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

Clinical trial: Pyrazoloacridine in Treating Patients With Metastatic Skin or Eye Melanoma

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: Phase II trial to study the effectiveness of pyrazoloacridine in treating patients who have metastatic skin or eye melanoma.

Detailed description: OBJECTIVES:
  -  Assess the antitumor activity of pyrazoloacridine (PZA) in chemotherapy naive patients with metastatic cutaneous or ocular melanoma.
  -  Determine the toxic effects of PZA in this patient population.
  -  Determine the pharmacokinetic profile of PZA in these patients.
  OUTLINE: Patients are stratified into cutaneous or ocular melanoma treatment groups.
  Patients receive pyrazoloacridine IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.
  PROJECTED ACCRUAL: Approximately 28-70 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed metastatic cutaneous or ocular melanoma that is chemotherapy naive
  -  Bidimensionally measurable disease
  -  No pleural effusions or ascites
  -  No untreated CNS metastases
  -  Stable brain metastases by CT or MRI scan
  -  At least 4 weeks since prior steroid therapy
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  ECOG 0-2
  Life expectancy:
  -  At least 12 weeks
  Hematopoietic:
  -  WBC at least 4,000/mm^3
  -  Absolute neutrophil count at least 1,500/mm^3
  -  Platelet count at least 100,000/mm^3
  Hepatic:
  -  Bilirubin no greater than 1.5 mg/dL
  -  SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN)
  -  Alkaline phosphatase no greater than 2.5 times ULN (unless due to hepatic metastases)
  Renal:
  -  Creatinine no greater than 1.5 mg/dL OR
  -  Creatinine clearance at least 60 mL/min
  Other:
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  -  No active infection
  -  No known hypersensitivity to E.coli derived proteins
  -  No other serious medical problems
  -  No more than 1 primary malignancy within past 5 years, other than:
  -  Nonmelanomatous skin cancer
  -  Carcinoma in situ of the cervix
  -  No history of spinal cord compression
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Prior biologic therapy allowed (e.g., interleukin-2, interferon alfa, or vaccine therapy)
  Chemotherapy:
  -  No prior chemotherapy
  Endocrine therapy:
  -  See Disease Characteristics
  Radiotherapy:
  -  Prior radiotherapy for primary ocular melanoma, brain metastases, or to metastatic sites encompassing less than 25% of the bone marrow allowed
  -  No other prior radiotherapy
  Surgery:
  -  At least 2 weeks since prior surgery and recovered

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

Clinical trial: Nitrocamptothecin in Treating Patients With Metastatic Melanoma

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have metastatic melanoma.

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

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

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

Clinical trial: Vaccine Therapy in Treating Patients With Metastatic Melanoma of the Eye

Summary: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Combining vaccine therapy with interleukin-2 may be a more effective treatment for metastatic melanoma of the eye.
  PURPOSE: Phase II trial to study the effectiveness of vaccine therapy and interleukin-2 in treating patients who have metastatic melanoma of the eye.

Detailed description: OBJECTIVES: I. Determine the clinical response in patients with metastatic ocular melanoma treated with gp100:209-217 (210M) antigen and MART-1:26-35 (27L) antigen emulsified in Montanide ISA-51.
  II. Determine the clinical benefit of interleukin-2 in combination with this vaccine in these patients.
  PROTOCOL OUTLINE: Patients receive vaccine subcutaneously once weekly. Treatment repeats every 4 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity.
  Patients with progressive disease may receive vaccine SC on day 1 followed by interleukin-2 IV over 15 minutes every 8 hours for a maximum of 12 doses. Treatment repeats every 3 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity.
  PROJECTED ACCRUAL:
  A total of 15-25 patients will be accrued for this study within 1 year.

Eligibility: PROTOCOL ENTRY CRITERIA:
  --Disease Characteristics-- Diagnosis of metastatic ocular melanoma Progressive disease Measurable disease HLA-A*201 positive --Prior/Concurrent Therapy-- Biologic therapy: At least 3 weeks since prior biologic therapy Chemotherapy: At least 3 weeks since prior chemotherapy Endocrine therapy: At least 3 weeks since prior endocrine therapy No concurrent steroid therapy Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Not specified --Patient Characteristics-- Age: 16 and over Performance status: ECOG 0-2 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 No coagulation disorders Hepatic: Bilirubin no greater than 2.0 mg/dL AST/ALT less than 3 times normal Hepatitis B surface antigen negative Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No major cardiovascular illness For interleukin-2 (IL-2) therapy: No cardiac ischemia No myocardial infarction No cardiac arrhythmias Pulmonary: No major respiratory system illness For IL-2 therapy: No obstructive or restrictive pulmonary disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active systemic infection No autoimmune disease No primary or secondary immunodeficiency by abnormal lymphocyte counts or presence of opportunistic infection

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

Clinical trial: Phase II Trial of Allovectin-7® for Metastatic Melanoma

Summary: The purpose of this clinical trial is to determine if Allovectin-7®, an experimental gene-based immunotherapy, can shrink melanoma tumors. The trial will also examine if this treatment can improve the time to disease progression.

Detailed description: Treatment - If you take part in this trial you will be treated for about 10 weeks. You will receive an injection of Allovectin-7® by needle, directly into one or more selected tumors once a week for the first six weeks. The injections may be given in a doctor's office. During a four-week observation period, your disease will be measured to see if the treatment is working. This will be done by general physical exams and scans (such as X-ray scans). Patients who show no sign of disease progression may be offered an option to repeat this treatment course.

Eligibility: In order to be in this trial, you must meet the enrollment criteria. Below is a list of some of the enrollment criteria.
  -  You have been diagnosed with Stage III or Stage IV melanoma
  -  Your cancer has returned after a prior treatment (e.g. radiation or chemotherapy) or you refused therapy with standard treatment
  -  You are able to carry out your normal daily activities
  -  Your melanoma has not spread to your brain

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 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: 49-year-old male with melanoma; genetic feature: extensive 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
Patient case: 49-year-old male with melanoma; genetic feature: extensive tumor infiltrating lymphocytes

Clinical trial: Study of Metastatic Ocular Melanoma

Summary: This study evaluates treatment with combination versus monotherapy for patients with metastatic ocular melanoma.

Detailed description: Treatment of patients with metastatic ocular melanoma with combination chemotherapy Gemcitabine and Treosulfan versus monotherapy with Treosulfan as first-line chemotherapy.

Eligibility: Inclusion Criteria:
  -  Metastatic ocular melanoma
  Exclusion Criteria:
  -  Prior treatment with chemotherapy
  -  Active 2nd malignancy
  -  Cerebral metastasis

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

Clinical trial: Study of NY-ESO-1 ISCOMATRIX® in Patients With High-risk, Resected Melanoma

Summary: The purpose of this trial is to assess whether treatment with NY-ESO-1 ISCOMATRIX® vaccine improves outcomes for people with Malignant Melanoma which has been removed, but is at high risk of relapse.

Detailed description: NY-ESO-1 protein is an immune target found in many cancers including melanoma. ISCOMATRIX® adjuvant enhances immune responses. This trial compares NY-ESO-1 ISCOMATRIX® vaccine with ISCOMATRIX® adjuvant alone to assess whether treatment with NY-ESO-1 ISCOMATRIX® vaccine improves outcomes for participants with Malignant Melanoma which has been removed, but is at high risk of recurrence.
  Eligible participants are randomly allocated to a treatment arm. Treatment involves four intramuscular (into a muscle) injections (1 injection every 4 weeks x 3, plus 1 injection at 6 months).
  Participants are assessed for recurrence of melanoma, safety and immune responses (by blood test) over the 18 month study period. Off study, their own doctor will follow them for melanoma recurrence and survival.

Eligibility: Inclusion Criteria:
  -  Histologically proven malignant melanoma.
  -  Tumor expression of NY-ESO-1 antigen by immunohistochemistry.
  -  Fully resected AJCC stage IIc, IIIb, IIIc or IV melanoma.
  -  Within six months of surgery for melanoma.
  -  Full recovery from surgery.
  -  No immunotherapy or systemic adjuvant therapy for melanoma since most recent relapse and/or resection. (Previous adjuvant therapy accepted providing pt relapsed and resected after this.)
  -  Age 18 years or older.
  -  Able to give written informed consent.
  -  Vital laboratory parameters within normal range, or protocol specified ranges.
  Exclusion Criteria:
  -  Other serious or significant illnesses.
  -  Resected cerebral metastases.
  -  Ocular melanoma.
  -  Other malignancy within last 3 years, except for treated non-melanoma skin cancer and cervical cancer in situ.
  -  Using immunosuppressive drugs.
  -  Anticoagulation.
  -  Known HIV positivity.
  -  Chemotherapy or radiation therapy in last four weeks (6 weeks for nitrosourea drugs).
  -  Not available for immunological and clinical follow-up assessments.
  -  Participation in prior clinical trial involving an investigational agent within last 4 weeks.
  -  Previous isolated limb perfusion (ILP).
  -  Pregnancy or breastfeeding.
  -  Refusal or inability to use effective means of contraception for women of childbearing potential.
  -  Mental impairment that may compromise ability to give informed consent and to comply with study requirements.

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

Clinical trial: Vaccination With Tumor mRNA in Metastatic Melanoma - Fixed Combination Versus Individual Selection of Targeted Antigens

Summary: The purpose of the vaccination protocol is to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen.

Detailed description: vaccination protocol to induce clinically specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigens. Half of patients is treated with mRNA coding for Melan-A, Mage-A1, Mage-A3, Survivin, GP100 and Tyrosinase. The other half of patients is treated with an individualized selection of mRNAs after analysis of overexpressed melanoma antigens in autologous tumor tissue. GM-CSF is used as an adjuvants. Phase I/II clinical trial to analyse safety and immune responses in stage III/IV melanoma patients.

Eligibility: Inclusion Criteria:
  -  malignant melanoma stage III/IV
  -  fresh frozen tumor tissue available
  -  informed consent given
  -  Karnofsky >= 70%
  Exclusion Criteria:
  -  brain metastasis
  -  parallel chemotherapy
  -  systemic treatment with glucocorticoids
  -  other malignancies

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

Clinical trial: Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases

Summary: The intra-/perilesional application of interleukin-2 seems to be a safe and effective treatment of skin and soft tissue metastases in malignant melanoma. Especially in case of intransit metastases the overall survival rate is still 20-30%.
  However, the management of intransit metastases is sometimes difficult because of frequent recurrences. IL-2 intralesionally seems to be an non-invasive option as pilot studies indicate. In this study the safety and efficacy of IL-2 are evaluated.


Eligibility: Inclusion Criteria:
  -  Age 18+
  -  Informed consent
  -  Histologically proven melanoma
  -  Have confirmed stage IIIB or stage IV disease (AJCC 2002) with skin or soft-tissue metastases
  Exclusion Criteria:
  -  Pregnant or lactating women
  -  Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina)
  -  Patients with severe liver disease or severe renal disease
  -  Simultaneous immunosuppressive treatment (e.g. steroids)
  -  Simultaneous chemotherapy
  -  Pretreated soft-tissue or skin metastases (e.g. cryo-, radiotherapy)

Relevance to patient case: not relevant