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Search Results within category "Kidney & Urinary System"

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Suggestions within category "Kidney & Urinary System"


6 Study Matches

Single Arm Phase Ib/II Study of Durvalumab and Guadecitabine in Advanced Kidney Cancer: Big Ten Cancer Research Consortium(BTCRC-GU16-043) (PSCI 18-008)

This study is being done to test the safety of combining durvalumab with guadecitabine. It will also measure the percentage of patients whose tumor shrank after receiving durvalumab in combination with guadecitabine. Participants with kidney cancer that has spread to other parts of the body, also known as 'metastatic kidney cancer' will be recruited to participate.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03308396
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Inclusion Criteria:
Histological diagnosis of clear cell renal cell carcinoma (pure or mixed) with radiologic or histologic evidence of metastatic disease
Prior cancer treatment must be completed at least 14 dats prior to study registration and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to Grade 1 or less baseline
ECOG Performance Status 0-1 within 28 days prior to registration
Demonstrate adequate organ function based on necessary screening labs to be obtained within 28 days prior to registration
Females of childbearing potential must have a negative serum pregnancy test within 28 days prior to registration
Exclusion Criteria:
Active infection requiring systemic therapy
Brain metastases or spinal cord compression
Pregnant or breastfeeding
Treatment with any investigational drug within 14 days prior to study registration
Current or prior use of immunosuppresive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiologic doses
Kidney & Urinary System, Cancer
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Hershey, PA

A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of MitoGel™(UGN-101) on Ablation of Urothelial Carcinoma Lesions in the Upper Urinary Tract

This is a clinical trial, designed to determine safety & effectiveness of and patient reaction to the use of MitoGel™ in the upper urinary system of patients with non-invasive low-grade (LG), urotheilal cancer (UTUC)
Kathleen Lehman at klehman3@pennstatehealth.psu.edu or 717-531-5930
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02793128
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Inclusion Criteria:
At least one (1) measurable and biopsy-confirmed papillary Low Grade tumor, evaluated visually, ≤ 15 mm.
ECOG (Eastern Cooperative Oncology Group) performance status <3 (with Karnofsky >40).
Life expectancy greater than 24 months.
Adequate organ and bone marrow function as determined by routine laboratory tests
New or recurrent patients with LG, non-invasive UTUC in the pyelocalyceal system.
Exclusion Criteria:
Patient received BCG treatment for UC during the 6 months prior to Visit 1.
The patient has untreated concurrent urothelial cancer in other locations other than the target area (unless treated during screening).
Carcinoma in situ (CIS) in the past in the urinary tract.
Patient has a history of invasive urothelial carcinoma in the urinary tract during the past 5 (Five) years.
Patient is actively being treated or intends to be treated with systemic chemotherapy during the duration of the trial.
Kidney & Urinary System, Cancer
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Hershey, PA

Phase 1b Clinical Trial of Eribulin Mesylate and the PD-L1 Monoclonal Antibody, Avelumab, in Cisplatin Ineligible or Platinum Resistant Metastatic Urothelial Cell Cancer Patients (BTCRC-GU16-051)(PSCI 17-050)

This study is being done to test the safety of combining eribulin mesylate with avelumab. It will also measure the percentage of patients whose tumor shrank after receiving eribulin mesylate in combination with avelumab. Eribulin mesylate: Eribulin mesylate is a chemotherapy that attack cells when they are dividing. Microtubules are part of the cell's structure for dividing and copying itself; like scaffolding on a building. Eribulin blocks microtubules. By blocking the microtubule structures, the cell can’t divide and grow, which causes cell death. Avelumab: Researchers have found that the body’s natural immune system sometimes cannot control cancer growth on its own. Some cancer cells and immune cells make signals that stop the body’s immune system from killing the cancer. In other words, these signals from cancer cells put the brakes on the immune system. Immunotherapy drugs help to take the brakes off the immune system. Avelumab is a drug that blocks a cell signal called PD-L1. This allows the immune system to attack and kill cancer cells.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Stage IV locally advanced node positive or metatatic-M1 positive urothelial cancer of bladder and upper tract
Histologically proven urothelial cancer of bladder with prdominant transitional cell component
Presence of measurable disease per RECIST v1.1 for solid tumors
Patients who are treatment naive and cisplatin ineligible or platinum resistant as defined in the protocol
patients must be treatment naive for metastatic disease.
Exclusion Criteria:
Previous treatment with PD1 or PD-L1 inhibitor, including Avelumab
Previous systemic immunotherapy
History of another primary malignancy (except for malignancy treated with curative inten & no known active disease for greater than 5 years, adequately treated non-melanoma skin cancer, lentigo maligna or carcinoma insitu without evidence of disease
Current or prior use of immunosuppressive medication within 28 days before registration
Clinically significant cardiovascular disease
Kidney & Urinary System, Cancer
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Hershey, PA

Site For 18-025, EA8143 A Phase 3 Study Comparing Perioperative Nivolumab Vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy

Site For 18-025, EA8143 A Phase 3 Study Comparing Perioperative Nivolumab Vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03055013
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Inclusion Criteria:
Newly Diagnosed higher risk RCC of any histology
No clinical or radiological evidence of distant metastases
No concurrent or prior systemic or local anti-cancer therapy for RCC is permitted
Age must be greater than or equal to 18 years old
ECOG Performance status must be 0 or 1
Exclusion Criteria:
Women must not be pregant or breast feeding
History of RCC that was resected with curative intent within the past 5 years
Prior or current prostate cancer is excluded
Active known or suspected autoimmune disease
Uncontrolled adrenal insufficiency
Kidney & Urinary System, Cancer
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Hershey, PA

Renal medullary oxygenation and blood flow during sympathetic activation in humans

The purpose of this study is to assess kidney oxygen levels and blood flow in humans.
Aimee Cauffman at acauffman@pennstatehealth.psu.edu or 717-531-1617
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
21
•35 years old
Free of acute medical conditions
Not currently taking any heart medication
Non-smoker
resting BP of <140/90 mmHg
Exclusion Criteria:
under 21 years old
Pregnant or nursing women
History of heart or kidney disease
Metal implants affected by MRI
Claustrophobia
Kidney & Urinary System, Heart & Vascular
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Location
Hershey, PA

A Phase 2b, Single-Arm, Multicenter Trial to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients with Low Grade (LG) Non-Muscle-Invasive Bladder Cancer (NMIBC) at Intermediate Risk of Recurrence

This study is for patients with bladder cancer (low-grade non-muscle-invasive) who are at an intermediate risk of recurrence. The purpose of this study is to evaluate the effectiveness and safety of an experimental gel which will serve as a reservoir for a more prolonged release of a type of chemotherapy locally in the bladder.
Kathleen Lehman at klehman3@pennstatehealth.psu.edu or 717-531-5930
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03558503
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Inclusion Criteria:
Newly diagnosed or historic LG NMIBC (Ta) histologically confirmed by cold cup biopsy at screening or within 6 weeks of screening
At intermediate risk for progression, defined as having 1 or 2 of the following: a. presence of multiple tumors, b. solitary tumor >3 cm c. recurrence (≥ 1 occurrence of LG NMIBC within 1 year of the current diagnosis).
Negative voiding cytology for HG disease at or within 6 weeks of enrollment.
Exclusion Criteria:
History of CIS on preliminary cystoscopy within 5 years of enrollment.
Received BCG treatment for UC within previous 2 years.
History of HG papillary UC in the past [2] years
History of pelvic radiotherapy.
Past or current muscle invasive (i.e., T2, T3, T4) or metastatic UC or concurrent upper tract urothelial carcinoma (UTUC).
Kidney & Urinary System, Cancer
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Study Locations

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Location
Hershey, PA