araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

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: 69-year-old female with melanoma; genetic feature: high serum LDH levels

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
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

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: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: A Trial to Evaluate the Safety of Intratumoral VCL-IM01 Followed by Electroporation in Metastatic Melanoma

Summary: To evaluate the safety of intratumorally injected VCL-IM01 at doses of 0.5 mg (1 tumor), 1.5 mg (1 tumor), 5 mg (1 tumor), 10 mg (2 tumors, 5 mg per tumor) and 15 mg (3 tumors, 5 mg per tumor) followed by electroporation.

Detailed description: Eligible subjects will receive intratumoral injections of VCL-IM01 followed by electroporation of the injected tumor(s).
  Subjects will be enrolled to receive one course of treatment. A course of treatment is two cycles, each cycle consisting of four weekly injection/electroporation administrations followed by an observation period of two weeks.
  Subjects' tumors will be evaluated at Screening, at the end of Cycle 2, and at six months (Week 26) from the initial drug administration.

Eligibility: Inclusion Criteria - Key criteria include:
  -  Confirmed recurrent metastatic melanoma
  -  Tumor(s) to be treated must be at least 1 cm by 1 cm, and be accessible to treatment
  -  Able to carry out normal daily activities and light work without assistance
  -  Not currently receiving chemotherapy or immunotherapy
  -  Normal blood chemistries and blood cell counts (elevation of LDH to less than or equal to 1.5 times normal is allowed)
  -  Able and willing to give informed consent.
  Exclusion Criteria - Key criteria include:
  -  History of brain tumors (resected or stereotactically treated is allowed)
  -  History of liver tumors
  -  Subjects whose melanoma can be cured by surgery
  -  Pregnant
  -  Subjects with electronic pacemakers, defibrillators, or any other implanted electronic device.

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma

Summary: The purpose of this multicenter study is to examine whether the proposed randomized treatment regime results in a significantly longer survival time and higher quality of life than any additionally applied multiple chemotherapy according to the CVD- scheme. So far neither established treatment regimes nor reliable data exist for the second-line chemotherapy of metastatic malignant melanoma. Patients are therefore mostly treated with single or multiple chemotherapeutics or/and immunomodulatory therapeutics. These regimes however imply often not only a higher toxicity but show rarely a response rate higher than 10%.


Eligibility: Inclusion Criteria:
  -  histological diagnosis of metastatic melanoma (stage IV)
  -  progressive disease after first-line chemotherapy or immuno-chemotherapy
  -  Karnofsky-index > 60%
  -  informed consent
  Exclusion Criteria:
  -  Uvea melanoma
  -  another primary malignancy except basal cell carcinoma or cervical carcinoma in situ
  -  severe and/or uncontrolled medical disease (diabetes mellitus, cardiac insufficiency)

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Direct Statin Comparison of LDL-C Values: an Evaluation of Rosuvastatin Therapy

Summary: The primary objective of the study is to compare the efficacy of rosuvastatin 10 mg with atorvastatin 10 mg by assessment of the percentage of subjects who reach EAS LDL-C target goals after 12 weeks of therapy.


Eligibility: Inclusion Criteria:
  -  Male or female subjects, age > 18 years
  -  Primary hypercholesterolaemia with CV risk > 20% (as defined in European Guidelines ) and/or type II diabetes and/or a history of CHD or other established atherosclerotic disease. Subjects may be lipid-lowering therapy naïve or have been treated for min. 4 weeks with a 'start' dose of any lipid-lowering therapy, which was ineffective.
  -  Naïve subjects must have completed 12-weeks dietary counselling before this visit.
  Exclusion Criteria:
  -  Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia).
  -  Documented secondary hypercholesterolaemia of any cause other than named in inclusion criteria 3.
  -  Serious or unstable medical condition
  -  Statin contraindication

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Peptide-pulsed vs. RNA-transfected Dendritic Cell Vaccines in Melanoma Patients

Summary: Dendritic cells (DCs)are the most potent antigen-presenting cells of the immune system, as such they are able to direct the immune system specifically against cancer cells. Currently DCs are used in clinical vaccination studies and immunological and clinical responses have been observed. For inducing anti-tumor immunity, the DCs have to be loaded with tumor antigen (i.e. molecular structures that are presented by the tumor, that are recognized by the immune system). Currently most studies use tumor peptides (small protein fragments) for this purpose. This approach has several disadvantages: only patients with a certain HLA-type can be treated and the immune response that is induced by the vaccine is limited to the used peptides. These disadvantages do not exist when the DCs present antigen which is endogenously processed, for example after RNA transfection. For this reason we investigate the immunogenicity of DCs that are pulsed with peptides or transfected with mRNA encoding melanoma associated antigens in stage III and IV melanoma patients.


Eligibility: Inclusion Criteria:
  For both stage III and IV
  -  Histological proof of cutaneous melanoma
  -  Melanoma expressing both gp100 and tyrosinase, each in approximately 20% or more of cells by immunohistochemistry staining,
  -  HLA type A2 and/or A3, with known HLA-DR4 expression,
  -  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.
  -  Expected adequacy of follow-up,
  -  Written informed consent.
  For Stage III only
  -  Stage III melanoma according to the 2001 AJCC criteria.
  -  Start of treatment within 2 months of lymph node dissection for melanoma stage III
  For stage IV only
  -Stage IV melanoma according to the 2001 AJCC criteria. Limited tumor burden; LDH < 2x upper limit of normal
  Exclusion Criteria:
  For both stage III and IV
  -  No autoimmune disorders, no concomitant use of immunosuppressive drugs,
  -  no serious concomitant disease, no serious active infections, no other malignancy in the past 5 years with the exception of curatively treated carcinoma in-situ of the cervix/squamous cell carcinoma of the skin,
  -  No known allergy to shell fish (contains KLH) are excluded.
  -  No pregnancy or lactation,
  For stage III only:
  -  No signs or symptoms of distant metastases as defined by normal history, physical examination, chest X-ray and serum LDH.
  -  No concomitant or previous systemic treatment for melanoma
  For stage IV only:
  -  No clinical signs of CNS metastases, in patients with a clinical suspicion of CNS metastases, a CT scan of the brain should be performed to exclude this.
  -  No prior chemotherapy, immunotherapy, or radiotherapy within three months before planned vaccination is allowed.

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy

Summary: This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)


Eligibility: Inclusion Criteria:
  -  Surgically incurable melanoma, either Stage IV or IIIC with N3 status for regional lymph nodes and in-transit or satellite lesions.
  -  Serum lactic acid dehydrogenase (LDH) <= 2 x ULN
  -  ECOG performance status of 0 or 1
  Exclusion Criteria:
  -  Received any systemic therapy for metastatic melanoma except post-surgical adjuvant treatment with cytokines (eg, alpha-interferon or GM-CSF) or with vaccines after complete resection of melanoma.
  -  History of brain metastases

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: RIMAG Study: Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy

Summary: Polyneuropathy associated with anti-MAG monoclonal IgM gammopathy is responsive of mainly a sensory deficit in predominantly males ,aged 40-70 years. Significantly high serum anti-MAG antibodies are linked with demyelinating features of the peripheral nerves.Rituximab, an anti-CD 20 monoclonal antibody is a new drug which reduces B-lymphocytes. This study will test the safety and efficacy of rituximab in the treatment of patients with anti-MAG polyneuropathy.

Detailed description: Acting of a polyneuropathy for which there is not any treatment of reference today (see supra), a test of double-knowledge versus placebo is justified. Acting of a chronic polyneuropathy, the clinical evaluation must be led over one one year period. Acting of a sensitive polyneuropathy and the awaited benefit being the IMPROVEMENT OF the CLINICAL SIGNS, the principal criterion is a sensitive score in addition validated in chronic sensitive polyneuropathies immunodeficiency syndrome.
  The patients answering the criteria of inclusion and none inclusion (see V-2) will be randomized in 2 groups: the first group will receive a perfusion IV of rituximab to the amount of 375 mg/m2 of body surface, once per week, during 4 weeks (see VII-3); the second group will receive 4 perfusions IV of placebo according to same methods'. The evaluation (see VI-1) will be carried out at the time of the randomization, then repeated in 3 months, 6 months, 9 months and 1 year.

Eligibility: Inclusion Criteria:
  -  IgM monoclonal gammopathy
  -  Anti-MAG antibody titers > 1.1000 BTU (ELISA)
  -  Worsening polyneuropathy with INCAT score > 4
  -  Informed consent
  Exclusion Criteria:
  -  Severe comorbidity
  -  Other concurrent causes of polyneuropathy
  -  Concurrent immunosuppressive therapies (wash-out > 3 months)
  -  Previous treatment with rituximab
  -  Lymphoproliferative disease indicating other immunosuppressive treatment
  -  Unability to follow-up
  -  Previous documented side-effects with components involved in the tested drug
  -  White cell count < 1500/mm3 or platelet count < 75.000/mm3
  -  Patient under law

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Efficacy of Chemotherapy Combined With Regional Hypothermia in Advanced Malignant Melanoma Patients With Progressive Soft Tissue Metastases

Summary: The incidence of malignant melanoma continues to rise throughout the world. Approximately 12 in 100,000 Germans are diagnosed with malignant melanoma per year. Malignant melanoma is often very aggressive since it may spread both through the lymphatic system and the bloodstream at an early stage of disease.
  While treatment of localized disease is mostly surgical, in patients with extensive disease, prognosis remains poor; the primary standard therapy of metastastic disease comprises dacarbazine (DTIC) eventually combined with other chemotherapeutic agents e.g., cisplatin or BCNU. The duration of response to systemic chemotherapy is generally short and so far, no standard second-line treatment has been established.
  To study the potential additional therapeutic effects of regional hyperthermia in advanced malignant melanoma patients with progressive chemotherapy refractory soft tissue metastases, in the present trial, we sought to compine local hyperthermia with concomitant systemic second-line chemotherapy.


Eligibility: Inclusion Criteria:
  -  age between 18 and 70
  -  histologically proven malignant melanoma with advanced inoperable soft tissue metastases
  -  progressive disease upon systemic first-line chemotherapy
  -  2 or more bidimensionally measurable soft tisue lesions
  -  WHO performance status (ECOG) of 2 or more
  -  life expectancy of 8 weeks and more
  -  prior informed consent
  Exclusion Criteria:
  -  participation in other therapy studies
  -  pregnancy or breast feeding
  -  concomitant clinically significant infection
  -  cardiac pacemaker or other medical implants, or implants within the hyperthermia treated region (including a safe distance of 5 cm)
  -  lack of physiological heat sensitivity within the hyperthermia treated region (including a safe distance of 5 cm)

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Phase I/II Study of High-Dose Calcitriol Plus Temodar for Patients With Metastatic Melanoma

Summary: RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Calcitriol may help temozolomide kill more tumor cells by making them more sensitive to the drug. Calcitriol may also stop the growth of melanoma by blocking blood flow to the tumor.
  PURPOSE: This phase I/II trial is studying the best dose of calcitriol, the side effects of calcitriol when given together with temozolomide, and to see how well they work in treating patients with metastatic stage IV melanoma.

Detailed description: * Phase I: Patients receive oral calcitriol on days 1 and 15 and oral temozolomide on days 2-8 and 16-22. Treatment repeats every 28 days for 2 courses in the absence of unacceptable toxicity. Responding patients continue therapy for up to 6 courses in the absence of unacceptable toxicity.
  Cohorts of 3-6 patients receive escalating doses of calcitriol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
  -  Phase II: Patients receive temozolomide and calcitriol at the MTD as in phase I.
  After completion of study treatment, patients are followed every 3 months.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed malignant melanoma
  -  Any primary tumor site
  -  Stage IV disease
  -  CNS metastases allowed
  -  Measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension as ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  -  Must have had at least 1 prior systemic therapy
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  Patients with no prior systemic therapy are eligible provided they are not candidates for high-dose interleukin-2
  -  Recovered from all toxic effects of prior therapy
  -  More than 4 weeks since prior and no concurrent radiotherapy, chemotherapy, or immunotherapy
  -  More than 4 weeks since prior and no concurrent radiotherapy, chemotherapy, or immunotherapy
  -  Fertile patients must use effective contraception
  Exclusion Criteria:
  -  Life expectancy less than 4 months
  -  known HIV positivity
  -  evidence of active infection requiring antibiotic therapy
  -  other malignancy within the past 5 years except surgically resected basal cell or squamous cell skin cancer
  -  significant medical disease which, in the opinion of the investigator, may interfere with study completion
  -  pregnant or nursing
  -  Negative pregnancy test
  -  prior temozolomide or dacarbazine
  -  investigational agent within 4 weeks prior to study entry
  -  concurrent magnesium-containing antacids, digitalis, bile-resin binding drugs, or calcium supplements

Relevance to patient case: not relevant