araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Mitomycin C With Hyperthermia and Intravesical Mitomycin C to Treat Recurrent Bladder Cancer

Summary: Hypothesis: In selected patients external hyperthermia will be used in combination with intravesical Mitomycin-C (MMC) to treat recurrent transitional cell carcinoma (TCC) of the bladder after local resection and standard adjuvant therapy and thus prevent or delay recurrence and the need for radical cystectomy.

Detailed description: It is well established that tumor cells are sensitive to heat and when combined with a chemotherapeutic agent, drug uptake and intracellular distribution of drug within malignant cells is improved due to increased cellular permeability. Further, hyperthermia inhibits deoxyribonucleic acid (DNA) repair as a result of increased reaction between DNA and chemotherapy. By heating bladder tissue and accelerating the necessary series of reactions to link agents such as mitomycin C to cell DNA, this effect may be optimized. Depending on the extent of resection (and location, size, and depth of invasion of remaining tumor) after transurethral resection of the bladder tumor(TURBT), recommended adjuvant therapy consists of intravesical chemotherapy. MMC has been studied at doses as high as 80 mg without producing significant or irreversible side effects. The most commonly used dose of mitomycin is 40 mg.2
  This pilot study proposes to use Mitomycin C at a dose of 40 mg in conjunction with deep hyperthermia to enhance the effect intravesical chemotherapy as second-line treatment of recurrent TCC (Stage Ta, T1, or Tis) of the bladder after surgical resection and standard adjuvant therapy.

Eligibility: Inclusion Criteria:
  -  Non-muscle invasive transitional cell carcinoma (TCC) of the bladder (Ta, T1, Tis) recurrent after initial surgery and at least one round of adjuvant treatment (i.e. 6 weeks of intravesical biological therapy with Bacillus Calmette Guerin (BCG) solution); or
  -  An inability to tolerate BCG
  -  Age > 18
  -  Eastern Cooperative Oncology Group(ECOG) Performance Status 0-2
  -  Laboratory tests performed within 14 days of study enrollment:
  -  Leukocytes ≥ 3,200, Absolute Neutrophil count ≥ 1,500, Platelets ≥ 100,000
  -  Hemoglobin ≥ 9.0 gm/dL, Total bilirubin ≤ institution upper limit of normal *(ULN), Asparate Aminotransferase(AST) and Alanine Aminotransferase(ALT) ≤ 2.5 times ULN, Alkaline phosphatase ≤ 2.5 times ULN
  -  Creatinine ≤ 1.5 times ULN
  -  Women of child bearing potential must have a negative pregnancy test
  -  If post-menopausal - Amenorrhea for ≥ 12 months
  Exclusion Criteria:
  -  Pregnancy or breastfeeding
  -  Muscle invasive disease (T2-T4)
  -  Prior radiation to the pelvis
  -  Peripheral neuropathy (any grade)
  -  Thrombocytopenia, coagulation disorder or an increase in bleeding tendency due to other causes
  -  Known bladder fistula
  -  Hypersensitive or idiosyncratic reaction to mitomycin-C or its components in the past

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Quality of Life and Symptom Management in Patients With Bladder Cancer

Summary: RATIONALE: Learning about quality of life and symptom management in patients with bladder cancer may help doctors learn about the effects of treatment and plan the best treatment.
  PURPOSE: This clinical trial is studying of quality of life and symptom management in patients with bladder cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To identify aspects of health-related quality of life (HRQOL) and symptom management in patients with non-invasive, low- or high-risk bladder cancer.
  -  To obtain feedback on data collection methods to enhance acceptability in these patients.
  OUTLINE: Patients undergo a 10-minute screening in person or by phone to obtain demographic data and medical information (e.g., bladder cancer diagnosis and treatment history). Additional information is obtained from the clinical databases at the Baylor College of Medicine and the Michael E. DeBakey Veterans Affairs Medical Center. Patients who are eligible for the study are added to a waiting list for 1 of 4 focus groups based on disease status (high-risk or low-risk non-invasive bladder cancer) and gender. Patients participate in a 1.5- to 2-hour focus group discussion about the impact of bladder cancer on their quality of life and relationships. Patients receive information about community and Internet-based resources at the end of each group session.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of bladder cancer within the past 4 years
  -  Non-invasive disease
  -  Low- or high-risk disease
  -  Recruited from patients at the Baylor College of Medicine Scott Department of Urology clinics, the Michael E. DeBakey Veteran Affairs Medical Center, and the Urology Clinic at MD Anderson Cancer Center OR from participants at a community event
  PATIENT CHARACTERISTICS:
  -  Not pregnant
  -  Able to read, speak, and understand English
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Phase I/II Study of TSU-68 for Advanced Hepatocellular Carcinoma

Summary: The purpose of this study is to evaluate the safety and efficacy of Orantinib, an oral tyrosine kinase inhibitor of vascular endothelial growth factor receptor-2, platelet-derived growth factor receptor, and fibroblast growth factor receptor, in patients with advanced hepatocellular carcinoma (HCC).

Detailed description: As HCC is a highly vascular tumor, a number of antiangiogenic agents have been tested for the treatment of HCC. Orantinib is an orally administered, small-molecule, multiple receptor tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor-2 (VEGFR-2), platelet-derived growth factor receptor (PDGFR), and fibroblast growth factor receptor (FGFR). Phase I studies that have been conducted in Japan for patients with solid tumors recommended a dosage of 400 mg bid. As a potent antiangiogenic agent, Orantinib is also expected to be effective against HCC. However, because most HCC patients have accompanying liver cirrhosis or hepatitis, its safety must be reevaluated in the presence of liver function impairment.

Eligibility: Inclusion Criteria:
  -  Age 20-74
  -  PS 0-2
  -  Patients who did not respond to surgery, RFA, TAE, chemotherapy, or radiotherapy
  -  Chid-Pugh A or B
  -  At least one measurable lesion by RECIST criteria
  Exclusion Criteria:
  -  Large amount of pleural effusion or ascites
  -  Esophageal varices
  -  Simultaneously active double cancer

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Phase II Study of TKI258 in Advanced Urothelial Carcinoma

Summary: This study will evaluate the efficacy of TKI258 in patients with advanced urothelial cancer


Eligibility: Inclusion Criteria:
  -  Patients with transitional cell cancer of the bladder, urethra, ureter, or renal pelvis
  -  Patients who have archival tumor tissue available for FGFR3 mutational status screening
  -  Patients with progressive disease
  -  Patients with measurable disease by RECIST
  -  Patients previously treated with at least 1 but not more than 3 systemic cytotoxic regimens with at least one of these regimens including at least one of the following: cisplatin, carboplatin, gemcitabine or taxane administered in the perioperative or advanced setting
  -  Age ≥ 18 years
  -  WHO Performance Status ≤ 2
  -  Patients willing and able to take oral medication, follow scheduled visits, treatment plan and laboratory tests
  -  Patients with signed and witnessed informed consent form
  -  Patients with adequate organ function
  Exclusion Criteria:
  -  Patients with brain cancer
  -  Patients with other cancers except for certain skin, cervical & prostate cancers
  -  Patients who have not recovered from previous cancer treatment
  -  Patients who have severe and/or uncontrolled medical conditions which could affect participation in the study
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: possibly relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)

Summary: This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease progression on protocol D9902 part B (NCT00065442)


Eligibility: Inclusion Criteria:
  -  Objective disease progression
  -  Subjects must have been enrolled in the APC-Placebo arm of D9902B (NCT00065442)
  Exclusion Criteria:
  -  Infection requiring IV antibiotics
  -  Treatment with anticancer interventions within 14 days prior to enrollment
  -  Any medical condition which could compromise the study's objectives (discretion from sponsor)

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Masitinib in Relapse or Refractory Multiple Myeloma With t(4/14) Translocation Expressing or Not FGFR3

Summary: This phase 2 study was designed to assess the safety and efficacy of masitinib (AB1010) in patients with relapsing/refractory t(4;14) Multiple Myeloma. Response and progression were assessed according to the Bladé revised IMWG criteria1 from lowest point.


Eligibility: Inclusion Criteria:
  -  Confirmed multiple myeloma with a t (4; 14) translocation by FISH and PCR, expressing or not expressing FGFR3 identified by FACS
  -  Patients with Multiple Myeloma progressing or relapsing after at least two prior therapies (including conventional chemotherapy and/or high dose therapy) or who get a reduction of M-protein less than 75% within 3 months after a high dose treatment (Melphalan 200mg/m2) or after the plateau obtained for 3 months duration following to a conventional chemotherapy
  -  Patient with rapidly progressive disease with cytopenia and / or renal failure have to be stabilized with chemotherapy (if possible 3 cycles of VTD ( Bortezomib/Thalidomide/dexamethasone) or high dose Melphalan regimen followed by a 4 weeks washout period before the inclusion in the study.
  -  Patients must have a clearly detectable and quantifiable monoclonal M- component value (>5 g/l) in the serum and / or urine light chain excretion (>0,5 g/d)
  Exclusion Criteria:
  -  Prior corticosteroids within two weeks before enrolment
  -  Prior local irradiation within two weeks before enrolment
  -  Prior experimental or standard treatment (other than steroids and local irradiation) within 30 days before enrolment

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: PHA-739358 for the Treatment of Multiple Myeloma

Summary: The purpose of this study is to determine the antitumor activity of PHA-739358 as single agent IV infusion in adult patients with Multiple Myeloma who have a history of at least 2 previous lines of treatment for the disease.


Eligibility: Inclusion Criteria:
  -  active multiple myeloma progressing after at least 2 prior lines of treatment
  -  measurable disease
  -  t(4;14) translocation
  -  life expectancy of at least 3 months
  Exclusion Criteria:
  -  uncontrolled hypertension
  -  myocardial infarction, unstable angina, symptomatic congestive heart failure, cerebrovascular accident in the past 6 months.
  -  pregnancy or breast feeding
  -  active infections, including HIV

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis

Summary: The purpose of this study is to assess the long-term safety and effectiveness of botulinum toxin type A on patients with overactive bladder as a result of spinal cord injury or multiple sclerosis. This is a follow-up study to two Allergan sponsored studies (NCT00311376 and NCT00461292).

Detailed description: Botulinum toxin Type A 300U has been discontinued from the study. Patients remaining in the arm containing botulinum toxin Type A 300U will receive botulinum toxin Type A 200U moving forward. Also, the masking of the study is now open-label.

Eligibility: Inclusion Criteria:
  -  Patient has participated in study 191622-515 or 191622-516 and the following criteria fulfilled:
  -  Patient completed at least 52 weeks in the preceding study.
  -  No longer than 6 months has elapsed since completion of the preceding study
  -  Patient has not received any prohibited medications during any intervening period between the preceding study and this long-term study.
  Exclusion Criteria:
  -  History or evidence of pelvic or urologic abnormality.
  -  Previous or current diagnosis of bladder or prostate cancer.

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: A Study to Evaluate Add on Effect of Solifenacin in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks

Summary: The purpose of this study is to evaluate the rate of "add-on" solifenacin treatment and its persistency in men with over active bladder symptoms after tamsulosin monotherapy for 4 weeks.

Detailed description: This is a multi-center study to evaluate the efficacy, safety, and persistency of solifenacin treatment in male patients with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence who are receiving tamsulosin monotherapy for LUTS at a stable dose for 4 weeks in real life practice. Also proportion of patients and predictive factors with persistent OAB symptoms after tamsulosin monotherapy will be investigated.

Eligibility: Inclusion Criteria:
  -  IPSS ≥ 12
  -  Symptoms of OAB as verified by the V8 (≥8)
  -  Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:
  -  Mean urinary frequency ≥8 times/24 hours
  -  Mean number of micturition-related urgency episodes ≥3 episode/24 hours (with a Urinary Sensation Scale rating of ≥3 marked for the corresponding micturition in the bladder diary)
  Exclusion Criteria:
  -  Treatment within the 14 days preceding treatment with any alpha blocker drugs
  -  A known history of bladder outlet obstruction due to: bladder neck contracture, clinical suspicion of prostate carcinoma, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis or urethral tumor

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: A 12-Gene Blood-Based Signature for Detecting Metastatic Bladder Cancer

Summary: The purposes of this study is to evaluate a new genetic-based test which will identify patients diagnosed with muscle-invasive bladder cancer before their surgery, who might have specific genes, which will increase their chances of recurrence of cancer after their surgery.
  Some patients who are diagnosed with bladder cancer and have their had bladder removed, will have a recurrence of cancer sometime after their surgery. This recurrence is usually caused by tumor cells that originated from the bladder tumor and traveled to other parts of the body, which is called metastatic cancer. Some patients are more likely than others to have metastatic disease. This test may help in identifying these patients who might develop metastases from having these specific genes.


Eligibility: Inclusion Criteria:
  -  Patients in whom pelvic lymph node dissection can be performed;
  -  Any male and/or female, who is ≥18 years of age;
  -  Pathological diagnosis of urothelial carcinoma of the bladder;
  -  Localized muscle-invasive disease defined as clinical stage T2-4aN0M0 tumors;
  -  Did not receive neoadjuvant therapy;
  -  No radiographic evidence of metastatic disease on CT scans of the abdomen and pelvis, chest x-ray, or bone scan;
  -  Informed consent before study participation
  Exclusion Criteria:
  -  Prior systemic chemotherapy;
  -  Prior radiation therapy;
  -  A history of another ongoing malignancy within the past 5 years other than basal cell carcinoma of the skin

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant

Summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to chronic graft-versus-host disease in patients who have undergone donor stem cell transplant.
  PURPOSE: This phase I trial is studying chronic graft-versus-host disease in patients who have undergone donor stem cell transplant.

Detailed description: OBJECTIVES:
  -  To determine and define the biological basis of different subtypes of chronic graft-vs-host disease using a targeted single nucleotide polymorphisms approach in patients who have undergone allogeneic stem cell transplantation.
  OUTLINE: Two important aspects of the methodologies that will be employed for the analysis of SNPs associated with GVHD are throughput efficiency to be able to perform the assays on a reasonable number of samples as well as having the ability to add or remove SNPs to the assay panel. While a genome-wide association study to identify variants associated with GVHD would offer an unbiased approach, our patient cohort size would not allow significant statistical power in the study. Therefore, a more targeted approach using two established technologies is proposed.
  The Sequenome assay uses the unique combination of a single-base primer extension assay incorporating one of four modified nucleotides. The four modified nucleotides each have a unique mass that allows them to be distinguished from one another using mass spectrometry. Each SNP is determined analyzing the primer extension product from a PCR amplicon that surrounds the SNP of interest. The development of each assay involves designing flanking PCR primers and an internal extension assay using web-based software provided by Sequenome. The assays can be designed to analyze up to 30 SNPs in a single reaction, providing a customizable, efficient and high-throughput assay for SNPs of interest.

Eligibility: DISEASE CHARACTERISTICS:
  -  Underwent prior matched related or unrelated allogeneic stem cell transplantation (SCT)
  -  Presence OR absence of chronic graft-vs-host disease after day 100 and alive after day 180 post-transplantation
  -  No T-cell depleted SCT, cord blood transplantation, mismatched allogeneic transplantation, or autologous transplantation
  -  Available recipient and donor DNA (samples collected from the Vanderbilt University or the Fred Hutchinson Cancer Center tissue bank)
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

Summary: The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety.


Eligibility: Inclusion Criteria:
  -  Patients with histologically/cytologically confirmed advanced solid tumors with FGFR1 or FGFR2 amplification or FGFR3 mutation, for which no further effective standard anticancer treatment exists
  -  Adequate bone marrow function
  -  Adequate hepatic and renal function
  -  Adequate cardiovascular function
  -  Contraception.
  -  For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be nursing.
  -  For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment period
  Exclusion Criteria:
  -  Patients with primary CNS tumor or CNS tumor involvement
  -  Patients with history and/or current evidence of endocrine alteration of calcium-phosphate homeostasis
  -  History and/or current evidence of ectopic mineralization/ calcification including but not limited to the soft tissue, kidneys, intestine, myocard and lung with the exception of calcified lymphnodes and asymptomatic coronary calcification
  -  Current evidence of corneal disorder/ keratopathy incl. but not limited to bullous/ band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis etc., confirmed by ophthalmologic examination.
  -  History or current evidence of cardiac arrhythmia and/or conduction abnormality
  -  Women who are pregnant or nursing.
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: possibly relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Safety and Efficacy of TKI258 in Relapsed or Refractory Multiple Myeloma Patients, Who Are With or Without t(4;14) Chromosomal Translocation

Summary: This study will evaluate safety and efficacy of TKI258 in patients with relapsed or refractory multiple myeloma


Eligibility: Inclusion Criteria:
  1. Cytopathologically or histologically confirmed diagnosis of multiple myeloma previously requiring systemic treatment.
  2. Evidence of relapsed or refractory disease as documented from the prior treatment history. (Refractory myeloma is defined as disease that is non-responsive while on salvage therapy, or progresses within 60 days of last therapy. Relapsed myeloma is defined as previously treated myeloma which after a period of being off-therapy requires the initiation of salvage therapy. Detailed definitions provided in the PTS-1)
  3. Have received at least 2 prior treatment regimens for multiple myeloma including chemotherapy, autologous transplantation, immunotherapy, or other investigational agents. Pre-planned induction, followed by transplant and maintenance should be considered as one regimen.
  4. Presence of measurable disease as defined by at least one of the following;
  -  Serum M-protein ≥ 1g/dL (measurable disease)
  -  Urine M-protein ≥ 200mg/24 hours by protein electrophoresis (measurable disease)
  Exclusion Criteria:
  1. Patients with non-secretory, or oligosecretory, multiple myeloma.
  2. Patients with symptomatic amyloidosis, or with plasma cell leukemia.
  3. Patients who have received allogeneic stem cell transplantation and who show evidence of active graft-versus-host disease that requires immunosuppressive therapy.
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant