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Clinical Index of Stable Febrile Neutropenia

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381. Safety and Effectiveness of Rilonacept for Treating Systemic Juvenile Idiopathic Arthritis in Children and Young Adults

collection, interview, and questionnaires. Urine collection may occur for some female participants. Other evaluations may be performed by the participant's regular doctor. Throughout the study, participants will maintain at-home diaries to record fever, morning stiffness and pain, when rilonacept or placebo was taken, any side effects experienced from treatment, and any additional medications that were taken. Study Design Go to Layout table for study information Study Type : Interventional (Clinical (...) that typically occurs before 16 years of age. SJIA usually involves heat, pain, swelling, and stiffness in the body's joints. It can also involve fever, rash, anemia, and inflammation in various parts of the body. Rilonacept is a drug that can reduce inflammation. The purpose of this study is to determine whether a rilonacept drug regimen initiated early is more effective than a similar rilonacept drug regimen initiated 4 weeks later when treating children and young adults with SJIA. Condition or disease

2007 Clinical Trials

382. Trial of Pemetrexed and Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal Cancer

Toxicities (DLTs) [ Time Frame: baseline through end of Phase 1 (up to 18 months) ] The following toxicities were considered DLT: CTCAE Grade 4 neutropenia (absolute neutrophil count [ANC] <0.5 × 10^9/L lasting ≥7 days. Febrile neutropenia (ANC <1.0 × 10^9/L, fever 38.5°C, and no documented infection). CTCAE Grade 4 thrombocytopenia (platelets <25.0 × 10^9/L). Any hemorrhage with CTCAE Grade ≥3 thrombocytopenia (50.0 × 10^9/L). CTCAE Grade ≥3 nonhematologic toxicity (excluding nausea, vomiting, or CTCAE (...) : Pemetrexed - Phase 1 Drug: Carboplatin - Phase 1 Drug: Pemetrexed - Phase 2 Drug: Carboplatin - Phase 2 Phase 1 Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 86 participants Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase 1 and 2 Clinical Trial of ALIMTA® (Pemetrexed) in Combination With Carboplatin in Patients With Recurrent

2007 Clinical Trials

383. An Investigational Drug, Palbociclib (PD-0332991), Is Being Studied In Combination With Velcade And Dexamethasone In Patients With Multiple Myeloma. Patients Must Have Received Prior Treatment For Multiple Myeloma.

1 up to Day 21 during Cycle 1 in schedule B ] MTD=highest dose level for which no more than 1 out of 6 participants experienced dose-limiting toxicity (DLT). DLT=any of the following treatment-related events: Absolute neutrophil count (ANC) less than (<)1000/microliter (mcL) (Grade 3 neutropenia) associated with documented infection/fever >=38.5degrees Celsius (C); Grade >=3 nonhematologic treatment-related toxicity, except those that were not maximally treated or considered tolerable, Grade 3 (...) : This is a Phase 1/2 study evaluating the safety and anti-tumor activity of PD 0332991 in combination with Velcade® [bortezomib] and dexamethasone in patients who have received at least one previous treatment for multiple myeloma. Condition or disease Intervention/treatment Phase Multiple Myeloma Drug: Bortezomib Drug: Dexamethasone Drug: PD 0332991 Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 53 participants Allocation: Non

2007 Clinical Trials

384. Phase 1 Study Of Aurora Kinase Inhibitor PF-03814735 In Patients With Advanced Solid Tumors

Criteria Adverse Events (CTCAE), Version 3 [ Time Frame: Day 1 up to Day 21 of first cycle ] DLT defined as any of the following during the first cycle of treatment and attributable to PF-03814735: Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) for >7 days or febrile neutropenia (ANC <1000/mm^3, fever ≥38 degrees Celsius; neutropenic infection (ANC <1000/mm^3); Gr 4 thrombocytopenia (platelets <25,000 cells/mm^3); ≥Gr 3 nausea, vomiting, or diarrhea, despite optimal (...) of aurora gene somatic mutations/amplification and pathway genes in relation to clinical response. Responses include CR: disappearance of all target lesions; PR: ≥30% decrease in sum of longest dimensions (LD) of target lesions referencing baseline sum LD; Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since Tx start or appearance of ≥1 new lesions; Stable disease: neither sufficient shrinkage to=PR nor sufficient increase to=PD during first 6 weeks after Tx

2007 Clinical Trials

385. Gemcitabine Plus Albumin-bound Paclitaxel In Patients With Advanced Metastatic Pancreatic Cancer

-limiting Toxicities [ Time Frame: Cycle 1 (Days 1-28) ] A dose-limiting toxicity (DLT) is defined as one or more of the following toxicities related to study drug during Cycle 1, according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3: Grade 4 neutropenia lasting >3 days in the absence of growth factor support; Grade 4 neutropenia associated with fever >38.5°C; Any other Grade 4 hematological toxicity; Grade 3 thrombocytopenia with hemorrhage (...) -related activities. Exclusion Criteria: Patient has known brain metastases unless previously treated and well controlled for at least 3 months (defined as stable clinically, no edema, no steroids and stable in two scans at least 4 weeks apart). Patient uses therapeutic coumadin for a history of pulmonary emboli and deep vein thrombosis (DVT). Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. Patient has known infection with human immunodeficiency

2006 Clinical Trials

386. LMB-2 to Treat Hairy Cell Leukemia

immunotoxin containing variable domains of MAb anti-Tac and truncated Pseudomonas exotoxin. A phase I trial at National Cancer Institute (NCI) found that the maximum tolerated dose (MTD) of LMB-2 was 40 microg/Kg intravenous (IV) given every other day for 3 doses (QOD x3). The most common adverse events were transient fever, hypoalbuminemia and transaminase elevations. In that trial, 4 of 4 patients with chemoresistant HCL had major responses, including one complete (CR) and 3 partial remissions (...) consolidation cycles, or 4 consolidation cycles if CR is with minimal residual disease. Dose level: LMB-2 40 microg/Kg QOD x3 Expected Accrual: 5-10 patients/year, total of 25 patients Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 15 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase II Clinical Trial of Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin for CD25

2006 Clinical Trials

387. Study of Dasatinib and Docetaxel in Metastatic Hormone Refractory Prostate Cancer

was defined as grade 4 neutropenia causing treatment interruption for >14 days, febrile neutropenia, grade 4 thrombocytopenia, grade 3 thrombocytopenia with a bleeding episode requiring platelet transfusion, nausea and/or vomiting despite medical intervention/prophylaxis causing treatment interruption for >14 days, grade 3-4 asthenia/fatigue, any other grade >=3 nonhematologic toxicity except alopecia or transient arthralgia/myalgia (unless unresponsive to intervention), or interruption of study drug (...) Response by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Pretreatment visit then every 6 weeks thereafter (up to 51.6 months) ] RECIST for target lesions: Complete Response (CR)=disappearance of clinical and radiologic evidence of target lesions. Partial Response (PR)=a 30% or greater decrease in the sum of the longest diameter (LD) of all lesions in reference to the baseline sum LD. Stable disease (SD)=neither sufficient increase to qualify for Progressive Disease (PD) nor

2007 Clinical Trials

388. A Study of ABT-263 in Subjects With Relapsed or Refractory Lymphoid Malignancies

in situ carcinoma of the cervix uteri; basal or squamous cell carcinoma; in situ carcinoma of the bladder; previous malignancy confined and surgically resected with curative intent. Evidence of other clinically significant uncontrolled condition(s), including, but not limited to active systemic fungal infection; diagnosis of fever and neutropenia with in 1 week prior to study drug. Received steroid therapy with in 7 days prior to 1st dose of study drug for anti-neoplastic intent. Received any anti (...) and Sezary syndrome or other indolent B-cell lymphomas such as marginal zone lymphoma; Received at least 1 prior chemotherapy treatment regimen (P1a/1b) and relapsed or refractory disease (P2a). Eastern Cooperative Oncology Group (ECOG) score of <= 1. Magnetic Resonance Imaging (MRI)/computed tomography (CT) negative for subdural or epidural hematoma w/in 28 days prior to first dose, if clinically indicated. Stable dose of Selective serotonin reuptake inhibitors (SSRI) antidepressants for at least 21

2006 Clinical Trials

389. A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)

[ Time Frame: Week 96 ] A qualifying relapse was defined as an increase of 2 points in at least one functional system of the expanded disability status scale (EDSS) or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement. Expanded disability status scale (EDSS) assesses disability in 8 functional (...) point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. Time to Disability Progression [ Time Frame: Baseline up to Week 96 ] Time to disability

2005 Clinical Trials

390. HuMax-CD20 in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients Failing Fludarabine and Alemtuzumab

or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349349 Sponsors and Collaborators GlaxoSmithKline Investigators Layout table for investigator information Study Director: GSK Clinical Trials GlaxoSmithKline More Information Go to Publications of Results: Other Publications: Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT (...) Type : Interventional (Clinical Trial) Actual Enrollment : 223 participants Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Single-arm, International, Multi-center Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With B-cell Chronic Lymphocytic Leukemia Who Have Failed Fludarabine and Alemtuzumab Study Start Date : June 2006 Actual Primary Completion Date : May 2008 Actual

2006 Clinical Trials

391. Study Evaluating SKI-606 (Bosutinib) In Advanced Malignant Solid Tumors

as tolerated and disease under study does not worsen. Outcome Measures Go to Primary Outcome Measures : Number of Participants With Dose-limiting Toxicities (DLT) in Part 1 [ Time Frame: Part 1 Baseline up to Day 28 ] DLT included any grade 3 or 4 clinically-evident non-hematologic toxicity, grade 4 neutropenia of greater than or equal to (>=) 7-day duration or with fever >= 38.5 degrees Celsius (febrile neutropenia); grade 4 thrombocytopenia >= 2-day duration or with bleeding requiring platelet (...) participants experienced DLT after 21 days of treatment (Cycle 1). DLT included any grade 3 or 4 clinically-evident non-hematologic toxicity, grade 4 neutropenia of >= 7-day duration or with fever >= 38.5 degrees Celsius (febrile neutropenia); grade 4 thrombocytopenia >= 2-day duration or with bleeding requiring platelet transfusion, any clinically-significant grade >= 2 toxicity that requires >=14 days to resolve (to =< grade 1) which occurred in first 21 days of study and considered at least possibly

2005 Clinical Trials

392. Systemic Lupus Erythematosus

Collaborating Clinic Index 2012 (SLICC'12) is more sensitive and may allow patients to be classified as having SLE earlier in the disease course. [ ] Investigations When SLE is suspected, useful screening investigations are urinalysis, FBC, ESR or plasma viscosity and antinuclear factor. : as initial test for proteinuria/haematuria. FBC and ESR: Mild normochromic normocytic anaemia is common. Anaemia in patients with lupus may be drug-induced or due to chronic disease, but it is sometimes due to haemolytic (...) , UK and European Guidelines. You may find the article more useful, or one of our other . In this article In This Article Systemic Lupus Erythematosus In this article Systemic lupus erythematosus (SLE) is a heterogeneous, inflammatory, multisystem autoimmune disease in which antinuclear antibodies occur (often years before clinical symptoms). [ ] Lupus erythematosus describes the typical rash of SLE and the term systemic emphasises the potential for multi-organ involvement. The cause of SLE

2008 Mentor

393. Candidiasis

): This is a form of systemic candidiasis, occurring in patients with a haematological malignancy and neutropenia. It develops during the recovery phase of a neutropenic episode. Clinical features are fever (unresponsive to broad-spectrum antibiotics), abdominal pain, tender hepatosplenomegaly, vomiting, dysphagia and jaundice. It may be a form of inflammatory immune reconstitution syndrome. Non-oesophageal GI candidiasis: This most commonly involves the stomach or small intestine. Candidal cholecystitis (rare (...) presentation). For neutropenic patients, fundoscopy should take place within a week of recovery from neutropenia. Test for treatment susceptibility. Blood cultures to assess for clearance of candidal infection daily or alternate days. If there are no complications, continue treatment for 2 weeks after the patient is clinically well, there is resolution of neutropenia and clearance from the bloodstream. Disseminated candidiasis (deep organ infection) General points Any internal organ, or multiple organs

2008 Mentor

394. Neutropaenic Patients and Neutropaenic Regimes

. 2013 May21(5):1487-95. doi: 10.1007/s00520-013-1758-y. Epub 2013 Feb 27. ; Predicting febrile neutropenic patients at low risk using the MASCC score: does bacteremia matter? Support Care Cancer. 2011 Jul19(7):1001-8. Epub 2010 Jul 2. ; A survey of the management of neutropenic fever in oncology units in the UK. Int J Antimicrob Agents. 2007 Apr29(4):430-3. Epub 2007 Feb 12. ; NICE Clinical Guideline (September 2012) ; NICE Evidence Services (UK access only) ; G-CSF and GM-CSF in Neutropenia. J (...) neutropenia patients although its use in the UK is still low. [ ] These are patients who are haemodynamically stable, who do not have acute leukaemia or evidence of organ failure, and who do not have pneumonia, an indwelling venous catheter or severe soft tissue infection. Quinolone with amoxicillin plus clavulanic acid is the preferred choice given the rise in Gram-positive febrile neutropenia episodes. [ ] Oral quinolone therapy should not be used in patients who have taken a quinolone antibacterial

2008 Mentor

395. The clinical effectiveness and cost-effectiveness of vinorelbine for breast cancer: a systematic review and economic evaluation

might result in more febrile neutropenia (15% versus 2%, P=0.001). Evidence from uncontrolled phase II studies appeared to complement the RCT findings but did not compensate for the lack of RCTs. These studies were compromised by potential biases, clinical diversity, statistical heterogeneity and a lack of precision. Cost information Four economic evaluations were included in the review. When comparing the cost-effectiveness of vinorelbine, paclitaxel and docetaxel, one study found vinorelbine (...) examined in the included trials. Funding NHS R&D Health Technology Assessment (HTA) programme, project number 00/15/03. Bibliographic details Lewis R, Bagnall A M, King S, Woolacott N, Forbes C, Shirran L, Duffy S, Kleijnen J, ter Riet G, Riemsma R. The clinical effectiveness and cost-effectiveness of vinorelbine for breast cancer: a systematic review and economic evaluation. Health Technology Assessment 2002; 6(14): 1-269 Original Paper URL Indexing Status Subject indexing assigned by NLM MeSH

2002 DARE.

396. Economic evaluation in a randomized phase III clinical trial comparing gemcitabine/cisplatin and etoposide/cisplatin in non-small cell lung cancer

of the analysis was that of the Spanish health care payer. Direct costs considered in the analysis included: hospitalisations (number of days due to drug administration, adverse events, diagnostic procedures, febrile neutropenia, and other reasons), transfusions, health care professional visits, (oncologist, general physician, emergency room, other visits), chemotherapy administration, concomitant medications, and radiotherapy. Since treatment did not extend beyond one year, discounting was not necessary (...) , Rosell R, Cardenal F, Anton A, Lomas M, Alberola V, Massuti B, Carrato A, Minshall M. Economic evaluation in a randomized phase III clinical trial comparing gemcitabine/cisplatin and etoposide/cisplatin in non-small cell lung cancer. Lung Cancer 2000; 28(2): 97-107 PubMedID Indexing Status Subject indexing assigned by NLM MeSH Aged; Antineoplastic Combined Chemotherapy Protocols /economics /therapeutic use; Carcinoma, Non-Small-Cell Lung /drug therapy /economics; Cisplatin /administration & Clinical

2000 NHS Economic Evaluation Database.

397. Economic evaluation of a randomized clinical trial comparing vinorelbine, vinorelbine plus cisplatin, and vindesine plus cisplatin for non-small-cell lung cancer

determined the sample size. Study design Randomised clinical trial based at 45 different sites in eight countries in Europe. All patients were treated until disease progression, unacceptable toxicity, stable disease for 18 weeks, or patient refusal. Analysis of effectiveness The analysis of the clinical study was based on intention to treat. The primary health outcome used was mean survival time for each of the treatment arms. Effectiveness results Vinorelbine alone resulted in a mean survival time (...) + cisplatin versus vindesine + cisplatin was $1,570; the incremental cost per patient of vindesine + cisplatin versus vinorelbine alone was $1,150; and the incremental cost per patient of vinorelbine + cisplatin versus vinorelbine alone was $2,700. The only toxicity that would incur significant cost, febrile neutropenia requiring hospitalization, occurred only 20 times during more than 9,000 weeks of chemotherapy experience and did not vary significantly among the three treatment arms. The cost of the two

1995 NHS Economic Evaluation Database.

398. Clinical practice guidelines for the management of advanced breast cancer

Clinical practice guidelines for the management of advanced breast cancer i Clinical practice guidelines for the management of advanced breast cancer Clinical practice guidelines for the management of advanced breast cancer Prepared by the iSource National Breast Cancer Centre Advanced Breast Cancer Working Group Endorsed January 2001ii Clinical practice guidelines for the management of advanced breast cancer © Commonwealth of Australia 2001 ISBN Print: 0642455457 Online: 0642455465 This work (...) Clinical practice guidelines for the management of advanced breast cancer has been endorsed without inclusion of a comparative economic analysis of the costs associated with their implementation. It is the understanding of the NHMRC that an up-to-date economic analysis will be included when the Clinical practice guidelines of the management of advanced breast cancer are next updated. This document is sold through AusInfo Government Info Bookshops at a price which covers the cost of printing

2000 Cancer Australia

399. Clinical practice guidelines for the management of early breast cancer

to I 298 6.2 cyclophosphamide, methotrexate and 5-fluoro- uracil (CMF) for both recurrence-free survival and overall survival at the increased risk of alopecia, cardiac toxicity and febrile neutropenia. 16.Dose intensity is important to outcome in II 311 6.2 adjuvant cytotoxic therapy, at least in dose ranges achievable without colony stimulating factor (CSF) support. 17.T reatment with high-dose chemotherapy outside II 314, 315 6.2 of clinical trials is not recommended. 18.Women should be fully (...) : AIHW (Cancer Series).12 Clinical practice guidelines for the management of early breast cancer Mortality Age-standardised rates have remained stable, at around 25–27 deaths per 100,000 woman-years between 1982 and 1996. 20 Survival The report Breast cancer survival in Australian women 1982–1994 showed that five-year relative survival in Australian women of all ages increased from 74.4 per cent in 1982–1987 to 78.9 per cent in 1988–1992. 21 Survival was best in women aged in their 40s and poorer

2001 Cancer Australia

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