araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer

Summary: RATIONALE: Detecting very early metastases in bone marrow and/or lymph nodes may help doctors plan better treatment for non-small cell lung cancer.
  PURPOSE: Clinical trial to detect the presence of metastatic cancer in patients with stage I non-small cell lung cancer that has not been previously treated.

Detailed description: OBJECTIVES:
  -  Determine whether the presence of occult micrometastases (OM) detected by immunohistochemistry or reverse transcriptase-polymerase chain reaction (RT-PCR) in histologically negative lymph nodes or bone marrow is associated with poorer survival among patients with stage I non-small cell lung cancer.
  -  Determine the incidence of OM in histologically negative lymph nodes and bone marrow by immunohistochemistry (staining for cytokeratins and the CEA glycoprotein) or RT-PCR (to detect CEA mRNA) in these patients.
  -  Assess the sensitivity of immunohistochemistry relative to RT-PCR for detecting OM in these patients.
  -  Determine the relationship between tumor size (or T-stage) and the presence of OM detected by immunohistochemistry or RT-PCR in these patients.
  -  Determine the relationship between the presence of OM and disease-free survival in these patients.
  -  Determine the relationship between the site of OM and incidence of recurrence, site of recurrence, and survival of these patients.
  OUTLINE: At the time of thoracotomy and pulmonary resection, patients have samples of bone marrow, primary tumor, and intrathoracic lymph nodes harvested. The presence of occult metastases in bone marrow and lymph nodes is assessed using immunohistochemistry or reverse transcriptase-polymerase chain reaction.
  Patients are followed every 6 months for 5 years.

Eligibility: -  Clinical stage I proven or suspected new non-small cell lung carcinoma T1 or T2 primary N1 or N2 lymph nodes <1cm on CT or negative mediastinoscopy
  -  ≥ 5 years since prior chemo or XRT; no prior mediastinal or chest XRT.
  -  ≥ 18 years of age
  -  No history of previous lung cancer or concomitant malignancy

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Randomized Study of Human Parathyroid Hormone in Middle-Aged Men With Idiopathic Osteoporosis

Summary: OBJECTIVES:
  I. Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men with idiopathic osteoporosis.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. All patients self-administer daily subcutaneous injections of human parathyroid hormone (1-34) or placebo for a period of 2.5 years.
  Patients are followed regularly for unacceptable toxicities.
  Completion date provided represents the completion date of the grant per OOPD records

Eligibility: PROTOCOL ENTRY CRITERIA:
  --Disease Characteristics--
  Osteoporosis as defined by: Bone mineral density at the lumbar spine or femoral neck that is 2.5 standard deviations below peak bone mass reference value (T score less than -2.5)
  No family history of male osteoporosis
  No other metabolic bone disease
  --Prior/Concurrent Therapy--
  Endocrine therapy:
  -  No concurrent glucocorticoid therapy
  -  No prior steroid use
  Surgery: No prior gastrointestinal tract surgery
  Other: No prior or concurrent anticonvulsant therapy
  --Patient Characteristics--
  Hematopoietic: Normal CBC
  Hepatic: Normal liver function
  Renal: Normal renal function
  Other:
  -  Normal thyroid function
  -  Normal adrenal function
  -  Normal gonadal status
  -  No myeloma or other malignancy
  -  No alcoholism, hypercortisolism or diabetes mellitus
  -  No gastrointestinal tract disease or disorder associated with malabsorption

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Phenoxodiol in Treating Patients With Refractory Solid Tumors

Summary: RATIONALE: Phenoxodiol may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.
  PURPOSE: Phase I trial to study the effectiveness of phenoxodiol in treating patients who have refractory solid tumors.

Detailed description: OBJECTIVES:
  -  Determine the maximum tolerated dose of phenoxodiol in patients with refractory solid tumors.
  -  Determine the steady-state pharmacokinetics of this drug in these patients.
  -  Determine the tumor response in patients treated with this drug.
  OUTLINE: This is a multicenter, dose-escalation study.
  Patients receive phenoxodiol IV continuously over days 1-7. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
  Cohorts of 3-6 patients receive escalating doses of phenoxodiol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
  Patients are followed at 4 weeks.
  PROJECTED ACCRUAL: Approximately 18-36 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed solid tumor
  -  Refractory to standard therapy OR
  -  No standard therapy exists
  -  No breast cancer
  -  No active CNS metastases
  -  Known CNS metastases must be previously treated with radiotherapy or surgery and stable for at least 4 weeks prior to study
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  Karnofsky 60-100%
  Life expectancy:
  -  At least 3 months
  Hematopoietic:
  -  Platelet count greater than 100,000/mm^3
  -  WBC greater than 3,000/mm^3
  -  Neutrophil count greater than 1,500/mm^3
  -  Hemoglobin greater than 10 g/dL (9 g/dL for women)
  Hepatic:
  -  Bilirubin less than 1.2 mg/dL
  -  Transaminases no greater than 3 times upper limit of normal
  Renal:
  -  Creatinine no greater than 1.4 mg/dL
  Other:
  -  No active infection
  -  No contraindication to the insertion of a vascular access device
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No concurrent systemic anticancer immunotherapy
  Chemotherapy:
  -  No concurrent systemic anticancer chemotherapy
  Endocrine therapy:
  -  No concurrent systemic anticancer hormonal therapy except luteinizing hormone-releasing hormone agonists or antagonists
  Radiotherapy:
  -  See Disease Characteristics
  -  Concurrent localized radiotherapy for control of local disease complications allowed
  Surgery:
  -  See Disease Characteristics
  Other:
  -  Recovered from prior antineoplastic therapy
  -  At least 4 weeks since prior investigational agents
  -  No other concurrent investigational drugs

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer

Summary: RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body build an immune response to kill tumor cells.
  PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have non-small cell lung cancer.

Detailed description: OBJECTIVES:
  -  Determine the safety and feasibility of immunization with autologous tumor lysate-pulsed dendritic cell vaccine in patients with non-small cell lung cancer.
  -  Determine the immunologic response in patients treated with this vaccine.
  OUTLINE: Patients undergo surgery to remove all or most of the gross evidence of tumor. Two months after surgery (or 4 months if chemotherapy and/or radiotherapy are required), patients undergo leukapheresis. Peripheral blood mononuclear cells are isolated and cultured with interleukin-4 and sargramostim (GM-CSF) to generate dendritic cells (DC). DC are then pulsed with tumor lysate prepared from previously removed tumor. Patients receive autologous tumor lysate-pulsed DC vaccine subcutaneously twice, 4 weeks apart.
  Patients are followed every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter.
  PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 2 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of operable stage IB, II, or IIIA non-small cell lung cancer
  -  Tumor diameter of at least 3 cm
  PATIENT CHARACTERISTICS:
  Age:
  -  18 to 75
  Performance status:
  -  ECOG 0-2
  Life expectancy:
  -  At least 3 months
  Hematopoietic:
  -  WBC at least 3,000/mm^3
  -  Platelet count at least 100,000/mm^3
  Hepatic:
  -  Bilirubin no greater than 2.0 mg/dL
  -  AST less than 2 times upper limit of normal (ULN)
  -  Lactate dehydrogenase less than 2 times ULN
  -  Hepatitis B and C negative
  Renal:
  -  Creatinine no greater than 1.4 mg/dL
  Other:
  -  Positive cell mediated immunity test (i.e., greater than 5 mm induration in 48 hours with purified protein derivative (of tuberculin), candida, and mumps intradermal injection skin test)
  -  HIV negative
  -  No active systemic infection
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  At least 4 weeks since prior biological materials
  Chemotherapy:
  -  At least 4 weeks since prior cytotoxic or chemotherapeutic agents
  -  Concurrent chemotherapy allowed after surgery and before vaccination
  Endocrine therapy:
  -  No concurrent steroid therapy
  Radiotherapy:
  -  At least 4 weeks since prior radiotherapy
  -  Concurrent radiotherapy allowed after surgery and before vaccination
  Surgery:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer

Summary: RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. CT-guided radiofrequency ablation may be effective treatment for lung cancer.
  PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have refractory or advanced lung cancer.

Detailed description: OBJECTIVES:
  -  Determine the safety and toxicity of radiofrequency ablation in patients with refractory or advanced pulmonary malignancies.
  -  Determine the efficacy of this treatment, in terms of local control, in these patients.
  -  Determine whether CT scan is a reasonable imaging assessment tool for treatment delivery and follow-up in these patients.
  OUTLINE: Patients undergo percutaneous CT-guided radiofrequency ablation directly to the tumor over 2 hours.
  Patients are followed at 1, 3, 6, and 12 months.
  PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility: Inclusion Criteria:
  -  Diagnosis of a primary or secondary intrathoracic malignancy
  -  Any cell type or origin
  -  Involving the intrapulmonary, mediastinal, or pleural/chest wall
  -  Inoperable primary or metastatic cancer to the lung
  -  Refractory to or not amenable to conventional therapy (e.g., surgery, chemotherapy, or radiotherapy)
  -  Single or multiple lesions that are non-contiguous with vital structures or organs such as:
  -  Trachea
  -  Heart
  -  Aorta
  -  Great vessels
  -  Esophagus
  -  Less than 5 cm in largest dimension
  -  Accessible via percutaneous transthoracic route
  -  Hepatic:
  -  Coagulation profile normal

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Radiofrequency Ablation During Surgery in Treating Patients With Non-Small Cell Lung Cancer

Summary: RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Combining radiofrequency ablation with surgery may kill more tumor cells.
  PURPOSE: Phase II trial to study the effectiveness of combining radiofrequency ablation with surgery in treating patients who have stage I or stage II non-small cell lung cancer.

Detailed description: OBJECTIVES:
  -  Determine the acute effects of intraoperative radiofrequency tumor ablation (RFA) in patients with resectable non-small cell lung cancer.
  -  Determine the treatment-related toxicity in patients treated with this therapy.
  -  Determine the dimensions of the RFA lesion produced by the ablation procedure in these patients.
  OUTLINE: Patients undergo intraoperative radiofrequency tumor ablation over 10-15 minutes for each tumor immediately followed by tumor resection.
  PROJECTED ACCRUAL: A maximum of 20 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of malignant non-small cell lung cancer (NSCLC)
  -  Intraoperative needle biopsy confirmation allowed
  -  Resectable disease (stage I or II)
  -  All tissue to be treated by radiofrequency tumor ablation must be completely contained within boundaries of planned lung resection
  -  Medically fit to undergo lung resection
  PATIENT CHARACTERISTICS:
  Age:
  -  Over 18
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  Not pregnant or nursing
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No prior or concurrent biologic therapy
  Chemotherapy:
  -  No prior or concurrent chemotherapy
  Endocrine therapy:
  -  No prior or concurrent endocrine therapy
  Radiotherapy:
  -  No prior or concurrent radiotherapy
  Surgery:
  -  See Disease Characteristics
  Other:
  -  No other prior therapy for NSCLC

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Study of 111In-DAC as an Medical Imaging Agent for Lung Cancer and Brain Cancer Consistent With Metastatic Lung Cancer

Summary: The purpose of this study is to investigate the safety and imaging ability of 111In-DAC when used with planar and SPECT imaging for the detection of lung cancer and brain cancer consistent with metastatic lung cancer.


Eligibility: Inclusion Criteria
  Patients will be eligible for the study if they:
  -  Are male or non-pregnant, non-lactating females 18 years of age or older (must agree to use an appropriate and effective method of birth control during the study and for 2 weeks after study)
  -  Have an ECOG performance status of Zero or One
  -  Are being evaluated for known or suspected non-small-cell lung cancer (NSCLC), or known brain lesions consistent with metastatic lung cancer
  -  (For NSCLC patients)Have been previously scheduled for biopsy or surgical excision of the suspected NSCLC, or have a pathological diagnosis of lung cancer within 2 months of enrollment but have received no previous treatment
  -  (For brain cancer patients) Have clinical signs and symptoms consistent with a primary NSCLC with histological or cytopathological confirmation. Patients cannot have received previous treatment with radiation to the brain.
  -  Have signed an informed consent form
  Exclusion Criteria
  Patients will not be eligible for this study if they:
  -  Have a history or suspicion of significant allergic reaction or anaphylaxis to any of the 111In-DAC components
  -  Have a clinically unstable medical condition or opportunistic infection, a life-threatening disease state, impaired renal or hepatic function or are immunosuppressed
  -  Are taking or have taken part in any investigational study within 30 days of start of study
  -  Have received an indium agent within 30 days of start of study
  -  Are not able to remain immobile during scanning time
  -  Have taken drugs that may damage the kidneys within 2 weeks of start of study
  -  Have abnormal laboratory test results: hemoglobin<9.5 gms/dl, serum creatinine>1.5mg/100ml, alkaline phosphatase 2X the upper limit of normal
  -  Have undergone an excisional and/or needle localization biopsy within 4 days prior to study drug administration
  -  Have undergone a PET scan within 7 days prior to study drug administration
  -  Have any active or previously treated second malignancy except carcinoma in situ of the uterine cervix or non-melanoma skin cancer

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Study of S-3304 in Patients With Locally Advanced Non-Small Cell Lung Cancer

Summary: A study to measure the safety and effectiveness of S-3304 when given in combination with conventional chemo-radiation therapy in patients with locally advanced non-small cell lung cancer.

Detailed description: A two part study to evaluate the safety and efficacy of S-3304 in combination with standard therapy in patients with locally advanced non-small cell lung cancer. The first part of the study is a Phase I design to evaluate the maximum tolerated dose of S-3304 when given in combination with radiation and paclitaxel/carboplatin chemotherapy that is appropriate for further evaluation. The second part of the study is a randomized Phase II design to evaluate the efficacy of recommended S-3304 dose in combination with chemo-radiation.

Eligibility: INCLUSION CRITERIA
  -  newly diagnosed non-small cell lung cancer of stage IIIA non-resectable or of stage IIIB without pleural effusion
  -  ECOG performance status 0-1
  -  adequate organ function
  -  clinically indicated and able to receive conventional chemoradiation therapy
  EXCLUSION CRITERIA
  -  patients with prior history of cancer, other than basal cell carcinoma after appropriate treatment, or prior systemic chemotherapy treatment
  -  patients with other serious intercurrent illness including HIV/AIDS, or contraindicated for paclitaxel/carboplatin or thoracic irradiation treatment

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Study of the Feasibility to Derive Vaccine From Tumor Tissue in Patients With Non-Small Cell Lung Cancer

Summary: Antigenics is enrolling patients in a Phase II study testing the feasibility to derive an autologous investigational vaccine (HSPPC-96) from the tumor tissue of patients with resectable non-small cell lung cancer.
  Vaccine production will be attempted on all patients who undergo surgery and meet all inclusion/exclusion criteria.

Detailed description: Antigenics is enrolling patients in a Phase II study testing the feasibility to derive an autologous investigational vaccine (HSPPC-96) from the tumor tissue of patients with resectable non-small cell lung cancer.
  All patients will undergo surgery to remove the tumor and will be followed for recurrence and overall survival.
  The primary goal of this trial is to determine if HSPPC-96 can be made from the tumor tissue of patients with resectable non-small cell lung cancer.
  The secondary goals are to further characterize the safety and efficacy profile, to evaluate disease recurrence in patients receiving, and to evaluate overall survival in patients receiving HSPPC-96.
  HSPPC-96 is an investigational, immunotherapeutic agent made from an individual patient's own tumor, which is collected at the time of surgery. A portion of the tumor tissue is sent to Antigenics' manufacturing facility where it will undergo processing to create a vaccine. This vaccine may help the patient's immune system attack cancerous cells while leaving healthy cells alone.

Eligibility: This is a summary of criteria. Only the Principal Investigator can determine eligibility.
  Inclusion Criteria:
  -  Suspected non-small cell lung cancer, Stage IB, Stage II, or Stage IIIA
  -  Tumor size > 3x3 cm or equivalent to a 9 cm² lesion
  -  Scheduled surgery with curative intent
  -  At least 18 years of age
  -  Must not be pregnant or breast feeding
  -  Agree to not receive any other investigative agent at any time while enrolled in this study
  Exclusion Criteria:
  -  Previous treatment for non-small cell lung cancer
  -  Clinical signs or symptoms of brain metastases
  -  History of immune suppression or autoimmune disorder
  -  Severe active infection or other serious medical illness, that in the opinion of the Principal Investigator, would prevent study completion
  -  Other malignancies in the past 5 years, except adequately treated in situ cervix carcinoma or non-melanoma skin cancer

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Self-Gated Breath-Hold Technique for Helical Tomotherapy in Patients With Non-Small Cell Lung Cancer

Summary: Non-small cell lung cancer (NSCLC) is a disease that often cannot be surgically operated on. As a result, treating the tumor with radiation has become the main standard of treatment. Radiation therapy though, is limited by various factors, including the difficulty in properly imaging the lung tumor since the lung can move up to 4 cm between breathing in and out. Consequently, a radiation oncologist must consider a larger area of the lung to treat with radiation - increasing the amount of normal tissue exposed to harmful rays and therefore leading to increased side-effects. Two techniques being explored into improving tumor management while minimizing the side effects in NSCLC are breath-held gating and tomotherapy. Breath-held gating is a technique for consistently imaging the tumor at the right moment in a patient's breathing cycle - decreasing the normal tissue exposed to harmful radiation. Tomotherapy, a new technique in delivering radiation, will further allow the investigators to focus treatment on the tumor and exclude more normal tissues. Therefore, they hope that these methods will prove to be a better way in treating people with NSCLC.

Detailed description: Non-small cell lung cancer (NSCLC) is a disease that often presents as an unresectable tumor. As a result, radiotherapy is the main standard of treatment. Unfortunately, radiotherapy is limited by several factors, including that the lung can move up to 4 cm between inspiration and expiration. As a result, a radiation oncologist often has to widen his treatment field to include for this motion. This leads to greater side effects for the patient. Two techniques that are being explored to improve the tumor control of radiotherapy and to minimize side effects to normal tissues in NSCLC treatment include breath-held gating and tomotherapy. Breath-held gating will allow the investigators to treat patients at the right moment in their breathing cycle consistently - minimizing the normal tissue exposed to radiation. In addition, both gated breathing and tomotherapy will allow the investigators to create a more refined tumor volume treated and exclude more of the normal tissues. Consequently, they hope these methods will prove to be a better way to treat patients with non-resectable NSCLC.

Eligibility: Inclusion Criteria:
  -  Stage I-III NSCLC
  -  Karnofsky Performance Status (KPS) equal to or greater than 70
  -  Forced expiratory volume in 1 second (FEV1) equal to or greater than 1.0L
  Exclusion Criteria:
  -  Myocardial infarction (MI) disease
  -  Recurrent disease
  -  Complete tumour resection

Relevance to patient case: not relevant