patients randomized to this arm are given ringer's lactate solution for cardiopulmonary bypass prime, which is the standard practice

patients randomized to this arm are given Plasma Lyte - A solution for cardiopulmonary bypass prime

Cardiopulmonary Bypass

Plasma Lyte -A is administered intra operatively to maintain the hemodynamic status of patients

Plasmalyte A

Ringer's lactate is administered intra operatively to maintain the hemodynamic status of patients

Ringer Lactate

Comparative Analysis Between Ringer's Lactate vs Plasma Lyte-A as Cardiopulmonary Bypass Prime

Comparative Analysis Between Ringer's Lactate vs Acetate Containing Balanced Crystalloid Solution (Plasma Lyte-A) as Cardiopulmonary Bypass Prime

Arterial blood gas analysis at before induction, five minutes after CPB, at the end of the termination of CPB, half an hour stay in the ICU soon after the patient is shifted from completion of surgery, before the patient is extubated

Doniparthi Pradeep

Junior Resident, Department of General Surgery

Postgraduate Institute of Medical Education and Research

Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy

SU11248

Age, Customized

Sex: Female, Male

Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.

Objective Tumor Response Rate (Complete and Partial Response)

Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.

The Percentage of Patients Who Survive Progression Free for at Least 6 Months

Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

Overall Survival

Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1

Progression-free Survival

Grade 3 or higher adverse events were graded by CTC AE v 4.

Number of Participants With Grade 3 or Higher Adverse Events

Change in Pro-angiogenic Protein Levels

Changes in Serum and Plasma Angiogenesis Markers by Enzyme-linked Immunosorbent Assays

Overall Study

Angela M. Kuras, Associate Director of Administration and Operations

Ovarian Clear Cell Adenocarcinoma

Recurrent Ovarian Carcinoma

Laboratory Biomarker Analysis

Sunitinib Malate

University of Alabama at Birmingham Cancer Center

Providence Saint Joseph Medical Center/Disney Family Cancer Center

John Muir Medical Center-Concord Campus

Los Angeles County-USC Medical Center

USC / Norris Comprehensive Cancer Center

UCSF Medical Center-Mount Zion

John Muir Medical Center-Walnut Creek

University of Colorado Hospital

Smilow Cancer Hospital Care Center at Saint Francis

AdventHealth Orlando

Northside Hospital

Saint Alphonsus Cancer Care Center-Boise

Sudarshan K Sharma MD Limited-Gynecologic Oncology

Elkhart Clinic

Michiana Hematology Oncology PC-Elkhart

Elkhart General Hospital

Saint Vincent Hospital and Health Care Center

Community Howard Regional Health

IU Health La Porte Hospital

Michiana Hematology Oncology PC-Mishawaka

Saint Joseph Regional Medical Center-Mishawaka

Michiana Hematology Oncology PC-Plymouth

Memorial Hospital of South Bend

Michiana Hematology Oncology PC-South Bend

South Bend Clinic

Northern Indiana Cancer Research Consortium

Michiana Hematology Oncology PC-Westville

McFarland Clinic PC - Ames

University of Iowa/Holden Comprehensive Cancer Center

Maine Medical Center-Bramhall Campus

Michigan Cancer Research Consortium NCORP

Saint Joseph Mercy Hospital

Beaumont Hospital - Dearborn

Ascension Saint John Hospital

Green Bay Oncology - Escanaba

Hurley Medical Center

Genesys Regional Medical Center

Green Bay Oncology - Iron Mountain

Allegiance Health

Bronson Methodist Hospital

West Michigan Cancer Center

Borgess Medical Center

Sparrow Hospital

Saint Mary Mercy Hospital

Lakeland Hospital Niles

Saint Joseph Mercy Oakland

Lake Huron Medical Center

Ascension Saint Mary's Hospital

Lakeland Medical Center Saint Joseph

Marie Yeager Cancer Center

University of Mississippi Medical Center

Washington University School of Medicine

Cancer Research for the Ozarks NCORP

Mercy Hospital Springfield

CoxHealth South Hospital

Nebraska Methodist Hospital

Center of Hope at Renown Medical Center

Renown Regional Medical Center

Carolinas Medical Center/Levine Cancer Institute

Novant Health Presbyterian Medical Center

Atrium Health Cabarrus/LCI-Concord

Duke University Medical Center

Case Western Reserve University

MetroHealth Medical Center

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland Clinic Foundation

Riverside Methodist Hospital

Hillcrest Hospital Cancer Center

UH Seidman Cancer Center at Lake Health Mentor Campus

University of Oklahoma Health Sciences Center

Oklahoma Cancer Specialists and Research Institute-Tulsa

Abington Memorial Hospital

Geisinger Medical Center

Geisinger Medical Center-Cancer Center Hazleton

Geisinger Medical Group

Geisinger Wyoming Valley/Henry Cancer Center

Women and Infants Hospital

Parkland Memorial Hospital

Clements University Hospital

UT Southwestern/Simmons Cancer Center-Dallas

M D Anderson Cancer Center

Green Bay Oncology at Saint Vincent Hospital

Saint Vincent Hospital Cancer Center Green Bay

Green Bay Oncology Limited at Saint Mary's Hospital

Saint Vincent Hospital Cancer Center at Saint Mary's

Holy Family Memorial Hospital

Bay Area Medical Center

Aurora Saint Luke's Medical Center

Saint Vincent Hospital Cancer Center at Oconto Falls

Green Bay Oncology - Sturgeon Bay

Aurora West Allis Medical Center

Keimyung University-Dongsan Medical Center

Samsung Medical Center

Asan Medical Center

Seoul National University Hospital

Gangnam Severance Hospital

Korea Cancer Center Hospital

Sunitinib Malate in Treating Patients With Persistent or Recurrent Clear Cell Ovarian Cancer

A Phase II Evaluation of SU11248 (Sunitinib Malate) (NSC #736511) in the Treatment of Persistent or Recurrent Clear Cell Ovarian Carcinoma

National Cancer Institute (NCI)

NRG Oncology

Patients receive sunitinib malate PO QD on days 1-28 and hydroxychloroquine PO QD or BID on days 1-42 (beginning day 4 of course 1). Treatment repeats every 42 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Adult Solid Neoplasm

Hydroxychloroquine

Pharmacological Study

Dana-Farber Cancer Institute

Rutgers Cancer Institute of New Jersey

Sunitinib Malate and Hydroxychloroquine in Treating Patients With Advanced Solid Tumors That Have Not Responded to Chemotherapy

Autophagic Modulation With Anti-angiogenic Therapy in Patients With Advanced Malignancies: A Phase I Trial of Sunitinib and Hydroxychloroquine

Analyzed using Kaplan-Meier product limit method.

Mean or median changes estimated by t-test or Wilcoxon signed rank test. Multiple test adjustment will be considered to control the overall type-I error rate.

Perform using a (pre-post samples) paired t-test.

The correlation between the steady-state plasma concentration of HCQ and of autophagy inhibition and pharmacokinetic (PK) interaction will be assessed by regression analyses with treatment (sunitinib malate and +HCQ) as a stratification covariate in the model.

The correlation between the steady-state plasma concentration of HCQ and of autophagy inhibition and PK interaction will be assessed by regression analyses with treatment (sunitinib malate and +HCQ) as a stratification covariate in the model.

Mean or median changes examined by t-test or Wilcoxon signed rank test. Multiple test adjustment will be considered to control the overall type-I error rate.

Patients receive sunitinib malate PO QD in weeks 1-4. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients receive sunitinib malate PO QD in weeks 1, 2, 4, and 5. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Clear Cell Renal Cell Carcinoma

Recurrent Renal Cell Carcinoma

Stage III Renal Cell Cancer

Stage IV Renal Cell Cancer

Computed Tomography

Fluorothymidine F-18

Positron Emission Tomography

University of Wisconsin Hospital and Clinics

Sunitinib Malate in Treating Patients With Unresectable or Metastatic Kidney Cancer or Other Advanced Solid Tumors

Pharmacodynamic Study of Sunitinib Malate in Patients With Renal Cell Cancer and Other Advanced Solid Malignancies

malate

hypoxia

malate/hypoxia

Comparative Analysis Between Ringer's Lactate vs Plasma Lyte-A as Cardiopulmonary Bypass Prime

Sunitinib Malate in Treating Patients With Persistent or Recurrent Clear Cell Ovarian Cancer

Sunitinib Malate and Hydroxychloroquine in Treating Patients With Advanced Solid Tumors That Have Not Responded to Chemotherapy

Sunitinib Malate in Treating Patients With Unresectable or Metastatic Kidney Cancer or Other Advanced Solid Tumors

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