araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma

Summary: RATIONALE: Diagnostic procedures that analyze surgically-removed tumor tissue and lymph node samples may help doctors identify patients with melanoma who are at risk for developing metastatic cancer.
  PURPOSE: This clinical trial is studying tumor tissue and lymph node samples to see how well they work in predicting the development of metastatic cancer in patients with stage I or stage II melanoma.

Detailed description: OBJECTIVES:
  -  Correlate degree of melastatin gene expression with risk of developing local regional metastases in patients with primary stage I or II melanoma.
  -  Correlate melastatin expression prospectively with event-free survival of these patients.
  OUTLINE: This is a multicenter study.
  Melastatin mRNA expression is determined by in situ hybridization using tissue from primary tumor and lymph nodes. Tissue is also examined by immunohistochemical staining using antibodies to S-100 and MART-1. Patients do not receive the results of these tests nor do the results influence individual therapy.
  Patients are followed every 4 months for 3.5 years.
  PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study within 3.5 years.

Eligibility: 1. Histologically documented primary AJCC stage I or II melanoma. Evidence of ulceration, vertical growth phase, regression, lymphocytic infiltration, vascular invasion, microscopic satellitosis, and mitotic rate shall be noted.
  2. Patients planning to undergo a sentinel lymph node biopsy, or an elective lymph node dissection of an anatomic draining region from the index primary melanoma.
  3. ≥18 years of age
  4. Patients must be registered prior to planned surgery. The surgery must be performed within 45 days following registration.
  5. No concurrent active malignancy other than carcinoma in situ of the cervix and basal cell carcinoma of the skin, or history of any other primary malignancy including previously primary melanoma.
  6. Tissue blocks: one of primary tumor tissue taken from region of greatest Breslow thickness. Note: If blocks cannot be sent due to institutional policy, slides may be substituted for the locks per the protocol.

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

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: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Volociximab in Combination With DTIC in Patients With Metastatic Melanoma Not Previously Treated With Chemotherapy

Summary: This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.


Eligibility: Inclusion Criteria:
  -  Males and females of at least 18 years of age with stage IV or unresectable stage III non-ocular melanoma who may have received 0 to 2 prior regimens for metastatic disease with a biological therapy or immunotherapy (e.g., IL-2 or interferon-alfa).
  -  Measurable disease according to Response Criteria for Solid Tumors (RECIST).
  -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1.
  -  Estimated survival is greater or equal to 4 months.
  -  Negative pregnancy test (women of childbearing potential only).
  -  Pretreatment laboratory levels that meet specific criteria.
  -  Signed informed consent, including permission to use protected health information.
  Exclusion Criteria:
  -  Prior treatment with M200 or a5b1 inhibitors and murine or chimeric monoclonal antibodies.
  -  Prior treatment with DTIC, temozolomide, or other chemotherapeutic regimens.
  -  Known sensitivity to murine proteins or chimeric antibodies or other components of the product.
  -  Use of any investigational drug within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer).
  -  Systemic biologic, immunotherapy, and/or radiation therapy within 4 weeks of the first dose of M200.
  -  Documented central nervous system (CNS) tumor or CNS metastasis.
  -  History of thromboembolic events and bleeding disorders within the past year.
  -  Medical conditions that may be exacerbated by bleeding.

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Safety and Efficacy Study of INGN 241 Gene Therapy in Patients With In Transit Melanoma

Summary: This is a research study to look at the ways in which a treatment called INGN241 can kill melanoma cells or help the patient's immune system kill melanoma cells.

Detailed description: INGN 241 is an adenoviral vector carrying the MDA-7 cDNA. MDA-7 is a novel tumor suppressor molecule with cytokine properties, recently designated as IL-24. Over expression of MDA-7 in melanoma cells in vitro has been shown to inhibit cellular proliferation and induce apoptosis. Loss of MDA-7 expression in human melanomas has been shown to correlate with invasion and metastasis. The INGN 241 gene transfer construct has been previously used in human subjects in an ongoing open label Phase I study using intratumoral administration, and has been well tolerated to date. The primary objectives of the present study are to determine if INGN 241, injected into a melanoma in transit lesion, can induce apoptosis in regional uninjected lesions and initiate systemic immune activation. Secondary objectives include examination of specific immunity and of clinical response and toxicity.

Eligibility: Inclusion Criteria:
  -  Histologically proven melanoma, must have 3 regional metastatic lesions that are in transit
  Exclusion Criteria:
  -  Central nervous system involvement by melanoma

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Comparison of Dendritic Cells Versus Montanide as Adjuvants in a Melanoma Vaccine

Summary: In this study, a melanoma vaccine (5 melanoma peptides) is given with either Montanide or dendritic cells as adjuvants. This randomized trial will establish the safety of both vaccines and compare the 2 vaccine adjuvants in their efficacy to induce immune responses.

Detailed description: In this study, we will examine whether DCs pulsed with candidate melanoma-specific peptides and KLH can boost CTL responses to melanoma antigens in melanoma patients who are clinically free of disease but at high risk for recurrence. This vaccine will be compared to direct injection of the same peptides with KLH and Montanide as adjuvant.

Eligibility: Inclusion Criteria:
  -  Resected stage IIB, IIC, or stage III melanoma.
  -  Fully recovered from surgery
  -  Human leukocyte antigen (HLA) A*0201 positive.
  -  Age >18 years.
  -  Karnofsky performance status: >80% and normal labs.
  Exclusion Criteria:
  -  Prior chemotherapy.
  -  Known chronic infection with HIV, hepatitis B or C.
  -  Patients with known autoimmune disease [e.g. systemic lupus erythematosus (SLE), rheumatoid arthritis (RA)]. Patients with vitiligo are not excluded.
  -  Pregnant women.
  -  Patients with known allergy to gentamicin, tobramycin, streptomycin and amikacin (risk of cross-reaction between aminoglycosides).
  -  Patients who have known retinal or choroidal eye disease.
  -  Patients previously treated with one of the peptides used in this trial, melanoma protein vaccine, melanoma whole cell vaccines, or with Montanide are not eligible.
  -  Allergy to shellfish.

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

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: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

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: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

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: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Testosterone Replacement in Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial

Summary: Growing evidence supports the notion that Late-onset Dysthymic disorder in middle aged men may be associated with age-related HPG hypofunctioning. In this study we seek to examine the efficacy of Testosterone replacement for this condition.
  Hypothesis:
  Testosterone replacement will be more effective than placebo, in treating men with late onset Dysthymic Disorder and hypo-gonadism.


Eligibility: Inclusion Criteria:
  1. Male, age 40-80 years.
  2. Diagnosed with hypogonadism (total T level below 350 ng/dl), but not previously treated.
  3. Diagnosis of Dysthymic disorder with onset after age 40.
  4. PSA < 4.0.
  5. Normal digital exam of the prostate in the preceding 1 year.
  6. For subjects currently taking an antidepressant: Current antidepressant treatment last 6 weeks or longer, with decent dose and with no remission (or with partial remission only HAM-D > 12).
  7. Able to give informed consent.
  Exclusion Criteria:
  1. Acute, severe, or unstable prostatitis, symptomatic prostatic hypertrophy, polycythemia, severe acne, breast cancer, prostate cancer, or hypopituitarism.
  2. Currently being treated with testosterone.
  3. Meets lifetime criteria for schizophrenia, schizoaffective disorder, any bipolar disorder (i.e., BP-I, BP-II, or BP NOS); or a major depressive episode in the preceding 5 years.
  4. Current suicidal risk.
  5. Current (past year) substance abuse or dependence.

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

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: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: The Final Diagnosis and Treatment Result of Metastatic Cervical Carcinoma of Unknown Primary

Summary: Investigate the final diagnosis and treatment result of metastatic cervical carcinoma of unknown primary

Detailed description: Carcinoma of unknown primary (CUP) is defined as biopsy-proven metastasis of an epithelial malignancy in the absence of an identifiable primary site after complete history and physical examination, basic laboratory studies, chest X-ray and additional directed studies indicated by positive findings during the initial work-up. It is characterized by its slow local development and its high metastatic potential.1,2 Patients with CUP represent 4–10% of all new cancer patients.3,4 The presenting sites of metastasis identified pathologically, radiographically or by physical examination were found most frequently in the lymph nodes (37.1%), followed by the liver, bone, lung, pleura/pleural space, brain, peritoneum, adrenal and skin. Of the lymph nodes of metastasis, the supraclavicular cervical area is the leading site (31.3%), followed by the mediastinum, axilla, retroperitonium, and inguina.5 The incidence of metastatic cervical CUP (MCCUP) varies between 2% and 9% of all head and neck cancers.6-8 The level of cervical metastatic involvement may give some clue as to the likely primary site. A submandibular mass (level I) would most commonly be related to a primary in the oral cavity or skin. Level II nodes, including the jugulodigastric node, may point to a primary in the oral cavity, oropharynx, or supraglottic larynx. Tumours of the nasopharynx generally spread to level II or the posterior triangle, as well as retropharyngeal nodes. Middle and lower jugular nodes (levels III and IV) are more likely related to a laryngeal or hypopharyngeal cancer. Metastatic disease restricted to the supraclavicular region is often due to an infraclavicular primary site.9 The prognosis is different according to the involved lymph node level and possible primary site. Modern cancer management relies heavily on recognition of the primary tumor; thus the absence of a primary site poses major diagnostic and therapeutic problems. The patient benefits from identification of the initial tumor site because postoperative irradiation ports may be reduced and because surveillance for recurrence may be improved.10 In order to identify the likely primary site of MCCUP and compare the prognoses of known and unknown primary groups, we report the results according to the different levels of metastatic cervical lymph nodes.

Eligibility: Inclusion Criteria:
  -  cases of metastatic cervical carcinoma of unknown primary
  Exclusion Criteria:

Relevance to patient case: not relevant