araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 74-year-old female with melanoma; genetic feature: no 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: 74-year-old female with melanoma; genetic feature: no 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: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Vaccine Biotherapy of Cancer: Autologous Tumor Cells and Dendritic Cells

Summary: This protocol was conducted as a single institution trial at Hoag Cancer Center, Hoag Hospital, Newport Beach, California. It was a single-arm phase II trial in which patients with metastatic melanoma received subcutaneous (s.c.) injections of irradiated autologous tumor cells that had been established as short-term cell lines, in conjunction with their own dendritic cells (DC) and granulocyte macrophage colony-stimulating factor [GM-CSF]. Eligible patients had regionally recurrent and/or distant metastatic cancer.

Detailed description: Patients were stratified by whether they had no measurable disease [NMD] at the time of treatment (usually because of surgical resection of metastases), or whether they had objectively measurable disease (OMD) by physical examination or radiologic scans per response evaluation criteria in solid tumors (RECIST criteria). Key endpoints were the results of delayed type hypersensitivity (DTH) skin testing to their own irradiated tumor cells, event-free survival [death or disease progression], overall survival, and objective tumor regression in patients who have measurable disease at the time vaccine therapy was initiated. This study was activated in the fall of 2000, and closed to accrual in June 2007.

Eligibility: Inclusion Criteria:
  -  Recurrent or metastatic melanoma as defined by stage IV disease (distant metastases), or any recurrent melanoma manifested by lymph node metastases or soft tissue nodules
  -  ECOG Performance status of 0-2
  -  Satisfactory medical condition for treatment in a phase I-II trial of anticancer therapy
  -  Age > 16 years
  -  Venous access for leukopheresis procedure to obtain peripheral blood lymphocytes to generate dendritic cells.
  -  Serum pregnancy test must be negative for women of childbearing potential.
  Exclusion Criteria:
  -  Active central nervous system metastases
  -  Known autoimmune disease or disease process that involves the use of immunosuppressive therapy.
  -  Underlying cardiac disease associated with New York Heart Association class III or IV function, or unstable angina related to atherosclerotic cardiovascular disease.
  -  Ongoing transfusion requirements, no significant hepatic or renal dysfunction, creatinine < 2.0 mg/dl, bilirubin < 2.0 mg/dl, albumin > 3.0 mg/dl, hematocrit > 25, platelets > 100,000.
  -  Active infection or other active medical condition that could be eminently life threatening, including no active blood clotting or bleeding diathesis.

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

Clinical trial: Ultraviolet Light Exposure and Immunosuppression in Cutaneous Melanoma

Summary: This project seeks to understand differences in the serum vitamin D levels and immune status in cutaneous malignant melanoma patients with different UV exposure histories in New Mexico.

Detailed description: It is well established that ultraviolet radiation (UV) exposure is related to the development of melanoma. There is also evidence that immune reactions are altered after UV exposure in the skin (locally) and perhaps throughout the body (systemically). Additionally, while the role of vitamin D and melanoma development has not been fully established, UV-B exposure is essential for vitamin D production in the skin. Increased sun exposure is also related to the presence of solar elastosis, which might protect (1) or improve survival from melanoma. Thus, melanoma represents a unique model for studying UV exposure, the immune system, and vitamin D. Malignant melanoma is an antigenic cancer; therefore, the role of UV exposure-induced immunosuppression and vitamin D production in the recognition, destruction and growth inhibition of cancerous melanocytes is worth further study.
  To underscore the importance of this project, the Scientific Advisory Committee of the Melanoma Research Foundation and the Steering Committee of the Society of Melanoma Research have indicated a need to collect more human data on the host immune response mechanisms in melanoma and also to focus on the skin as a whole microenvironment, moving away from only in vitro experiments.

Eligibility: Inclusion Criteria:
  -  Resident of New Mexico
  -  Age between the 1 and 95
  -  Newly diagnosed with cutaneous invasive melanoma; any stage permitted (ICDO C44.0-9) between September 1, 2008 and December 31, 2011.
  -  SSM (superficial spreading melanoma) and NM (nodular melanoma) histological subtypes are allowed
  -  Access to a telephone or be able to participate in a personal interview at the clinic
  -  Physically and mentally competent to complete a 1-hour telephone or personal interview
  Exclusion Criteria:
  -  Ocular melanoma, LMM (lentigo maligna melanoma) or ALM (acral lentigo melanoma), and mucosal melanoma cases.
  -  No access to a telephone or is not able to meet with the interviewer.

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

Clinical trial: Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer

Summary: This research study is looking at tumor tissue samples from patients who have undergone surgery for advanced stage III or stage IV ovarian epithelial cancer. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn how tumor infiltrating T cells can predict how patients will respond to treatment.

Detailed description: PRIMARY OBJECTIVES:
  I. To validate the ability of intratumoral tumor-infiltrating T lymphocytes (TILs) to predict progression-free survival (PFS) in patients with suboptimally debulked advanced stage III or IV ovarian epithelial cancer.
  II. To validate the ability of intratumoral TILs to predict PFS in patients with optimally debulked disease.
  SECONDARY OBJECTIVES:
  I. To validate the ability of intratumoral TILs to predict overall survival of patients with suboptimally debulked disease.
  II. To validate the ability of intratumoral TILs to predict overall survival of patients with optimally debulked disease.
  OUTLINE:
  Patients are stratified according to status of debulked disease (suboptimal vs optimal).
  Previously collected tumor tissue samples are analyzed for tumor-infiltrating lymphocytes (TIL) via immunohistochemistry and double immunofluorescence assays using standard immunostaining.

Eligibility: Inclusion Criteria:
  -  Diagnosis of stage III or IV ovarian epithelial cancer and enrolled on Gynecologic Oncology Group (GOG)-0136 and a GOG front-line platinum/taxol chemotherapy trial (GOG-0114, GOG-132, GOG-0158, or GOG-0162)
  -  Must have fixed and paraffin-embedded tissue from primary surgery available from 1 of the following sources:
  -  Patients enrolled on GOG-0136 and a GOG front-line platinum/taxol chemotherapy trial(GOG-0114, GOG-0132, GOG-0158, and GOG-0162)
  -  Patients who have had either optimal or suboptimal cytoreductive surgery
  -  Patients for whom adequate demographic data, including major prognostic factors and follow-up information, were collected
  -  Evaluable patients must have had measurable or nonmeasurable disease
  -  Demographic and follow-up data available

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

Clinical trial: Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin

Summary: The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).


Eligibility: Inclusion Criteria:
  -  Subjects chronically infected with HCV genotype 1 (Phase 2a and Phase 2b)
  -  Subjects chronically infected with HCV genotype 4 (Phase 2b only)
  -  HCV RNA viral load of ≥ 10*5* IU/mL at screening
  -  BMI of 18 - 35 kg/m² at screening
  Exclusion Criteria:
  -  Cirrhosis (Phase 2a only)
  -  Decompensated cirrhosis (Phase 2b)
  -  Co-infection with HBV or HIV
  -  Hepatocellular carcinoma
  -  Prior treatment with anti-HCV drugs

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

Clinical trial: Rituximab in Metastatic Melanoma

Summary: The purpose of this study is to determine whether rituximab as an adjuvant therapy in clinical stage IIIc / IV (no evidence of disease, AJCC (American Joint Committee on Cancer) 2002) melanoma patients is safe and prolongs overall survival and disease-free interval.


Eligibility: Inclusion Criteria:
  -  Histologically verified non-ocular melanoma stage IIIc/IV, no evidence of disease
  Exclusion Criteria:
  -  ECOG (Eastern Cooperative Oncology Group) performance status > 2
  -  Ocular melanoma
  -  Immunodeficiency syndromes or hypogammaglobulinaemia
  -  Active autoimmune diseases
  -  Treatment with immunosuppressive agents other than steroids
  -  Depressed bone marrow function (Leukopenia <3000, platelet count <100.000)
  -  Cardiac insufficiency NYHA (New York Heart Association) IV
  -  active Hepatitis B,C, or HIV infection
  -  Pregnancy or lactation
  -  Interstitial pulmonary disease
  -  Former treatment with anti-CD20 antibody

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

Clinical trial: A Study of Immunotherapy With TIL (Tumor Infiltrating Lymphocytes) in Combination With Intra-tumoral Injections of Interferon Gamma-adenovirus (Ad-IFNg) in Patients With Stage IIIc or Stage IV Metastatic Melanoma (AJCC)(Protocol TIL-Ad-INFg)

Summary: The main objective of this study is to evaluate the clinical and biologic toxicity of cell therapy by adoptive transfer of TIL in combination with intra-tumoral injections of Ad-INFg.


Eligibility: Pre-Inclusion Criteria:
  -  Male or female patients ≥ 18 and ≤ 75 years of age
  -  Patients must have signed informed consent
  -  A negative pregnancy test for women with childbearing potential
  -  Patients with stage IIIc/IV metastatic melanoma (AJCC 6th edition) with nodal relapse, in transit metastasis, unresectable cutaneous metastases, visceral metastases except bone and brain metastases
  -  Presence of at least one lesion accessible for intra-tumoral injections of Ad-IFNg
  -  A negative brain scan, eliminating any brain metastases
  -  ECOG performance status of 0-2
  -  Adequate bone-marrow reserve, renal function and hepatic function as assessed by standard laboratory criteria
  -  Subjects affiliated to an appropriate social security system
  Inclusion Criteria:
  -  Negative viral serology (HIV ½, p24 Ag, HTLV 1 / 2, B and C hepatitis)
  Exclusion Criteria:
  -  For female : the patient is pregnant or lactating or not using contraception and proved by a negative pregnancy test
  -  Positive viral serology for HIV ½, p24 Ag, HTLV 1 / 2 or B and C hepatitis
  -  History or current manifestations of severe progressive heart disease (congestive heart failure, coronary artery disease, uncontrolled arterial hypertension, serious rhythm disorders or ECG signs of previous myocardial infarction)
  -  Any serious illness, acute or chronic, e.g. active infection requiring antibiotics, bleeding disorders or any other condition that requires concomitant medications not allowed during this study
  -  Presence of a second active cancer except in situ cervical cancer or skin carcinoma
  -  Intercurrent disease requiring a corticosteroid treatment or a treatment with interferon-α
  -  Any autoimmune disease including active diabetes mellitus or immunodeficiency. Vitiligo in not an exclusion criteria
  -  Uncontrolled thyroid dysfunction
  -  Concurrently participation in a biomedical research (drug or radiotherapy) within the month preceding inclusion
  -  Metastatic lymph node stage alone with an indication of lymphadenectomy
  -  Brain or bone metastases discovered by radiological examination during the inclusion assessment
  -  Surgically resectable metastases
  -  Ocular melanoma
  -  More than one line of chemotherapy for treatment of melanoma
  -  Chemotherapy, immunotherapy or radiotherapy within 4 weeks before baseline (6 weeks for nitroso-ureas and mitomycin C)
  -  Contraindication for the use of vasopressor agents
  -  Treatment with molecules in pre-marketing development or whose development is finished less than 4 weeks

Relevance to patient case: possibly relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Early Diagnosis of Malignant Transformation of Pigmentary Skin Lesions

Summary: Malignant Melanoma is a deadly skin cancer that can be cured if diagnosed early. To date atypical pigmented skin lesions are diagnosed by appearance alone and many moles and lesions are excised unnecessarily and on the other hand malignant lesions are missed and diagnosed too late. In this study a protein conjugated to a florescent dye is spread on a suspicious pigmented lesion, the hypothesis is that this protein binds to malignant cells only and thus with a special camera that picks up the dye we can find pigmented lesions with early malignant transformation.


Eligibility: Inclusion Criteria:
  -  pigmented lesion indicated for surgical excision
  -  over 18 years of age
  Exclusion Criteria:
  -  pregnancy

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

Clinical trial: IL15 Dendritic Cell Vaccine for Patients With Resected Stage III (A, B or C) or Stage IV Melanoma

Summary: The purpose of the study is to gather data on feasibility as well as immune and clinical efficacy of of a dendritic cell vaccine using IL15 in patients with resected stage III or stage IV melanoma

Detailed description: IL15 is a T cell growth factor that pre-clinical data overwhelmingly suggests could have a very important role in cancer immunotherapy. A desirable property for a dendritic cell vaccine directed against cancer is the ability to efficiently prime naïve, tumor associated antigen specific T cells into potent CTLs. Results of studies in healthy volunteers have shown that IL15 DCs are particularly efficient at priming functional melanoma specific CD8+ T cells. The use of IL15 in the manufacture of the DC vaccine could result in an improved immunotherapy product.

Eligibility: Inclusion Criteria:
  -  HLA A201 + phenotype
  -  Biopsy-proven melanoma, Stages III (A, B and C) or stage IV.- no evidence of disease at study entry
  -  Age: 21-75 years
  -  ECOG performance status 0-1
  -  Adequate marrow function
  -  Adequate hepatic function
  -  Adequate renal function
  -  Written informed consent
  Exclusion Criteria:
  -  Subjects with measureable non-resectable melanoma
  -  Subjects who have had chemotherapy less than 4 weeks before starting trial
  -  Subjects who received IFN-a or GM-CSF less than 4 weeks before starting trial
  -  Subjects who received IL2 less than 4 weeks before starting trial
  -  Subjects with a baseline LDH greater than 1.1 times the ULN
  -  Subjects who are HIV positive
  -  Female subjects who are pregnant
  -  Subjects who have received corticosteroids or other immunosuppressive agents less than 4 weeks before starting trial
  -  Subjects who have asthma and/or are on treatment for asthma
  -  Subjects with angina pectoris
  -  Subjects with congestive heart failure
  -  Subjects with history of autoimmune disease including lupus, rheumatoid arthritis or thyroiditis
  -  Subjects with active infections including viral hepatitis
  -  Subjects with a history of neoplastic disease othe than melanoma within the last 5 years
  -  History of neoplastic disease within the last 5 years except for carcinoma in situ of the cervix, superficial bladder cancer or basal/squamous cell carcinoma of the skin.
  -  Subjects who present with open wounds

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

Clinical trial: Nordic Adjuvant IFN Melanoma Trial

Summary: The aim of this study is to evaluate the effect of giving adjuvant treatment with intermediate doses of interferon-alpha2b to patients operated for high risk melanoma. Patients are randomly assigned to either observation only or interferon treatment for 2 different durations. The outcome with respect to overall survival, relapse-free survival, side effects and quality of life is analysed.

Detailed description: This is an open multicenter, prospective randomised phase III trial evaluating the efficacy of two different schedules of Interferon-alpha2b (IFN-alpha2b) administered in an adjuvant setting after adequate surgery in high risk cutaneous melanoma patients (T4N0M0/TxN1-2M0). The patients have been operated for either a thick primary melanoma (> 4 mm) without evidence of distant metastasis or have undergone surgery for regional lymph node metastases.
  The study consists of a control arm (A) and two treatment arms, B and C. The outcome in arms B and C with adjuvant treatment with IFN-alpha2b will be compared to the outcome of arm A in which the patients will only be observed after the surgery. The primary endpoint is overall survival. Secondary endpoints are relapse-free survival, safety-toxicity and health-related quality of life.

Eligibility: Inclusion Criteria:
  -  T4 N0 M0 - Thick primary melanoma: > 4.0 mm Breslow depth, without lymph node involvement, or
  -  Tx N1-2 M0 Primary melanoma of any thickness with regional lymph node metastases confirmed by lymphadenectomy, or
  -  Tx N1-2 M0 Recurrent melanoma in regional lymph node(s) confirmed by lymphadenectomy.
  -  ECOG performance status of 0-1
  -  No active medical or psychiatric disorder requiring therapy that would prevent completion of protocol
  -  Written informed consent
  Exclusion Criteria:
  -  Patients with unknown primary site of melanoma or primary melanoma originating apart from the skin, except subungual melanoma
  -  Patients who have clinical, radiological/laboratory or pathological evidence of incompletely resected melanoma or distant metastatic disease
  -  Patients who have had prior adjuvant radiotherapy, chemotherapy, immunotherapy including preoperative infusion or perfusion therapy
  -  Female patients who are pregnant or lactating

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

Clinical trial: Immunotherapy of HLA-A2 Positive Stage II-IV Melanoma Patients

Summary: The purpose of this study is to determine whether vaccination with tumor antigenic peptides and both IMP321/LAG-3 and Montanide adjuvants can induce an immune response in melanoma patients and to assess the safety and tolerability of this vaccination. Tumor responses following this vaccination will also be documented.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed stage II, III or IV melanoma patients.
  -  Tumor expression of Melan-A.
  -  Human leukocyte antigen-A2 (HLA-A2) positive.
  -  Expected survival of at list 3 months.
  -  Karnofsky scale performance status of 70 % or more.
  -  Age ≥ 18 years.
  -  Able to give a written informed consent.
  -  The following laboratory results:
  Hemoglobin ≥ 100g/L Neutrophil count ≥ 1.5 x 109/L Lymphocyte count ≥ 0.5 x 109/L Platelet count ≥ 100 x 109/L Serum creatinine ≤ 2 mg/dL (0.18mmol/L) Serum bilirubin ≤ 2mg/dL (0.034mmol/L) Granulocyte count > 2.5x109/L ASAT, ALAT < 2.5 x upper limit of normal aPTT within the normal ranges ±25% TP ≥ 80%
  Exclusion Criteria:
  -  Clinically significant heart disease.
  -  Serious illness, eg. serious infections requiring antibiotics, uncontrolled peptic ulcer, or central nervous system disorders.
  -  History of immunodeficiency disease or autoimmune disease.
  -  Metastatic disease to the central nervous system, unless treated and stable.
  -  Known HIV positivity.
  -  Known seropositivity for hepatitis B surface antigen.
  -  Concomitant treatment with steroids, antihistamine drugs. Topical or inhalation steroids are permitted.
  -  Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
  -  Pregnancy or lactation.
  -  Women of childbearing potential not using a medically acceptable means of contraception.
  -  Psychiatric or addictive disorders that may compromise the ability to give informed consent.
  -  Lack of availability of the patient for immunological and clinical follow-up assessment.
  -  Coagulation or bleeding disorders.
  -  Kidney dysfunction with creatinine > 2 X the upper limit of the normal value.
  -  Reported strong (allergic) reactions to previous vaccination.

Relevance to patient case: not relevant