araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 54-year-old female with lung adenocarcinoma; genetic feature: SND1-BRAF fusion

Clinical trial: Continued Access to RXDX-105

Summary: This study is being done to see if people with Non-Small Cell Lung Cancer (NSCLC) or ovarian cancer benefit from continued treatment with the study drug, RXDX-105.


Eligibility: Inclusion Criteria:
  -  This individual patient protocol includes treatment for 4 patients previously enrolled on IRB #15-270 (phase1/1b clinical trial RXDX-105-01):
  Exclusion Criteria:
  -  Any patients other than those described above are excluded.

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with lung adenocarcinoma; genetic feature: SND1-BRAF fusion

Clinical trial: An Open Label Phase II Study Combining Nivolumab and Celecoxib in Patients With Advanced " Cold " Solid Tumors

Summary: This is an open-label study to evaluate the safety and the anti-tumor activity of the combination of nivolumab and celecoxib.
  The total numbers of participants to be enrolled will be up to 68 participants, depending on the investigated dose of celecoxib during the safety run-in phase.


Eligibility: Inclusion Criteria:
  -  Men and women ≥ 18 years of age.
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  -  Measurable disease as per RECIST 1.1.
  -  Adequate renal, hepatic and hematologic functions as defined by laboratory parameters within ≤ 7 days before treatment initiation.
  -  Metastases biopsiable on two occasions
  -  Recently acquired (within 90 days prior to treatment) tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses. In order to include only IDO1 positive (≥5% expression of tumor cells) and non T-cell infiltrated tumors (<1% T cells infiltrating the tumor bed)
  -  Cancer types with an indication of treatment with anti-PD1 antibodies such as
  -  Melanoma non BRAF mutated in first line of treatment
  -  Melanoma BRAF mutated in first or second line of treatment
  -  Lung cancer (NSCLC) in second line of treatment
  -  Renal cell Cancer (RCC) in second line of treatment
  -  Head and Neck squamous carcinoma (HNSC) after platinum salt based chemotherapy
  -  Bladder cancer after platinum salt based chemotherapy
  Exclusion Criteria:
  -  Active brain metastases or leptomeningeal metastases.
  -  Ocular melanoma.
  -  Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement therapy, psoriasis not requiring systemic treatment, or other autoimmune condition not expected to recur in the absence of an external trigger are permitted to enroll.
  -  Subjects must also meet other study criteria including exclusions for medical history, positive Hep B/C, HIV, and pregnancy tests, and other laboratory criteria.

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with lung adenocarcinoma; genetic feature: SND1-BRAF fusion

Clinical trial: Folfirinox + Cetuximab Chemotherapy, in First Line, With Wild RAS and According to BRAF Status in Metastatic Colorectal Cancer

Summary: This retrospective study, will evaluate patient outcomes after triplet chemotherapy (FOLFIRINOX) (5 Fluorouracil + oxaliplatin + irinotecan) plus cetuximab 1st line treatment focusing on efficacy and safety in a RAS (KRAS, NRAS (neuroblastoma rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer population, and according to BRAF (murine sarcoma viral oncogene homolog B) status and primary tumor location.

Detailed description: In Europe, there are 447,000 new cases of colorectal cancer each year. Approximately 25% of patients present with metastases at initial diagnosis and almost 50% of patients with mCRC (metastatic colorectal cancer) will develop metastases
  . Chemotherapy represents the backbone of treatment, and survival is linked with the administration of all three active cytotoxic agents (5-fluorouracil/folinate, oxaliplatin, and irinotecan) in the first line treatment of metastatic colorectal disease.
  Monoclonal antibodies such as cetuximab in combination with chemotherapy are a first line treatment option in metastatic RAS (rat sarcoma viral oncogene homolog) wild type metastatic colorectal cancer (mCRC).
  Phase II trials evaluating triplet chemotherapy plus cetuximab reported interesting results in terms of efficacy (response rate, resectability...), but at the price of an increased rate of toxic effects.
  This retrospective study, will evaluate patient outcomes after triplet chemotherapy (FOLFIRINOX) (5 Fluorouracil + oxaliplatin + irinotecan) plus cetuximab 1st line treatment focusing on efficacy and safety in a RAS (KRAS, NRAS (neuroblastoma rat sarcoma viral oncogene homolog) wild-type mCRC (metastatic colorectal cancer) population, and according to BRAF (murine sarcoma viral oncogene homolog B) status and primary tumor location.

Eligibility: Inclusion Criteria:
  1. Colorectal cancer confirmed as RAS wild by tumor tissue analysis
  2. Non resectable and measurable metastatic disease
  3. Patients treated with FOLFIRINOX + cetuximab in first line metastatic disease
  4. Males or females aged over 18 years.
  Exclusion Criteria:
  1. Known brain metastases
  2. RAS not assessable (e.g., material not available or insufficient)
  3. The first administration of cetuximab was more than 30 days after the first administration of FOLFIRINOX
  4. History of other malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years

Relevance to patient case: not relevant
Patient case: 54-year-old female with lung adenocarcinoma; genetic feature: SND1-BRAF fusion

Clinical trial: K-RAS and EGFR in Lung Cancer

Summary: Retrospective analysis where patients with histologically confirmed Non-small cell lung cancer (NSCLC) were centrally evaluated for the presence of KRAS and EGFR mutations.

Detailed description: A retrospective analysis, performed by the Hellenic Co-operative Oncology Group (HeCOG), in samples from patients with histologically confirmed NSCLC, who had been treated within HeCOG-affiliated centres from March 2000 through December 2012, were centrally evaluated for the presence of KRAS and EGFR mutations. All patients had available clinicopathological data at diagnosis. Formalin-fixed, paraffin-embedded tissue blocks were retrospectively retrieved from the HeCOG tumor repository. Cytologic material was prospectively submitted for genotyping in more recent years (2010-2012).

Eligibility: Inclusion Criteria:
  -  Patients with histologically confirmed NSCLC
  -  Signed and dated written informed consent
  -  Age 18 years
  -  Available cytological material
  Exclusion Criteria: -

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Immunotherapy After Surgery in Treating Patients With Breast Cancer, Colon Cancer, or Melanoma

Summary: RATIONALE: Immunotherapy uses different ways to stimulate the immune system and stop cancer cells from growing. Immunotherapy biological extracts may be useful as adjuvant therapy in treating patients who have had surgery for breast cancer, colon cancer, or melanoma.
  PURPOSE: Phase III trial to study the effectiveness of Corynebacterium granulosum extract as maintenance immunotherapy following surgery in treating patients with breast cancer, colon cancer, or melanoma.

Detailed description: OBJECTIVES:
  -  Determine the survival of patients with colon cancer, breast cancer, or melanoma with minimal residual disease after surgical resection treated with maintenance immunotherapy using Corynebacterium granulosum P40.
  -  Determine leucocyte adherence inhibition, an indication of metastases, over time in patients treated with this regimen.
  OUTLINE: This is a multicenter study. Patients are stratified by center and are matched with case-controls by disease type and stage.
  Beginning 2 weeks after surgical resection, patients receive Corynebacterium granulosum P40 subcutaneously weekly for 6 weeks, followed by rest for 3 months. Treatment continues for life.
  Patients are followed for survival.
  PROJECTED ACCRUAL: Not specified

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of colon cancer, breast cancer, or melanoma with minimal residual disease (at least 90% of tumor mass resected) after surgical resection
  -  Hormone receptor status:
  -  Not specified
  PATIENT CHARACTERISTICS:
  Age:
  -  20 to 80
  Sex:
  -  Not specified
  Menopausal status:
  -  Not specified
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  Not specified
  Surgery
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Gene Testing in Patients With Colon Cancer

Summary: RATIONALE: Analyzing the structure of genes found in a person's cancer cells may help doctors improve methods of treating patients with colon cancer.
  PURPOSE: Clinical trial to study the genes of patients treated with chemotherapy for colon cancer.

Detailed description: OBJECTIVES:
  -  Determine the relationship between disease free survival, overall survival, and tumor replication error status for patients who have received adjuvant chemotherapy for colon cancer on CALGB protocol 8896.
  -  Determine the prognostic and predictive values for response to this therapy in these patients.

Eligibility: DISEASE CHARACTERISTICS:
  -  Patients who received chemotherapy for colon cancer as part of CALGB protocol 8896
  -  Underwent an initial resection for adenocarcinoma of the colon and were determined to have a high risk of tumor recurrence based upon nodal disease or local extension of tumor with obstruction or perforation due to tumor
  -  Surgical specimen blocks available, including tumor tissue and normal tissue

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
  PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic colorectal cancer.

Detailed description: OBJECTIVES:
  -  Determine the response rate of patients with metastatic colorectal carcinoma treated with O6-benzylguanine and carmustine.
  -  Evaluate tumor tissue biochemical and immunohistochemical predictors of response in patients treated with this regimen.
  -  Correlate carcinoembryonic antigen levels in the peripheral blood with response in patients treated with this regimen.
  OUTLINE: This is a multicenter study.
  Patients receive O6-benzylguanine (BG) IV over 1 hour and carmustine IV over 1 hour (beginning 1 hour after completion of BG infusion) on day 1. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.
  Patients are followed every 3 months.
  PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for this study within 1.7-3 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of metastatic colorectal carcinoma
  -  Bidimensionally measurable disease
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  ECOG 0-2
  Life expectancy:
  -  At least 12 weeks
  Hematopoietic:
  -  WBC at least 4,000/mm^3
  -  Granulocyte count at least 1,500/mm^3
  -  Absolute neutrophil count at least 1,500/mm^3
  -  Platelet count at least 100,000/mm^3
  -  Hemoglobin greater than 8 g/dL
  Hepatic:
  -  Bilirubin no greater than 1.2 mg/dL
  -  AST and ALT less than 2.5 times upper limit of normal (ULN)
  -  PT no greater than ULN (not on anticoagulation therapy)
  Renal:
  -  Creatinine no greater than 1.5 mg/dL
  -  Creatine clearance greater than 60 mL/min
  Pulmonary:
  -  DLCO at least 60%
  Other:
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception during and for 2 months after study
  -  No other concurrent active malignancies
  -  Prior malignancies presumed to be cured allowed
  -  No other concurrent uncontrolled severe medical problem that would preclude study participation
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  At least 6 months since prior adjuvant chemotherapy without disease recurrence
  -  No more than 1 prior chemotherapy regimen for metastatic disease
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  Prior adjuvant radiotherapy allowed
  -  No prior radiotherapy to more than 25% of total bone marrow
  Surgery:
  -  Not specified
  Other:
  -  No other prior therapy for advanced disease

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Gene Therapy in Treating Patients With Advanced Head and Neck Cancer

Summary: RATIONALE: Gene therapy may kill cancer cells by inhibiting a gene that promotes the development and growth of cancer.
  PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have advanced head and neck cancer.

Detailed description: OBJECTIVES: I. Determine the safety and biological activity of EGFR antisense DNA and DC-chol liposomes in patients with advanced squamous cell carcinoma of the head and neck. II. Determine the toxicity and maximum tolerated dose of this regimen in these patients. III. Determine the antitumor response in patients treated with this regimen. IV. Determine the effect of this regimen on EGFR expression levels, STAT protein expression/activation levels, and apoptosis rates in biopsied tumor cells of these patients.
  OUTLINE: This is a dose-escalation study. Patients receive EGFR antisense DNA and DC-chol liposomes intratumorally weekly for 4 weeks. Courses repeat every 4 weeks for up to 6 months in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of EGFR antisense DNA and DC-chol liposomes until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity. Patients are followed at 1 month.
  PROJECTED ACCRUAL: A total of 20-36 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed advanced squamous cell carcinoma of the head and neck Primary or recurrent disease Not amenable to standard therapy (surgery, chemotherapy, or radiotherapy) Second primary lesions allowed Brain metastases allowed after definitive radiotherapy
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 8 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT no greater than 4 times normal Renal: Creatinine no greater than 2 mg/dL Calcium no greater than 10.5 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception (double-barrier method and oral contraception) prior to, during, and for at least 2 weeks after study
  PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Genetic Study of Familial Factors in Patients With Colon Cancer

Summary: RATIONALE: Genetic studies may help in understanding the genetic processes involved in the development of some types of cancer.
  PURPOSE: Clinical trial to study the cancer-related genes in patients who have colon cancer or adenomatous polyps.

Detailed description: OBJECTIVES:
  -  Identify human colon neoplasia susceptibility genes in patients with colon cancer or adenomatous polyps.
  -  Correlate the inheritance of novel susceptibility alleles for adenomatous polyposis of the colon with colon neoplasia in these patients.
  -  Correlate colon neoplasia susceptibility with the presence of COX-2, sPLA2, and DNMT genes in these patients.
  -  Identify a novel gene that governs increased susceptibility to colon adenoma and cancer in the genome of these patients.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of colon cancer or polyps at age 70 or under
  -  Has a living full sibling with diagnosis of colon cancer or polyps at age 70 or under
  -  No history of familial adenomatous polyposis syndrome
  -  No hereditary nonpolyposis colon cancer, according to Amsterdam criteria
  -  No known I1370K adenomatous polyposis of the colon susceptibility variant
  -  Enrolled on 1 of the following clinical trials:
  -  CLB-9581
  -  CLB-89803
  -  CLB-80001 NOTE: Patients do not need to be receiving protocol therapy. Patients who are outside the treatment protocol's follow-up range are eligible. Patients who discontinued therapy for any reason, including toxic effects, are eligible.
  PATIENT CHARACTERISTICS:
  Age
  -  70 and under at diagnosis
  Other
  -  No significant psychiatric illness that would preclude giving informed consent
  -  No inflammatory bowel disease (in patient or sibling)

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer

Summary: The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in first line advanced or metastatic breast cancer.


Eligibility: Inclusion criteria:
  -  Signed Informed Consent
  -  Able to swallow an oral medication
  -  Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram
  -  Adequate kidney and liver function
  -  Adequate bone marrow function
  -  Tumor tissue available for testing
  -  Prior adjuvant or neoadjuvant therapy is permitted with an anthracycline or anthracenedione-containing regimen however, subjects must have had cumulative doses of less than 360 mg/m2 of doxorubicin, 720 mg/m2 of epirubicin, or 72 mg/m2 of mitoxantrone
  -  No Her2/neu overexpression in tumor tissue tested or status unknown if tissue has never been tested
  Exclusion criteria:
  -  Prior treatment regimens for advanced or metastatic breast cancer.
  -  Pregnant or lactating
  -  Conditions that would effect the absorption of an oral drug
  -  Active infection
  -  Brain metastases
  -  Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor.
  -  Known hypersensitivity to Taxol or excipients of Taxol
  -  Peripheral neuropathy of Grade 2 or greater is not permitted
  -  Severe Cardiovascular disease or cardiac disease requiring a device.
  -  Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer

Summary: This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic breast cancer.


Eligibility: Inclusion criteria:
  -  Histologically confirmed invasive breast cancer with incurable stage IIIB, IIIC with T4 lesion or stage IV disease at primary diagnosis or at relapse after curative intent surgery.
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  -  Documented amplification of ErbB2 by Fluorescence in situ hybridization (FISH)
  -  Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST)
  -  Adequate renal, hepatic and cardiac function
  Exclusion criteria:
  -  Prior chemotherapy, immunotherapy, biologic therapy or anti-ErbB1/ErbB2 therapy other than adjuvant therapy. [Prior neo-adjuvant or adjuvant therapy (including trastuzumab) will be allowed provided it was stopped at least 12 months before study entry.
  -  Patients with active brain metastases
  -  Patients with bilateral breast cancer, bone metastases as the only disease site or metastases to more than 30% of the hepatic parenchyma.

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Her-2/Neu in Patients With Metastatic Breast Cancer (AdHERe)

Summary: The purpose of this study is to determine the maximum tolerated dose and/or maximum attainable dose of a vaccine consisting of human autologous dendritic cells transduced by an adenovector expressing rat Her-2/neu (AdHer-2/neu) in patients with metastatic breast cancer.


Eligibility: Inclusion Criteria:
  1. Metastatic or locally recurrent breast cancer
  2. 18 years of age or older
  3. Her-2/neu positive (3+ by immunohistochemistry or fluorescence in-situ hybridization [FISH] +)
  4. One of the following:
  1. currently receiving hormonal therapy or are candidates for such, or
  2. being considered for trastuzumab, or
  3. cancer has progressed on trastuzumab.
  Exclusion Criteria:
  1. Pregnant or lactating women.
  2. Prior or concurrent malignancies except for treated basal cell or squamous cell carcinoma of the skin or in situ cancer of the cervix or any other cancer treated and presumed cured for more than five years prior to study entry.
  3. Currently receiving chemotherapy, immunotherapy, adenoviral gene therapy or biological cancer therapy. [Note: concurrent hormonal therapy (tamoxifen, aromatase inhibitors, or megace) is permitted.]
  4. Treatment with trastuzumab within 4 weeks prior to first dose of vaccine therapy.
  5. Hemoglobin < 80 g/L or granulocytes < 1.5 × 10^9/L or lymphocytes < 1.0 × 10^9/L or platelets < 100 × 10^9/L.
  6. Baseline liver enzymes (AST or ALT) greater than 3 times the upper limit of normal or greater than 5 times the upper limit of normal if liver metastases are present and/or bilirubin is greater than 50 mmol.
  7. CD4 cells < 0.5 ×10^9/L
  8. Patients with documented brain metastases.
  9. Patients with any acute illness that would interfere with the collection of CD34+ cells or administration of vaccination cellular therapy (i.e. unstable angina, renal or liver failure, or severe chronic obstructive airway disease).
  10. Any patients requiring concurrent immunosuppressive therapy (e.g. corticosteroids).
  11. Eastern Cooperative Oncology Group (ECOG) performance status of > 2.
  12. Patients with a life expectancy of less than 6 months.
  13. Geographic inaccessibility which would preclude follow-up. Patients registered on the trial must be treated and followed at the Juravinski Cancer Center and the Henderson site of the Hamilton Health Sciences.
  14. Failure to give written informed consent.
  15. Baseline left ventricular ejection fraction (LVEF) < 55% by echocardiography or multigated acquisition (MUGA) scan.

Relevance to patient case: not relevant