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

Clinical trial: Multiepitope Peptide Vaccination in Melanoma

Summary: This trial assesses the clinical efficacy of a multiepitope peptide vaccine with GM-CSF and KLH as immunological adjuvants in stage IV melanoma patients


Eligibility: Inclusion Criteria:
  -  Metastatic melanoma
  -  HLA-A1, -A2, -A24, -B44
  Exclusion Criteria:

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

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

Clinical trial: Dendritic Cell Based Therapy of Malignant Melanoma

Summary: The aim of the study is to show if vaccination with autologous dendritic cells pulsed with peptides or tumor lysate in combination with adjuvant cytokines and Cyclophosphamide can induce a measurable immune response in patients with metastatic malignant melanoma, and to evaluate the clinical effect (objective response rate) of the vaccination regime.

Detailed description: Eligible patients receive vaccination with tumor antigen pulsed autologous monocyte-derived mature dendritic cells with a fixed interval. The dendritic cells are generated from leukapheresis products and frozen after antigen loading.
  HLA A2 positive patients are treated with PADRE and oncopeptide pulsed DC; p53, survivin and telomerase peptides. HLA A2 negative patients are treated with KLH and tumorlysate pulsed DC; autologous or allogeneic. Each patient is given 6 immunizations with at least 5x106 peptide/lysate pulsed autologous DC. Vaccination 1-4 is given weekly and 4-6 at 2-week intervals. Those patients who exhibit stable disease, partial response or complete response after 6 injections will be given 4 more vaccinations at 2-week interval. The vaccine is applied by intradermal injection near the inguinal region.
  IL-2 2 MIU s.c. day 2-6, Cyclophosphamide (Sendoxan®, Baxter A/S) 50 mg twice a day bi-weekly and 200 mg Celecoxib (Celebra®, Pfizer) daily are used. Scans and re-staging tests are performed at scheduled intervals throughout the study.

Eligibility: Inclusion Criteria:
  -  Histologically proven progressive metastatic or locally advanced melanoma
  -  No standard treatment indicated
  -  Age: > 18
  -  WHO-Performance Status 0-1
  -  At least tone measurable tumor lesions according to the RECIST criteria.
  -  Life expectancy more than 3 months
  -  Acceptable CBC and blood chemistry results
  -  Written informed consent
  Exclusion Criteria:
  -  Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin).
  -  Patients with metastatic disease in the central nervous system (CNS).
  -  Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.
  -  Patients with acute or chronic infection including HIV, hepatitis and tuberculosis.
  -  Patients who are pregnant.
  -  Patients who have received antineoplastic therapy including chemotherapy or immunotherapy less than 4 weeks before beginning the trial.
  -  Patients who receive corticosteroids or other immunosuppressive agents.
  -  Baseline serum LDH greater than 2.5 times the upper limit of normal.
  -  Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.

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

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

Clinical trial: Local Treatment of Metastatic Melanoma With Autologous Lymphocytes and the Bispecific Antibody rM28

Summary: Phase I/II clinical trial to analyze safety and efficiency of intralesional application of the bispecific single chain antibody rM28 and autologous PBMCs in patients with metastatic melanoma stage III/IV and unresectable metastasis.

Detailed description: Phase I/II clinical trial to analyze safety and efficiency of intralesional application of the bispecific single chain antibody rM28 and autologous PBMCs in patients with metastatic melanoma stage III/IV and unresectable metastasis. The antibody is directed against epitops of human CD28 and the melanoma associated surface antigen HMV-MAA. Treatment over 5 days with dose escalation.

Eligibility: Inclusion Criteria:
  -  malignant melanoma stage III/IV
  -  injectable soft tissue metastasis
  -  informed consent given
  -  Karnofsky >= 70%
  Exclusion Criteria:
  -  additional chemotherapeutical treatment
  -  systemic glucocorticoids
  -  brain metestasis
  -  other malignancies

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

Clinical trial: Dendritic Cell Vaccination in Melanoma Patients Scheduled for Regional Lymph Node Dissection

Summary: Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As such they are currently used in clinical vaccination protocols in cancer patients, and both immunological and clinical responses have been observed. For these therapies accurate delivery to target organs is essential. Correct delivery and subsequent migration of vaccinated DCs to regional lymph nodes is of paramount importance for effective stimulation of the immune system. Currently it is not known what the best route of administration is for DC vaccines.
  Using magnetically labeled DCs, we investigate the potential of MRI cell tracking to monitor DC therapy. This is investigated in stage III/IV melanoma patients in whom a regional lymph node dissection is scheduled. Autologous monocyte-derived DCs are labeled with the clinically approved superparamagnetic iron oxide (SPIO) formulation Endorem and 111In-oxine and injected either in the skin or directly in lymph nodes under ultrasound guidance. Two days after vaccination patients are monitored with scintigraphy and MR imaging. Lymph nodes are then resected. Subsequently patients receive 3 more vaccination with DCs. During and after therapy immune responses against the used melanoma peptides are monitored.


Eligibility: Inclusion criteria:
  Histologically documented evidence of melanoma
  Stage III-IV melanoma according to the 2001 AJCC criteria
  Radical lymph node dissection planned, either with curative (stage III) or palliative (stage IV) intent
  Melanoma expressing gp100 (compulsory) and tyrosinase (non-compulsory)
  HLA-A2.1 phenotype according to lymphocyte HLA typing
  ECOG performance status 0-1, life expectancy > 3 months
  Age 18-75 years
  Interval since last prior chemotherapy, immunotherapy or radiotherapy at least 4 weeks, no residual toxicity of prior treatment.
  WBC > 3.0 x 109/l, lymphocytes > 0.8 x 109/l, platelets > 100 x 109/l, serum creatinine < 150 μmol/l, serum bilirubin < 25 μmol/l
  Written informed consent
  Expected adequacy of follow-up
  Exclusion criteria:
  No clinical signs of CNS metastases, in patients with a clinical suspicion of other metastases diagnostic tests should be performed to exclude this.
  No concomitant use of corticosteroids or other immunosuppressive agents
  No history of second malignancy within the last 5 years. Adequately treated basal carcinoma of skin or carcinoma in situ of cervix is acceptable within this period
  No serious concomitant disease, no active infections. No autoimmune disease or organ allografts, no clinical suspicion of HIV or Hepatitis B
  No contra-indications for MRI-scanning: claustrophobia, pacemaker or pacemaker threads, cerebral clips or artificial heartvalves, internal hearing prosthesis No known allergy to shell fish (contains KLH)
  No pregnant or lactating women

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

Clinical trial: Trial of Autologous, Hapten-Modified Vaccine in Patients With Stage III or IV Melanoma

Summary: The purpose of this study is to determine whether a vaccine composed of patients' own melanoma cells treated with the chemical, dinitrophenyl (DNP)(called a hapten), is safe and stimulates an immune response to patients' own cancer cells.

Detailed description: Patients with stage III or IV melanoma need to have at least one tumor mass of at least 2.5 cm (about 1 inch) diameter than can be removed for vaccine production. If the vaccine is successfully made and if the patient is eligible, the patient will be assigned to receive one of 4 doses of the vaccine, include one group that will receive a zero dose. All patients will receive injections of their vaccine as part of immune system testing and will receive low dose cyclophosphamide and BCG. Eight injections of the vaccine will be administered as an injection into the skin of the arm over a 6 month period. Before and after vaccine administration, patients will be tested for immunity to their own melanoma cells by DTH testing, which is similar to a tuberculosis test. All side effects caused by the vaccine will be recorded.

Eligibility: Inclusion Criteria:
  -  stage III or IV melanoma at least one tumor mass of at least 2.5 cm diameter that can be excised to make vaccine good performance status
  Exclusion Criteria:
  -  brain metastases need for steroids or other immunosuppressive drugs positive PPD tests positive test for HIV, hepatitis B (antigen), or hepatitis C other serious medical illnesses

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

Clinical trial: A Study for the Treatment of Unresectable Stage III or Metastatic Stage IV Melanoma

Summary: A study with YM155 for the treatment of unresectable stage III or metastatic stage IV melanoma.

Detailed description: A phase II, multicenter, open-label study in subjects with unresectable Stage III or metastatic (Stage IV) Melanoma to evaluate the efficacy and safety of YM155

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed unresectable stage III or IV malignant melanoma
  -  Life expectancy >12 weeks
  Exclusion Criteria:
  -  History of other malignancy in the last 5 years
  -  Major surgery within the past 21 days

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

Clinical trial: A Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

Summary: The purpose of this clinical research study is to evaluate the Best Overall Response Rate (BORR), (as per modified WHO criteria) in patients with previously treated melanoma-Stage III (unresectable) or Stage IV melanoma receiving 10 mg/kg of ipilimumab. The safety of this product will also be evaluated.


Eligibility: Inclusion Criteria:
  -  Patients with previously treated Stage III (unresectable)or Stage IV melanoma

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

Clinical trial: Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

Summary: The purpose of this clinical research study is to compare the best overall response rate (BORR)(as per modified WHO criteria) in patients with previously treated, therapy-refractory, or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. The safety of this product will also be evaluated.


Eligibility: Inclusion Criteria:
  -  Patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma

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

Clinical trial: Safety and Immunogenicity of a Melan-A VLP Vaccine in Advanced Stage Melanoma Patients

Summary: The purpose of this study is to evaluate whether vaccination with a Melan-A VLP vaccine leads to a specific cellular immune response in patients with malignant melanoma at advanced stage of the disease.


Eligibility: Inclusion Criteria:
  -  Able to provide written informed consent
  -  Able and willing to complete all protocol requirements
  -  Age: 18 years and older
  -  Histologically confirmed stage III or IV melanoma
  -  HLA-A*0201 haplotype
  -  Expected survival of at least 6 months
  -  ECOG performance status of 0 or 1
  -  At least one and no more than 2 previous systemic therapies for metastatic melanoma
  -  Able to undergo computed tomography (CT) scan/ magnetic resonance imaging (MRI) scan for tumor assessment.
  -  Lack of response to or progression after most recent systemic therapy for metastatic melanoma.
  -  Adequate organ and bone marrow functions
  -  All adverse events (AEs) from prior anticancer therapy have resolved to ≤ Grade 1
  -  Sexually active males should use adequate contraception throughout the study period and 3 months thereafter.
  -  Females of child bearing potential should use adequate contraception throughout the study period and 3 months thereafter, that can be oral contraception or a double-barrier local contraception (intra-uterine device plus condom or spermicidal gel plus condom), and have a negative serum pregnancy test within 4 weeks prior to the first dose of the vaccine.
  Exclusion Criteria:
  -  Pregnant or nursing
  -  Use of an investigational drug within 30 days before enrollment
  -  Known or suspected brain metastases
  -  Active malignancy in the 5 years prior to enrollment other than melanoma, basal cell carcinoma or cervical carcinoma in situ.
  -  Major surgery within 4 weeks prior to enrollment.
  -  Current use of an immunosuppressive drug or any concomitant medication that could potentially interfere with the study drug.
  -  Presence of significant cardiovascular, renal, pulmonary, endocrine, infectious, or neurological disorders.
  -  Serum tests positive for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV).
  -  Active autoimmune diseases or severe allergies.
  -  Known type 1 allergy.
  -  Current diagnosis or history of relevant and severe psychiatric disorder that compromises the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol or to complete the study.
  -  Blood donation or loss of > 400mL within 8 weeks prior to inclusion.
  -  Hemoglobin (Hb) < 10g/dL
  -  Abuse of alcohol or other recreational drugs.
  -  Previous vaccination with a Melan-A peptide analogue.

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

Clinical trial: Bevacizumab, Dacarbazine and Interferon-Alfa to Treat Metastatic Melanoma

Summary: The purpose of this study is to determine whether combination therapy with bevacizumab (Avastin), dacarbazine and interferon-alfa-2a (Roferon-A) is effective in patients with locally advancing or metastatic melanoma.

Detailed description: Dacarbazine (DTIC) has been approved for treating metastatic melanoma in the 1970s, and after that numerous schedules and dacarbazine-based combinations have been studied in this disease. DTIC as a single agent gives a response rate of only 20%, but there have been efforts to improve this poor result by using DTIC in different combinations.Treatment of melanoma with combination chemotherapy and interferon-α (IFN-α) has given 50-60% response rates,but increase in the overall survival time has not been reached in controlled phase III studies. Thus, standard reference therapy in treatment of metastatic melanoma still is single dacarbazine or its combination with s.c. IFN-α. In addition, new studies with melanoma cells in vitro show that dacarbazine causes transcriptional up-regulation of vascular endothelial growth factor (VEGF), suggesting a potential clinical benefit of combination of DTIC and anti-VEGF therapy. IFN-α has been used in adjuvant therapy and in treatment of metastatic melanoma. IFN-α exerts its effects through antiproliferative, apoptosis-inducing and particularly antiangiogenic effects in addition to immunologic modulation.
  The purpose of this study is to determine whether combination therapy with bevacizumab (Avastin), dacarbazine and interferon-alfa-2a (Roferon-A) can increase progression-free survival and overall survival in patients with locally advancing or metastatic melanoma.

Eligibility: Inclusion Criteria:
  -  histologically confirmed malignant melanoma either locally progressing inoperable or metastatic
  -  measurable/evaluable disease in accordance with RECIST criteria
  -  WHO performance status 0-2
  -  normal organ function
  -  signed written informed consent
  Exclusion Criteria:
  -  unevaluable disease
  -  major surgery within 28 days prior to day 0
  -  uncompleted radiotherapy
  -  CNS metastases
  -  serious non-healing wound or ulcer
  -  bleeding diathesis or coagulopathy
  -  uncontrolled hypertension
  -  clinically significant cardiovascular disease
  -  depression or psychosis, which needs medication
  -  ongoing treatment with aspirin (>325 mg/day)
  -  pregnancy
  -  any other serious or uncontrolled illness
  -  previous chemotherapy for metastatic melanoma

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

Clinical trial: Safety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma

Summary: AMP-005 is a Phase 1b/2 clinical trial designed to evaluate whether the new drug, imexon, can be administered in combination with the approved drug, dacarbazine (DTIC), for the treatment of patients with stage III or IV inoperable melanoma. The Phase 1b part of the study is designed to determine whether the two drugs can be safely combined together, and the Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether adding imexon to DTIC can improve the outcome for melanoma patients versus the findings from prior clinical studies of DTIC alone.


Eligibility: Inclusion Criteria:
  -  Malignant melanoma; inoperable stage III or IV disease.
  -  Able to perform the activities of daily living.
  -  A projected life expectancy of at least 4 months.
  -  If female, neither pregnant nor nursing.
  -  Willing to use contraceptives to prevent pregnancy.
  -  Blood cell counts and blood chemistries in or near normal range.
  -  Prior radiation is permitted.
  -  No other serious illnesses.
  -  No other active malignancy.
  -  No serious infections.
  -  No other current drug therapy for the cancer or steroid therapy.
  Exclusion Criteria:
  -  No prior chemotherapy for the stage III or IV disease.
  -  Brain metastases

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

Clinical trial: Randomised Study to Compare the Efficacy of AZD6244 vs TMZ

Summary: The primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with temozolomide in patients with advanced melanoma


Eligibility: Inclusion Criteria:
  -  Diagnosed with late stage malignant melanoma
  -  Aged 18 or over
  -  Female patients must be post-menopausal or with negative urine pregnancy test if pre-menopausal
  Exclusion Criteria:
  -  Any previous radiotherapy or chemotherapy (palliative radiotherapy is acceptable)
  -  Participation in any other trial with an investigational product within the previous 30 days

Relevance to patient case: not relevant