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    Participants who either do not have cancer but are at high risk for developing the disease or have had cancer and are at high risk for developing a new cancer.
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    These trials look at ways to improve the quality of life of cancer patients, especially those who have side effects from cancer and its treatment. They find new ways to help people cope with pain, nutrition problems, infection, nausea and vomiting, sleep disorders, depression and other health problems.
  • open for enrollment

    Intensity Modulated Accelerated Partial Breast Irradiation in Treating Older Patients with Hormone Responsive Stage 0-I Breast Cancer before Surgery

    Protocol: OSU-13282

    Eligibility:

    Inclusion Criteria:

    COHORT I:

    The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines

    Patient must be > 18 years

    The patient must have clinical node negative, stage I breast cancer

    The surgical treatment must be intended to be a lumpectomy

    The biopsy site must have been demarcated by a clip(s)

    Gross disease must be unifocal on mammogram (mammo)/magnetic resonance imaging (MRI) imaging

    Patient must be able to tolerate lying in the prone position with arms extended forward

    Must be able to tolerate MRI scan with contrast

    COHORT II: The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines

    COHORT II: Patient must be >= 60 years

    COHORT II: Core biopsy demonstrating breast cancer and receptors that are estrogen receptor (ER) or progesterone receptor (PR) positive

    COHORT II: Core tissue must have human epidermal growth factor receptor 2 (HER 2) testing

    COHORT II: The patient must have clinical node negative, stage I breast cancer

    COHORT II: The surgical treatment must be intended to be a lumpectomy

    COHORT II: The biopsy site must have been demarcated by a clip(s)

    COHORT II: Gross disease must be unifocal on Mammo/ MRI imaging

    COHORT II: Patients must have estrogen receptor (ER) and progesterone receptor (PR) analysis performed on core biopsy

    COHORT II: Patient must be able to tolerate lying in the prone position with arms extended forward

    COHORT II: Must be able to tolerate MRI scan with contrast

    COHORT II: At the time of enrollment, patients must have had bilateral mammograms within 6 months

    COHORT II: Patients must be willing to undergo breast cancer surgery minimally 4, maximally 6 weeks post APBI

    COHORT II: Patients with a history of non-breast malignancies are eligible if they have been disease free for 5 or more years prior to enrollment and are deemed by their physicians to be at low risk for recurrence; patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin

    Exclusion Criteria:

    COHORT II:

    Age < 60 years

    Hormone unresponsive breast cancer

    T-2 (> 3.0 cm), T-3, stage III, or stage IV breast cancer

    N-1, N-2, or N-3 pathologic axillary nodes

    Mastectomy intended

    Unwilling to undergo anti-endocrine therapy

    Suspicious microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign

    Non-epithelial breast malignancies such as sarcoma or lymphoma

    Paget’s disease of the nipple

    Proven multicentric carcinoma (invasive or ductal carcinoma in situ [DCIS]) in more than one quadrant or separated by > 4 centimeters

    Any prior treatment with radiation therapy, chemotherapy, biotherapy, or hormone therapy for the currently diagnosed breast cancer prior to study enrollment

    Prior breast or thoracic radiation therapy (RT) for any condition

    Psychiatric of addictive disorders or other condition that in the opinion of the investigator would preclude the patient from meeting the study requirements

    Principal Investigator: Julia White, MD

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  • open for enrollment

    Trametinib, Combination Chemotherapy, and Radiation Therapy in Treating Patients with Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

    Protocol: OSU-14034

    Eligibility:

    Inclusion Criteria:

    Patients must have histologically confirmed, newly diagnosed or recurrent from a previously treated early stage lung cancers that are locally confined, non-small cell lung cancers that are considered unresectable and for which chemoradiation will be considered definitive therapy; patients with recurrent cancer that is amendable for chemoradiation can be eligible only if patients with prior lobectomy for stage I cancer had not had adjuvant chemotherapy, and more than 8 weeks have elapsed from surgery to allow for wound healing; patients who recur from prior X-ray therapy (XRT) or stereotactic body radiation therapy (SBRT) will not be eligible

    Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan, magnetic resonance imaging (MRI), or calipers by clinical exam

    Prior thoracic radiation allowed only if there is minimal to no overlap with the treatment area estimated at the time of consultation, and there is no cumulative esophageal dose that exceeds more than 50% of the maximal acceptable dose tolerance

    Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

    Life expectancy of greater than 6 months

    Able to swallow and retain orally-administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels

    Absolute neutrophil count (ANC) >= 1.5 x 10^9/L

    Hemoglobin >= 9 g/dL

    Platelets >= 100 x 10^9/L

    Albumin >= 2.5 g/dL

    Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)

    Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN

    Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min

    Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN

    Left ventricular ejection fraction >= institutional lower limit of normal (LLN) by echocardiogram (ECHO) or multi gated acquisition scan (MUGA)

    Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the study participation, and for four months after the last dose of the drug; women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to registration and agree to use effective contraception throughout the treatment period and for 4 months after the last dose of study treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately

    Ability to understand and the willingness to sign a written informed consent document

    Activating Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation (any G12, G13, Q61) confirmed by Clinical Laboratory Improvement Amendments (CLIA)-certified testing

    The availability of formalin-fixed paraffin embedded archival tissue from core biopsy of tumors is recommended for exploratory analysis

    Exclusion Criteria:

    History of another malignancy

    Exception: patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligible; consult the Cancer Therapy Evaluation Program (CTEP) Medical Monitor if unsure whether second malignancies meet the requirements specified above

    History of interstitial lung disease or pneumonitis

    Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to enrollment

    Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of trametinib and during the study

    Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib, or excipients or to dimethyl sulfoxide (DMSO) or to either carboplatin or paclitaxel

    Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:

    Other anti-cancer therapy while on study treatment; (note: megestrol [Megace] if used as an appetite stimulant is allowed)

    Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis

    Concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)

    History or current evidence/risk of retinal vein occlusion (RVO)

    History or evidence of cardiovascular risk including any of the following:

    Left ventricular ejection fraction (LVEF) < LLN

    A QT interval corrected for heart rate using the Bazett’s formula corrected QT (QTcB) >= 480 msec

    History or evidence of current clinically significant uncontrolled arrhythmias (exception: patients with controlled atrial fibrillation for > 30 days prior to registration are eligible)

    History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to registration

    History or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system

    Treatment-refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mmHg which cannot be controlled by anti-hypertensive therapy

    Known cardiac metastases

    Known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (patients with chronic or cleared HBV and HCV infection are eligible); patients with human immunodeficiency virus (HIV) are not eligible if on anti-retroviral medications

    Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

    Pregnant women or nursing mothers; women of childbearing potential should be advised to avoid pregnancy and use effective methods of contraception; men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception; if a female patient or a female partner of a patient becomes pregnant while the patient receives trametinib, the potential hazard to the fetus should be explained to the patient and partner (as applicable)

    HIV-positive patients on combination antiretroviral therapy are ineligible

    Patients who do not consent for PK studies to be performed (alternatively: patients who initially consent to be on study but withdraws consent for PK study will be taken off study and replaced)

    Principal Investigator: Meng X Welliver, MD, PhD

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  • open for enrollment

    Paclitaxel and Carboplatin with or without Metformin Hydrochloride in Treating Patients with Stage III, IV, or Recurrent Endometrial Cancer

    Protocol: GOG-0286B

    Eligibility:

    Inclusion Criteria:

    Patients must have measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial carcinoma

    Histologic confirmation of the original primary tumor is required; patients with the following histologic epithelial cell types are eligible:

    • Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.)

    Measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1); measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI

    Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2

    Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl

    Platelets greater than or equal to 100,000/mcl

    Creatinine less than 1.4 mg/dl

    Bilirubin less than or equal to 1.5 x institutional/laboratory upper limit of normal (ULN)

    Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x ULN

    Alkaline phosphatase less than or equal to 2.5 x ULN

    Patients must NOT have received prior chemotherapy or targeted therapy, including chemotherapy used for radiation sensitization for treatment of endometrial carcinoma

    Patients may have received prior radiation therapy for treatment of endometrial carcinoma; prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, and/or intravaginal brachytherapy; all radiation therapy must be completed at least 4 weeks prior to the first date of study therapy

    Patients may have received prior hormonal therapy for treatment of endometrial carcinoma; all hormonal therapy must be discontinued at least one week prior to the first date of study therapy

    Patients must be able to swallow and retain orally-administered medication

    Patients must have signed an approved informed consent and authorization permitting release of personal health information; individuals with impaired decision-making capacity are not eligible to participate on the study

    Exclusion Criteria:

    Patients must NOT be taking metformin or have been on metformin in the past 6 months

    Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the last three years

    Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

    Patients who are pregnant or nursing; if patients are of reproductive age and have not undergone hysterectomy, they must use an effective contraceptive method for the duration of this study

    Any condition associated with increased risk of metformin-associated lactic acidosis; (e.g. congestive heart failure defined as New York Heart Association [NYHA] class III or IV functional status, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day)

    Principal Investigator: David M O'Malley, MD

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  • open for enrollment

    Stereotactic Body Radiation Therapy and Transarterial Chemoembolization in Treating Patients with Liver Cancer That Cannot Be Removed by Surgery

    Protocol: OSU-15032

    Eligibility:

    Inclusion Criteria:

    Patients must have a diagnosis of hepatocellular carcinoma by at least one criterion listed below:

    Histologically confirmed

    Magnetic resonance imaging (MRI) or computerized tomography (CT) findings consistent with hepatocellular carcinoma

    Alpha fetoprotein (AFP) > 400 ng/mL AND evidence of at least one solid liver lesion > 2 cm regardless of specific imaging characteristics on CT or MRI

    Patients must be non-transplantable, unresectable, or medically inoperable and eligible for TACE as determined by a multi-disciplinary team

    Absolute neutrophil count >= 1.5 × 10^9/L

    Hemoglobin >= 9 g/dl

    Platelets >= 50,000/mm^3

    Prothrombin time (PT)/international normalized ratio (INR) =< 1.5

    Albumin >= 2.5 g/dL

    Alkaline phosphatase < 5 x upper limit of normal (ULN)

    Total bilirubin =< 2.0 mg/dL

    Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 5 x ULN

    Creatinine =< 1.5 ULN OR calculated creatinine clearance >= 50 mL/min

    Must have Childs-Pugh A or B liver disease

    Patients must have no clinical signs of heart failure and meet New York Heart Association functional classification I or II defined as:

    Class I – patients with no limitation of activities; they suffer no symptoms from ordinary activities

    Class II – patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion

    Must have 1-3 liver lesions amenable to SBRT with tumor size < 15 cm (single lesion or sum)

    Must be able to undergo two MRI scans, one before study treatment begins and another shortly after SBRT

    Patients with extrahepatic disease, portal hypertension, or bilobar disease are allowed

    Within 2 weeks of registration: patients must have vital signs, history/physical examination, laboratory studies (complete blood count [CBC] with differential, chemistries including liver function tests, AFP, creatinine clearance [CrCl] assessment, pregnancy test if needed)

    Life expectancy of at least 12 weeks in the opinion of investigator

    Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

    Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed

    Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of the first administration of study treatment; urine human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment

    Women/men of reproductive potential must be counseled on contraception/abstinence while receiving the study treatment

    Exclusion Criteria:

    Childs-Pugh C liver function

    Major liver vascular invasion

    Prior radiation to the liver or other upper abdominal regions

    Must not have any evidence of bleeding diathesis or active gastrointestinal bleeding

    Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix; patients with a previous malignancy without evidence of disease for >= 3 years will be allowed to enter the trial

    History of active connective tissue disease (scleroderma)

    Subjects who are breast-feeding, or have a positive pregnancy test will be excluded from the study; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

    Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds)

    Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator; this could include severe, active co-morbidities such as:

    Uncontrolled cardiac disease (hypertension, unstable angina, myocardial infarction within last 6 months, uncontrolled congestive heart failure, cardiomyopathy with decreased ejection fraction)

    Acute bacterial or fungal infection requiring intravenous antibiotics at time of registration

    Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration

    Hepatic insufficiency resulting in jaundice and/or coagulation defects

    Principal Investigator: Terence M Williams, MD, PhD

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  • open for enrollment

    Maintenance Pembrolizumab vs Placebo after First-line Chemo in Pts w/ Metastatic Urothelial Cancer

    Protocol: OSU-16133

    Principal Investigator: Amir Mortazavi, MD

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  • open for enrollment

    Atezolizumab in Combo w/ Gemcitabine & Cisplatin as First-Line Tx in Met Urothelial Cancer

    Protocol: OSU-17141

    Principal Investigator: Amir Mortazavi, MD

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  • open for enrollment

    Chemotherapy and Pelvic Radiation Therapy with or without Additional Chemotherapy in Treating Patients with High-Risk Early-Stage Cervical Cancer after Radical Hysterectomy

    Protocol: RTOG-0724

    Eligibility:

    Inclusion Criteria:

    Patients must have undergone radical hysterectomy (open, laparoscopically or robotic) and staging including pelvic node sampling or dissection for cervical carcinoma within 70 days prior to study entry (NOTE: if the patient did not have a para-aortic lymph node sampling/dissection, but had common iliac node dissection that was negative, a positron emission tomography [PET]-computed tomography [CT] is recommended, but not required; a negative pre or post-operative PET scan or PET-CT scan of the para–aortic nodes is required if the patient did not undergo para-aortic or common iliac nodal sampling/dissection)

    Patients with clinical stage IA2, IB or IIA squamous, adenosquamous, or adenocarcinoma of the cervix who have any/all of the following high-risk features after surgery:

    Positive pelvic nodes

    Positive parametrium

    Positive para-aortic nodes- completely resected, PET/CT negative (PET only required if positive para-aortic nodes during surgery)

    No distant metastases, based upon the following minimum diagnostic workup (NOTE: patients with positive para-aortic nodes- completely resected, PET/CT negative are eligible):

    History/physical examination within 56 days prior to study entry

    Contrast-enhanced imaging of the abdomen and pelvis by either CT, magnetic resonance imaging (MRI), or whole body PET-CT (with or without contrast) within 90 days prior to registration (NOTE: whole body PET-CT is preferred)

    Chest x-ray (posterioranterior [PA] and lateral) or chest CT within 70 days prior to study entry (except for those who have had whole body PET-CT)

    Zubrod performance status 0-1

    Absolute neutrophil count (ANC) >= 1,800 cells/mm^3

    Platelets >= 100,000 cells/mm^3

    Hemoglobin >= 10.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable)

    White blood cell count >= 4000 cells/mm^3

    Serum creatinine =< 1.5 mg/dL within 14 days prior to study entry

    Bilirubin =< 1.5 times normal 14 days prior to study entry

    Alkaline phosphatase within upper limits of institutional normal within 14 days prior to study entry

    Alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) and/or aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) within upper limits of institutional normal within 14 days prior to study entry

    Patients with known human immunodeficiency virus (HIV) positive must have a cluster of differentiation (CD)4 cell count be >= 350 cells/mm^3 within 14 days prior to study entry (note, however, that HIV testing is not required for entry into this protocol)

    Patient must provide study-specific informed consent prior to study entry

    Exclusion Criteria:

    Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)

    Patients can not have any neuroendocrine histology in pathology

    Prior systemic chemotherapy for the current cervical cancer; note that prior chemotherapy for a different cancer is allowable

    Prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields

    Severe, active co-morbidity, defined as follows:

    Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

    Transmural myocardial infarction within the last 6 months

    Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study entry

    Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry

    Coagulation defects; note, however, that coagulation parameters are not required for entry into this protocol

    Prior allergic reaction to carboplatin, paclitaxel, and/or cisplatin

    Patients who have gross residual disease or distant metastatic disease

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  • open for enrollment

    MRI Before and During Surgery in Diagnosing Patients With Bladder Cancer

    Protocol: OSU-08063

    Eligibility:

    Inclusion Criteria:

    Patient with known bladder cancer

    Patient is scheduled for radical cystectomy and lymph node dissection

    Patient is able and willing to give valid written informed consent

    Patient has no contraindications to the MRI

    Exclusion Criteria:

    Women who are pregnant or planning to become pregnant during the trial

    Women who are breastfeeding

    Patient with allergy to contrast agent

    Patient with significant renal insufficiency, i.e. an estimated glomerular filtration rate (eGRF) less than 30 mL/min/1.73m^2

    Any condition conflict based on the investigation’s clinical judgment that would prevent the patient from completion all trial assessments and visits

    Inability or unwillingness to cooperate with requirements of this trial

    Patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the MR

    Patients with sickle cell anemia and other hemolytic anemia

    Principal Investigator: Michael V Knopp, MD, PhD

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  • open for enrollment

    Safety and Tolerability of GemRIS 225 mg in Subjects With Muscle-Invasive Bladder Cancer

    Protocol: OSU-16090

    Eligibility:

    Inclusion Criteria:

    Histological proof of muscle-invasive transitional cell carcinoma of the bladder

    (stage II-IIIb). Patients with evidence of metastatic nodal disease to the obuturator

    or presacral lymph nodes only may be included (N1 M0). Subjects with any degree of

    fixation of the pelvic sidewall are not eligible.

    Patient must have residual visible tumor following TURBT measuring no less than 3-cm.

    Adequate laboratory parameters.

    Subjects must be willing to undergo a cystoscopy on study for investigational product

    removal.

    Eligible for and willing to undergo radical cystectomy per the attending urologist.

    Subjects must be deemed ineligible for cisplatin-based combination chemotherapy by

    the attending medical oncologist.

    Subjects medically eligible for neoadjuvant cisplatin-based combination chemotherapy

    who refuse this therapeutic option and understand the risks and benefits of doing so.

    Prior radiation therapy is allowed provided that no radiation therapy was

    administered to the urinary bladder.

    Written informed consent and HIPAA authorization for release of personal health

    information.

    Age > 18 years at the time of consent.

    Exclusion Criteria:

    A history of prior malignancy, however the following are allowed:

    1. non-muscle invasive transitional cell carcinoma

    2. adequately treated basal cell or squamous cell skin cancer

    3. in situ cervical cancer

    4. Gleason < grade 7 prostate cancers

    5. Other cancer for which the subject has been disease-free for at least 5 years

    Prior systemic chemotherapy for transitional cell carcinoma of the bladder. Any other

    prior systemic chemotherapy for a non-urothelial carcinoma must have been completed >

    5 years prior to initiation of study.

    Previous exposure to gemcitabine instillations.

    Currently receiving other intravesical chemotherapy.

    Concurrent clinically significant infections as determined by the treating

    investigator.

    Presence of any bladder or urethral anatomic feature that in the opinion of the

    investigator may prevent the safe placement, indwelling use or removal of GemRIS.

    Documented history of vesicoureteral reflux or the presence of an indwelling ureteral

    stent or nephrostomy tube at the time of screening.

    Pelvic radiotherapy administered within less than 6 months prior to enrollment.

    Subjects who received radiotherapy ≥ 6 months prior to enrollment must demonstrate no

    cystoscopic evidence or symptoms of radiation cystitis.

    Bladder Post-Void Residual Volume (PVR) of > 250-mL.

    Active, uncontrolled urogenital bacterial, viral or fungal infections, including

    urinary tract infection. Subject must not have a UTI within one month prior to GemRIS

    Insertion Visit, Study Day 0. Skin/nail fungal infections are not exclusionary.

    Subjects with active shingles (varicella zoster infection) will be excluded from the

    study.

    History or presence of any significant cardiovascular, pulmonary, hepatic, renal,

    gastrointestinal, gynecological, endocrine, immunological, dermatological,

    neurological or psychiatric disease or disorder that, in the opinion of the

    investigator, contraindicates participation.

    History of diagnosis of neurogenic bladder.

    Concomitant immunosuppressive medications, such as methotrexate or TNF inhibitors,

    within 2 weeks of Study Day 0.

    Difficulty providing blood samples.

    Unwilling or unable to provide informed consent or comply with the requirements of

    this protocol, including the presence of any condition (physical, mental or social)

    that is likely to affect the subject's return for scheduled visits and follow-up.

    Other unspecified reasons that, in the opinion of the investigator or TARIS, make the

    subject unsuitable for enrollment.

    Principal Investigator: Kamal S Pohar, MD

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