araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 62-year-old female with mucosal melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer

Summary: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have stage IV colorectal cancer. Imatinib mesylate may interfere with the growth of tumor cells by blocking certain enzymes necessary for cancer cell growth

Detailed description: PRIMARY OBJECTIVES:
  I. To determine response to Gleevec (Imatinib Mesylate) in patients with metastatic colorectal cancer and with c-Kit, Arg, Abl, or PDGF-R expression.
  II. To determine the side effects of Imatinib Mesylate in patients with colorectal cancer.
  III. To study the biologic effects of Imatinib Mesylate on the c-Kit and PDGF-R system and downstream signaling in metastatic colorectal cancer.
  OUTLINE:
  Patients receive oral imatinib mesylate twice daily. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease or better continue therapy until disease progression or 1 year after complete response.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed stage IV colorectal cancer
  -  Arg, KIT (CD117), or PDGF-R expression (1+ in 20% of cells) in the tumor or microvasculature
  -  At least one unidimensionally measurable lesion
  -  At least 10 mm by spiral CT scan
  -  No known brain metastases
  -  Performance status - ECOG 0-2
  -  Performance status - Karnofsky 60-100%
  -  At least 12 weeks
  -  Granulocyte count at least 1,500/mm^3
  -  Platelet count at least 100,000/mm^3
  -  Bilirubin no greater than 2.0 mg/dL
  -  AST/ALT less than 2.5 times upper limit of normal
  -  Creatinine no greater than 2.0 mg/mL
  -  No symptomatic congestive heart failure
  -  No unstable angina pectoris
  -  No cardiac arrhythmia
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective barrier contraception during and for 3 months after study participation
  -  No other malignancy within the past 3 years except non-melanoma skin cancer or carcinoma in situ of the cervix
  -  No concurrent uncontrolled illness
  -  No ongoing or active infection
  -  No psychiatric illness or social situation that would preclude study compliance
  -  More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  -  More than 4 weeks since prior radiotherapy and recovered
  -  More than 3 weeks since prior surgery (excluding diagnostic biopsy)
  -  No other concurrent investigational agents
  -  No concurrent therapeutic doses of anticoagulants (e.g., warfarin)
  -  No concurrent grapefruit
  -  No concurrent combination antiretroviral therapy for HIV-positive patients

Relevance to patient case: not relevant
Patient case: 62-year-old female with mucosal melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

Summary: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
  PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.

Detailed description: OBJECTIVES:
  -  Determine the antitumor immune response in patients with unresectable stage III or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51.
  OUTLINE: Patients receive vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51 on days 1, 8, 15, 29, 36, and 43. Patients undergo removal of the lymph node draining the vaccination site on day 22 to assess immune response.
  PROJECTED ACCRUAL: A maximum of 29 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of melanoma
  -  Unresectable stage III or IV disease
  -  Mucosal or ocular disease allowed
  -  Positive HLA-A1, -A2, or -A3 expression
  PATIENT CHARACTERISTICS:
  Age
  -  12 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
  -  Weight ≥ 100 pounds
  -  Not pregnant or nursing
  -  No other malignancy within the past 5 years except squamous cell or basal cell skin cancer without known metastasis, carcinoma in situ of the breast, or carcinoma in situ of the cervix
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  No prior vaccination with any of the peptides used in this protocol
  -  More than 1 year since prior melanoma vaccine therapy
  -  More than 4 weeks since prior immunotherapy
  -  More than 4 weeks since prior growth factors
  -  More than 4 weeks since prior allergy shots
  Chemotherapy
  -  More than 4 weeks since prior chemotherapy
  Endocrine therapy
  -  More than 4 weeks since prior steroid therapy
  Radiotherapy
  -  More than 4 weeks since prior radiotherapy
  Surgery
  -  Prior tumor resection allowed

Relevance to patient case: not relevant
Patient case: 62-year-old female with mucosal melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer

Summary: The purpose of this research study is to test the safety and effectiveness of palifermin to determine if weekly doses can be safely administered to reduce the incidence (occurrence of), duration (length of time) and severity (amount of pain) of oral mucositis (painful sores in the mouth). Mucositis is a common side effect for patients receiving chemotherapy (cancer-killing drug) and radiotherapy (cancer-killing x-rays) for the treatment of head and neck cancer (HNC).

Detailed description: This study consisted of 2 phases. The acute oral mucositis (OM) evaluation phase includes the time from randomization to the time of severe OM (WHO Grade 3 or 4) resolution (up to Week 12 or up to Week 15 for participants whose severe OM is not resolved at Week 12). In the acute OM evaluation phase, participants were randomized to receive either a single IV dose of palifermin or placebo at 180 μg/kg, 3 days before the start of radiotherapy, plus 7 once-weekly palifermin or placebo doses at the same dose level during a 7-week radio/chemotherapy course. In the long-term follow up phase, participants are followed until death, withdrawal of consent, or loss to follow-up. The long-term follow up phase is still ongoing.

Eligibility: Key Inclusion Criteria:
  -  Histologically documented squamous cell carcinoma involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx
  -  Newly diagnosed, locally advanced stage head and neck cancer (unresectable/unresected disease); American Joint Committee on Cancer [AJCC] Stage III, IVA or IVB amenable to radiotherapy with concurrent chemotherapy as the definitive treatment modality
  -  At least 50 Gray of radiation treatment to areas of the oral cavity/oropharynx mucosa that can be visualized
  -  Concurrent chemotherapy regimen of Cisplatin 100mg/m^2 on days 1, 22, and 43
  -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than or equal to 2
  -  Adequate hematologic, renal and hepatic function
  -  Negative pregnancy test by serum or urine
  -  Signed informed consent
  Key Exclusion Criteria:
  - Presence or history of any other primary malignancy (other than curatively treated in situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for greater than 3 years)

Relevance to patient case: not relevant
Patient case: 62-year-old female with mucosal melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: Phase II Study of Imatinib Mesylate in Patients With Life Threatening Malignant Rare Diseases

Summary: Exploratory study to examine the effect(s) of Imatinib mesylate treatment on life threatening rare diseases with known associations to one or more Imatinib mesylate -sensitive tyrosine kinases, and to identify the contribution of specific protein tyrosine kinases (PTKs) of that specific disease.


Eligibility: Inclusion Criteria:
  -  Patients ≥ 15 years of age
  -  Life threatening disease documented by conventional criteria to be resistant to standard, approved therapy.
  -  Experimental documentation of functional significance of either Abl, Kit (CD117), or PDGF-R in the relevant target tissue (preferably on a sample taken within 6 weeks of study entry).
  -  ECOG Performance status of 0, 1, or 2.
  -  Adequate end organ function defined as: total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x UNL (or < 5 x ULN for patients with hepatic disease), creatinine < 1.5 x ULN, ANC > 1.5 x 109/L, platelets > 100 x 109/L.
  -  Negative serum or urine pregnancy test for women of child bearing potential (WOCBP) within 7 days of study initiation. Post menopausal women must have experienced amenorrhea for at least 12 months. Male and female patients must use effective birth control methods throughout the study and for up to 3 months after study discontinuation.
  -  Life expectancy of more than 3 months.
  -  Written, voluntary, informed consent for retrieval, evaluation and investigational use of tissue samples.
  Exclusion Criteria:
  -  Patients who have received any other investigational agent within 28 days of study initiation.
  -  Patients with another primary malignancy except if other primary malignancy is neither currently clinically significant nor requiring active intervention.
  -  Patients with Grade III/IV cardiac problems defined by the New York Heart Association Criteria (e.g. congestive heart failure, myocardial infarction within 6 months of study).
  -  Female patients who are pregnant or breast-feeding.
  -  Patients who have another severe and/or life threatening medical disease.
  -  Patients with acute or known chronic liver disease (e.g. chronic active hepatitis, cirrhosis).
  -  Patients with a known diagnosis of the human immunodeficiency virus ((HIV) infection.
  -  Patients who have received chemotherapy within 4 weeks (6 weeks allowed for nitrosourea, mitomycin-C or any antibody therapy) prior to study entry.
  -  Patients who have had major surgery within 2 weeks prior to study entry.
  -  Patients with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
  Other protocol-defined inclusion/exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 62-year-old female with mucosal melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: Role of Glivec in Patients With Tumor Cells Positive for C-kit or PDGFR; a Multi Center Study.

Summary: This is a phase II, multi-center (Israeli), open label, non-randomized trial for every patient with the specified tumors expressing c-kit or PDGFR. Expression of these kinases will be investigated in tumor samples obtained at the time of diagnosis or from the time of recurrent disease. Every patient with positive expression of either of the kinases will be evaluated for quantitative and qualitative evidence of disease prior to entry into the study, and if possible, no other treatment will be given concomitantly, to allow evaluation of the net effect of Glivec on tumor growth kinetics, searching for measurable evidence of response.
  Glivec is supplied to the study investigators by Novartis Pharmaceutical. Patients will receive Glivec 400mg-800mg p.o./day for an exposure period of up to 12 months provided that in the opinion of the investigator the patient is benefiting from treatment with Glivec, and in the absence of any safety concern. For patients with brain tumors who are not receiving concomitant enzyme inducing anti-convulsant drugs, the recommended dose of Glivec is 800mg/day.


Eligibility: Inclusion Criteria:
  -  Patients > 18 years of age.
  -  Histologically documented diagnosis of one of the specified tumors, which is malignant as well as unresectable and/or metastatic and therefore, incurable with any conventional multimodality approach and immunohistochemical documentation of c-kit (CD117) or PDGFR expression in the primary tumor or metastases by tumor (preferably on a tumor sample taken within 6 week of study entry).
  -  At least one measurable site of disease as defined by Southwestern Oncology Group Solid Tumor Response Criteria.
  -  Female patients of child-bearing potential must have negative pregnancy test.
  -  Signed informed consent form.
  -  Life expectancy >3 months.
  Exclusion Criteria:
  -  Patient has received any other investigational agents within 28 days of the first day of study drug dosing.
  -  Existence of any evidence of another malignant disease, except superficial non-melanoma skin cancer.
  -  Patient has a known brain metastases.
  -  Patient previously received radiotherapy to >25% of the bone marrow.

Relevance to patient case: not relevant
Patient case: 62-year-old female with mucosal melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes

Summary: This trial is for various types of malignancies which may depend on certain enzymes (tyrosine kinases) for growth. The objective of this study is to assess to what extent imatinib mesylate blocks these enzymes and to assess the effect on the malignancy.

Detailed description: Condition
  Diverse malignancies either associated with or thought to be associated with activated tyrosine kinase enzymes including hypereosinophilic syndrome systemic mastocytosis chronic myelomonocytic leukaemia, dermatofibrosarcoma protuberans and other diseases.
  Not included:
  Patients with chronic myeloid leukemia, some other types of leukemias (abl-mutated) some types of gastrointestinal stromal tumours (c-KIT-positive), some systemic mastocytosis (if c-KIT D816V mutation), brain, prostate, breast or lung cancers.

Eligibility: Inclusion Criteria:
  1. Malignancy likely related to an activated tyrosine kinase enzyme sensitive to imatinib mesylate.
  2. Spread of the disease to the rest of the body (confirmed by tissue sample) beyond the skin.
  3. Malignant tissue showing activation of certain tyrosine kinases (ABL, ARG, KIT (CD117), or PDGF-R alpha or beta) & preferably within 6 weeks of entry.
  Exclusion Criteria:
  1. Certain leukaemias (abl-mutated), some gastrointestinal stromal tumours (c-KIT-positive) or certain systemic mastocytosis (if c- KIT D816V mutation).
  2. A primary prostate, breast, lung or brain tumour,
  3. Patient has previously been treated with imatinib mesylate except where treatment was more than 6 months previously and there is no suggestion of clinical resistance nor lack of response.
  Other protocol-defined inclusion / exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 62-year-old female with mucosal melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma (PXS-X02)

Summary: The purpose of this study is to determine the safety of an injection of coxsackievirus A21 into a melanoma tumour, and also to see if there is a tumour response.

Detailed description: Coxsackievirus A21, a naturally occurring enterovirus, has shown that in vivo it can infect and lyse melanoma. This study is to assess safety of a single intratumoural injection of the virus into an accessible subcutaneous melanoma metastasis.

Eligibility: Inclusion Criteria:
  -  stage IV melanoma (AJCC classification)
  -  minimum of 2 sc metastases
  -  failure or refusal of standard chemotherapy
  -  ECOG score of 0 or 1
  -  other
  Exclusion Criteria:
  -  metastatic CNS disease
  -  ocular or mucosal melanoma
  -  immunodeficiency
  -  splenectomy
  -  other

Relevance to patient case: not relevant
Patient case: 62-year-old female with mucosal melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: A Study of the Efficacy and Safety of Imatinib Mesylate in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Expressing C-kit Gene

Summary: In the core study, participants with unresectable or metastatic gastrointestinal stromal tumors expressing c-kit were treated with either 400 mg or 600 mg imatinib mesylate for 3 years. The 10 year extension study allowed participants, who successfully completed the core study, to continue study treatment with imatinib mesylate provided they still benefited from treatment and did not demonstrate safety concerns as per the investigator's opinion.


Eligibility: Inclusion Criteria:
  -  Men and non-pregnant women ≥18 years of age with the histopathologically documented diagnosis of malignant GIST that was unresectable and/or metastatic. Confirmation of KIT (CD117) expression via immunohistochemical analysis of tumor sample was also required
  -  At least one measurable lesion, as defined by Southwestern Oncology Group (SWOG) Solid Tumor Response Criteria, which had not been previously embolized or irradiated
  -  Performance status ≤3 as defined by the Eastern Cooperative Oncology Group (ECOG) criteria, as well as a life expectancy ≥6 months and adequate end organ function defined as follows: Total bilirubin <1.5 times upper limit of normal (ULN), aspartate aminotransferase (SGOT) and alanine aminotransferase (SGPT) <2.5 x ULN (or <5 x ULN if hepatic metastases were present), creatinine <1.5 x ULN, absolute neutrophil count (ANC) >1.5 x 10^9/L, platelet count >100 x 10^9/L
  Exclusion Criteria:
  -  Patients with fewer than five years of disease-free survival from any other (non-GIST) malignancy except if the other malignancy was not currently clinically significant and did not require active intervention or if the other malignancy was a basal cell skin cancer or a cervical carcinoma in situ
  -  Patients with known brain metastases
  -  Evidence of any of the following disorders: Grade III/IV cardiac failure as defined by the New York Heart Association Criteria, severe concomitant disease, acute or known chronic liver disease (i.e. chronic active hepatitis, cirrhosis) or HIV infection
  -  Chemotherapy or other investigational therapy within four weeks prior to study entry (six weeks for nitrosourea or mitomycin-C) and/or radiotherapy to ≥25% of the bone marrow
  -  Inability to cooperate
  -  Major surgery within two weeks or exposure to other investigational agents within 28 days of entry into the study
  Other protocol-defined inclusion / exclusion criteria may have applied.

Relevance to patient case: not relevant
Patient case: 62-year-old female with mucosal melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: Development of Tuberculosis Diagnostic Kit

Summary: Pulmonary tuberculosis is one of the most important infectious diseases in human with high mortality.
  Early diagnosis followed by antibiotic treatment is the only way for control of the disease. However, most of commercial tuberculosis diagnostic kits are of moderate sensitivity. Oncoprobe Inc. recently developed a tuberculosis diagnostic kit (HR-103) based on detection of antibody against Mycobacterium tuberculosis in serum. The main purpose of this project is to evaluate the sensitivity and specificity of the kit in detection of pulmonary tuberculosis from saliva, urine, pleura and serum samples.Capilia TB assay and another Immunochromatographic assay such as ESAT-6 and CFP-10 based or other PCR based immunochromatographic assay will be tried to detection tuberculous disease.

Detailed description: Sputum samples from 200 patients with chest or respiratory problems will be collected. Presence of M.
  tuberculosis in the samples will be checked by acid-fast stain and bacterial culture and identification methods.
  At the same time, saliva, urine, and serum samples from these 200 patients and 50 healthy volunteers will be collected. The tuberculosis diagnostic kit (HR-103) from Oncoprobe Inc. or capilia TB assay or another Immunochromatographic assay such as ESAT-6 and CFP-10 based or other PCR based immunochromatographic assay will be used to detect tuberculosis disease from these samples. By comparing the results with the stain and identification results of sputum samples from the 200 patients, the sensitivity and specificity of the kit in detection of pulmonary tuberculosis from saliva, urine,pleura and serum samples, as well as from combination of these samples, will be obtained. In addition to pulmonary tuberculosis, M. tuberculosis causes pleural tuberculosis. Diagnosis of pleural tuberculosis involves determination of activities of adenosine deaminase and interferon-gamma in pleural effusion, which is tedious. We also plan to collect pleural effusion samples from 100 patients, and examined by the tuberculosis diagnostic kit (HR-103) from Oncoprobe Inc. By comparing the results with the adenosine deaminase and interferon-gamma activities of the same samples, the sensitivity and specificity of the kit in detection of pleural tuberculosis from pleural effusion samples will be obtained.

Eligibility: Inclusion Criteria: clinical suspicious of tuberculosis
  -
  Exclusion Criteria:
  -  HIV

Relevance to patient case: not relevant