: vaccination with Melan-A analog (both EAA and ELA), Mage-A10, NY-ESO-1 peptides+ Montanide + CpG adjuvant
  -  Group 4: vaccination with Melan-A (ELA), Mage-A10,long NY-ESO-1LP peptides + Montanide + CpG
  -  Group 5: vaccination with Melan-A(both EAA and ELA), Mage-A10, long NY-ESO-1 LP peptides + Montanide + CpG + low dose rIL-2

Eligibility: Inclusion Criteria:
  -  Histologically confirmed stage III or stage IV melanoma
  -  Tumor expression of Melan-A +/- one of the tumor antigens MAGE-A10, NY-ESO-1, or LAGE-1
  -  Human leukocyte antigen-A2 (HLA-A2) positive
  Exclusion Criteria:
  -  Clinically significant heart disease
  -  Serious illnesses, eg, serious infections requiring antibiotics, uncontrolled peptic ulcer, or central nervous system disorders
  -  History of immunodeficiency disease or autoimmune disease
  -  Coagulation or bleeding disorders

Relevance to patient case: not relevant
Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

Clinical trial: Vaccine Therapy in Treating Patients With Malignant Melanoma

Summary: RATIONALE: Vaccines made from tumor cells may help the body build an effective immune response to kill tumor cells.
  PURPOSE: This phase II trial is studying vaccine therapy to see how well it works in treating patients with malignant melanoma.

Detailed description: OBJECTIVES:
  -  Determine the response in patients with in-transit cutaneous malignant melanoma treated with active immunotherapy comprising polyvalent melanoma vaccine (Canvaxin™).
  OUTLINE: This is an open-label, multicenter study.
  Patients receive polyvalent melanoma vaccine (Canvaxin™) subcutaneously to the armpit and groin areas every 2 weeks for approximately 10 weeks (5 doses) and then every 4 weeks for up to approximately 1 year of total treatment (total of 15 doses). Patients with no evidence of response at week 24 receive no further treatment. Patients whose disease continues to respond after completion of study treatment are eligible for a new study in which they will continue treatment with polyvalent melanoma vaccine (Canvaxin™).
  After completion of study treatment, patients are followed at 30 days.
  PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed malignant melanoma
  -  At least 1 in-transit skin lesion measuring 3-10 mm in the longest diameter
  PATIENT CHARACTERISTICS:
  Age
  -  18 to 80
  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
  -  Not specified

Relevance to patient case: not relevant
Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

Clinical trial: NY-ESO-1 Protein Vaccine With Imiquimod in Melanoma (Adjuvant Setting)

Summary: This study evaluates a cancer vaccine in melanoma patients who have resected melanoma but are at high risk for recurrence (stages IIB-III). This is a single arm, open label, pilot/phase I study evaluating safety and immunogenicity of NY-ESO-1 protein vaccination with Imiquimod as an adjuvant.
  Imiquimod is a FDA approved immune response modifier for the treatment of HPV associated genital warts (but used for a different indication here) and has been shown to attract and mature dendritic cells in areas of topical application. This will be utilized in this application to inject a protein vaccine into this site, to prime and boost anti-NY-ESO-1 immune responses.
  9 patients will be treated to receive 4 vaccination cycles, 21 days apart. Each vaccination cycle consists of topical application of Imiquimod 250mg to healthy skin of extremities for the first five days of each cycle and intradermal injection of NY-ESO-1 protein 100mcg to the pretreated area on day 3.
  Immunization will be assessed by T-cell assays, NY-ESO-1 specific antibody titers, and evaluation of 3 small skin biopsies.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed, resected AJCC Stage IIB, IIC or III malignant melanoma
  -  Fully recovered from surgery
  -  Age >18 years.
  -  ECOG performance status <2
  -  Adequate organ and marrow function.
  -  Ability to understand and the willingness to sign a written informed consent document.
  Exclusion Criteria:
  -  Chemotherapy, immunotherapy (including interferon), or radiotherapy within 4 weeks prior to first dosing of study agent.
  -  Prior treatment with NY-ESO-1 vaccines.
  -  Known HIV infection or autoimmune disease (RA, SLE). Patients with vitiligo or melanoma-associated hypopigmentation are not excluded.
  -  History of allergic reactions attributed to compounds of similar chemical or biologic composition to imiquimod or other agents used in the study.
  -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  -  Pregnancy or lactation.
  -  Women of childbearing potential not using a medically acceptable means of contraception.
  -  Patients with known history of inflammatory skin disorders, as imiquimod might exacerbate these conditions.
  -  Patients who receive chronic corticosteroid or immunosuppressive therapies.
  -  Lack of availability for immunological and clinical follow-up assessments.

Relevance to patient case: not relevant