Kidney/Renal Cancer

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A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of Pembrolizumab (MK-3475) in Combination With Epacadostat (INCB024360) in Subjects With Selected Cancers (KEYNOTE-037/ ECHO-202)


Condition: Solid Tumors and Hematologic Malignancy, Endometrial Cancer, NSCLC (Non-small Cell Lung Carcinoma), HNSCC (Head and Neck Squamous Cell Cancer, Gastric Cancer, HCC (Hepatocellular Carcinoma), Lymphoma, Large B-Cell, Diffuse (DLBCL), CRC (Colorectal Cancer), Ovarian Cancer, RCC (Renal Cell Carcinoma), UC (Urothelial Cancer), Breast Cancer, Melanoma

Intervention:

  • Drug: MK-3475
  • Drug: INCB024360

Purpose: The purpose of this study is to assess the safety, tolerability, and efficacy when combining MK-3475 and INCB024360 in subjects with certain cancers. This study will be conducted in 2 phases, Phase 1 and Phase 2.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02178722

Sponsor: Incyte Corporation

Primary Outcome Measures:

  • Measure: Phase 1: Number of subjects with dose limiting toxicities (DLTs) of INCB024360 in combination with MK-3475
  • Time Frame: 56 days
  • Safety Issue:
  • Measure: Phase 2: Objective response rate
  • Time Frame: Assessed every 9 weeks for duration of study participation which is estimated to be 18 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Progression free survival
  • Time Frame: Response is measured every 9 weeks for duration of study participation which is estimated to be 18 months
  • Safety Issue:
  • Measure: Number of subjects with Adverse Events as a Measure of Safety and Tolerability of INCB024360 in combination with MK-3475
  • Time Frame: Adverse events are assessed every 3 weeks for duration of study participation which is estimated to be 18 months
  • Safety Issue:
  • Measure: Overall survival (OS)
  • Time Frame: Patients are checked for survival every 12 weeks for duration of study participation which is estimated to be 18 months
  • Safety Issue:

Estimated Enrollment: 508

Study Start Date: June 2014

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Subjects with histologically or cytologically NSCLC, melanoma, transitional cell carcinoma of the genitourinary (GU) tract, renal cell cancer, triple negative breast cancer, adenocarcinoma of the endometrium or squamous cell carcinoma of the head and neck (Phase 1).
  • Subjects with histologically confirmed melanoma, NSCLC, transitional cell carcinoma of the GU tract, TNBC, SCCHN, ovarian cancer, MSI high colorectal cancer (CRC), RCC, gastric cancer, HCC and DLBCL (Phase 2).
  • Life expectancy > 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0
  • 1.
  • Presence of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or Lugano Classification for subjects with DLBCL.
  • Laboratory and medical history parameters within protocol-defined range.
  • For Phase 1: Subjects who have advanced or metastatic disease as noted above that have received at least one prior therapy or have advanced or metastatic disease for which no curative treatment is available may be enrolled.
  • For Phase 2 expansion cohorts: Subjects with NSCLC, melanoma (checkpoint inhibitor naïve, primary refractory melanoma, relapsed melanoma), transitional cell carcinoma of the GU tract, SCCHN, ovarian cancer, MSI high CRC, RCC, DLBCL, and TNBC.
  • Phase 2 expansion: NSCLC
  • Subjects who have received at least 1 prior platinum-based therapy. Subjects who have a non-platinum-based regimen may be enrolled with medical monitor approval.
  • Tumors with epidermal growth factor receptor mutation positive or anaplastic lymphoma kinase fusion oncogene positive treated with a tyrosine kinase inhibitor are permitted; however, subjects should have progressed on or be intolerant to the targeted therapy.
  • Subjects must not have received immunotherapy with programmed death receptor-1 (PD-1) or cytotoxic T-lymphocyte antigen (CTLA-4) targeted therapy.
  • Phase 2 expansion: Melanoma
  • Documentation of V600E-activating BRAF mutation status.
  • Prior systemic therapy requirements.
  • Melanoma immune checkpoint-naïve: Subjects must not have received immunotherapy with anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy. Exception: Prior anti−CTLA-4 in the adjuvant setting would be permitted.
  • Primary refractory melanoma: Subjects must have received prior treatment with anti-PD-1 or anti-PD-L1 therapy (alone or as part of a combination) in the advanced or metastatic setting and have progressive disease as their best response to treatment that is confirmed 4 weeks later.
  • Relapsed melanoma: Subjects must have received prior anti−PD-1 or anti−PD-L1 therapy (alone or as part of a combination) in the advanced or metastatic setting and achieved partial response ore complete response but later have confirmed progressive disease.
  • Subjects enrolling in the primary refractory or relapsed melanoma must be willing to undergo mandatory pretreatment and on-treatment biopsies.
  • Ocular melanoma is excluded.
  • Phase 2 expansion: Transitional cell carcinoma of the GU tract
  • Metastatic or locally advanced and not amenable to curative therapy with disease progression on or after platinum-based chemotherapy or alternative therapy if platinum-based therapy is not appropriate.
  • Prior PD-1 or CTLA-4 targeted therapies are excluded
  • Phase 2 expansion: SCCHN
  • Histologically confirmed metastatic or recurrent squamous cell carcinoma not amenable to local therapy with curative intent (surgery or radiation with or without chemotherapy). Carcinoma of the nasopharynx, salivary gland, or * *Subjects must have received at least 1 prior systemic chemotherapy regimen that must have included a platinum-based therapy.
  • Prior PD-1 or CTLA-4 targeted therapies are excluded.
  • Phase 2 expansion: Ovarian cancer
  • Subjects with FIGO Stage Ic, Stage II, Stage III, Stage IV, recurrent, or persistent (unresectable) histologically confirmed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube carcinoma.
  • Subjects must have received a platinum-taxane-based regimen as first-line therapy.
  • Prior PD-1 or CTLA-4 targeted therapies are excluded.
  • Borderline, low-malignant-potential epithelial carcinoma per histopathology is excluded.
  • Phase 2 expansion: Relapsed or refractory DLBCL
  • Prior allogeneic stem-cell transplantation is excluded.
  • Must have received > or = 1 prior treatment regimen.
  • Not a candidate for curative therapy or hematopoietic stem-cell transplantation (either due to disease burden, fitness, or preference).
  • Prior PD-1 or CTLA-4 targeted therapies are excluded.
  • Phase 2 expansion: TNBC
  • Histologically confirmed breast adenocarcinoma that is unresectable loco regional, or metastatic
  • Pathologically confirmed as triple negative, source documented, defined as both of the following:
  • Estrogen receptor (ER) and progesterone receptor (PgR) negative.
  • Human epidermal growth factor receptor 2 (HER2) negative as per American Society of Clinical Oncology/College of American Pathologists guidelines.
  • Subject must have received at least 1 prior systemic regimen for advanced or metastatic disease
  • Prior PD-1 or CTLA-4 targeted therapies are excluded.
  • Phase 2 expansion: RCC
  • Subjects with histological or cytological confirmation of clear cell RCC.
  • Not curable by surgery.
  • Subjects must have received prior antiangiogenic therapy.
  • Subjects must not have received prior immunotherapy with anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy.
  • Phase 2 expansion: MSI high CRC
  • Subjects with histological confirmation of locally advanced unresectable or metastatic MSI high CRC.
  • MSI status is, respectively, determined by examining CRC tumor.
  • Subjects may have received no more than 2 lines of prior therapy for advanced disease.
  • Phase 2 expansion: Gastric Cancer
  • Must have histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.
  • Must have progression on or after therapy containing platinum/fluoropyrimidine or refused standard therapy.
  • Subjects may have received no more than 2 lines of prior therapy for advanced disease.
  • Prior PD-1 or CTLA-4 targeted therapies are excluded.
  • Phase 2 expansion: HCC
  • Must have histologically or cytologically confirmed diagnosis of HCC (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible).
  • Barcelona Clinic Liver Cancer (BCLC) Stage C disease (Llovet et al 1999), or BCLC Stage B disease.
  • Subjects may have received no more than 2 lines of prior therapy for the advanced disease
  • Must have progressed on, refused, or were intolerant of sorafenib.
  • The following are excluded: Subjects with liver transplants, clear invasion of the bile duct or main portal branch(es), or hepatorenal syndrome, or subjects who have required esophageal variceal ablation within 28 days of starting study treatment.
  • Prior PD-1 or CTLA-4 targeted therapies are excluded.
  • Tumor biopsies are required. If a subject has inaccessible lesions, such as in ovarian cancer, HCC, or gastric cancer, or highly vascular lesions, such as RCC, enrollment may be considered with medical monitor approval, and archived tissue may be acceptable.
  • Females of child-bearing potential and males who use adequate birth control through 120 days post dose.

Exclusion Criteria:

  • Subjects who participated in any other study in which receipt of an investigational study drug or device occurred within 2 weeks or 5 half-lives (whichever is longer) prior to first dose.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). Exception: Prior anti−CTLA-4 in the adjuvant setting for subjects with melanoma would be permitted.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable.
  • Has an active autoimmune disease.
  • Has evidence of noninfectious pneumonitis that required steroids or current pneumonitis.
  • Live vaccine use within 30 days of first dose of study medication.
  • Monoamine oxidase inhibitors.

Contact:

  • Incyte Call Center
  • 1-855-463-3463

Locations:

  • UC San Diego Moores Cancer Center
  • La Jolla California 92093 United States
  • The Angeles Clinic and Research Institute
  • Los Angeles California 90025 United States
  • US Davis Cancer Center
  • Sacramento California 95817 United States
  • University Of Colorado Cancer Center
  • Aurora Colorado 80045 United States
  • University of Connecticut Health Center Carole And Ray Neag Comprehensive Cancer Center
  • Farmington Connecticut 06030-1601 United States
  • Miami Cancer Institute at Baptist Health, Inc
  • Miami Florida 33176 United States
  • Georgia Cancer Specialists affiliated with Northside Hospital Cancer Institute
  • Atlanta Georgia 30342 United States
  • The University of Chicago Medicine
  • Chicago Illinois 60637 United States
  • St. Francis Cancer Center
  • Topeka Kansas 66618 United States
  • Greater Baltimore Cancer Center
  • Baltimore Maryland 21204 United States
  • St. Agnes Hospital Cancer Institute
  • Baltimore Maryland 21229 United States
  • The Center for Cancer and Blood Disorders (RCCA MD LLC- Maryland Division)
  • Bethesda Maryland 20817 United States
  • University of Michigan Hospital and Health Systems
  • Ann Arbor Michigan 48109 United States
  • Health Partners Institute
  • Saint Louis Park Minnesota 55426 United States
  • Hackensack University Medical Center - John Theurer Cancer Center
  • Hackensack New Jersey 07601 United States
  • The Christ Hospital Hematology Oncology, Lindner Research Center
  • Cincinnati Ohio 45219 United States
  • University of Pennsylvania Hospital
  • Philadelphia Pennsylvania 19104 United States
  • Fox Chase Cancer Center
  • Philadelphia Pennsylvania 19111-2497 United States
  • University of Pittsburgh Medical Center Hillman Cancer Center
  • Pittsburgh Pennsylvania 15232 United States
  • Greenville Health System Cancer Institute
  • Greenville South Carolina 29605 United States
  • West Cancer Center
  • Germantown Tennessee 38120 United States
  • Sarah Cannon Research Institute at Tennessee Oncology
  • Nashville Tennessee 37203-2173 United States
  • University Of Texas Southwestern Medical Center At Dallas
  • Dallas Texas 75390 United States
  • Virginia Cancer Specialists
  • Arlington Virginia 22031 United States

View trial on ClinicalTrials.gov


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Kidney Cancer DNA Registry


Condition: Renal Cancer

Intervention:

  • Other: salvia for germline DNA
  • Behavioral: the Kidney Cancer Questionnaire
  • Behavioral: Family History Questionnaire (when applicable)

Purpose: This registry will help us develop better methods of: - Preventing these cancers - Diagnosing these cancers - Treating these cancers

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT02087852

Sponsor: Memorial Sloan Kettering Cancer Center

Primary Outcome Measures:

  • Measure: establish a kidney cancer registry
  • Time Frame: 5 years
  • Safety Issue:

Estimated Enrollment: 750

Study Start Date: March 2014

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Kidney Cancer Case Cohort:
  • Must be ≥ 18 years of age AND
  • Must be an English-speaker AND
  • Must have a diagnosis or suspicion of kidney cancer Family Member Cohort:
  • Must be ≥ 18 years of age AND
  • Must be an English-speaker AND
  • Must be a blood relative of the proband. Family members of probands including mother, father, sisters, brothers, half-sisters, half-brothers, daughters, sons, grandmothers, grandfathers, as well as aunts and uncles are eligible. These individuals need not have kidney cancer, as they will be used for segregation analysis of suspected variants found in the proband; requesting DNA from relatives is required. Control Cohort:
  • Must be ≥ 18 years of age AND
  • Must be an English-speaker AND
  • Must not have a personal history of cancer, with the exception of nonmelanoma skin cancer, AND
  • Must not be a blood relative of any cases or controls enrolled in this study

Exclusion Criteria:

  • Patients who, in the opinion of the primary MSKCC clinician or the investigator, have a condition that precludes their ability to provide an informed consent

Contact:

  • Jonathan Coleman, MD
  • 646-422-4432

Location:

  • Memorial Sloan Kettering Cancer Center
  • New York New York 10065 United States

View trial on ClinicalTrials.gov


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Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney, a Phase II Clinical Trial (FASTRACK II)


Condition: Renal Cell Carcinoma

Intervention:

  • Radiation: SABR

Purpose: This study is evaluating the activity and efficacy of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of kidney cancers.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02613819

Sponsor: Trans-Tasman Radiation Oncology Group (TROG)

Primary Outcome Measures:

  • Measure: Activity and efficacy of SABR measured by Freedom from local progression assessed by RECIST Criteria
  • Time Frame: 12mths post treatment
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Tolerability of SABR Assessed as cummulative incedents of severe toxicity by CTCAE v4
  • Time Frame: From date of treatment commencement until first documented progression or date of death from any cause, whichever came first, assessed from 4wks, 3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mth post treatment
  • Safety Issue:
  • Measure: Estimated Survival after SABR assessed by clinincal assessment
  • Time Frame: assessed up to 60 months
  • Safety Issue:
  • Measure: Estimated Distant Failure Rate after SABR assessed by CT scan and clinical assessment
  • Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed from 6 mths, 9 mths, 12 mths, 18mths, 33 mths, 42 mths, 51 mths, and 60 mths post treatment
  • Safety Issue:
  • Measure: Renal Function Change after SABR assessed by split renal function and GFR
  • Time Frame: Baseline, 12mths post treatment, and 24 mths post treatment
  • Safety Issue:
  • Measure: Renal Function Change after SABR assessed by using eGFR
  • Time Frame: Baseline,3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mths
  • Safety Issue:

Estimated Enrollment: 70

Study Start Date: July 2016

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Age > 18 years old
  • All patients must have a biopsy confirmed diagnosis of renal cell carcinoma with a single lesion within a kidney
  • Eastern Cooperative Oncology Group (ECOG) performance of 0-2 inclusive.
  • Life expectancy > 9 months
  • Either medically inoperable, technically high risk for surgery or decline surgery.
  • Multidisciplinary decision for active treatment

Exclusion Criteria:

  • Pre-treatment estimated glomerular filtration rate < 30 mls/min
  • Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Delivery of targeted agents (such as sunitinib) are allowable only when at least 7 days separate the delivery of the proposed agent and the delivery of the stereotactic radiotherapy.
  • Previous high-dose radiotherapy to an overlapping region
  • Tumours of larger than 8cm is size

Contact:

  • Rebecca Montgomery
  • +61 2 40143911

Location:

  • Peter MacCallum Cancer Centre
  • East Melbourne Victoria 3000 Australia

View trial on ClinicalTrials.gov


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Study of PSMA-targeted 18F-DCFPyL PET/CT in the Evaluation of Patients With Renal Cell Carcinoma


Condition: Renal Cell Carcinoma, Kidney Cancer

Intervention:

  • Drug: 18F-DCFPyL
  • Procedure: PET/CT

Purpose: In this study the investigators aim to evaluate diagnostic utility of PSMA-targeted 18F-DCFPyL PET/CT in patients with renal cell carcinoma.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02687139

Sponsor: Johns Hopkins University

Primary Outcome Measures:

  • Measure: Sensitivity of 18F-DCFPyL PET/CT for the detection of sites of metastatic renal cell carcinoma found on conventional imaging
  • Time Frame: 12 months
  • Safety Issue:

Estimated Enrollment: 30

Study Start Date: October 2015

Eligibility:

  • Age: minimum 18 Years maximum 100 Years
  • Gender: All

Inclusion Criteria:

  • Clinically diagnosed or histologically proven stage II-IV renal cell carcinoma
  • Completed staging evaluation with computed tomography (CT) or magnetic resonance imaging (MRI) of the chest, abdomen and pelvis ≤90 days prior to study enrollment

Exclusion Criteria:

  • History of other malignancy diagnosed within the last 3 years (with the exception of low risk prostate cancer, ductal carcinoma in situ of the breast, squamous cell carcinoma or basal cell carcinoma of the skin)
  • Administered a radioisotope within 5 physical half-lives prior to study enrollment
  • Pregnancy ((as determined in accordance with the policies of the positron emission tomography (PET) center))
  • Intention to enroll in a blinded therapeutic clinical trial following Positron emission tomography-computed tomography (PET/CT)

Contact:

  • Michael A. Gorin, M.D.
  • (410) 614-8151

Location:

  • Johns Hopkins Hospital
  • Baltimore Maryland 21287 United States

View trial on ClinicalTrials.gov


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Phase I Trial of Stereotactic Body Radiotherapy (SBRT) of the Primary Tumor in Renal Cell Carcinoma (RCC)


Condition: Primary Tumor, Renal Cell Carcinoma

Intervention:

  • Radiation: Stereotactic Body Radiotherapy (SBRT)

Purpose: The purpose of this study is to evaluate the safety and efficacy of the use of stereotactic body radiotherapy (SBRT) for the treatment of the primary tumor in renal cell carcinoma (RCC) in medically inoperable patients and/or patients who refuse surgery. Standard treatment of RCC is surgery. A number of non-surgical treatments of RCC are also available, but are highly invasive and are associated with significant side effects. SBRT is a non-invasive, non-surgical treatment that requires tumor immobilization and image guidance in order to deliver a very precise, high-dose treatment. This trial will assess the use of SBRT to treat primary renal tumors by determining the maximum tolerated dose and toxicity. Subjects enrolled in this study will then be followed and evaluated for toxicity, serum chemistry, complete blood count, and urinalysis. In addition, they will undergo renal scans to assess the functionality of their renal tissue.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02410174

Sponsor: Beth Israel Medical Center

Primary Outcome Measures:

  • Measure: Local Failure
  • Time Frame: up to 10 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Regional Nodal Failure
  • Time Frame: up to 10 years
  • Safety Issue:
  • Measure: Metastases
  • Time Frame: up to 10 years
  • Safety Issue:
  • Measure: Overall survival
  • Time Frame: up to 10 years
  • Safety Issue:
  • Measure: Serum Creatinine Level
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: 24 Hour Creatinine Clearance
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Results of Tc-99m Glucoheptonate Renal Scan
  • Time Frame: 1 year
  • Safety Issue:

Estimated Enrollment: 3

Study Start Date: May 2012

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Any patient with a primary renal cell carcinoma (RCC) tumor who is inoperable for technical (i.e surgical) or medical reasons
  • Patient must be screened by a urologic surgeon to verify eligibility on the above basis
  • Biopsy proof of RCC is preferred; however, in current practice the diagnosis is often clinical based on characteristic imaging. If there are compelling clinical reasons not to proceed with biopsy, the clinical diagnosis will suffice.
  • Patient with metastases are eligible if in the opinion of the treating physicians the patient could benefit from treatment of the primary renal tumor.
  • ECOG performance status 0-2
  • Age ≥18 years
  • Signed informed consent

Exclusion Criteria:

  • Inadequate renal function, as measured by creatinine clearance calculated from 24 hour urine collection. Creatinine clearance values of at least 50 ml/min are required
  • Prior attempt at curative treatment of this primary kidney tumor
  • Inability to lie still for approximately 1 hour in immobilization device
  • Presence of a connective tissue disorder other than rheumatoid arthritis.
  • Pregnancy
  • Inability to develop a radiation treatment plan that adheres to the dose constraints described below in Radiotherapy Treatment Planning section.

Locations:

  • Mount Sinai Beth Israel Hospital
  • New York New York 10003 United States
  • Mount Sinai Roosevelt Hospital
  • New York New York 10014 United States

View trial on ClinicalTrials.gov


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Robot-Assisted Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage : Clinical Outcomes of a Randomised Controlled Trial


Condition: Renal Cell Carcinoma

Intervention:

  • Procedure: zero ischemia robot-assisted laparoscopic RFA assisted TE
  • Procedure: zero ischemia robot-assisted laparoscopic partial nephrectomy

Purpose: To evaluate the feasibility and efficiency of zero ischemia robot-assisted laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with robot-assisted laparoscopic partial nephrectomy without hilar clamping.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02924597

Sponsor: RenJi Hospital

Primary Outcome Measures:

  • Measure: The absolute change in glomerular filtration rate (GFR) of the affected kidney
  • Time Frame: baseline and 12 months
  • Safety Issue:
  • Measure: The changes of estimated GFR (eGFR)
  • Time Frame: baseline and 12 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: estimated blood loss
  • Time Frame: during surgery
  • Safety Issue:
  • Measure: changes in GFR of total kidneys by renal scintigraphyby
  • Time Frame: baseline and 12 months
  • Safety Issue:
  • Measure: surgical margin
  • Time Frame: postoperative,up to 2 weeks after surgery
  • Safety Issue:
  • Measure: postoperative complications
  • Time Frame: postoperative,up to 30 days
  • Safety Issue:
  • Measure: progression-free survival
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: local recurrence
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: operative time
  • Time Frame: During surgery
  • Safety Issue:
  • Measure: Hospital stay time
  • Time Frame: The time from the surgery day to patient discharge, up to 2 weeks
  • Safety Issue:
  • Measure: changes in GFR of total kidneys by renal scintigraphyby of 6 month
  • Time Frame: baseline and 6 months
  • Safety Issue:

Estimated Enrollment: 100

Study Start Date: January 2016

Eligibility:

  • Age: minimum 15 Years maximum 80 Years
  • Gender: All

Inclusion Criteria:

  • patients with sporadic, unilateral, newly diagnosed T1a presumed renal cell carcinoma
  • patients scheduled for robot-assisted laparoscopic nephron sparing surgery
  • patients with normal contralateral renal function (differential renal function of >40% as determined by radionuclide scintigraphy)
  • patients agreeable to participate in this long-term follow-up study

Exclusion Criteria:

  • patients' aged >80 years
  • patients with other renal diseases,(including kidney stone, glomerular nephritis, etc.) which might affect the renal function of the operative kidney
  • patients not able to tolerate the robot-assisted laparoscopic procedure
  • patients with previous renal surgery or history of any inflammatory conditions of the operative kidney
  • patients with the renal tumor involving urinary collecting system

Contact:

  • Jin Zhang, PhD.
  • +8618801967501

Location:

  • Ethics Committee of Shanghai Renji Hospital
  • Shanghai Shanghai China

View trial on ClinicalTrials.gov


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A Randomized Phase II Trila of Sunitinib Four-weeks on/Two-weeks Off Versus Two-weeks on/One-week Off as First Line Therapy in Metastatic Renal Cell Carcinoma.


Condition: Metastatic Renal Cell Carcinoma

Intervention:

  • Drug: Sunitinib

Purpose: Sunitinib given at 50 mg/day on schedule 4/2 (4 weeks on treatment, 2 weeks off) is the standard care for first-line treatment of metastatic renal cell carcinoma, but the schedule was reported with a high rate of dose reduction and dose discontinuation because of the safety profile. So investigators conducte this randomized, multi-center phase II study to determine whether a sunitinib regimen of 50 mg/day 2-weeks on/1-week off could provide the same efficacy in terms of progression-free survival, objective response, and overall survival, while reducing drug-related toxicity.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02398552

Sponsor: Beijing Cancer Hospital

Primary Outcome Measures:

  • Measure: progress-free survival (PFS)
  • Time Frame: 2 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: The percentage of patients who can get complete response, partial response.
  • Time Frame: 2 years
  • Safety Issue:

Estimated Enrollment: 80

Study Start Date: March 2015

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 75 Years
  • Gender: All

Inclusion Criteria:

  • Age≥18 years, ≤75 years, male or female
  • Advanced renal cell carcinoma is diagnosed histologically or pathologically
  • Treatment naive at diagnosed
  • At least one measurable tumor lesion (Response Evaluation Criteria In Solid Tumors)
  • Eastern Cooperative Oncology Group(ECOG) performance scale is 0 or 1
  • The expected life span is ≥12 weeks
  • No contraindications for targeted therapy, with enough liver function and renal function and normal ECG recording Peripheral hemogram: neutrophil≥1.5×109/L, Plt≥100×109/L, Hgb≥90g/L Renal function: serum creatinine≤1.5 folds the upper limit of normal (ULN) For patients with non-metastatic liver dysfunction:alanine aminotransferase and aspartate aminotransferase≤2.5 ULN, For patients with metastatic liver dysfunction: alanine aminotransferase and aspartate aminotransferase≤5 ULN
  • The patients participate voluntarily and have signed the informed consent form

Exclusion Criteria:

  • Patients who have received any systemic therapy including targeted therapy,immunotherapy,chemotherapy etc at diagnosed.
  • Pregnant and lactating women, or female patients of child-bearing age without taking contraceptive measures
  • Patients with severe acute infection without being controlled effectively or having pyogenic and chronic infections with persistently unhealed wounds
  • Past history of serious heart diseases, including: cardiac function classification ≥NYHA class II, unstable angina pectoris, myocardial infarction, arrhythmia requiring anti-arrhythmic drug therapy (excluding β-blockers or digoxin), and uncontrolled hypertension
  • Patients with a history of HIV infection or active phase of chronic hepatitis B/C
  • negative imaging examination result 4 weeks prior to enrollment)
  • Epilepsy patients requiring drug therapy (e.g. steroids or antiepileptic drugs)
  • A history of allogeneic organ transplantation

Contact:

  • Chuanliang Cui, MD
  • 0086-10-88196951

Locations:

  • Chinese acadamy of medical science cancer institute & hospital
  • Beijing Beijing 100021 China
  • Peking University First Hospital
  • Beijing Beijing 100034 China
  • Beijing Cancer Hospital
  • Beijing Beijing 100142 China
  • Sun Yat-sen university cancer center
  • Guangzhou Guangdong 510060 China
  • Cancer Hospital, Fudan University
  • Shanghai Shanghai 200032 China
  • Tianjin medical university cancer institute & hospital
  • Tianjin Tianjin 300060 China

View trial on ClinicalTrials.gov


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