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Study Objectives
The purpose of this study is to assess the efficacy of a PARP inhibitor, rucaparib, in progressing breast cancer patients and who are carrying a BCRAness profile defined by genomic signature or BRCA 1 or 2 somatic mutation, without known BRCA 1 or 2 germline mutation.
Intervention / Treatment
DRUG: rucaparib
| Inclusion Criteria:
* Women with histologically proven breast cancer.
* No Her2 over-expression.
* Progressive metastatic disease previously treated with at least one line of chemotherapy at the metastatic setting.
* Molecular analysis using the Affymetrix (CytoScan HD, SNP *0, or OncoScan) array available from the SAFIR02 protocol, or from other programs.
* BRCAness profile as defined by the Clovis genomic signature or BRCA1/2 somatic mutation (without known germline BRCA).
* Age ≥ 18 years
* WHO Performance Status 0/1
* Presence of measurable target lesion according to RECIST criteria v*1
* Patients will have had at least a 21-day wash-out period from last chemotherapy or targeted therapy administration prior to inclusion and should have recover (grade ≤1) from all residual toxicities, excluding alopecia.
* Potentially reproductive patients must agree to use an effective contraceptive non-hormonal method or practice adequate methods of birth control or practice complete abstinence while on treatment, and for at least 6 months after the last dose of study drug.
* Women of childbearing potential must have a negative serum pregnancy test done within 14 days of enrollment and/or urine pregnancy test 72 hours prior to the administration of the study drug.
* Women who are breastfeeding should discontinue nursing prior to the first dose of study drug and until 6 months after the last dose.
* Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
* Patient with social insurance coverage.
Exclusion Criteria:
* BRCA1 or 2 germline known mutation.
* Life expectancy <3 months.
* Less than 14 days from radiotherapy (whatever the indication). Fields should not have involved all target lesions.
* Patients previously treated with a PARP inhibitor.
* Spinal cord compression and/or symptomatic or progressive brain metastases (unless asymptomatic or treated and stable off steroids for at least 30 days prior to start of study drug).
* Patients with all target lesions in a previously irradiated region, except if clear progression has been observed prior to study in at least one of them
* Inability to swallow
* Major problem with intestinal absorption
* Previous or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin.
* Evidence of severe or uncontrolled systemic disease (active bleeding diatheses, or active Hepatitis B, C and HIV)
* Previous history of myelodysplastic syndrome
* History of hypersensitivity to active or inactive excipients of the rucaparib.
* Toxicities of grade ≥2 from any previous anti-cancer therapy, with the exception of alopecia.
* Altered haematopoietic or organ function, as indicated by the following criteria:
* Polynuclear neutrophils <*5 x 10⁹/L
* Platelets <100 x 10⁹/L
* Haemoglobin <90 g/L
* ALAT/ASAT >*5 x upper limit of normal (ULN) in the absence of or >5 x ULN in the presence of liver metastases
* Bilirubin >*5 x ULN
* Creatinine clearance ≤30 mL/min (measured or calculated by Cockcroft and Gault formula
* Women who are pregnant.
* Patients using drugs that are known potent inhibitors or potent inducers of CYP1A2 or CYP3A4 are not eligible if those treatments cannot be substituted before inclusion
* Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.
* Individuals deprived of liberty or placed under the authority of a tutor. |
Study Objectives
The most popular surgical treatment of peritoneal cancer is the type known as hyperthermic intraperitoneal chemoperfusion (HIPEC), a type of cytoreductive surgery for which a significantly high survival rate has been demonstrated by several studies. It is widely known that HIPEC entails severe physiological changes and precautions during anesthesia. However, very few studies have systematically outlined and organized these changes for each system, and most existing studies only report retrospective data or are limited to gynecological surgeries. Therefore, the present researchers planned a prospective observational study to determine the physiological changes that occur in patients during HIPEC cytoreductive surgeries performed in the colon and rectal surgery department of the investigators hospital. The investigators planned to monitor the patients' body temperature, metabolism, cardiovascular and respiratory changes during HIPEC cytoreductive surgery and analyze the anesthetic methods applied to identify the optimal anesthetic management strategy for HIPEC cytoreductive surgeries.
Intervention / Treatment
DRUG: HIPEC cytoreductive surgery
| Inclusion Criteria:
* Adult patients 20 years of age or older who will undergo HIPEC cytoreductive surgery at the colon and rectal surgery department of our hospital
Exclusion Criteria:
* Cases in which there is a sudden change of surgery plans, or those in which consent forms are retracted. |
Study Objectives
The primary hypothesis to be tested is:
The detection of breast cancer will be increased with tomosynthesis (3D) imaging
Intervention / Treatment
DEVICE: Tomosynthesis, DEVICE: Conventional
| Inclusion Criteria:
* Female
* Any ethnic origin
* No contraindication for routine bilateral mammography
Exclusion Criteria:
Potential subjects with any of the following will not be enrolled in the study:
* Any contraindications to mammographic screening, including, but not limited to:
* Significant existing breast trauma
* Under the age of 30 at the time of consent
* Breast Implants
* Prior Surgeries
* Unable to understand and execute written informed consent
* Pregnant
* Lactating |
Study Objectives
This is a randomized phase III open-label, multicenter trial evaluating standard induction therapy (daunorubicin \[DNR\] and cytarabine \[Ara-C\]) and consolidation therapy (high-dose cytarabine \[HDAC\]) with or without dasatinib in adult patients with newly diagnosed CBF-AML
Intervention / Treatment
DRUG: Dasatinib, DRUG: Cytarabine, DRUG: Daunorubicin, DRUG: Idarubicin
| Inclusion Criteria:
* Core-binding factor (CBF) AML with molecular diagnosis of RUNX1-RUNX1T1 fusion transcript resulting from t(8;21)(q22;q*1) (or a variant form) or of CBFB-MYH11 fusion transcript resulting from inv*(p*1q22)/t(16;16)(p*1;q22) as assessed in one of the central AMLSG reference laboratories (Ulm, Hannover)
* Age ≥ 18; there is no upper age limit
* No prior chemotherapy for leukemia except hydroxyurea for up to 5 days during the diagnostic screening phase
* Non-pregnant and non-nursing. Due to the unknown teratogenic potential of dasatinib in humans, pregnant or nursing patients may not be enrolled. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 mIU/mL with-in 72 hours prior to registration. Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control - one highly effective method (e.g., IUD, hormonal, tubal ligation, or partner's vasectomy), and one additional effective method (e.g., latex condom, diaphragm, or cervical cap) - AT THE SAME TIME, at least four weeks before she begins dasatinib therapy. "Women of childbearing potential" is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months.
* Men must agree not to father a child and must use a latex condom during any sexual contact with women of childbearing potential while taking dasatinib and for 3 months after therapy is stopped, even if they have undergone a successful vasectomy.
* Signed written informed consent.
Exclusion Criteria:
* Performance status WHO >2
* Pulmonary edema and/or pleural/pericardial effusion within 14 days of day * If edema/effusion resolves to CTC Grade ≤1, patients can be treated with dasatinib.
* Patients with ejection fraction <50% by echocardiography within 14 days of day 1
* Organ insufficiency (creatinine >*5x upper normal serum level; bilirubin, AST or AP >*5x upper normal serum level; heart failure NYHA III/IV; severe obstructive or restrictive ventilation disorder)
* Uncontrolled infection
* Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy, if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year.
* Severe neurological or psychiatric disorder interfering with ability of giving an informed consent
* Known positive for HIV, active HBV, HCV, or Hepatitis A infection
* Bleeding disorder independent of leukemia
* No consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician and/or other physicians involved in the treatment of the patient about study participation.
* No consent for biobanking. |
Study Objectives
This is an open label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture bb2121 chimeric antigen receptor (CAR) modified T cells. Prior to bb2121 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.
Intervention / Treatment
BIOLOGICAL: bb2121
| Inclusion Criteria:
Eligibility is determined prior to leukapheresis. Subjects must satisfy the following criteria to be enrolled in the study:
* Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
* Documented diagnosis of multiple myeloma
* Must have received at least 3 prior MM treatment regimens. Note: induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen.
* Must have undergone at least 2 consecutive cycles of treatment for each regimen, unless PD was the best response to the regimen.
* Must have received a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.
* Must be refractory to the last treatment regimen.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or *
* Subjects must have measurable disease, including at least one of the criteria below:
* Serum M-protein greater or equal to *0 g/dL
* Urine M-protein greater or equal to 200 mg/24 h
* Serum free light chain (FLC) assay: involved FLC level greater or equal to 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal
* Recovery to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy.
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
* Subjects with known central nervous system involvement with myeloma.
* History or presence of clinically relevant central nervous system (CNS) pathology.
* Subjects with active or history of plasma cell leukemia.
* Subjects with solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease
* Inadequate organ function
* Ongoing treatment with chronic immunosuppressants
* Previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or BCMA targeted therapy
* Evidence of human immunodeficiency virus (HIV) infection.
* Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV)
* Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV) and Hepatitis C virus (HCV)
* Subjects with a history of class III or IV congestive heart failure (CHF) or severe non-ischemic cardiomyopathy, history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months.
* Subjects with second malignancies in addition to myeloma if the second malignancy has required therapy in the last 3 years or is not in complete remission
* Pregnant or lactating women.
* Subject with known hypersensitivity to any component of bb2121 productThe presence of any of the following will exclude a subject from enrollment:
* Subjects with known central nervous system involvement with myeloma. * History or presence of clinically relevant central nervous system (CNS) pathology.
* Subjects with active or history of plasma cell leukemia. * Subjects with solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease * Inadequate organ function * Ongoing treatment with chronic immunosuppressants * Previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or BCMA targeted therapy * Evidence of human immunodeficiency virus (HIV) infection. * Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV) and Hepatitis C virus (HCV) * Subjects with a history of class III or IV congestive heart failure (CHF) or severe non-ischemic cardiomyopathy, history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months. * Subjects with second malignancies in addition to myeloma if the second malignancy has required therapy in the last 3 years or is not in complete remission * Pregnant or lactating women. 13 Subject with known hypersensitivity to any component of bb2121 product, cyclophosphamide, fludarabine, or tocilizumab. |
Study Objectives
BKM-120 is a drug that may slow the growth of cancer cells. This drug has been used in laboratory experiments and information from those research studies suggests that this drug may help to slow the growth of renal cancer cells. In this research study, the investigators are testing the safety to BKM-120 at different dose levels. The investigators will also be studying how well tolerated BKM-120 is, and how effective BKM-120 can be in the treatment of kidney cancer.
Intervention / Treatment
DRUG: BKM-120 Bevacizumab
| Inclusion Criteria:
* Metastatic RCC with clear cell component or papillary RCC
* Life expectancy > 12 weeks
* Must have failed at least 1 prior anti-VEGF systemic therapy for metastatic RCC
Exclusion Criteria:
* Prior treatment with a P13K inhibitor or bevacizumab
* Untreated brain metastases
* Acute or chronic liver or pancreatic disease
* Major mood disorder
* Concurrent severe and/or uncontrolled medical condition
* Diabetes mellitus
* GI disease
* Currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant
* Pregnant or breastfeeding
* HIV positive
* History of another malignancy within 3 years except cured basal cell carcinoma of the skin or excised in situ carcinoma of the cervix
* Uncontrolled hypertension |
Study Objectives
This study will explore the information needs of patient's with advanced cancer, and their carers, when making a decision to commence or discontinue parenteral nutrition. Interviews will be conducted with both patients with advanced cancer, and their carers to determine the information they need to make a shared decision with the healthcare team.
Intervention / Treatment
OTHER: Non-interventional study
| Inclusion Criteria:
* Adults aged 18 years and over
* Fluent English speaker
* Is aware of diagnosis of advanced cancer
* Patient considering starting PN, is currently receiving PN or has previously received PN OR
* Carer of a patient considering, receiving or who has received PN
* NHS patient
* Assessed as having capacity to give consent and participate
* Current patient at one of the recruiting hospital sites
Exclusion Criteria:
* Private patients |
Study Objectives
The purpose of this study is to observe the number of new cases of infections per population in a given time period and their characteristics in a pathology (myelodysplastic syndrome, MDS)that involves ineffective production (or dysplasia) of a class of blood cells.
Intervention / Treatment
DRUG: Antibiotic and antifungal drugs
| Inclusion Criteria:
* All adult patients (>18 years) with newly diagnosed myelodysplastic syndrome or patients who have undergone a bone marrow reevaluation;
* Signed written informed consent;
Exclusion Criteria:
* Psychiatric patients;
* Patients with life expectancy less than three months. |
Study Objectives
The purpose of this research study is to determine if the addition of dutasteride to a regimen with abiraterone acetate and prednisone will improve on therapy in patients with castrate-resistant prostate cancer and metastatic disease. This study will also help determine the side effects of the study treatment and how often they occur.
Intervention / Treatment
DRUG: Abiraterone acetate, DRUG: Dutasteride, DRUG: Prednisone
| Inclusion Criteria:
* Diagnosis of adenocarcinoma of the prostate
* Castrate resistant disease
* Metastatic disease
* Normal organ and marrow function
* Subjects with partners of childbearing potential must be willing to use adequate methods of birth control
Exclusion Criteria:
* Uncontrolled intercurrent illness
* Uncontrolled hypertension
* Active or symptomatic viral hepatitis or chronic liver disease
* History of pituitary or adrenal dysfunction
* Clinically significant heart disease
* History of a different malignancy unless disease-free for at least 5 years
* Known brain metastasis
* History of gastrointestinal disorders
* Prior therapy with abiraterone acetate
* HIV-positive individuals on antiretroviral therapy
* Requirement for steroid use greater than the equivalent of 5 mg of prednisone daily
* Atrial fibrillation or other cardiac arrhythmia requiring therapy
* Thromboembolism in the last 6 months |
Study Objectives
To compare safety of adjuvant OFS combined with anastrozole versus OFS combined with exemestane in Chinese premenopausal hormonal receptor(HR) positive breast cancer patients.
Intervention / Treatment
DRUG: OFS + Anastrozole, DRUG: OFS + Exemestane
| Inclusion Criteria:
* Women aged ≥18 years;
* Histologically confirmed invasive breast cancer by core needle biopsy or surgery,hormonal receptor positive, defined as estrogen receptor(ER)/progesterone receptor(PR) positive;
* Premenopausal defined as
* who have been menstruating regularly during the 6 months prior to randomization and have not used any form of hormonal contraception or any other hormonal treatments during the 6 months prior to randomization.
* premenopausal status confirmed by an estradiol (E2) in the premenopausal range after chemotherapy related amenorrhea;
* Patients must have received standard local therapy: normalized modified radical mastectomy or breast conserving surgery with negative margin and post-surgical radiotherapy. Patient should completed adjuvant therapy according to conditions, including adjuvant radiotherapy, neoadjuvant or adjuvant chemotherapy;
* Patients who did not receive chemotherapy should be randomized within 24 weeks after definitive surgery.Patients who received prior adjuvant and/or neoadjuvant chemotherapy should be randomized after completing chemotherapy and within 8 months of the final dose of chemotherapy as soon as premenopausal status is confirmed;
* Leukocyte ≥ 3\*109/L; Platelets ≥ 75\*109/L; Serum glutamate;
* oxaloacetate(AST/SGOT) or serum glutamic-pyruvic transaminase(ALT/SGPT) <*5 times of upper limit of normal (UNL) range;
* Serum creatinine/blood urea nitrogen(BUN) ≤ upper limit of normal (UNL) range;
* Written informed consent according to the local ethics committee requirements.
* Has Eastern Cooperative Oncology Group(ECOG) Performance Score 0-2;
Exclusion Criteria:
* Histologically confirmed hormonal receptor negative.
* Post-menopausal.
* Patients with inoperable local advanced breast cancer including inflammatory breast cancer or supraclavicular node involvement or with enlarged internal mammary nodes (unless pathologically negative).
* Definitive surgery was done over 24 weeks before randomization for patients who did not receive chemotherapy.The final dose of chemotherapy was completed over 8 months before randomization for patients who received prior adjuvant and/or neoadjuvant chemotherapy.
* Pregnant or lactating.
* Patients with previous or concomitant invasive malignancy are not eligible. The exceptions are patients with the following (and only the following) malignancies (previous or concomitant) who are eligible if adequately treated: basal or squamous cell carcinoma of the skin in situ non-breast carcinoma without invasion contra- or ipsilateral in situ breast carcinoma non-breast invasive malignancy diagnosed at least 5 years ago and without recurrence:
* stage I papillary thyroid cancer
* stage Ia carcinoma of the cervix
* stage Ia or b endometrioid endometrial cancer
* borderline or stage I ovarian cancer
* Patients who received endocrine therapy (including neoadjuvant and adjuvant) for more than 8 months after their breast cancer diagnosis.
* Patients who were taking tamoxifen or other selective estrogen receptor modulator (SERM,e.g. Raloxifene) or hormone replacement therapy (HRT) within one year prior to their breast cancer diagnosis.
* Patients who have had a bilateral oophorectomy or ovarian irradiation prior to their breast cancer diagnosis.
* With severe hepatic dysfunction, Child-Pugh C.
* With severe cardiac dysfunction, New York Heart Association (NYHA) grading III or worse.
* Known severe hypersensitivity to any drugs in this study.
* Participants of other experimental drug clinical trials |
Study Objectives
The purpose of this study is to evaluate the effect of the anti-programmed death 1 (PD-1) agent nivolumab following selective internal radiation therapy (SIRT) for patients with unresectable hepatocellular carcinoma (HCC).
SIRT using yttrium90-loaded microspheres is increasingly used to treat patients with HCC, particularly those that are not good candidates for transarterial chemoembolization or TACE. SIRT induces disease control (objective tumor remission or stabilization) in most patients while progression usually results from the growth of new lesions. SIR-Spheres are resin-made microspheres used for SIRT.
On the other hand, nivolumab is under clinical development for the treatment of more advanced HCC. Available data in patients that mostly had progression to other therapies and vascular involvement or metastatic disease show significant systemic antitumor activity that results in durable objective remissions and disease stabilizations.
Therefore, in patients with HCC that has not spread beyond the liver, the systemic action of nivolumab may improve the anti-tumor effect of SIRT. Furthermore, by inducing immunogenic tumor cell death, SIRT may have a synergistic effect with nivolumab.
Intervention / Treatment
DRUG: Nivolumab, DEVICE: SIR-Spheres
| Inclusion Criteria:
* Diagnosis of HCC based on histology or non-invasive criteria if cirrhotics. Patients with fibrolamellar carcinoma are not excluded.
* Cirrhosis absent, non-viral or due to hepatitis C or B virus infection. Subjects with chronic hepatitis B virus infection must be on effective antiviral therapy
* Preserved liver function (without cirrhosis or with compensated cirrhosis in Child Pugh Class A).
* ECOG performance status 0 or 1
* Willing to have a liver biopsy pre-treatment
* Considered candidates for locoregional therapy using SIR-Spheres based on
* the absence of extrahepatic disease (patients with regional lymph nodes < 2 cm in short axis are accepted)
* unsuitability for liver resection or transplantation, or percutaneous ablation
* considered not good candidates for TACE because they have; Single tumors larger than 5 cm. Multiple tumors that cannot be targeted superselectively. Unilobar tumors with segmental or lobar portal vein thrombosis.
* At least one measurable lesion by RECIST *1 criteria.
* Adequate organ and marrow function as evidenced by:
* White blood cell count ≥ 2000/μL.
* Neutrophils ≥ 1000/μL.
* Platelets ≥ 60 x 103/μL.
* Hemoglobin ≥ *0 g/dL.
* Creatinine Clearance > 40 mL/min.
* AST and ALT ≤ 5 X ULN
* Bilirubin ≤ 2 mg/dL
* INR ≤ **
* Albumin ≥ *0 g/dL
* Willing and able to comply with immune-monitoring sample collection and required study follow-up.
Exclusion Criteria:
* Any history of hepatic encephalopathy
* Any prior (within 6 months) or current clinical ascites.
* Any history of clinically meaningful variceal bleeding within the last three months.
* Active coinfection with both hepatitis B and C or hepatitis D infection in subjects with hepatitis B
* Occlusive main trunk portal vein thrombosis or absence of intrahepatic portal blood flow if patient carries a portocaval shunt.
* Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
* Any autoimmune disease that may require immunosuppressive therapy.
* Any severe organ disease
* Prior therapy with any drug specifically targeting T-cell costimulation or checkpoint pathways.
* Prior organ allograft or allogeneic bone marrow transplantation
* Active bacterial or fungal infections within 7 days of study entry.
* Any condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of study drug administration. |
Study Objectives
The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA） for nasopharyngeal carcinoma.
Intervention / Treatment
PROCEDURE: interventional therapy
| Inclusion Criteria:
* Age:18-80
* Karnofsky performance status >60
* Diagnosis of nasopharyngeal carcinoma based on histology or the current accepted radiological measures.
* Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
* Will receive interventional therapy
* Life expectancy: Greater than 3 months
* Patients' routine blood test, liver function and kidney function have no obvious abnormalities
* Ability to understand the study protocol and a willingness to sign a written informed consent document
Exclusion Criteria:
* Patients with other primary tumor except nasopharyngeal carcinoma
* History of coagulation disorders or anemia |
Study Objectives
This study is a retrospective study with a propensity score-matched analysis in order to balance differences between patients with D1 and D2 lymphadenectomy for gastric cancer.The main aim is to analyse differences in the postoperative and oncological outcomes of patients with gastric cancer (GC) who underwent D1 and D2 gastrectomy.
Intervention / Treatment
PROCEDURE: Lymphadenectomy type
| Inclusion Criteria:
* patients diagnosed with GC stage I-III who underwent a curative gastrectomy +/- perioperative chemotherapy
Exclusion Criteria:
* patients with adenocarcinoma Siewert type I/II, palliative surgery, R1/R2 resections and pathological stage (pStage) IV. |
Study Objectives
This study aimed to evaluate the pharmacokinetic characteristics and bioequivalence of two olaparib tablets in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Intervention / Treatment
DRUG: The test olaparib tablet (T), DRUG: The reference olaparib tablet (R)
| Inclusion Criteria:
* Had BMI *0 kg/m\^2, and weight ≥ 50 kg for male, or ≥ 45 kg for female
* Patients who were on olaparib treatment, had epithelial ovarian, fallopian tube, or primary peritoneal cancer, or were eligible for olaparib treatment judged investigators
* Had ECOG performance status 0-1
* Had life expectancy >12 weeks
* Had Adequate organ function or clinically irrelevant abnormal result
* Agreed to use adequate contraception from 14 days before treatment initiation to 6 months after last dose
Exclusion Criteria:
* Allergic to any component of study drugs
* Had central nervous system metastases (stable and asymptomatic metastases were acceptable)
* Had other malignancy within 5 years
* Had disease affecting swallow or absorption
* Received major surgery within 1 month before study drug administration
* Had major disease
* Had continuous grade 3-4 adverse event
* Had drug abuse
* Had (suspected) pneumonitis
* Participated in other clinical trial of drug or device within 1 month
* Lost or donated blood > 200 mL or received blood transfusion within 1 month
* With average alcohol consumption > 14 units/week or cigarette consumption > 20/day within 1 month
* Positive for human immunodeficiency virus, hepatitis B, C, or syphilis test
* Received strong or moderate CYP3A inducer or inhibitor within 3 half-lives of the drug
* Consumed grape fruit juice, or other food or beverage containing caffeine or xanthine
* For female, pregnant or breastfeeding |
Study Objectives
The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastim and daily dosing of filgrastim for prevention of neutropenia in patients receiving AT (docetaxel 75 mg/m2 + doxorubicin 50 mg/m2).
Intervention / Treatment
BIOLOGICAL: Empegfilrastim 6 mg, BIOLOGICAL: Filgrastim, BIOLOGICAL: Placebo №1, BIOLOGICAL: Placebo №2, BIOLOGICAL: Empegfilrastim 7.5 mg
| Inclusion Criteria:
* Signed informed consent form;
* Histologically verified diagnosis of stage IIb/III/IV breast cancer;
* Age of 18-70 years inclusive;
* Life expectancy of at least 6 months after inclusion in the study;
* If the patient had received the chemotherapy for breast cancer, it should be finished 30 days before the beginning of the study;
* ECOG Performance Status of 0- 2, not increasing within during 2 weeks before randomization;
* ANC level of 1500/μL and more at the beginning of the study
* Platelet count of 100 000/μL and more at the beginning of the study
* Hemoglobin level of 90 g/l and more
* Creatinine level <*5 mg/dl
* Total bilirubin level <*5 × the upper limit of normal (ULN)
* ALT and/or AST levels <*5×ULN (5×ULN for patients with liver metastases);
* Alkaline phosphatase <5×ULN;
* Left ventricular ejection fraction >50% and more;
* If the patient had received adjuvant and/or neoadjuvant therapy, the cumulative dose of anthracyclines should not exceed 250 mg/m2 for doxorubicin or 540 mg/m2 for epirubicin,if in this study planned 6 cycles of chemotherapy ;
* If the patient had received adjuvant and/or neoadjuvant therapy, the cumulative dose of anthracyclines should not exceed 350 mg/m2 for doxorubicin or 660 mg/m2 for epirubicin,if in this study planned 4 cycles of chemotherapy ;
* Ability of the participant to follow the protocol requirements, according to the Investigator's opinion;
* Patients of childbearing potential must implement reliable contraceptive measures during the study treatment, starting 4 weeks prior randomization and for 6 months after the last administration of the study drug;
* Patients should be able to follow the Protocol procedures (according to Investigator's assessment.
Exclusion Criteria:
* Patient has received two or more chemotherapy regimens for the metastatic breast cancer;
* Documented hypersensitivity to filgrastim, pegfilgrastim, docetaxel, doxorubicin, dexamethasone and/or its excipients, PEGylated drugs, recombinant proteins.
* Pregnancy or breastfeeding;
* Systemic antibiotic therapy within 72 h prior empegfilgrastim/filgrastim administration;
* Concomitant radiotherapy (except selective radiotherapy of bone metastases);
* Surgery, radiotherapy (except selective radiotherapy of bone metastases), administration of any experimental drugs within 30 days prior randomization;
* History of bone marrow/stem cell transplantation;
* Conditions limiting the patient's ability to follow the protocol;
* CTCAE grade 3-4 neuropathy;
* HIV, HCV, HBV, T.Pallidum infection(s);
* Acute or active chronic infections;
* Severe concurrent diseases (for example, severe arterial hypertension, severe heart failure, and other);
* Severe depression, schizophrenia, any other mental disorders;
* Obstacles in intravenous administration of study drugs;
* Simultaneous participation in other clinical trials, previous participation in other clinical trials within 30 days before entering into the trial, previous participation in the same trial. |
Study Objectives
This randomized phase II trial is studying how well SGN-00101 vaccine works compared to a placebo in treating human papillomavirus and preventing cervical cancer in patients with abnormal cervical cells. Vaccines, such as SGN-00101, may make the body build an immune response to kill human papillomavirus and abnormal cervical cells and may be effective in preventing cervical cancer
Intervention / Treatment
BIOLOGICAL: HspE7, OTHER: placebo, OTHER: laboratory biomarker analysis
| Inclusion Criteria:
* Meets criteria for 1 of the following groups:
* Prospective group, meeting the following criteria:
* Evidence of atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesions (LSIL) by Pap test
* Human papillomavirus (HPV)-16-positive by polymerase chain reaction (PCR) and PGMY09/PGMY11 oligonucleotide primers viral load assay
* Medical records-based group, meeting the following criteria:
* Medical-record evidence of ASCUS or LSIL by Pap test within the past 6-12 months
* Meets 1 of the following criteria:
* Liquid-cytology findings of ASCUS or LSIL
* Colposcopic evidence of a LSIL by the Reid Index score of 1-5
* Historically persistent HPV-16-infection by PCR and HPV reverse transcription (RT)-PCR
* No evidence of high-grade squamous intraepithelial lesions (HSIL) by colposcopy (Reid Index ≥ 6)
* Reports no sex partner change since last index Pap screening test
* Specimen-based group, meeting the following criteria:
* Medical-record evidence of ASCUS or LSIL by Pap test within the past 6-12 months
* Liquid-based cytology specimen available
* Meets 1 of the following criteria:
* Liquid-cytology findings of ASCUS or LSIL
* Colposcopic evidence of a LSIL by the Reid Index score of 1-5
* Historically persistent HPV-16-infection by PCR and, where measurable, HPV RT-PCR showing no greater than 3-fold reduction over the index liquid-cytology specimen
* No evidence of HSIL by colposcopy (Reid Index ≥ 6)
* Menstrual period occurred at least once within the past 52 weeks
* No HSIL by Pap test within the past year
* Performance status - ECOG 0
* No severe or unstable coagulation
* Hepatitis B surface antigen negative
* Hepatitis C antibody negative
* No angina
* No heart failure
* No other cardiac condition
* No respiratory condition
* No asthma
* No immunological disorders (e.g., lupus, diabetes, multiple sclerosis, or myasthenia gravis)
* Not immunocompromised, suggestive of severe immune deficiency
* HIV negative
* No AIDS
* No active infection, defined as fever > 100° F
* No syphilis
* No severe allergic reactions (anaphylactic response) to drugs or any other allergen
* No history of allergy to any vaccine constituents, including cell- or tissue-system elements used to prepare the vaccine (e.g., bread products, yeast, or recombinant DNA technology using yeast systems)
* Must agree to use effective form of contraception throughout vaccination period
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during vaccination period and for 5 months after study treatment
* No sexual intercourse within 48 hours of virus specimen collection during study visits
* No objects (e.g., tampons, douche, suppositories, fingers, or toes) within the vagina or rectum within 48 hours of virus specimen collection during study visits
* No prior malignancy except nonmelanoma skin cancer
* No medical or psychiatric illness than would preclude study participation or compliance
* No other disorders requiring medical intervention that would preclude study participation
* No prior HPV vaccine
* More than 30 days since prior investigational vaccine
* More than 30 days since prior systemic steroid therapy
* No prior splenectomy
* More than 30 days since prior investigational drug
* More than 72 hours since prior antibiotic therapy for active infection |
Study Objectives
A research study of a new method of visualizing internal organs called 18F-FLT PET/CT that yields better tracking of cancer treatment progress. PET/CT stands for positron emission tomography with low dose computed tomography and has been used for many years. 18F-FLT PET/CT uses a new tracer, fluorothymidine, which is taken up by cells that are actively proliferating or dividing such as cancer cells. We hope to learn whether this tracer is superior to the conventional tracer for monitoring treatment of diffuse large B-cell lymphoma (DLBCL).
Intervention / Treatment
DIAGNOSTIC_TEST: FLT-PET/CT, DIAGNOSTIC_TEST: FDG-PET/CT, DRUG: FLT
| Inclusion Criteria:
* All patients must have a histologic or cytological diagnosis of de novo DLBCL and be scheduled to receive first line chemotherapy with R-CHOP given every 21 days (R-CHOP-21) within 6 weeks of their enrollment and for 6 cycles.
* Patients must be >=18 years of age, but there will be no discrimination based on gender, race, creed, or ethnic background.
* Patients must have an ECOG performance status of 0-*
* Patients must sign an informed consent, and be mentally responsible.
Exclusion Criteria:
* Subjects with significant concurrent medical complications that in the judgment of the Principal Investigator(s) could affect the patient's ability to complete the planned trial, including the multiple imaging studies.
* Patients with history of prior lymphoma (e.g., follicular lymphoma) and/or second cancers other than basal cell carcinoma.
* Patients planned to be treated with R-CHOP-14 (i.e., R-CHOP given every 14 days) will be excluded (this should be extremely rare, if at all, since R-CHOP-21 is the standard treatment.
* Patients who are scheduled to receive Rituxan or any other therapy (e.g., XRT, radioimmunotherapy) as adjuvant therapy after completion of R-CHOP-*
* Pregnant women will be excluded.
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) after study entry and for the duration of study participation. The effects of FLT on the developing human fetus are unknown. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A screening urine human chorionic gonadtropin (hCG) (pregnancy test) will be administered in Nuclear Medicine to women of childbearing potential before each FLT scan and pregnant women will be stopped from participating further in this study. |
Study Objectives
The purpose of this study is to compare progression-free survival (PFS) of patients with advanced, recurrent or metastatic endometrial cancer who have received one, but not more than two, prior lines of chemotherapy either as adjuvant therapy or treatment for advanced disease, and then when treated with ridaforolimus or the investigators' choice of progestin or chemotherapy.
Intervention / Treatment
DRUG: ridaforolimus, DRUG: medroxyprogesterone acetate tablets OR megestrol acetate, DRUG: chemotherapy
| Inclusion Criteria:
* 18 years of age or older
* Endometrial cancer
* Patients must have been treated with at least one line of chemotherapy, but not more than two lines of chemotherapy, and experienced progressive disease
* At least one measurable lesion
* ECOG performance status less than or equal to 1
* Minimum life expectancy of 3 months
* Adequate renal and hepatic function
* Adequate bone marrow function
* Serum cholesterol <350 mg/dL and triglycerides < 400 mg/dL
* Able to understand and give written informed consent
* Females of childbearing potential must have a negative pregnancy test and use approved contraception from screening to 30 days after the last study drug is given
Exclusion Criteria:
* Two lines of chemotherapy for recurrent or metastatic disease
* Chemotherapy for recurrent or metastatic disease administered within six months of adjuvant therapy
* More than two lines of chemotherapy of any type
* Prior therapy with hormonal agents
* Women who are pregnant or lactating
* Presence of brain or other central nervous system metastases
* Prior therapy with rapamycin, rapamycin analogues or tacrolimus or known sensitivity to these agents
* Anticancer treatment (chemotherapy, radiotherapy) within 4 weeks prior to randomization
* Ongoing toxicity associated with prior anticancer therapy
* Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to randomization.
* Another primary malignancy within the past five years (except for non-melanoma skin cancer and cervical carcinoma in situ)
* Known Grade 3 or 4 hypersensitivity to macrolide antibiotics
* Significant uncontrolled cardiovascular disease
* Active infection
* Known HIV infection
* Known Hepatitis B or C infection
* Newly diagnosed (within 3 months before enrollment) or poorly controlled Type 1 or 2 diabetes
* Concurrent treatment with immunosuppressive agents
* A requirement for concurrent treatment with medication that strongly induce or inhibit cytochrome P450 (CYP3A) |
Study Objectives
This is 3-arm, multicenter study that will be conducted through the Pacific Pediatric Neuro-oncology Consortium (PNOC).
This study will assess the safety and immune activity of a synthetic peptide vaccine specific for the H3.3.K27M epitope given in combination with poly-ICLC and the H3.3.K27M epitope given in combination with poly-ICLC and the PD-1 inhibitor, nivolumab, in HLA-A2 (02:01)+ children with newly diagnosed DIPG or other midline gliomas that are positive for H3.3K27M.
Intervention / Treatment
BIOLOGICAL: K27M peptide, DRUG: Nivolumab
| Inclusion Criteria:
* Stratum A:
* Newly diagnosed children (3-21 years old) with DIPG who are positive for the H*3K27M mutation (positive testing in Clinical Laboratory Improvement Amendments (CLIA) laboratory) that underwent standard radiation therapy.
* Stratum B:
* Newly diagnosed children (3-21 years old) with diagnosis of glioma other than DIPG who are positive for the H*3K27M mutation (positive testing in CLIA laboratory) including spinal cord gliomas that underwent standard radiation therapy.
* Stratum C:
* Newly diagnosed children 3-21 years of age with diagnosis of DIPG or midline glioma other than DIPG (excluding primary spinal cord gliomas) who are positive for the H*3K27M mutation (positive testing from a CLIA or equivalent laboratory required), that underwent standard radiation therapy.
The following eligibility criteria apply to strata A, B and C:
* The patient must test positive for HLA-A\*02:01 (positive testing from a CLIA or equivalent laboratory required; only the HLA A\*02:01 subtype is eligible; other subtypes are excluded)
* The patient must be either off systemic steroids or be on stable dose of dexamethasone or equivalent (max *1 mg/kg/day; maximum 4mg/day) at time of enrollment.
* Patients must not have received any prior chemotherapy, immunotherapy or bone marrow transplant for the treatment of their tumor. Prior use of temozolomide during radiation at maximum of the standard pediatric dosing (defined as 90 mg/m\^2/dose continuously during radiation therapy for 42 days) or dexamethasone is allowed.
* Patients must have undergone radiation therapy and surgery as part of their standard of care.
* Stratum A: Radiation therapy must have started within 4 weeks of diagnosis by imaging or surgery, whichever is later.
* Stratum B: For subjects undergoing surgery for more extensive resection, radiation therapy should be started within 4-6 weeks from surgery.
* Stratum C: Radiation therapy must have started within 4 weeks of diagnosis by imaging or surgery, whichever is later. For subjects undergoing surgery for more extensive resection, radiation therapy should be started within 4-6 weeks from surgery.
* Karnofsky ≥ 50 for patients ≥ 16 years of age, and Lansky ≥ 50 for patients < 16 years of age (See Appendix A). Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
* The patient must have adequate organ function defined as
Adequate Bone Marrow Function Defined as:
* Peripheral absolute neutrophil count (ANC) ≥ 1000/mm3 and
* Platelet count ≥ 100,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).
Adequate Renal Function Defined as:
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL/min/*73 m2 or
* A serum creatinine based on age/gender as follows:
Age Maximum Serum Creatinine (mg/dL) Male Female 3 to < 6 years *8 *8 6 to < 10 years 1 1 10 to < 13 years *2 *2 13 to < 16 years *5 *4 The threshold creatinine values in this table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Center for Disease Control (CDC).
Adequate Liver Function Defined as:
* Bilirubin (sum of conjugated + unconjugated) ≤ *5 x upper limit of normal (ULN) for age and
* serum glutamic-pyruvic transaminase (SGPT)/ alanine aminotransferase (ALT) ≤ 110 U/L and
* Serum albumin ≥ 2 g/dL.
Adequate Pancreatic Function Defined as:
* Serum lipase ≤ ULN at baseline.
Adequate Pulmonary Function Defined as:
* No evidence of dyspnea at rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry of > 92% while breathing room air.
Adequate Neurologic Function Defined as:
* Patients with seizure disorder may be enrolled if seizure disorder is well controlled.
* The effects of the H*3K27M vaccine and nivolumab on the developing human fetus are unknown. For this reason, females of child-bearing potential and males must agree to use adequate contraception. Adequate methods include: hormonal or barrier method of birth control; or abstinence prior to study entry and for the duration of study participation. 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. Males treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation.
* Ability to understand a written informed consent document, and the willingness to sign it. Assent will be obtained when appropriate based on the subjects age.
Exclusion Criteria:
* Investigational Drugs
* Patients who are currently receiving another investigational drug are not eligible.
* Prior treatment with another investigational drug.
* Anti-cancer Agents
* Patients who are currently receiving other anti-cancer agents are not eligible.
* Prior treatment with other anti-cancer agents.
* Patients who have received a live / attenuated vaccine within 30 days of first treatment.
* Patients with evidence of disseminated or leptomeningeal disease.
* Patients with a known disorder that affects their immune system, such as HIV or Hepatitis B or C, or an auto-immune disorder requiring systemic cytotoxic or immunosuppressive therapy are not eligible. Note: Patients that are currently using inhaled, intranasal, ocular, topical or other non-oral or non-IV steroids are not necessarily excluded from the study but need to be discussed with the study chair.
* Patients with a ≥ Grade 2 hypothyroidism due to history of autoimmunity are not eligible. (Note: Hypothyroidism due to previous irradiation or thyroidectomy will not impact eligibility).
* Patients who have received prior solid organ or bone marrow transplantation are not eligible.
* Patients with uncontrolled infection.
* Female patients of childbearing potential must not be pregnant or breast-feeding. Female patients of childbearing potential must have a negative serum or urine pregnancy test prior to the start of therapy (as clinically indicated). |
Study Objectives
Investigation on safety, tolerability and efficacy of H-1 parvovirus (H-1PV) in subjects suffering from glioblastoma multiforme.
Intervention / Treatment
DRUG: H-1PV
| Inclusion Criteria:
* Age over or equal to 18 years old,
* Diagnosis of glioblastoma multiforme,
* Written informed consent,
* Recurrent or progressive disease despite previous radio- and/or chemotherapy,
* Indication for complete or subtotal tumor resection,
* Life expectancy of at least 3 months,
* Consent for sampling and investigation of biological specimens,
* Karnofsky Performance Score over or equal to 60,
* Adequate seizure control,
* Adequate bone marrow function: neutrophils > *5 x 10exp9/L, platelets > 100 x 10exp9/L, hemoglobin > *0 g/dL,
* Adequate liver function: Bilirubin < *0 g/dL, ASAT, ALAT, AP, GGT < 3 x ULN,
* Adequate renal function: Creatinine < *8 g/dL,
* Adequate blood clotting: aPTT < 35 sec, INR < *2,
* Negative serology for HIV, HBV and HCV,
* Negative Beta-HCG test in women of childbearing potential,
* Commitment to use adequate contraception (in both genders) for up to six months after study entry,
* Commitment to omit exposure to infants < 18 months of age or immunocompromised individuals for up to 28 day after first administration of IMP.
Exclusion Criteria:
* Multifocal disease,
* Evidence of distant tumor metastases,
* Contraindications for MRI,
* Active infection within 5 days prior to the study inclusion,
* Chemotherapy within 4 weeks prior to the study inclusion,
* Radiotherapy within 6 weeks prior to the study inclusion,
* Participation in another interventional trial within the last 30 days,
* Treatment with antiangiogenic substances within 21 days prior to therapy. |
Study Objectives
The purpose of this study is the evaluation of the safety of autologous tissue-engineered dermal substitutes "denovoDerm" (first arm) and dermo-epidermal skin substitutes "denovoSkin" (second arm) transplanted onto the wound bed in children and adults.
Intervention / Treatment
BIOLOGICAL: denovoDerm, BIOLOGICAL: denovoSkin
| Inclusion Criteria:
* Deep partial or full thickness skin defect of at least 9 cm2 requiring surgical wound coverage due to:
* Acute cases: burn injury, soft tissue injury, skin necrosis after purpura fulminans
* Reconstructive cases (elective surgery): scar formation after burn injuries, congenital giant nevus, skin tumours
* Informed consent by patients/parents or other legal representatives
Exclusion Criteria:
* Infected wounds or positive general microbiological swabs taken from the nose for multi-resistant germs
* Patients tested positive for HBV, HCV, syphilis or HIV
* Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, systemic skin diseases, any kind of congenital defect of metabolism including diabetes)
* Coagulation disorders as defined by INR outside its normal value, PTT >ULN and fibrinogen <LLN and / or at the Investigator's discretion
* Previous enrolment of the patient into the current study
* Participation of the patient in another study within 30 days preceding and during the present study
* Patients or parents/other legal representatives expected not to comply with the study protocol
* Suspicion of child abuse
* Pregnant or breast feeding females
* Contamination derived from biopsy which could interfere with patients health
* Due to patient derived variations, isolated cells from biopsy do not proliferate or proliferate insufficiently
* Skin substitute has not been released due to production specific deviations
* Patients allergic to amphotericin B and gentamicin |
Study Objectives
This pilot clinical trial studies the safety of a dendritic cell vaccine when given with gemcitabine hydrochloride in treating patients with breast cancer that has spread beyond the breast and local lymph nodes to other organs in the body. The vaccine is made up of natural cells found in the blood, called dendritic cells, and peptides, or small fragments of protein which are loaded onto the dendritic cells. This combination may help activate the immune system against stromal cells, which are cells that help cancer cells survive in the body. Gemcitabine hydrochloride is a chemotherapy drug that is given before the vaccine to help shrink the tumor and control cells that may interfere with the activity of the vaccine. Interfering with the stromal cells that help support the growth of cancer cells may lead to the death of the cancer cells.
Intervention / Treatment
BIOLOGICAL: tumor blood vessel antigen peptide-pulsed alpha-type-1 polarized dendritic cell vaccine, DRUG: gemcitabine hydrochloride
| Inclusion Criteria:
* Patients must be human leukocyte antigen (HLA)-A2+
* Histologically confirmed breast cancer
* Patients must have evidence of metastatic disease measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or non-measurable lytic or mixed (lytic + blastic) bone lesions in the absence of measurable disease; Note: Measurable lesions include lytic or mixed (lytic + blastic) bone lesions, with an identifiable 10 mm soft tissue component that meets the measurability criteria per RECIST
* There is no limit to the number of prior systemic treatment regimens
* Patients must have a life expectancy of > 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Prior GEM therapy is acceptable as long as the last dose was ≥ 3 months from registration on this study
* Patients may have treated and stable brain metastases; they must be off steroids and must have had stable brain metastases for at least 6 months
* White blood cell (WBC) > *0 x 10\^9/L
* Platelets > 100 x 10\^9/L
* Hemoglobin (Hgb) ≥ *0 gm/dl
* Creatinine < *5 mg/dl
* Bilirubin (total) < *0 ml/dl
* Aspartate aminotransferase (AST) < *0 x normal institutional limits
* Alkaline phosphatase < *5 upper limit of normal (ULN) (< 10 x ULN in presence of bone metastases)
* Serum calcium ≤ 12 mg/dl
* International normalized ratio (INR) < *5, except for subjects receiving warfarin therapy; for subjects who are receiving warfarin for prophylaxis or treatment of thrombosis, INR values should be carefully monitored while patients are on study
* All patients must be informed of the investigational nature of this study and must provide written informed consent in accordance with institutional and federal guidelines; a copy of the informed consent document signed by the patient must be given to the patient
* Patients must have a negative pregnancy test by urinalysis
* Use of an effective means of contraception (men and women) is mandated in subjects of child-bearing potential; female subjects will be advised that they not become pregnant for at least one month after completing participation in the study; avoiding sexual activity is the only certain method to prevent pregnancy; however, if subjects choose to be sexually active, they should use an appropriate "double barrier" method of birth control (such as female use of a diaphragm, intrauterine device \[IUD\], or contraceptive sponge, in addition to male use of a condom) or the use of prescribed "birth control" pills, injections, or implants
Exclusion Criteria:
* HLA-A2 negative patients
* Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness
* Presence of bleeding diathesis
* Current treatment on another clinical trial
* Patients with organ allografts
* Pregnancy or breast-feeding; female patients must be surgically sterile or be post-menopausal, or must agree to use effective contraception during the period of therapy; all female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment; male patients must be surgically sterile or must agree to use effective contraception during the period of therapy; the definition of effective contraception will be based on the judgment of the principal investigator or a designated associate
* Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study |
Study Objectives
Endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) is a valid and recommended technique for tissue diagnosis of pancreatic masses. However, the diagnostic yield is with a sensitivity of 64%-95% and an accuracy of 78%-94% still very low. The EUS-FNB of pancreatic masses is usually performed with a 22-gauge biopsy needle. The small diameter of the needle is usually responsible for the low yield of tissue samples for histopathological examination. The 19-gauge needles help to overcome the limitations of a 22-gauge needle by acquiring a larger amount of cellular material. Thus, performing EUS-FNB with a 19-gauge needle can maximize tissue acquisition and sample adequacy, which is important for appropriate diagnosis. Contrariwise, the technical success rate for sample retrieval in patients with pancreatic head lesions is significantly lower using the 19-gauge compared to the 22-gauge needle. This is attributable to the technical difficulty to push the needle out of the endoscope in the duodenum. Since about 60% of pancreatic cancers are located in the head region, it is therefore particularly important to improve technical success in these cases. The new 19-gauge biopsy needle "Olympus EZ Shot3 Plus" is more flexible than common biopsy needles such as "EZ Shot2" and should therefore provide improved access to regions like pancreatic head. The aim of this multicenter prospective randomized crossover study is to compare those two needles during EUS-FNB of solid pancreatic masses.
Therefore this study will enroll 40 patients in five German centers with solid pancreatic masses and consecutive indication for EUS-FNB. Both needles will be used in each patient following a predetermined random order.
Primary endpoint is the correct histological diagnosis of the mass assessed by each needle. Technical failure is regarded as a negative histological diagnosis.
Secondary endpoints include a comparison of technical failure using each needle, histological quality, duration of procedure and rate of adverse events.
Intervention / Treatment
DEVICE: EUS-FNB with EZ Shot 3Plus first, DEVICE: EUS-FNB with EZ Shot 2 19G first
| Inclusion Criteria:
* solid pancreatic mass and consecutive indication for EUS-FNB
Exclusion Criteria:
* incapacity to give informed consent
* Haemorrhagic disease, disorder of hemostasis and coagulation (PT <60%, PTT> 42 sec. and platelets <60000/µL)
* oral anticoagulants
* dual antiplatelet therapy with thienopyridines (e.g. clopidogrel)
* Pregnant or lactating |
Study Objectives
The purpose of this research study is to compare a new educational material to another widely available educational brochure. The goal is to see if the new educational material will change knowledge and behaviors about colorectal cancer and colorectal screening.
Intervention / Treatment
OTHER: Fecal Immunochemical Test (FIT) Kit, BEHAVIORAL: Culturally targeted Photo Novella Booklet, BEHAVIORAL: Screen for Life Brochure
| Inclusion Criteria:
* Community-based recruitment methods will be used including promotional flyers and word of mouth at locations such as churches, barber shops, civic/community social service centers, senior centers, cultural groups. The flyers will provide brief information and advertise a telephone number for potential participants to call the study office at Moffitt.
* Self identify as Black or African American
* Have no symptoms of colorectal cancer (CRC), or personal diagnosis of CRC or bowel inflammatory disease or related syndromes
* Have not had recent CRC screening per guidelines (never screened or overdue)
* Participants must provide at least two forms of contact information (mailing address, home telephone or cell phone or email address), and contact information of a secondary individual who has a number that is different from the participant (this person may be a relative or friend living with the respondent).
* Spouse or relatives of respondent are potentially eligible.
Exclusion Criteria:
* Individuals who have participated in a colorectal cancer screening (CRCS) research in the past 1 year will not be eligible for this study.
* Additional criteria may apply. |
Study Objectives
The purpose of this research study is to determine the safety of RAD001(Everolimus) and the highest dose of this drug that can be given to people safely. RAD001(Everolimus) is a drug that works by preventing cells in the body from growing and dividing. Information from basic and Phase I clinical research studies suggests that RAD001 also may help to prevent tumor growth in people with relapsed or refractory lymphoma.
Intervention / Treatment
DRUG: RAD001
| Inclusion Criteria:
* 18 years of age or older
* Adequate liver and renal function as outlined in the protocol
* Fasting serum cholesterol 300mg/dl or less OR *75mmol/L or less AND fasting triglycerides *5 x institutional ULN or less.
* Clinicopathological diagnosis of Waldenstrom's macroglobulinemia as defined by consensus panel of the Second International Workshop on Waldenstrom's macroglobulinemia
* No previous therapy for WM
* Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level of 2 times the upper limit of each institution's normal value or greater is required
* ECOG Performance status of 0-2
* Patients must have a life expectancy of at least 3 months
* Baseline platelet and absolute neutrophil as outlined in the protocol
* INR and PTT *5 x normalized ratio or less
* A male subject agrees to use an acceptable method for contraception for the duration of study and for 8 weeks after the last dose of the study drug
* Female subject either post-menopausal or surgically sterilized or willing to use acceptable methods of birth control for the duration of the study and for 8 weeks after the last dose of study drug
Exclusion Criteria:
* Patients experiencing symptomatic hyperviscosity and requiring plasmapheresis. This includes any patient who, in the judgement of the investigator requires urgent response and will not be eligible. These patients have hyperviscosity which includes serum IgM levels of 5000 mg/dL or greater. Symptoms may include nosebleeds, visual complications, fatigue, headaches, confusion, etc.
* Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery or patients that may require major surgery during the course of the study.
* Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
* Patients should not receive any immunization with attenuated live vaccines within one week of study entry or during study period.
* Patients who have had any severe and/or uncontrolled medical conditions or other conditions that would affect their participation in the study.
* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD*
* Female patients that are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
* Patients with known hypersensitivity to RAD001 or other rapamycins or to its excipients
* Patients with other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell of the skin
* Patients with known history of HIV seropositivity
* History of noncompliance to medical regimens
* Patients unwilling to or unable to comply with the protocol |
Study Objectives
To characterize the safety and tolerability of 1) MBG453 as a single agent or in combination with PDR001 or 2) PDR001 and/or MBG453 in combination with decitabine or azacitidine in AML and intermediate or high- risk MDS patients, and to identify recommended doses for future studies.
Intervention / Treatment
DRUG: Decitabine, DRUG: PDR001, DRUG: MBG453, DRUG: Azacitidine
| Inclusion Criteria:
* Written informed consent must be obtained prior to any screening procedures
* Male or female patients ≥ 18 years of age who present with one of the following:
Arms 1-3:
* Relapsed/refractory AML following ≥1 prior therapies who have relapsed or exhibited refractory disease (primary failure) and are deemed by the investigator not to be candidates for standard therapy, including re-induction with cytarabine or other established chemotherapy regimens for patients with AML (patients who are suitable for standard re-induction chemotherapy or hematopoietic stem cell transplantation and willing to receive it are excluded)
* Newly diagnosed AML patients who are suitable for treatment with decitabine (patients who are suitable for standard induction chemotherapy or hematopoietic stem cell transplantation and willing to receive it are excluded)
* Intermediate or high risk MDS or MDS/MPN including CMML (patients who are suitable for standard re-induction chemotherapy or hematopoietic stem cell transplantation and willing to receive it are excluded)
Arms 4-5:
* Refractory / relapsed AML following ≥1 prior therapies (Arms 4a \& 5a)
* Intermediate or high risk MDS or MDS/MPN including CMML who have failed hypomethylating agent therapy (Arms 4b \& 5b) (Note: hypomethylating agent failure is defined as progressive disease on hypomethylating agent therapy or lack of clinically meaningful response as deemed by investigator after at least 4 cycles of hypomethylating agent therapy.)
Arm 6:
* Newly diagnosed AML patients who are suitable for treatment with azacitidine (patients who are suitable for standard induction chemotherapy or hematopoietic stem cell transplantation and willing to receive it are excluded) (Arm 6a)
* Intermediate or high-risk MDS or MDS/MPN including CMML (patients who are suitable for standard induction chemotherapy or hematopoietic stem cell transplantation and willing to receive it are excluded) (Arm 6b)
* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Patient must be a candidate for serial bone marrow aspirate and/or biopsy according to the institutions guidelines and be willing to undergo a bone marrow aspirate and/biopsy at screening, during and at the end of therapy on this study. Exceptions may be considered after documented discussion with Novartis.
* Arms 1-3: Patients must be fit for standard treatment with decitabine as determined by the investigator and as per local decitabine package insert.
* Arm 6: Patients must be fit for standard treatment with azacitidine as determined by the investigator and as per the local azacitidine package insert.
Exclusion Criteria:
* Arms 1-3 or Arm 6: Patients who have received prior hypomethylating agent treatment for AML or MDS.
* Patients with active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur should not be excluded.
* History of, or current drug-induced interstitial lung disease or pneumonitis grade ≥ *
* Patients who discontinued prior PD-1 or PD-L1 directed therapy due to a treatment related toxicity should not be included in the PDR001 containing arms of the study. Patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded.
* Systemic antineoplastic therapy (including cytotoxic chemotherapy, alphainterferon, kinase inhibitors or other targeted small molecules, and toxinimmunoconjugates) or any experimental therapy within 14 days or 5 half-lives, whichever is shorter, before the first dose of study treatment.
* Systemic chronic corticosteroid therapy (>10 mg/day prednisone or equivalent) or any immunosuppressive therapy within 7 days of first dose of study treatment. Topical, inhaled, nasal and ophthalmic steroids are allowed.
Other protocol-defined inclusion/exclusion criteria may apply. |
Study Objectives
This study will evaluate the mass balance of talazoparib after a single dose of talazoparib.
Intervention / Treatment
DRUG: Talazoparib
| Inclusion Criteria:
* At least 18 years of age and willing and able to provide informed consent.
* Histologically confirmed advanced solid tumor (limited to platinum-resistant ovarian carcinoma, cervical adenocarcinoma, small cell lung carcinoma or triple-negative breast cancer) judged by the Investigator to not be appropriate for standard therapy.
* Eastern Co-Operative Oncology Group (ECOG) performance status ≤ 2 at screening and Day -*
* Expected life expectancy of ≥ 3 months.
* Able to swallow the study drug and comply with study requirements.
* Female subjects may be enrolled if they are considered not of childbearing potential, or who are post-menopausal, or of childbearing potential using a highly effective form of contraception, and female subjects should not donate eggs from the time point of IMP administration until at least 45 days thereafter.
* Males with partners of childbearing potential may be enrolled if they use a condom when having sex with a pregnant woman or with a woman of childbearing potential from 21 days before the first dose of study drug through 105 days after the last dose of study drug, and males should not donate sperm from the time point of study drug administration until at least 105 days thereafter.
* Female patients must not be breastfeeding at screening and during the study participation until 45 days after the last dose of the study drug.
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Exclusion Criteria:
* Treatment within 14 weeks or five half-live prior to dosing with any type of systemic anticancer therapy or any investigational agent, whichever is longer.
* Major surgery within 8 weeks before screening.
* Serious accompanying disorder or impaired organ function.
* Symptomatic or impending spinal cord compression or cauda equina syndrome.
* Non-healing wound, ulcer, or bone fracture, not including a pathological bone fracture caused by a pre-existent pathological bone lesion.
* Known myelodysplastic syndrome.
* Patients with the following serologies should be excluded: HBsAg+ or anti-HBc+; HCV+; HIV+.
* Serious or unstable medical condition that interferes with ability to tolerate treatment or assessments associated with the protocol.
* Gastrointestinal disorder affecting absorption.
* Known hypersensitivity to any of the talazoparib solution components.
* Use of a strong P-gp inhibitor, strong P-gp inducer, or strong inhibitor of BRCP within 7 days or 5 half-lives, whichever is longer, before Day *
* Any condition or reason that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the Investigator or Sponsor (e.g. non-compliance, excessive alcohol consumption, intake of drugs of abuse unless these drugs are medically indicated \[e.g. opiates for pain relief\]). |
Study Objectives
In general, patients with Human Papilloma Virus Positive Oropharyngeal Squamous Cell Carcinoma (HPVOPC) are curable, young and will live for prolonged periods. They are at high risk for long-term toxicity and mortality from therapy. While the long-term consequences of chemotherapy and surgery for head and neck cancer are relatively constrained, high-dose radiotherapy (RT) and chemoradiotherapy (CRT) substantially impact on local tissues and organ function and result in a significant rate of late mortality and morbidity in patients. Studies are now being designed to reduce the impact of RT and CRT for patients.
Patients with intermediate stage HPV positive oropharyngeal cancer will be screened for poor prognostic features and undergo robotic surgery. Patients in whom pathology demonstrates good prognosis features will then be followed without postoperative radiotherapy. Patients with subsequent recurrence will be treated with either surgery and postoperative radiotherapy or postoperative chemoradiotherapy alone. Patients with poor prognostic features (ECS, LVI, PNI) will receive reduced dose radiotherapy or chemoradiotherapy based on pathology. It is expected that over 50% of patients treated with surgery will have had a curative treatment and will avoid radiation therapy entirely and long-term survival will not be changed by withholding radiation therapy to good prognosis patients after surgery. There are exploratory biomarkers of risk of recurrence that will be collected and studied.
There are currently few trials examining the role of de-escalation using surgery alone in intermediate and early T-stage HPV related disease. New surgical techniques have broadened the range of patients capable of achieving a complete resection and the functional outcomes in such patients are outstanding. Furthermore, the sensitivity of HPVOPC to chemotherapy and radiotherapy raise the possibility that delayed or salvage treatment in early stage patients would be highly effective, would result in similar survival outcomes and radiotherapy could be applied to a much smaller population then current standards call for. Looked at from a different perspective, the need for post-operative radiotherapy in this younger, HPV+ and more functional population has not been validated in clinical trials to date.
Intervention / Treatment
PROCEDURE: PET/CT, RADIATION: Radiotherapy, RADIATION: Concurrent Chemoradiation, RADIATION: Concurrent Chemoradiation
| Inclusion Criteria:
* Patients may be screened and consented if they display clinical features that are consistent with p16 positivity, they are p16+ but and not yet tested for p16 by IHC and for HPV by PCR and if they meet the other eligibility criteria. They will enter the experimental post-surgical portion of the study if they have surgery performed at MSSM and surgical specimens or biopsies proven to be both p16+ on IHC testing and HPV+ on PCR testing
* Participants must have histologically or cytologically confirmed and identified resectable primary squamous cell carcinoma of the oropharynx that is HPV 16 positive or positive for any high risk HPV subtype (i.e., 18, 33, 35, etc.) as determined by PCR at the central laboratory. Patients must have p16+ status as determined by IHC performed or reviewed at the central laboratory prior to consent. Both p16 and HPV status must be determined prior to post-surgical adjuvant treatment assignment. Tissue from the primary site must be available for biomarker studies after surgery.
* Stage 1, 2, 3 or early and intermediate stage IVa (T1N0-2B, T2N0-2B) (Level 2, non-matted) disease without evidence distant metastases or extracapsular extension. Primary site must be lateralized for a functional dissection.
* Age > 18 years.
* No previous surgery, radiation therapy or chemotherapy for SCCHN (other than biopsy or tonsillectomy) is allowed at time of study entry.
* ECOG performance status of 0 or *
* No active alcohol addiction (as assessed by medical caregiver).
* No active tobacco use (>10 years tobacco free interval, <20pk/yr. history)
* Ability to understand and the willingness to sign a written informed consent document.
* Participants must have adequate bone marrow, hepatic and renal functions as defined below:
* Hematology:
* Neutrophil count > *5 x 109/l.
* Platelet count > 100 x 109/l.
* Hemoglobin > 10 g/dl (may achieve by transfusion).
* Renal function: > 60 ml/min (actual or calculated by the Cockcroft-Gault method) as follows:
* CrCl (mL/min) = (140-age) (weight kg)
* 72 x serum creatinine (mg/dL)
* N.B. For females, use 85% of calculated CrCl value.
* Or a Creatinine < the upper limits of normal
Exclusion Criteria:
* Patients < age *
* Pregnant or breast feeding women.
* Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, thyroid cancer, or other cancer curatively treated by surgery and with no current evidence of disease for at least 5 years.
* Other serious illnesses or medical conditions including but not limited to:
* Unstable cardiac disease despite treatment, myocardial infarction with months prior to study entry.
* History of significant neurologic or psychiatric disorders including dementia or seizures
* Active clinically significant uncontrolled infection
* Active peptic ulcer disease defined as unhealed or clinically active
* Active drug addiction including alcohol, cocaine or intravenous drug use defined as occurring within the 6 months preceding diagnosis
* Chronic Obstructive Pulmonary Disease, defined as being associated with a hospitalization for pneumonia or respiratory decompensation within 12 months of diagnosis. This does not include obstruction from tumor
* Autoimmune disease requiring therapy, prior organ transplant, or known HIV infection
* Interstitial lung disease
* Hepatitis C by history
* Concurrent treatment with any other anticancer therapy.
* Participation in an investigational therapeutic drug trial within 30 days of study entry.
* Advanced Stage III,IV (N2C, N3) or surgically unresectable disease or disease that cannot be fully resected, obvious radiologic ECS, supraclavicular or matted metastatic disease, >3 cervical nodes. (These patients will be placed on the Quarterback trial due to advanced state of disease and poor prognostic features)
* HPV negative OPSCC as determined by determined by PCR. |
Study Objectives
This is a multi-center, phase II study to determine the efficacy and safety of CTL019 in adult patients with relapsed or refractory DLBCL.
Intervention / Treatment
BIOLOGICAL: Tisagenlecleucel, DRUG: Lymphodepleting chemotherapy
| Inclusion Criteria:
* Written informed consent must be obtained prior to any screening procedures
* Histologically confirmed DLBCL at last relapse(by central pathology review before enrolment.
.- Relapsed or refractory disease after ≥2 lines of chemotherapy including rituximab and anthracycline and either having failed autologous Hematopoietic stem cell transplantation (ASCT), or being ineligible for or not consenting to ASCT
* Measurable disease at time of enrollment
* Life expectancy ≥12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening
* Adequate organ function:
* Renal function defined as:
* A serum creatinine of ≤*5 x Upper Limit of Normal ULN OR
* Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/*73 m\^2
* Liver function defined as:
* Alanine Aminotransferase (ALT) ≤ 5 times the Upper Limit of Normal (ULN) for age
* Bilirubin ≤ *0 mg/dl with the exception of patients with Gilbert-Meulengracht syndrome; patients with Gilbert-Meulengracht syndrome may be included if their total bilirubin is ≤ *0 x ULN and direct bilirubin ≤ *5 x ULN
* Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation > 91% on room air
* Hemodynamically stable and Left Ventricle Ejection Fraction (LVEF) ≥ 45% confirmed by echocardiogram or Multigated Radionuclide Angiography (MUGA)
* Adequate bone marrow reserve without transfusions defined as:
* Absolute neutrophil count (ANC) > *000/mm\^3
* Absolute lymphocyte count (ALC) ≥ 300/mm\^3 and absolute number of CD3+ T cells > 150/mm\^3
* Platelets ≥ *000//mm\^3
* Hemoglobin > *0 g/dl
* Must have an apheresis product of non-mobilized cells accepted for manufacturing
* Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants must agree to use highly effective methods of contraception for at least 12 months following CTL019 infusion and until CAR T cells are no longer present by PCR on two consecutive tests
Exclusion Criteria:
* Prior treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy
* Treatment with any prior gene therapy product
* Active Central Nervous System (CNS) involvement by malignancy
* Prior allogeneic HSCT
* Eligible for and consenting to HSCT
* Chemotherapy other than lymphodepleting chemotherapy within 2 weeks of infusion
* Investigational medicinal product within the last 30 days prior to screening
* The following medications are excluded:
* Steroids: Therapeutic doses of steroids must be stopped >72 hours prior to leukapheresis and >72 hours prior to CTL019 infusion. However, the following physiological replacement doses of steroids are allowed: < 12 mg/m\^2/day hydrocortisone or equivalent
* Immunosuppression: Any other immunosuppressive medication must be stopped ≥2 weeks prior to leukapheresis and ≥ 2 weeks prior to CTL019 infusion. This could include check point inhibitors (monoclonal antibodies and small molecule modulators)
* Antiproliferative therapies other than lymphodepleting chemotherapy within two weeks of leukapheresis and 2 weeks prior to infusion
* Short acting drugs used to treat leukemia or lymphoma (e.g. tyrosine kinase inhibitors, and hydroxyurea) must be stopped > 72 hour prior to leukapheresis and > 72 hours prior to CTL019 infusion
* Other cytotoxic drugs, including low dose daily or weekly maintenance chemotherapy, must not be given within 2 weeks prior to leukapheresis and within 2 weeks prior to CTL019 infusion
* Fludarabine may be associated with prolonged lymphopenia. This should be taken into consideration when evaluating the optimal timing for leukapheresis collection.
* Antibody use including anti-CD20 therapy within 4 weeks prior to infusion or 5 half-lives of the respected antibody, whichever is longer
* CNS disease prophylaxis must be stopped > 1 week prior to CTL019 infusion (e.g. intrathecal methotrexate)
* Prior radiation therapy within 2 weeks of infusion
* Active replication of or prior infection with hepatitis B or active hepatitis C( HCV RNA positive )
* HIV positive patients
* Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
* Unstable angina and/or myocardial infarction within 6 months prior to screening
* Previous or concurrent malignancy with the following exceptions:
* Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry)
* In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to the study
* A primary malignancy which has been completely resected and in complete remission for ≥ 5 years
* Pregnant or nursing (lactating) women. NOTE: female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 24 hours before lymphodepletion
* Intolerance to the excipients of the CTL019 cell product
* Cardiac arrhythmia not controlled with medical management
* Prior treatment with any adoptive T cell therapy
* Patients with T-cell rich/histiocyte rich large B-cell lymphoma (THRBCL), primary cutaneous large B-cell lymphoma, primary mediastinal B-cell lymphoma (PMBCL), EBV positive DLBCL of the elderly, Richter's transformation, and Burkitt lymphoma
* Patients with active neurological auto immune or inflammatory disorders (e.g. Guillain Barre Syndrome, Amyptrophic Lateral Sclerosis) |
Study Objectives
Patients with advanced microsatellite unstable (MSI-H) colorectal cancer will be vaccinated with three so called frame shift peptides (FSPs), AIM2(-1), HT001(-1) and TAF1B(-1) combined with Montanide® ISA-51 VG. By this, an immune response directed against MSI-induced FSPs that are shared by the majority of MSI-H colorectal cancers can be induced. The aim is to show that vaccination against MSI-induced FSPs is safe and can induce or enhance immune responses against MSI-H colorectal cancer-associated antigens.
Intervention / Treatment
BIOLOGICAL: FSP peptides
| Inclusion Criteria:
Phase I part inclusion criteria (inclusion criteria for phase IIa part will be defined later using a study amendment):
* Histologically confirmed, surgically resected colorectal cancer of advanced stage (UICC stage III/UICC stage IV). This comprises patients with lymph node metastases (UICC stage III), metastasis to one distant organ (UICC IV, M1a), to more than one distant organ, or patients with peritoneal carcinosis (UICC IV, M1b)
* Detection of high level microsatellite instability (MSI-H) in the resected tumor sample according to the international consensus criteria (multiplex PCR of quasi-monomorphic microsatellite markers BAT25, BAT26, CAT25), see Appendix *
* Prior adjuvant standard therapy (chemotherapy with 5-fluorouracil/folinic acid, oxaliplatin, irinotecan or combinations of these) OR Prior palliative standard therapy in the first, second and third line (chemotherapy with 5-fluorouracil, oxaliplatin, irinotecan or combinations of these and/or treatment with anti-EGFR antibodies cetuximab or panitumumab alone or in combination with chemotherapy) with either complete or partial remission, stable disease, or disease progression under therapy; OR Patient has refused adjuvant or palliative standard therapy (chemotherapy using 5-fluorouracil, oxaliplatin, or regimens combining these).
* Expected survival of at least six months.
* Full recovery from surgery or radiation therapy
* ECOG performance status 0, 1 or *
* The following laboratory results:
* Neutrophil count ≥ *5 x 109/L
* Lymphocyte count ≥ *5 x 109/L
* Platelet count ≥ 100 x 109/L
* Serum bilirubin < 2mg/dL
* Male or female patients ≥ 18 years old
* Last therapy discontinued at least 4 weeks prior to vaccination.
* Patient´s written informed consent for participation in the trial
Exclusion Criteria:
* Prior treatment with FSPs AIM2(-1), HT001(-1) and TAF1B(-1)
* Clinically significant heart disease (NYHA Class IV).
* Other serious illnesses, eg, serious infections requiring antibiotics or bleeding disorders.
* History of immunodeficiency disease or autoimmune disease.
* Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available.
* HBV, HCV or HIV positivity.
* Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry
* Concomitant treatment with steroids, antihistaminic drugs, or nonsteroidal anti-inflammatory drugs (unless used in low doses for prevention of an acute cardiovascular event or for pain control). Topical or inhalational steroids are permitted.
* Participation in any other clinical trial
* Pregnancy or lactation.
* Women of childbearing potential who are not using a medically acceptable means of contraception.
* Psychiatric or addictive disorders that may compromise the ability to give informed consent.
* Lack of availability of a patient for immunological and clinical follow-up assessment.
* Brain metastases (symptomatic and non-symptomatic) |
Study Objectives
The purpose of this study is to evaluate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.
Intervention / Treatment
DRUG: Abraxane and Gemcitabine
| Inclusion Criteria:
* Female between 18 and 70 years old;
* Patients with histologic proved metastatic breast cancer, unsuitable to be treated with surgery;
* ECOG (Eastern Cooperative Oncology Group) 0\~1;
* Normal functions with heart, liver,renal and bone marrow:WBC≥*5×109/L；Hb≥90 g/L；plt≥100×109/L;
* Got ICF (Informed Consent Form) before enrollment;
* Life expectancy more than 12 weeks
Exclusion Criteria:
* Pregnant or breast-feeding women or positive serum pregnancy test;
* Uncontrolled brain metastases. Patients with brain metastases must be locally treated and the disease must be stable for at least one month at the time of enrolling;
* Participation in any investigational drug study within 4 weeks preceding treatment start;
* Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin or a contralateral breast cancer;
* Serious uncontrolled intercurrent infections;
* Poor compliance |
Study Objectives
The purpose of this study is to learn how often lung cancer survivors exercise. We also want to learn what helps people to be active or prevents them from being active. Learning this will help us to expand services for lung cancer survivors.
Intervention / Treatment
| Inclusion Criteria:
* Diagnosis of primary Stage IA or IB NSCLC;
* Underwent surgical resection for NSCLC at MSKCC;
* From 1 to 5 years post-treatment for NSCLC prior to study recruitment;
* No evidence of disease (NED) at the time of recruitment;
* Can be reached by telephone;
* Able to provide informed consent.
Exclusion Criteria:
* Undergoing active antineoplastic treatment;
* Major psychopathology or cognitive impairment likely in the judgment of the investigator to interfere with participation and compliance with the protocol. |
Study Objectives
This study will assess the maximum tolerated dose of low dose interferon in conjunction with nilotinib in pretreated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia patients in chronic phase (CML-CP).
Intervention / Treatment
DRUG: Nilotinib, interferon-alfa
| Inclusion Criteria:
* Patients with chronic myeloid leukemia in chronic phase (CML-CP) at screening
* Initial diagnosis of CML cytogenetically confirmed by the presence of the Ph+ metaphases from the bone marrow
* Patients who have been treated with nilotinib for a minimum of 6 months (1 month represents 28 days) after switch from previous CML treatments
* Patients who have been treated with stable dosing of 2x400mg nilotinib within the last month before start of study treatment
* No grade 3-4 CTC toxicities on nilotinib alone in the last month preceding the start of the study regimen
Exclusion Criteria:
* Patients who are considered Ph- because they do not have a confirmed cytogenetic diagnosis of the t(9;22) translocation in their bone marrow metaphases
* Evidence of a point mutation within the BCR-ABL gene leading to a clinically relevant amino acid exchange in the kinase domain at position T315 (gatekeeper mutation T315I)
* Impaired cardiac function
* Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
Other protocol-defined inclusion/exclusion criteria may apply |
Study Objectives
The investigators are doing this study to learn about the quality of life patients have at the end of treatment. Some patients' cancers are related to human papilloma virus or HPV; others are not. HPV is a virus that can be sexually transmitted and is known to cause some types of cancers. If your throat cancer was related to HPV, your doctor can discuss this with you in detail. The investigators want to see if there are differences in quality of life between patients whose cancers are caused by HPV and those who cancers are not caused by HPV. Throat cancers caused by HPV behave differently than throat cancers not caused by HPV. The investigators believe that patients with these two different types of throat cancer will also have different experiences after completing therapy. The investigators would like to understand what those differences are. The long-term goal of this study is to see what symptoms most patients have. The investigators can then try to treat them earlier, and hopefully, improve the symptoms. The investigators will also be able to plan more research to improve treatment for symptoms following treatment for cancer of the mouth and throat.
Intervention / Treatment
BEHAVIORAL: questionnaire and semi-structured interviews
| Inclusion Criteria:
* 18 years of age or older
* Diagnosis of squamous cell carcinoma of the oropharynx confirmed by the pathology department at MSKCC
* Completed last treatment for oropharynx cancer (surgery, chemotherapy, or radiation) at least 12 months and no more than 5 years before the date of study enrollment
* Known tumor status or tumor available for HPV testing \[based on chromogenic in situ hybridization with wide spectrum HPV probe (HPV III family 16 probe (Ventana) with affinity to HPV genotypes 16, 18, 31, 33, 35, 45, 51, 52, 56, 58, and 66) or p16 immunohistochemistry done in a Clinical Laboratory Improvement Amendment (CLIA)-approved laboratory; if either of these 2 tests are positive, the patient is classified as positive\].
* Able to speak and read English (study questionnaire-Aim 1 and interview guide-Aim 2 are currently only available in English).
* Received at least one component of treatment for oropharynx cancer at MSKCC or the regional network sites
* If radiation therapy was part of treatment, it must have been delivered at MSKCC or the regional network sites
* For Aim 2 only, diagnosed with an HPV+ oropharynx cancer and have knowledge of this diagnosis prior to study enrollment
Exclusion Criteria:
* Diagnosed with recurrent disease following completion of primary curative treatment |
Study Objectives
The hypothesis of the present trial was that the use of a defunctioning loop stoma reduces the rate of symptomatic anastomotic leakage from 15% to 7.5% after low anterior resection of the rectum for cancer.
Intervention / Treatment
| Inclusion Criteria:
* Absence of intraoperative adverse events according to the study protocol and the operating surgeon.
Exclusion Criteria:
* Presence of intraoperative adverse events according to the study protocol and the operating surgeon. |
Study Objectives
The study hypothesis is that clearer visual presentation of guideline recommendations and educational outreach, or academic detailing, can improve guideline compliance. However, it will investigate other aspects of screening-related decision-making, such as provider and patient beliefs about screening, provider-patient communication and patient's willingness to forgo expected testing. The research question is whether educational interventions can decrease non-compliance with screening guidelines for 5 common cancers.
Intervention / Treatment
OTHER: Color-coded materials, OTHER: Academic detailing, OTHER: Standard support, OTHER: No academic detailing
| Inclusion Criteria:
* Patients: healthy men and women ages 30-89 seeing their primary care provider for routine visit
* Providers: non-pediatric primary care physicians from Mount Sinai Beth Israel or St. Luke's-Roosevelt associated practices
Exclusion Criteria:
* Patient life expectancy of less than 1 year in primary care provider's judgment
* Inability to read and understand English
* Transgender status |
Study Objectives
This study pilots a 7-session group intervention among 40 screened women, 20 of whom will be randomly assigned to take part in the intervention, and 20 to the wait-list control. Assessments will be administered at baseline and month 6 to index participants as well as up to three unscreened female social network members of each index participant (up to 120 total). The primary outcome is CC screening among participating social network members.
Intervention / Treatment
BEHAVIORAL: WOMEN FIGHTING TO STOP CERVICAL CANCER
| Inclusion Criteria:
* age 18 years or older
* has been previously screened for cervical cancer
* has told at least one woman in her social network about her cervical cancer screening experience
Exclusion Criteria:
* unstable medical status (e.g., advance disease stage that calls into question her ability to complete the 6-month study) |
Study Objectives
Cholangiocarcinomas (CCCs) are malignant tumors arising from the biliary epithelium. CCCs are characterised by a high mortality and the only curable therapy is complete tumor resection, if feasible, or in some cases liver transplantation. Since surgery for CCC is a procedure associated with a high mortality itself it needs to be ascertained that an accurate preoperative diagnosis has been established. However, it often appears to be difficult to get a preoperative pathological diagnosis, since it is difficult to obtain tumor specimens using cytologic brushings, biopsy forceps, bile aspiration or endoscopic ultrasonography guided-fine needle aspiration. This is reflected by a nearly 100% specificity but low sensitivity rates.
The aim of this study is to compare a new method of biliary biopsy using a double-balloon enteroscopy (DBE) forceps to enable a safe and reliable tissue specimen collection within the proximal biliary tract with cytology brushings in patients with suspected malignant proximal biliary strictures.
Intervention / Treatment
DEVICE: double-balloon enteroscopy forceps biopsy, DEVICE: Transpapillary brush cytology
| Inclusion Criteria:
* biliary stenosis with suspected malignancy
Exclusion Criteria:
* no definite diagnosis available |
Study Objectives
This study evaluates the effect of adaptative Intensity-Modulated Radiation Therapy (IMRT) in the treatment of locally advanced cervical cancer on acute genito-urinary (GU), and gastrointestinal (GI) toxicities. Every patients will be treated according to the adaptative IMRT strategy.
Intervention / Treatment
OTHER: Adaptative treatment plan, RADIATION: External radiotherapy
| Inclusion Criteria:
* Cervix carcinoma proved by histology
* According International Federation of Gynecology and Obstetrics (FIGO) classification, stages IB2, IIA, IIB, IIIA and IIIB without lumbo-aortic lymph node damage (surgical or radiologic)
* Patient treated with radio-chemotherapy then curietherapy with curative aim, validated in multidisciplinary meeting
* Renal, hepatic and cardiovascular functions that allow administration of the associated systemic treatment
* Older than 18 years
* Good general status, World Health Organization less or equal to 1
* Signed informed consent
Exclusion Criteria:
* History of cancer that is not controlled and / or treated for less than 5 years (excepted for cutaneous baso-cellular cancer)
* History of pelvic irradiation
* Simultaneous participation to another research that could interfere with the study results
* Pregnant or breastfeeding patient
* Patient under tutor or guardian
* Patient not able to respect medical follow-up for geographical, social or psychological reasons
* Not affiliated to a system of French social security |
Study Objectives
The purpose of this study is to test the safety, tolerability and pharmacokinetic (PK) profile of AMG 386 after intravenous administration in adult subjects with advanced solid tumors.
Intervention / Treatment
DRUG: AMG 386
| Inclusion Criteria: - Have evaluable disease - Must be able to undergo MRI evaluation:
* Must not have cardiac pacemakers or neurostimulators not specifically approved for use in the MRI environment;
* Must not have metal implants, other than those approved as safe for use in MRI;
* Must not be claustrophobic or have physical characteristics that will preclude undergoing MRI; - Subjects enrolling to the Dose Expansion Cohort must have at least one tumor that is amenable to DCE-MRI evaluation (e.g., greater than or equal to 3 cm lesion outside the thoracic cavity) - Have Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 - Adequate hematologic, renal and hepatic function Exclusion Criteria: - Presence of untreated CNS metastasis or symptoms of brain metastases - Presence of leukemia or myelodysplastic syndrome - History of high-dose chemotherapy requiring bone marrow or peripheral stem cell support - Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure \[NYHA greater than class II\], uncontrolled hypertension \[diastolic greater than 85 mmHg; systolic greater than 145 mmHg\] or cardiac arrhythmia) - History of arterial thrombosis (i.e., stroke, transient ischemic attack or myocardial infarction) within 6 months of study day 1 - History of bleeding diathesis or hypercoagulopathy within 6 months of study day 1 - Active peptic ulcer disease or gastritis - Unresolved toxicities from prior anti-cancer therapy, excluding alopecia - Anti-tumor treatment within 3 weeks of study day * If anti-tumor treatment was an antibody therapy, the interval must be 6 weeks - Anticoagulation therapy, except a low dose of Coumadin™ (less than 2 mg) for prophylaxis against central catheter-related thrombosis - Major surgery within 4 weeks of study day 1 - History of allergic reaction to bacterially produced proteins - Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus or chronic hepatitis B infection - Pregnant or breastfeeding - Not using adequate contraceptive precautions, in the judgment of the investigator |
Study Objectives
This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.
Intervention / Treatment
OTHER: Elagolix placebo, DRUG: Elagolix, DRUG: 0.5 mg estradiol / 0.1 mg norethindrone acetate, DRUG: 1 mg estradiol / 0.5 mg norethindrone acetate, DRUG: E2/NETA placebo
| Inclusion Criteria:
* Subject is pre-menopausal female 18 to 51 years of age at Screening.
* Subject has diagnosis of uterine fibroids documented by a Pelvic Ultrasound.
* Subject has heavy uterine bleeding associated with uterine fibroids.
Exclusion Criteria:
* Subject has had a myomectomy, uterine artery embolization or high intensity focused ultrasound for fibroid destruction within 6 months prior to Screening or endometrial ablation within 5 years prior to Screening.
* Subject has a history of osteoporosis or other metabolic bone disease.
* Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression, schizophrenia, bipolar disorder), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes. Subject has any history of attempted suicide.
* Subject has a history of clinically significant condition(s) including but not limited to: \* Symptomatic Endometriosis \* Epilepsy or seizures \* Type 1 diabetes \* Chronic kidney disease \* Any cancer (except treated basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy |
Study Objectives
Pegylated-asparaginase (PEG-ASP) is an important part of the treatment of childhood acute lymphoblastic leukaemia (ALL). Unfortunately 13% of patients develops allergy and further treatment is impossible. Furthermore, 6% of patients have developed antibodies (silent inactivation) and have no effect of the PEG-ASP treatment. Truncated asparaginase therapy is associated with inferior event-free survival outcomes, in particular relapse in central nervous system (CNS).
Eryaspase is a new formulation of asparaginase encapsulated in erythrocytes. The erythrocyte membrane protects asparaginase against fast degradation and elimination processes. The encapsulation eliminates the direct somatic contact, and it is hypothesized that this provides the potential to prolong the activity of the enzyme and reduce toxicities.
Intervention / Treatment
DRUG: GRASPA
| Inclusion Criteria:
* Male or female aged 1-45 years at diagnosis of ALL.
* First line non-high risk ALL patients enrolled in NOPHO ALL2008 or ALLTogether pilot protocols including PEG-ASNase regimen.
* Documented hypersensitivity reaction to PEG-ASNase with either:
Clinical allergy to PEG-ASNase (mild/severe). Serum ASNase activity below the lower level of quantification.
* Karnofsky/Lansky score ≥*
* Ability to understand and willingness to sign a written ICF and to comply with the scheduled visits, treatment plans, laboratory tests and other study procedures. For patients under 18 years of age, either both parents or the legally appointed representatives had to provide consent.
Exclusion Criteria:
* Philadelphia chromosome positive ALL.
* Participation in another clinical trial interfering with the study therapy with exception of NOPHO ALL-2008 or ALLTogether pilot protocol. Patients can participate in other clinical trials not interfering with the study drug. In case of doubt this is assessed by the PI.
* Uncontrolled intercurrent illness including, but not limited to, patients receiving combination antiretroviral therapy or patients with severe or systemic infection, or psychiatric illness/social situations that would limit compliance with study requirements.
* Other severe acute/chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
* Pregnant or lactating females (serum human chorionic gonadotropin pregnancy test at screening). Use of a highly effective contraceptive measure in women of child-bearing potential and sexually active girls that are of child-bearing potential is required (contraceptive measures are specified in section *0).
* Inadequate organ functions, which prohibit further asparaginase administration;
* History of pancreatitis
* History of serious hemorrhage or serious thrombosis with prior asparaginase therapy
* Severe hepatic impairment at the time of administration (bilirubin >3 times ULN, transaminases >10 times ULN)
* Pre-existing known coagulopathy (e.g. haemophilia)
* History of grade 3 or higher transfusion reactions or any contraindication to receive blood transfusion. Presence of specific anti-erythrocytes antibodies (auto-antibodies or anti-public antibodies) preventing from getting a compatible packed Red Blood Cells for the patient.
* Patient under concomitant treatment likely to cause hemolysis. |
Study Objectives
Desmoid-type fibromatosis (or desmoid tumor) represents an intermediate grade neoplasm with a striking predilection for locally invasive growth and recurrence following resection. It occurs in children as well as young adults. As a typically localized disease, the historical standard of care for treatment has been surgical resection, with or without ionizing radiation. In some cases where surgical resection or radiation is not feasible, chemotherapy has been used. Two clinical trials conducted in the Pediatric Oncology Group (POG) and the Children's Oncology Group (COG) evaluated the role for either low intensity or non-cytotoxic chemotherapy for children with desmoid tumor that is not amenable to standard therapy. These were largely empirical treatment strategies or based on somewhat anecdotal observations. By better understanding desmoid tumor biology, even more effective therapy targeting a particular protein that is central to the disease can be developed.
Desmoid tumor is well-known to be associated with deregulation of the Adenomatous Polyposis Cell/beta-catenin (APC/β-catenin pathway). This is true of familial cases associated with Gardner's Syndrome and also in sporadic desmoid tumor, nearly all of which display histological or molecular evidence of Adenomatous Polyposis Cell/beta-catenin (APC β-catenin) pathway activation (Alman et al., 1997; Lips et al., 2009). Several new pieces of evidence support the concept that deregulation of the mammalian target of rapamycin (mTOR) cell proliferation/survival pathway may play an important role in tumor biology when the APC/β-catenin pathway is disrupted. Sirolimus, a drug that inhibits mammalian target of rapamycin (mTOR), is currently being evaluated as an anti-cancer agent in a variety of tumor types, but it has not been previously studied in desmoid tumor.
The investigators are conducting this pilot study to begin to explore whether mTOR inhibition may be beneficial for children and young adults with desmoid tumor.
Intervention / Treatment
DRUG: Sirolimus
| Inclusion Criteria:
* Must be less than 30 years of age at time of original diagnosis
* Must have biopsy-proven desmoid tumor (or aggressive fibromatosis). For patients with recurrent disease, a biopsy is not required at the time of recurrence
* Patients known to have germ-line adenomatous polyposis coli (APC) mutations or clinical manifestations of Familial Adenomatous Polyposis(FAP)/Gardner's syndrome can be included
* Patients must have surgery planned to remove the desmoid tumor and either:
* the desmoid tumor has already recurred after a prior surgery or
* the newly diagnosed and/or previously unresected disease is judged to be at high risk for recurrence due to its size (>5 centimeters) or location at an anatomic site making it unlikely to be resected with negative margins (eg. adjacent to neurovascular structures)
* There must be a commitment by the surgical team to resect the primary tumor within 3 days following the 4 weeks of sirolimus unless the clinical situation at the time of resection suggests that these interventions are not in the patient's best interest
* Concomitant medication restrictions:
* Patients may have received prior chemotherapy (excluding prior mTOR inhibitors)
* Use of steroids for non-tumor indications (for example: asthma or severe allergic reaction) is permitted
* Patients must have a Karnofsky performance status of greater than or equal to 50 for patients older than 16 years of age or Lansky performance status of greater than or equal to 50 for patients less than or equal to 16 years of age.
* Patients must have a life expectancy of greater than or equal to 8 weeks.
* Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
* Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea)
* Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biological agent
* Stem Cell Transplant (SCT): No evidence of active graft versus host disease. For allogeneic SCT, greater than or equal to 6 months must have elapsed.
* Patients must be able to consume oral medication in the form of tablets or solution
* Patients must have normal laboratory values as defined below:
* Creatinine clearance or radioisotope Glomerular Filtration Rate ≥ 70millileters/minute/*73 meters2 or a normal serum creatinine based on age/gender
* Hepatic: Adequate liver function is defined as:
* Total bilirubin less than or equal to *5 x upper limit of normal (ULN)for age, and
* Serum glutamic pyruvic transaminase (SGPT) less than or equal to *5 x upper limit normal (ULN) for age
* Hematologic function: Adequate bone marrow function is defined as:
* Absolute Neutrophil Count (ANC) greater than or equal to 1 x 10 to the ninth/Liter
* Hemoglobin greater than or equal to 10 gram/deciliter
* Platelet count greater than or equal to 100 x 10 to the ninth/Liter
* Female patients must have a negative pregnancy test
* Female patients who are lactating must agree to stop breast-feeding
* Sexually active patients of childbearing potential must agree to use effective contraception
* Patients must be able to cooperate fully with all planned protocol therapy
* Signed informed consent MUST be obtained from patient or parent/legal guardian (if patient is less than 18 years of age). Consent must be signed prior to any study procedures and study entry
Exclusion Criteria:
* Patients with other fibroblastic lesions or other fibromatoses are NOT eligible.
* Concomitant medication restrictions
* Patients may NOT have received prior mTor inhibitors
* Growth factor(s): Must not have received within 1 week of entry onto this study.
* Patients must not be known to be Human Immunodeficiency Virus positive. Testing for Human Immunodeficiency Virus is not mandatory.
* Patients must not be taking medicines known to influence sirolimus metabolism |
Study Objectives
This is a monocentric study in 2 steps: A safety part to assess the feasibility of using Xenon in association with a thoracic epidural analgesia (TEA) with a sequential recruitment of 3, 6 or 9 patients according to predefined safety rules. The second part will randomly allocated patients (1:1) to receive TEA+Xenon or TEA+Desflurane. 28 patients will be enrolled and followed over 45 days.
Intervention / Treatment
DRUG: Xenon, DRUG: Desflurane
| Inclusion Criteria:
* Older than 18 years old
* Planned surgery for oncologic colic and/or rectal surgery
* ASA score I or II
* Indication of complementary thoracic epidural analgesia
* Agree to use an effective form of contraception
* Patients who can understand, read and write French language
* Covered by a medical insurance
* Patients who have dated/signed an inform consent
Exclusion Criteria:
* Unstable angina within the 30 last days
* Myocardial infarction within 28 days prior to surgery
* Uncontrolled arterial high blood pressure
* Severe cardiac insufficiency
* Severe chronic obstructive pneumopathy
* Patient who requires FiO2 > 40%
* Patient already enrolled in a clinical study which may interfere with the present study
* Known hypersensitivity to one of the study drugs
* History or familial history of malignant hyperthermia
* Documented high intracranial pressure
* Eclampsia or pre-eclampsia
* Pregnant or breastfeeding woman
* Liver injury (icterus) and/or unexplained fever and/or eosinophilia after halogen exposure
* Failure in epidural anesthesia installation
* Patient refusal
* Patient who can't be compliant to the present protocol |
Study Objectives
This is an open-label, multicenter, phase 1, dose escalation study that will evaluate the safety profile, establish Maximum Tolerated Dose (MTD), and inform the recommended phase 2 dose of MLN4924 as well as evaluate antitumor activity in patients with metastatic melanoma.
Intervention / Treatment
DRUG: MLN4924
| Inclusion Criteria:
Each patient must meet all of the following criteria to be enrolled in the study:
* Diagnosis of metastatic melanoma
* Measurable disease
* Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse
* Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse
* Willing and able to give written informed consent
* Suitable venous access for study-required blood sampling
* Appropriate functional status, including the recovery from the effects of prior antineoplastic therapy, and acceptable organ function as described in the protocol
Exclusion Criteria:
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
* Major surgery or, serious infections, or infections that required systematic antibiotic therapy within 14 days before the first dose of study drug
* Systemic antineoplastic or radiation therapy within 14 days or treatment with any investigational products within 21 days before the first dose of study treatment
* CYP3A inducers within 14 days of study treatment. Moderate and strong CYP3A inhibitors and CYP3A inducers are not permitted during the study
* No prior history of amiodarone in the 6 months before the first dose of MLN4924
* Diarrhea that is greater than Grade 1 as outlined in the protocol
* Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months
* Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.
* Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
* Other clinical and laboratory assessments that do not meet the criteria specified in the protocol |
Study Objectives
To establish a serial ascertainement of specimens from patients with bone sarcomas to be used in ongoing cytogenetic and molecular genetic analyses. These data will be integrated and correlated with the established Orthopaedic Service clinical database.
Intervention / Treatment
| Inclusion Criteria:
* Patients must be undergoing diagnostic biopsy or resection of their primary or metastatic bone sarcoma for therapeutic purposes.
* The specimen must be large enough to allow routine pathological analysis, with the specimen for research excised from residual tissue that would otherwise be discarded.
Exclusion Criteria:
* N/A |
Study Objectives
The study objective:
* To evaluate the response and survival rates after treating stage III cervical cancer with retinoic acid and interferon-α combined with radiotherapy in the study group.
* To evaluate the response and survival rates after treating stage III cervical cancer patients with concomitant cisplatin and radiotherapy in the control group.
* To evaluate the safety and tolerability of the combination of retinoic acid, interferon-α and radiation therapy compared with concomitant chemo-radiation therapy.
* To determine if there is an immune response to Human Papillomavirus (HPV) by estimating serum IgG1 and IgG2 antibodies against E7 proteins of HPV types 16 and 18 before and after treatment.
The study hypothesis:
* The response rates and survival rates of retinoic acid and interferon-α combination with radiation will be better than chemo-radiation to treat stage III cervical cancer.
* Treatment with the retinoic acid, interferon-α and radiation combination therapy will be less toxic and better tolerated than chemo-radiation therapy.
Intervention / Treatment
DRUG: Interferon, Retinoic Acid and radiation, DRUG: Cisplatin and radiation
| Inclusion Criteria:
* Advanced cervical cancer
Exclusion Criteria:
* Previously treated for cancer of the cervix
* Karnofsky Performance Score less than 50
* Renal dysfunction ( Serum creatinine > *0mg/dl)
* Hepatic dysfunction (Serum bilirubin> *0 mg/dl, transaminases > *5 times normal)
* Pregnant or lactating women: Women will be tested by pregnancy test for possibility of existing pregnancy. Those that meet criteria of trial will be asked to promise that they don't become pregnant; barrier contraception will be recommended. |
Study Objectives
The purpose of this extension is to observe the incidence rates of cancer, total mortality, and mortality due to cancer over a 21 month follow-up period in patients from the SEAS trial (2004_050, MK0653A-043; NCT00092677).
Intervention / Treatment
| Inclusion Criteria:
* The cohort will include all patients from the five participating countries (Sweden, Denmark, Norway, Finland, and United Kingdom) who were randomized into the SEAS base study and who were known to be alive at the end of the base study |
Study Objectives
Targeted therapy in the treatment of breast cancer targets HER2 receptor (Human Epidermal growth factor Receptor). HER2 receptor plays an important role in cell growth and differentiation (5). However, when HER2 overexpresses, it may lead to cancer. HER2 positive malignance exacerbates pathology and worsens clinical outcome, such as shortened overall survival (OS) compared with non-HER2 overexpression patients (6), (7). About 20-30% overexpression HER2/neogene breast cancer patients and patients having HER2 overexpression tumor have disease progression and poor prognosis in metastatic process (8), (9).
Currently, targeted therapeutic, which attaches to the HER2 receptor, inhibiting the growth of cancer cells has been approved. One of these products is Trastuzumab.
The study processed on 50 females aged between 18 and 65, recurrent or metastatic breast cancer patients with positive HER2.
The subjects were randomly distributed in 2 groups as NNG-TMAB + docetaxel or Herceptin® + docetaxel, in blocks of 4 in a 1:1 ratio (NNG-TMAB: Herceptin®). In each block of 4 will be 2 patients in the experimental group and 2 patients in the control group.
Primary endpoint is serum peak concentrations (Cmax), area under the curve from 0 to t (AUC0-t).
This trial is intended to assess the biosimilarity of pharmacokinetic parameters, safety between Faceptor (experimental drug) and Herceptin (reference).
Intervention / Treatment
DRUG: Faceptor, DRUG: Herceptin, DRUG: Docetaxel
| Inclusion Criteria:
* Female patients from 18 to 65 years old.
* Willing to give written and signed informed consent.
* Have pathologically or cytologically confirmed breast cancer.
* Inoperable, recurrent or metastatic breast cancer according to TNM classification and investigator' s assessment.
* Presence of at least 1 tumour with a size not less than 1 cm (revealed with computed tomography (CT) slice thickness not more than 5 mm). Patients having bone metastasis as the only measurable tumour are not eligible for the trial.
* Grade 3+ HER2 overexpression confirmed by immunohistochemical (IHC) staining or grade 2+ HER2 overexpression accompanied by HER2 gene amplification confirmed by fluorescent hybridization in situ (FISH).
* Eastern Cooperative oncology group performance status ≤ 2
* Willing to comply the requirements of the study protocol.
* Have a survival expectancy of at least 6 months.
* At screening period: Hb ≥ 9 g/dL; Neutrophils ≥ 1,5x10\^9/L; platelets ≥ 100x10\^9/L; creatinine level ≤ 1,5 x upper limit of normal (ULN); bilirubin level < 1,5 x ULN; ALT/AST < 2,5 x ULN (< 5 x ULN for patients with liver metastases), ALP < 5 x ULN.
* Patients of childbearing potential and her partner must implement reliable contraceptive measures during the study treatment, starting 4 weeks prior to inclusion into the trial and until 6 months after the last administration of the study drug
Exclusion Criteria:
* Previous anticancer therapy for metastatic BC, including previous anticancer therapy with signal transduction inhibitors (e.g. lapatinib), biological drugs (e.g. trastuzumab, bevacizumab), experimental (not approved for BC therapy) anticancer drugs. Any previous chemotherapy or hormonal therapy is allowed.
* Previously treated with doxorubicin > 400 mg/m2; epirubicin > 800 mg/m2 in accumulative dosages.
* Surgery, radiation therapy, use of any experimental medications within 4 weeks prior to randomization.
* Clinical evidence or X-ray show that breast cancer metastases in central nervous system
* Patients with metastatic tumor to the bone is the only tumor to be measured
* Systolic blood pressure >150mmHg and/or diastolic blood pressure >100mmHg. Uncontrolled hypertension comprising all cases of arterial hypertension when no decrease in blood pressure could be achieved despite treatment with a combination of 3 antihypertensive drugs including one diuretic and non-medicamental correction methods (low salt diet, physical exercise)
* Cardiovascular system pathology (congestive heart failure (CHF) stage III-IV according to New York Heart Association (NYHA) classification, unstable angina pectoris, myocardial infarction) within 12 months prior to randomization. LVEF < 50% according to echocardiogram when screening.
* Acute or chronic infection (except for acute or chronic infection that is stable and does not affect the study evaluation). Infecting HIV, HBV or HCV, Syphilis
* Patients with a history of severe allergic reaction to trastuzumab, paclitaxel, docetaxel or other ingredients in the formulation
* The patient has evidence of a serious illness (such as resting dyspnea or severe lung disease, etc.) or an abnormal laboratory test that, in the judgment of the researcher, will affect participation. research and completion of patient research, or may affect the patient's response evaluation.
* Pregnancy, intend to get pregnant, lactation |
Study Objectives
This study will assess the safety and efficacy of avutometinib (VS-6766) monotherapy or VS-6766 in combination with defactinib in subjects with recurrent Non-small cell lung cancer.
Intervention / Treatment
DRUG: avutometinib (VS-6766), DRUG: avutometinib (VS-6766) and Defactinib
| Inclusion Criteria:
* Male or female subjects ≥ 18 years of age
* Histologic or cytologic evidence of NSCLC
* Known KRAS or BRAF mutation
* The subject must have received appropriate prior therapy
* Measurable disease according to RECIST *1
* An Eastern Cooperative Group (ECOG) performance status ≤ 1
* Adequate organ function
* Adequate recovery from toxicities related to prior treatments
* Agreement to use highly effective method of contraceptive
Exclusion Criteria:
* Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy
* History of prior malignancy, with the exception of curatively treated malignancies
* Major surgery within 4 weeks (excluding placement of vascular access)
* History of treatment with a direct and specific inhibitor of MEK, KRAS or BRAF except for treatment of BRAF V-600E mutant NSCLC
* Exposure to strong CYP2C9 and CYP3A4 inhibitors or inducers within 7 days prior to the first dose and during the course of therapy
* Symptomatic brain metastases requiring steroids or other local interventions.
* Known SARS-Cov2 infection ≤28 days prior to first dose of study therapy
* Active skin disorder that has required systemic therapy within the past 1 year
* History of rhabdomyolysis
* Concurrent ocular disorders
* Concurrent heart disease or severe obstructive pulmonary disease
* Subjects with the inability to swallow oral medications |
Study Objectives
The purpose of this research study is to assess the safety and immune activity of a vaccine made from the participant's own cancer cells, when administered after a reduced intensity transplant. In recent years, researchers at Dana-Farber Cancer Institute have discovered that vaccines made from a patients's own cancer cells, that have been engineered in the laboratory to produce a protein called GM-CSF, can be effective in stimulating a powerful immune response specific to that cancer.
Intervention / Treatment
BIOLOGICAL: GM-K562 vaccine, PROCEDURE: stem cell transplantation
| Inclusion Criteria:
* Advanced CLL, defined as no response or progressive disease during standard nucleoside analogue based regimen; or, evidence of progressive disease within 24 months of completion of nucleoside analogue regimen; or, intolerance to fludarabine; or, failure to achieve complete remission following salvage regimen.
* no sites of adenopathy > 5cm
* (8/8) HLA matched related or unrelated donor available.
* Must have prior banked tumor, collected by peripheral blood draw, leukapheresis, bone marrow biopsy or by lymph node dissection, per DF/HCC protocol 06-200
* ECOG performance status 0-2
Exclusion Criteria:
* Serum creatinine greater than or equal to *0mg/dl
* ALT or AST greater than or equal to 3x ULN
* Total bilirubin greater than or equal to *0mg/dl (except for patients with Gilbert's syndrome)
* Cardiac ejection fraction greater than or equal to 30%
* HIV infection
* Pregnancy |
Study Objectives
This phase II study is assessing the correlation between M1/M2 macrophage polarization determined by tumor immunohistochemistry analysis and \[18F\]DPA-714 PET/CT binding (qualitative and texture analysis) in patients with operable triple negative breast cancer.
Intervention / Treatment
DRUG: [18F]-DPA-714 PET/CT scan
| Inclusion Criteria:
* 18 Years and older
* Triple negative primary breast cancer based on immunohistochemical results as follows:
* Estrogen receptor < 10%
* And Progesterone receptors < 10%
* And HER2 (Human Epidermal Growth Factor Receptor-2) not amplified or not overexpressed
* Patient with a primary tumor eligible for primary surgery
* Performance Status equal to 0 or 1
* Fertile patients must use effective contraception
* Patient must be affiliated to a Social Health Insurance
* Written informed consent
Exclusion Criteria:
* Patient with No triple negative breast cancer
* Patient with inflammatory breast cancer
* Patient with metastatic breast cancer
* Patient receiving cancer treatments such as chemotherapy, immunotherapy, biologic response modifiers, hormonal therapy, and radiotherapy BEFORE the biopsy and PET scans are performed
* Treated diabetes with fasting blood glucose > 10 mmol/L
* Patient who received antibiotics and/or steroidal and/or non-steroidal anti-inflammatory drugs within 30 days PRIOR to \[18F\]-DPA-714 PET scan
* Contraindication to MRI (implants or metallic prosthesis, severe claustrophobia, pacemaker ...)
* Patient deprived of liberty, under a measure of safeguard of justice, under guardianship or under the authority of a guardian
* Pregnant or nursing patient
* Agitation; impossibility of lying motionless for at least 1 hour, or known claustrophobia |
Study Objectives
On March 17th, 2011, the European Commission issued a marketing authorization valid throughout the European Union for Eribulin mesylate (Halaven; Eisai Limited), for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapic regimens for advanced disease.
As the use of Eribulin will be widespread in this tumor setting, a better knowledge of its safety profile outside clinical trials is warranted.
Indeed the possibility to select patients at risk for developing Eribulin-induced neuropathy, will allow the exclusion from these treatment of those patients harbouring the specific single nucleotide polymorphism (SNP). Given that Eribulin toxicity often results in treatment discontinuation, the ability to anticipate which patients will experience severe toxicity could allow for either early intervention or even possibly for prophylactic therapy, or for selection of the patients to be treated.
Intervention / Treatment
DRUG: ERIBULIN MESYLATE
| Inclusion Criteria:
* Diagnosis of metastatic breast cancer
* Previous treatment with anthracyclines and taxanes
* Patients who will start Eribulin or who have already received only the first dose (cycle 1, day 1) of Eribulin according to the approved indication
* Ability to comply with sample collection
* Patient has signed the study Informed Consent Form (ICF) and the specific Pharmacogenetic ICF.
* Absence of any contraindication to treatment
Exclusion Criteria:
* Previous treatment with Eribulin in a previous line of treatment
* Previous treatment with Eribulin off label |
Study Objectives
It is a prospective, non-randomized, monocentric study. The purpose of the study is to assess the predictive value of VE-cadherin on the objective tumor response.
Biological factors will be correlated to clinical outcome measures.
100 patients treated with bevacizumab for a metastatic colorectal adenocarcinoma will be enrolled.
Patients will be followed every 10 weeks until progression in spite of bevacizumab or until they stop bevacizumab because of toxicity.
Bevacizumab will be administered according to investigators appreciation.
Blood samples will be collected at enrollment, at second bevacizumab's administration and every 10 weeks until progression, or until patients stop bevacizumab because of toxicity or until one year at most in case that patients still receive bevacizumab.
Intervention / Treatment
BIOLOGICAL: Bevacizumab + blood samples
| Inclusion Criteria:
* Patient with a metastatic colorectal cancer proved histologically and treated with bevacizumab in first line.
* At least one extra-osseous, non-irradiated, measurable site (>= 10 mm with spiral CT).
* No prior radiotherapy treatment unless treatment is over for at least 4 weeks.
* Adult patients.
* PS <= *
* Life expectancy greater than 3 months.
* Mandatory affiliation with a healthy security insurance.
* Signed written informed consent.
Exclusion Criteria:
* Prior chemotherapy for the metastatic cancer.
* Prior bevacizumab treatment.
* Other current cancer or previous cancer detected in the last 5 years that can be linked to the current disease.
* Patient deprived of freedom.
* Pregnant or lactating women. |
Study Objectives
This clinical trial is studying the side effects of Erwinia asparaginase and what happens to the drug in the body in treating young patients with acute lymphoblastic leukemia who are allergic to PEG-asparaginase. Drugs used in chemotherapy, such as Erwinia asparaginase, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Intervention / Treatment
DRUG: Asparaginase, OTHER: Laboratory Biomarker Analysis, OTHER: Pharmacological Study
| Inclusion Criteria:
* Diagnosis of acute lymphoblastic leukemia
* Concurrently enrolled on a frontline Children's Oncology Group treatment trial (i.e., COG-AALL0232 or COG-AALL0531, COG-AALL0331, or COG-AALL0434) at a participating institution
* Must have 1 or more courses of asparaginase remaining to be administered on the treatment protocol
* Must have had a grade ? 2 hypersensitivity reaction to PEG-asparaginase
* No history of pancreatitis ? grade 2
* No prior Erwinia asparaginase |
Study Objectives
The purpose of this study is to assess the safety, pharmacokinetics and tolerability, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD \[in the absence of establishing the MTD\]) for single agent MEDI2228 in adult subjects with multiple myeloma who are either transplant ineligible or post autologous stem cell transplant and are relapsed/refractory.
Intervention / Treatment
BIOLOGICAL: Dose Escalation, MEDI2228, ADC (antibody drug conjugate), BIOLOGICAL: Dose Expansion, MEDI2228, ADC (antibody drug conjugate)
| Inclusion Criteria:
* Subjects must be ≥ 18 years of age at the time of screening.
* Subjects must have a confirmed diagnosis of relapsed/refractory MM as per IMWG criteria (Rajkumar et al, 2014) and have exhausted standard of care regimens with proven clinical benefit, which include agents from the following anti myeloma therapies: PIs, IMIDs, and mAbs and have measurable disease with at least one of the following criteria:
* Serum M-protein ≥ *5 g/dL
* Urine M-protein ≥ 200 mg/24 hours
* Serum free light chain (FLC) assay: involved FLC level ≥ 10 mg/dL provided serum FLC ratio is abnormal.
* Subjects must either be ineligible for or post-autologous stem cell transplant.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to *
* Adequate organ and marrow functions as determined per protocol-defined criteria.
Exclusion Criteria
Any of the following would exclude the subject from participation in the study:
Target Disease:
* Subjects who have previously received an autologous stem cell transplant if less than 90 days have elapsed from the time of transplant or the subject has not recovered from transplant associated toxicities prior to the first scheduled dose of MEDI2228
* Subjects who have previously received an allogeneic stem cell transplant
* Central nervous system (CNS) involvement(including meningeal involvement) by MRI or cerebrospinal fluid exam
* Known history of polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome, plasma cell leukemia, Waldenstrom's macroglobulinemia, or amyloidosis
Medical History and Concurrent Diseases:
* Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results |
Study Objectives
Cirrhotic patients may be at high risk for esophageal cancer. Endoscopic resection is the standard treatment for superficial tumors. However, cirrhosis might be associated with upper gastrointestinal bleeding, particularly in case of portal hypertension or coagulopathy. This study aims to assess safety, efficacy and methods to prevent potential complications in cirrhosis or portal hypertension context for esophageal endoscopic resection.
This retrospective multicentric French-Belgian study includes all consecutive patients with cirrhosis or portal hypertension who underwent esophageal endoscopic resection from January 2005 to 2021.
Intervention / Treatment
PROCEDURE: Endosocpic resection of early esophageal tumor
| Inclusion Criteria:
* older than 18 years with cirrhosis or portal hypertension who underwent endoscopic resection of an early esophageal tumor
Exclusion Criteria:
* younger than 18 |
Study Objectives
The purpose of this study is to evaluate overall response rate (ORR) by Independent Review Committee (IRC) assessment, when combined with rituximab in Japanese participants with treatment naïve or relapsed/refractory Waldenstrom's Macroglobulinemia (WM).
Intervention / Treatment
DRUG: Ibrutinib, DRUG: Rituximab
| Inclusion Criteria:
* Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia (WM) in accordance with the consensus panel of the second International Workshop on Waldenstrom's Macroglobulinemia (IWWM)
* Japanese participants with treatment naïve or relapsed/refractory WM
* Measurable disease defined as serum monoclonal immunoglobulin M (IgM) greater than (>) *5 gram per deciliter (g/dL)
* Symptomatic disease, requiring treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (<=) 2
* Hematology and biochemical values within protocol-defined limits
* Female participants of childbearing potential must have a negative serum pregnancy test at screening and agree to use highly effective methods of contraception while taking study drug. Women of childbearing potential must be practicing a highly effective, preferably user independent method of birth control during treatment with any drug in this study and for up to 12 months after the last dose of rituximab, 1 month after last dose of ibrutinib. Male participants must use an effective barrier method of contraception during the study and after receiving the last dose of ibrutinib, and for up to 12 months after last dose of rituximab if sexually active with a female of childbearing potential
* Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. Participants must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
* Must be willing and able to adhere to the lifestyle restrictions specified in this protocol
Exclusion Criteria:
* Involvement of the central nervous system by WM
* Prior exposure to ibrutinib or other Bruton's Tyrosine Kinase (BTK) inhibitors
* Rituximab treatment within the last 12 months before the first dose of study intervention
* Received any WM-related therapy <=30 days prior to first administration of study treatment
* Plasmapheresis less than (<) 35 days prior to the initiation of study drug, except when at least one serum IgM central assessment was performed during the screening period and was >35 days from the most recent plasmapheresis procedure
* History of other malignancies
* Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug
* Infection requiring systemic treatment that was completed <=14 days before the first dose of study drug
* Currently active, clinically significant Child-Pugh Class B or C hepatic impairment
* Inability or difficulty swallowing capsules, malabsorption syndrome, or any disease or medical condition significantly affecting gastrointestinal function
* Stroke or intracranial hemorrhage within 12 months prior to enrollment
* Currently active, clinically significant cardiovascular disease
* Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor
* Infection with human immunodeficiency virus (HIV) or active infection with hepatitis B or hepatitis C virus
* Major surgery within 4 weeks of first dose of study drug
* Lactating or pregnant
* Male participants who plan to father a child while enrolled in this study or within 3 months after the last dose of ibrutinib, and within 12 months after last dose of rituximab
* Any contraindication to ibrutinib or rituximab including hypersensitivity to the active substance or to any of the excipients of ibrutinib or rituximab per local prescribing information
* Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before the planned first dose of study intervention or is currently enrolled in an investigational study
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg \[for example\], compromise the wellbeing) or that could prevent, limit, or confound the protocol-specified assessments
* Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator |
Study Objectives
This is a monocentric, prospective and interventional study aimed to investigating the physiological responses of eccentric compared to concentric cycling realized 1) at the same metabolic demand and 2) at the same mechanical power output. In order to compare the physiological responses between these two cycling modalities, 3 cycling sessions should be performed for each patient where concentric one will serve as reference / comparison to the eccentric one:
* Session (a): eccentric cycling
* Session (b): high intensity concentric cycling realized at the same mechanical power output than eccentric cycling
* Session (c): low intensity concentric cycling realized at the same metabolic demand than eccentric cycling The 3 sessions will be performed for each patient and order will be randomized.
Intervention / Treatment
OTHER: Session (a), OTHER: Session (b), OTHER: Session (c)
| Inclusion Criteria:
* Woman who completed (neo)adjuvant chemotherapy since less than 1 year for a breast cancer
* Woman under hormonotherapy, or menopausal woman, or woman in amenorrhea
Exclusion Criteria:
* Pregnant and nursing woman
* psychiatric, musculoskeletal or neurological disorders
* presenting at least one contraindication to the use of the transcranial magnetic stimulation
* presenting at least one contraindication to the realisation of the maximum effort test |
Study Objectives
The purpose of this study is to assess the feasibility of image-guided surgery in patients with early stage gastric cancer using Robotic Surgery with Tile-pro program. For the assessment of the feasibility, conversion to open or laparoscopic surgery due to disturbance of will indicate the failure.
Intervention / Treatment
PROCEDURE: preoperative 3D-CT reconstruction
| Inclusion Criteria:
* Patients who are older than 20 years
* Histologically confirmed gastric adenocarcinoma
* Patients who want robotic gastric cancer surgery
* Preoperative clinical stage Stage I (T1N0, T1N1, T2N0) diagnosed with EGD, EUS \& CT scan
* No history of drug allergy
* creatinine < *5 X upper normal limit
* Informed consent
Exclusion Criteria:
* Previous history of upper abdominal surgery
* Patient refused the study |
Study Objectives
The purpose is to investigate the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics and efficacy of BI 836826 monotherapy in patients with relapsed or refractory non-Hodgkin lymphoma with at least prior treatments.
Intervention / Treatment
DRUG: BI 836826
| Inclusion criteria:
* Patients with relapsed or refractory non-Hodgkin lymphoma of B cell origin (mature B cell lymphoma according to WHO) not considered candidates for intensive anti-lymphoma therapy
* Patients must have either aggressive NHL and received at least one prior anti-CD20 containing immunochemotherapy or indolent NHL and received anti-CD20 therapy and at least two prior therapies
* Measurable disease on computed tomography (CT) scan with involvement of one clearly demarcated lesion =2 cm or two or more clearly demarcated lesions of >*5 cm at longest diameter (this criterion applies only for the expansion cohort)
* Relapse or progression of disease with an indication for therapy as per investigator's judgement
* Life expectancy of =3 months
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Exclusion criteria:
* Primary central nervous system (CNS) lymphoma or known CNS involvement
* Prior history of malignancy other than a mature B cell neoplasm according to WHO classification (except basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the uterine cervix or breast treated with curative therapy) unless the subject has been free of disease and without treatment for at least 5 years
* Last chemotherapy <4 weeks prior to visit 1
* Last anti-CD20 therapy (non-radiolabelled) <4 weeks prior to visit 1
* Last corticosteroid <2 weeks prior to visit 1 unless the dose is less or equal of 10 mg/day prednisolone or equivalent
* High-dose therapy with stem cell support <6 months prior to visit 1
* Radio-immunotherapy <3 months prior to visit 1 |
Study Objectives
Comparative study of two information modalities during the care course, aiming to propose the preservation of fertility to young women with breast cancer (but not yet under treatment): standard oral information during the PF consultation vs. an online decision support tool, consulted prior to the PF consultation, during which the standard oral information is provided.
Intervention / Treatment
BEHAVIORAL: Online support decision tool, BEHAVIORAL: standard oral information
| Inclusion Criteria:
* 18-40 years women
* with breast cancer
* cancer treatment not started, no antecedent of chemotherapy
* speaking French
* affiliated in Social Insurance
Exclusion Criteria:
* recurrence of breast cancer
* metastatic breast cancer
* pregnancy in progress
* Adults protected (wardship, guardianship, protection of justice) |
Study Objectives
For patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT), the survival benefit of transarterial chemoembolization (TACE) remains modest. This study aimed to investigate whether TACE in combination with irradiation stent placement (ISP) could prolong the survival in patients with HCC and PVTT.
Intervention / Treatment
DRUG: ethiodized oil; doxorubicin;Gelfoam;, DEVICE: stent; idoine-125
| Inclusion Criteria:
* * newly diagnosed HCC with type II or III PVTT, * Child-Pugh classification grade A or B, * Eastern Cooperative Oncology Group (ECOG) performance status score 0-*
Exclusion Criteria:
* * type I or IV PVTT, * received sorafenib, systemic chemotherapy, or external radiotherapy during the treatment, * suffered from malignancy other than HCC, * with an incomplete data. |
Study Objectives
The purpose of this study is to determine whether weekly SMS reminders are effective in improving medication adherence of adjuvant aromatase inhibitors in women with breast cancer.
Intervention / Treatment
OTHER: SMS reminder
| Inclusion Criteria:
* Women who have been receiving adjuvant endocrine therapy for at least 1 year, and are continuing to receive adjuvant AI therapy for at least 1 more year.
* Have cellular phone that can receive text messages.
* Singaporean or permanent resident who is currently residing in Singapore.
* Able to give informed consent.
Exclusion Criteria:
* Unable or not willing to comply with study procedures. |
Study Objectives
The investigators hypothesize that a primary embolization, 3-4 weeks before surgery, would allow development of vascular collaterality, in particular for the marginal artery which will ensure a better colonic perfusion.
Intervention / Treatment
PROCEDURE: embolization of the inferior mesenteric artery, PROCEDURE: Inferior mesenteric artery ligation
| Inclusion Criteria:
* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient is at least 18 years old and less than 80 years old
* Patient has rectal cancer or sigmoid colon cancer requiring surgical treatment
Exclusion Criteria:
* The subject is participating in another study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient has a history of abdominal surgery
* Patient suffers from a hemostasis disorder (hemophilia, von Willebrand disease, thrombocytopenia) and is on anticoagulant therapy.
* Patient whose general condition appears too precarious or is taking corticosteroids or immunosuppressants leading to an unacceptable surgical risk.
* Renal insufficiency with clearance <45ml / min
* Known allergy to contrast media
* Patient who had treatment of the abdominal aorta or its branches Reported pregnancy (the existence of effective contraception will be verified for women of childbearing age).
* Anatomical variant at risk or absence of marginal artery highlighted at the time of arteriography.
* Abnormality of the superior mesenteric artery
* Historic occlusion of the inferior mesenteric artery |
Study Objectives
Main purpose: To compare the intraoperative and postoperative recovery of laparoscopic surgery for ovarian benign tumors through different approaches; Secondary objective: Will vNOTES increase the risk of cesarean section during pregnancy and affect the quality of sexual life after surgery.
Intervention / Treatment
PROCEDURE: operation ways
| Inclusion Criteria:
Preoperative consideration was for benign ovarian tumors requiring surgical treatment.
Exclusion Criteria:
* * Ovarian malignant tumor or borderline tumor was considered before surgery or proved during surgery. * Severe endometriosis, previous severe pelvic inflammation, peritonitis, and other serious pelvic adhesions are considered. * Pregnancy status. * Postoperative follow-up is not convenient and lost visitors. |
Study Objectives
This clinical trial is looking at a drug called BT1718 in adult patients with advanced solid tumours. The main aim of the study is to find the maximum dose of BT1718 that can be given safely to patients; learn more about the potential side effects of BT1718 and how they can be treated and also what happens to BT1718 inside the body.
Intervention / Treatment
DRUG: BT1718
| Inclusion Criteria:
* Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up
* Phase I, dose escalation phase (Stages 1 and 2):
* Histologically or cytologically proven advanced solid tumour, refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator or is declined by the patient.
Phase IIa, expansion phase:
* Histologically or cytologically proven advanced solid tumour of particular interest based on pre-clinical and clinical data, refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator or is declined by the patient. Phase IIa expansion cohorts will be:
* Squamous NSCLC cohort - retrospective MT1-MMP testing.
* Basket cohort (advanced solid tumours, excluding patients eligible for one of the other recruiting expansion cohorts) - high MT1-MMP expression by IHC assay using archival tumour sample (mandatory fresh tumour samples for those patients without available archival tumour samples or additional analysis is deemed necessary). Retrospective testing may be permitted for tumour types estimated to have high MT1-MMP positivity rates as per the Laboratory manual.
* Additional expansion cohort(s) of squamous oesophageal cancer if confirmed as recruiting by the Sponsor.
* At least one measurable lesion according to RECIST criteria Version *1, that has had objective radiological progression on or after the last therapy.
* Consent for pre-treatment and post-treatment fresh tumour biopsy sample in a minimum of eight patients in the squamous NSCLC cohort, squamous oesophageal cohort (if confirmed as recruiting by the Sponsor) and all patients in the basket cohort (except patients with a very high MT1-MMP H-score if agreed with the Sponsor and PI as defined in the Laboratory Manual).
* Consent for pre-treatment and post-treatment non-tumour sample (optional) for patients having a pre and post treatment tumour biopsy.
* Consent for pre and post treatment skin punch biopsy (optional).
* Life expectancy of at least 12 weeks.
* World Health Organisation (WHO) performance status of 0 - *
* Haematological and biochemical indices within the ranges shown below. These measurements should be performed to confirm the patient's eligibility.
Haemoglobin (Hb): ≥*0 g/L, or ≥*0 g/L if transfusion within last four weeks Absolute neutrophil count (ANC): ≥*5 x 10\^9/L Platelet count: ≥100 x 10\^9/L Bilirubin: ≤*5 x upper limit of normal (ULN). NB: >*5 ULN, acceptable if conjugated bilirubin is ≤*5x ULN Alanine amino-transferase (ALT), aspartate amino-transferase (AST) and alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT) : ≤*5 x ULN (or ≤5 x ULN if has liver metastases) Renal function
Either:
Serum creatinine: ≤*5 x ULN
Or:
Calculated creatinine clearance (using the Wright or Cockcroft \& Gault \[C\&G\] formula): GFR ≥50 mL/min (uncorrected value)
Or:
Isotope clearance measurement: GFR ≥50 mL/min (corrected value)
* 16 years or over at the time consent is given
* Consent to access and analyse any available archival tissue.
Exclusion Criteria:
* Radiotherapy (except for palliative reasons), systemic anti-cancer therapy (with the exception of life-long hormone suppression such as LHRH agents in prostate cancer) or investigational medicinal products during the previous four weeks (six weeks for nitrosoureas, mitomycin-C) before treatment (or first dose of an immunotherapy during the previous 12 weeks).
* Prior bone marrow transplant, myeloablative conditioning, or extensive radiotherapy to greater than 25% of bone marrow, within previous eight weeks of first BT1718 dose.
* Ongoing toxic manifestations of previous treatments greater than NCI CTCAE Grade * Exceptions to this are alopecia, amenorrhea/oligospermia and any other ongoing toxic manifestation which in the opinion of the Investigator and the Medical Advisor should not exclude the patient.
* Any CNS metastases (unless had local therapy and are asymptomatic and radiologically-stable off steroids for the last four weeks).
* Current or prior malignancy which could affect compliance with the protocol or interpretation of results. Patients with curatively-treated non-melanoma skin cancer, non-muscle-invasive bladder cancer, or carcinomas-in-situ are generally eligible.
* Female patients who are able to become pregnant (or are already pregnant or lactating). However, those patients who have a negative serum or urine pregnancy test before enrolment and agree to use two forms of contraception (one effective form plus a barrier method) \[oral, injected or implanted hormonal contraception and condom; intra-uterine device and condom; diaphragm with spermicidal gel and condom\] or agree to sexual abstinence, effective from the first administration of BT1718, throughout the trial and for six months afterwards are considered eligible.
* Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using a barrier method of contraception \[condom plus spermicide\] or to sexual abstinence effective from the first administration of BT1718, throughout the trial and for six months afterwards. Men with partners of child-bearing potential must also be willing to ensure that their partner uses an effective method of contraception for the same duration for example, hormonal contraception, intrauterine device, diaphragm with spermicidal gel or sexual abstinence). Men with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure of the foetus or neonate.
* Surgery from which the patient has not yet recovered.
* At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
* Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
* Patients with significant cardiovascular disease are excluded as defined by:
* Current congestive heart failure requiring therapy (NYHA III or IV - Appendix 3) or known LVEF <40% (moderate to severe)
* History of unstable angina pectoris or myocardial infarction up to six months prior to trial entry, or of current poorly controlled angina (symptoms weekly or more)
* Presence of symptomatic or severe valvular heart disease (severe by local echographic criteria or AHA/ACC Stage C or D - Appendix 4)
* History of a clinically significant cardiac arrhythmia up to six months prior to trial entry (asymptomatic atrial fibrillation or asymptomatic first-degree heart block are permitted)
* Previous known allergy to one of the constituents or excipients of BT*
* Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this Phase I/IIa study of BT* Participation in an observational trial or interventional clinical trial which does not involve administration of an IMP and which would not place an unacceptable burden on the patient in the opinion of the Investigator and Medical Advisor would be acceptable.
* Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial. |
Study Objectives
Adult patients evaluated at Lahey Clinic with known or suspected gastrointestinal or gynecologic malignancies and with an indication for diagnostic laparoscopy will be offered participation in the study. The proposed study is a randomized, controlled feasibility trial with crossover design. The study's aim is to evaluate the effectiveness of laparoscopic narrow band imaging (NBI) compared to standard white-light laparoscopy for detection of peritoneal cancer metastases. Study patients will undergo laparoscopic evaluation of the peritoneal cavity using a routine white-light videolaparoscope with the capability of NBI. The order of white-light and NBI laparoscopy will be randomized for each patient (crossover design). Frozen-section histopathology biopsies will be retrieved of all suspicious-appearing abnormalities using best clinical practices. The number of detected peritoneal metastases will be compared between each diagnostic laparoscopy technique. To gauge the rate of potentially missed metastases, peritoneal cancer recurrence will be surveyed through a 1-year follow-up.
Intervention / Treatment
DEVICE: Laparoscopic narrow band imaging, DEVICE: Standard white-light laparoscopy
| Inclusion Criteria:
* adult patients
* diagnosis or suspicion of malignancy of the gastrointestinal or gynecologic tract
Exclusion Criteria:
* clinical contraindication to diagnostic laparoscopy |
Study Objectives
This study is being conducted by the University of Rochester Cancer Center to determine the levels of cytokines in the blood, and to determine if blood levels of these cytokines are related to the side effects of radiation therapy combined with other treatments.
Intervention / Treatment
| Inclusion Criteria:
Patients receiving radiation therapy for lung cancer combined with surgery either pre or post RT to the chest for lung cancer not associated with atelectasis, pleural effusion.
Patients receiving HDR Brachytherapy for lung cancer.
Patients receiving concomitant radiation and interferon therapy for lung cancer.
Patients receiving concomitant chemotherapy and radiation for lung cancer. Prior drug therapy does not make patients ineligible.
Karnofsky ≥ 70 %.
There are no age restrictions.
Acceptable bone marrow function - WBC 2 3000/mm3, platelet count > 100,000, hematocrit ≥ 33%, hemoglobin ≥ 11 gms/dl.
Life expectancy > 6 months.
Patients must sign informed consent meeting all federal and institutional guidelines.
Exclusion Criteria:
Patients not meeting eligibility criteria stated above |
Study Objectives
The purpose of this First in Man study is to evaluate the safety and tolerability, as well as to explore efficacy of PeproStat, a new peptide based coagulant (haemostat), when used in patients undergoing open liver resection surgery.
Intervention / Treatment
DRUG: PeproStat
| Inclusion Criteria:
* Are able and willing to provide written informed consent to participate in this study, confirmed by signing the informed consent documents
* Adult males and females ≥18 years of age
* Female subjects must be post-menopausal. Post-menopausal status is defined as any of the following: natural menopause with menses >1 year ago; radiation induced oophorectomy with last menses >1 year ago; chemotherapy induced menopause with 1 year interval since last menses
* Willing and able to comply with all protocol requirements including follow-up
* Subject must have a haemoglobin ≥ *0 g/dL at screening
* Subject must have a platelet count ≥ 100,000/mm3 at screening
* Subject is undergoing a planned open liver resection
* Male subjects must be willing and able to use adequate contraception from enrollment through to the 30 day follow-up visit
* During the surgery, the subject presents an identified target bleeding site (TBS) with oozing, mild or moderate bleeding, which conventional surgical techniques are insufficient to control and would otherwise be a candidate for standard haemostats
* During the surgery, subject presents no intraoperative complications, other than bleeding, that may interfere with study assessments as judged by the investigator
Exclusion Criteria:
* Subject is undergoing emergency surgical procedure
* Recipient of a liver transplant
* Females of child-bearing potential
* Active infection at the time of the liver resection
* International Normalized Ratio (INR) > *0 or APTT ratio > *0 at screening
* Fibrinogen level < *5g/L at screening
* History of thromboembolic disease and/or thrombophilia
* Any other disease or condition that may affect normal blood clotting, for example thrombocytopenia, as judged by the investigator
* A known history of anaphylaxis or allergic reaction to human albumin, PEGylated proteins, yeast or moulds, porcine products or other components in the IMP
* Participation in another investigational drug or device research study within 30 days before and after enrolment in the current study
* Current known or suspected alcohol and/or drug abuse or dependence at the time of screening
* Any concurrent medical, surgical, or psychiatric condition that may, in the investigator's opinion, affect the subject's willingness or ability to meet all study requirements during the study duration
* During the surgery, subject presents severe bleeding where use of a topical haemostat would be inappropriate
* Subject is taking any prohibited medications
* BMI at screening of ≥35 |
Study Objectives
PEComa is rare tumor affecting particularly patients with Tuberous Sclerosis. Biological similarities were seen between PEComa and infantile hemangioma. Propranolol is highly efficient to treat infantile hemangioma and we believe that this drug can also be useful for the treatment of PEComa.
Purpose : to understand the mechanism of action of propranolol in PEComas and related pediatric vascular lesions and to select possible novel targets of betablockers in vascular tumors related to PEComas by using YAP oncogene activation as a molecular marker
Intervention / Treatment
OTHER: Biopsy
| Inclusion Criteria:
* patients who will have biopsy or surgery for PEComa or vascular pediatric tumor (RICH, NICH, hemangioma or pyogenic granuloma)
* A free, informed and written consent will be established
Exclusion Criteria:
* none |
Study Objectives
This phase II trial studies how well pazopanib hydrochloride works in treating patients with advanced angiosarcoma. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Intervention / Treatment
DRUG: pazopanib hydrochloride, OTHER: laboratory biomarker analysis, PROCEDURE: positron emission tomography, PROCEDURE: computed tomography, RADIATION: fludeoxyglucose F 18
| Inclusion Criteria:
* Subjects must provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up
* Note: informed consent may be obtained prior to start of the specified screening window
* Note: procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study such as bone scan) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol
* Histologically or cytologically proven diagnosis of advanced stage angiosarcoma that is not amenable to treatment with curative intent; specify site of origin as cutaneous vs. non-cutaneous
* Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
* Must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) *1 or cutaneous disease amenable to serial measurements should be present; a measurable lesion is defined as a lesion that can be accurately measured in at least one dimension with the longest diameter >= 10 mm with computed tomography (CT) scan; lesions that have been treated with therapeutic intent will be considered measurable if they have increased in size by more than 20%
* Absolute neutrophil count (ANC) >= *5 X 10\^9/L
* Hemoglobin >= 9 g/dL (*6 mmol/L)
* Platelets >= 100 X 10\^9/L
* International normalized ratio (INR) =< *2 X upper limit of normal (ULN)
* Activated partial thromboplastin time (aPTT) =< *2 X ULN
* Total bilirubin =< *5 X ULN (may not have abnormalities in both bilirubin and transaminases)
* Alanine amino transferase (ALT) and aspartate aminotransferase (AST) =< *5 X ULN (may not have abnormalities in both bilirubin and transaminases)
* Serum creatinine =< *5 mg/dL (133 umol/L)
* Or, if serum creatinine > *5 mg/dL: calculated creatinine clearance (ClCR) > 50 mL/min
* Urine Protein to Creatinine Ratio (UPC) < 1
* Able to swallow pills whole and retain oral medication
* A female is eligible to enter and participate in this study if the following apply:
* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:
* A hysterectomy
* A bilateral oophorectomy (ovariectomy)
* A bilateral tubal ligation
* Is post-menopausal
* Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40pg/mL (< 140 pmol/L)
* Subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT
* Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment and for 3 months after the completion of treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception; acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow:
* Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product
* Oral contraceptive, either combined or progestogen alone
* Injectable progestogen
* Implants of levonorgestrel
* Estrogenic vaginal ring
* Percutaneous contraceptive patches
* Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year
* Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject
* Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
* Female subjects who are lactating must discontinue nursing prior to the first dose of study drug and refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug
* A male is eligible to enter and participate in this study if he and his female sexual partner in the reproductive age group agree to use effective methods of contraception
Exclusion Criteria:
* Prior malignancy:
Subjects with a history of a prior malignancy other than angiosarcoma who have been disease-free for at least 2 years prior to the first dose of study drug and/or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible
* History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medications for 3 months prior to first dose of study drug; screening with CNS imaging studies (CT or magnetic resonance imaging \[MRI\]) is required only if clinically indicated or if the subject has a history of CNS metastases
* Clinically significant gastrointestinal (GI) abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
* Active peptic ulcer disease
* Known intraluminal metastatic lesion/s with risk of bleeding
* Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation
* History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment
* Clinically significant (> 1/2 teaspoon) hemoptysis or gastrointestinal hemorrhage in the past 6 months
* Evidence of active bleeding or bleeding diathesis; recent hemoptysis (>= 1/2 teaspoon of red blood within 8 weeks before first dose of study drug)
* Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
* Malabsorption syndrome
* Major resection of the stomach or small bowel
* Corrected QT interval (QTc) > 480 msecs using Bazett's formula
* Left ventricular ejection fraction < 50%
* History of any one or more of the following cardiovascular conditions within the past 6 months:
* Cardiac angioplasty or stenting
* Myocardial infarction
* Unstable angina
* Coronary artery bypass graft surgery
* Symptomatic peripheral vascular disease
* Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
* Poorly controlled hypertension (defined as systolic blood pressure \[SBP\] of >= 140 mmHg or diastolic blood pressure \[DBP\] of >= 90mmHg); Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; following antihypertensive medication initiation or adjustment, blood pressure (BP) must be re-assessed three times at approximately 2-minute intervals; at least 24 hours must have elapsed between anti-hypertensive medication initiation or adjustment and BP measurement; these three values should be averaged to obtain the mean diastolic blood pressure and the mean systolic blood pressure; the mean SBP / DBP ratio must be < 140/90 mmHg in order for a subject to be eligible for the study
* Cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
* Note: subjects with recent DVT who have been therapeutically coagulated for at least 6 weeks are eligible
* Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery)
* Evidence of active bleeding or bleeding diathesis; recent hemoptysis (>= ½ teaspoon of red blood within 8 weeks before first dose of study drug)
* Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels (Note: tumor abutting the vessel is acceptable, but contiguous tumor and vessel is not; CT with contrast is strongly recommended to evaluate such lesions)
* Abnormal serum calcium, magnesium, or potassium levels
* Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
* Use of any prohibited medication within the timeframes
* Treatment with any of the following therapies:
* Radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib hydrochloride OR
* Chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib
* Patients who require chronic use of strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers including but not limited to grapefruit juice
* Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 (except hemoglobin value) and/or that is progressing in severity, except alopecia
* Previous exposure to pazopanib hydrochloride or a vascular endothelial growth factor receptor (VEGFR) targeted kinase therapy, except for bevacizumab or VEGFR-Trap (Aflibercept)
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib |
Study Objectives
The purpose of this study is to evaluate a new instrument that shines light and takes digital pictures of skin. The goal is to develop a technique that may enable fast and accurate assessment of surgical margins in the excision of basal cell carcinoma (BCC) or squamous cell carcinoma (SCC). The investigators will evaluate the pictures obtained by the confocal microscope to determine whether this technique may be useful in the future for helping Mohs surgeons remove cancers. In the future, patients may benefit with shorter surgery and improved care.
Intervention / Treatment
| Inclusion Criteria:
* Patients undergoing Mohs surgery for basal cell carcinoma (BCC )or squamous cell carcinoma (SCC). .
* Ability to sign informed consent.
* Age ≥ 18 years.
Exclusion Criteria:
* Mohs surgery located on a site that may not be convenient to confocal imaging.
* Inability to give informed consent.
* Inability to tolerate imaging procedure (i.e., remain relatively still for multiple short durations of 3-4 minutes) over a total time of 20 minutes. |
Study Objectives
Data from this study are expected to demonstrate that V501 (Human Papillomavirus (HPV) \[Types 6, 11, 16, 18\] Recombinant Vaccine) , when administered concomitantly with a combined diphtheria, tetanus, pertussis (Tdap) vaccine and a meningococcal conjugate vaccine in adolescents remains immunogenic and well-tolerated and it does not impair the immunogenicity of the concomitant vaccines.
Intervention / Treatment
BIOLOGICAL: Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine, BIOLOGICAL: Comparator: Menactra™ (Concomitant), BIOLOGICAL: Comparator: Adacel™ (Concomitant), BIOLOGICAL: Comparator: Menactra™ (Non-concomitant), BIOLOGICAL: Comparator: Adacel™
| Inclusion Criteria:
* Must be healthy boys or girls, 11-17 years of age
* Must be a virgin with no intention of becoming sexually active during the study period
* Must have been properly vaccinated against diphtheria, tetanus and pertussis
Exclusion Criteria:
* Must not have received a vaccine against diphtheria, tetanus and pertussis in the past 5 years
* Must not have received any prior human papillomavirus (HPV) vaccine or meningococcal vaccine |
Study Objectives
The first objective of this study is to assess the accuracy of digital image-processing techniques to provide measurements of human breast physical dimensions. The ultimate usefulness of these techniques is to develop quantitative outcome measures of the visual appearance of breast after local treatments for breast cancer. These measures will be used to improve clinical outcomes from multimodality therapy that includes surgery and radiotherapy and form the basis for the future development of patient decision making aids. The second objective is to evaluate the relationship between patient reported body image outcomes and measurement of human breast physical dimensions for patients with breast cancer.
Intervention / Treatment
BEHAVIORAL: Questionnaire, PROCEDURE: Digital Imaging
| Inclusion Criteria:
* Female
* Age greater than 21 years old.
* Candidate who has had or is planning to have breast reconstructive surgery and has at least one breast mound.
* Willing to participate in the study and able to complete informed consent.
* Proficient at reading and speaking English.
Exclusion Criteria:
* Women who have undergone previous bilateral mastectomy without reconstruction.
* Women who are unable to stand unassisted for 2 minutes.
* Diagnosis of serious mental illness (e.g. schizophrenia) or cognitive impairment. |
Study Objectives
Preoperative chemoradiation leads to increased pelvic control and overall survival, but both distant and local disease control remain problematic in locally advanced rectal cancer patients. Enhancing the effect of chemotherapy and radiotherapy can increase tumor response as well as distant disease control. Patients who have complete response to therapy have increased sphincter preservation, and can possibly have more limited surgery (full thickness local excision). When combined with standard chemotherapy, bevacizumab \[RHUMAB VEGF, Avastin\] has been shown to improve response and median survival in patients with metastatic colorectal cancer in a recent randomized trial, has led to increased activity in preclinical studies with radiotherapy, and has been found to be very well tolerated with chemoradiation in a phase I trial conducted at the M.D. Anderson Cancer Center (MDACC) in patients with locally advanced pancreatic cancer. The hypothesis is that the addition of bevacizumab to standard chemoradiation will safely lead to increased tumor response in patients with locally advanced rectal cancer.
Intervention / Treatment
DRUG: Avastin (Bevacizumab, RHUMAB VEGF), DRUG: Capecitabine, RADIATION: Radiation Therapy
| Inclusion Criteria:
* ECOG status of 0 or *
* Patients must be greater than or equal to 18 years of age.
* All patients must have histologically confirmed adenocarcinoma of the rectum with pathologic material reviewed by the Department of Pathology at MDACC. The clinical stage must be T3, T4, or recurrent based on CT, MRI or EUS criteria.
* All patients must have no distant metastatic disease on abdominopelvic CT scan performed with IV contrast. If the CT was performed outside of MDACC, the slice thickness is *5 mm. Criteria for pathologic enlargement of lymph nodes is > 15 mm on short axis dimension. If CT findings of lung, liver, or peritoneal metastases are equivocal, patients are eligible to participate.
* The rectal tumor must be either palpable on digital rectal exam or the inferior edge of the tumor must be within 12 cm of the anal verge based on rigid proctoscopy.
* Patients must have WBC > 4000 cells/mm3, ANC of >1500/L, platelets > 100,000/mm3, total serum bilirubin < *0 mg%, BUN < 30 mg%, creatinine < *5 mg% and/or creatinine clearance >30ml/min (estimated as calculated with Cockcroft-Gault equation). Note: In patients with moderate renal impairment (estimated creatinine clearance 30-50 mL/min) at baseline, a dose reduction to 75% of the capecitabine starting dose is recommended.
* Hemoglobin of >9 gm/dL (may be transfused or receive Procrit to maintain or exceed this level)
* Patients must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary.
Exclusion Criteria:
* Known compromised renal or hepatic function.
* Participation in any other experimental drug study.
* AST or ALT >5 times upper limit of normal for subjects with documented liver metastases; >*5 times the upper limit of normal for subjects without evidence of liver metastases.
* Pregnant or lactating woman. Woman of childbearing potential with either a positive or no pregnancy test at baseline. Woman / men of childbearing potential not using a reliable contraceptive method. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Patients must agree to continue contraception for 30 days from the date of the last study drug administration.
* Any prior chemotherapy.
* Any prior radiation therapy.
* Serious, uncontrolled, concurrent infection(s) requiring IV antibiotics.
* Treatment for other carcinomas within the last five years, except cure non-melanoma skin cancer and treated in-situ cervical cancer.
* Clinically significant cardiac disease (e.g., uncontrolled hypertension \[blood pressure of >160/110 mmHg on medication\], any history of myocardial infarction, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix H), unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), or grade II or greater peripheral vascular disease(see Appendix H).
* Inability to to swallow oral medication.
* Evidence of bleeding diathesis or coagulopathy, INR greater than or equal to **
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study; fine needle aspirations or core biopsies within 7 days prior to Day *
* Proteinuria at baseline or clinically significant impairment of renal function Subjects unexpectedly discovered to have 1+ proteinuria at baseline should undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate <500 mg of protein/24 hr to allow participation in the study (see appendix F).
* Currently has serious, nonhealing wound, ulcer, or bone fracture.
* Had aneurysms, strokes, transient ischemic attacks, and arteriovenous malformations within the past year.
* Patients who have had an organ allograft.
* Patients on Coumadin must be changed to Lovenox at least 1 week prior to starting capecitabine. Low dose (1 mg) Coumadin is allowed.
* Patients taking Sorivudine or Brivudine A must be off of these drugs for 4 weeks. Patients taking cimetidine must have this drug discontinued. Ranitidine or a drug from another anti-ulcer class can be substituted for cimetidine if necessary. If patient is currently receiving allopurinol, must discuss with PI to see of another agent may substitute for it. |
Study Objectives
The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia Treatment (PSQ-AT) in gynecological cancer patients treated with darbepoetin alfa or recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.
Intervention / Treatment
DRUG: darbepoetin alfa, DRUG: recombinant human erythropoietin (rHuEPO)
| Inclusion Criteria: - Subjects receiving multi-cycle chemotherapy for gynecological cancer - Anemia due to chemotherapy (hgb less than or equal to *0 g/dL) - Expected to receive greater than or equal to 8 additional weeks of chemotherapy as part of their planned treatment - Karnofsky Performance Scale (KPS) greater than or equal to 50% - Adequate renal function - Adequate liver function Exclusion Criteria: - Iron deficiency - Known positive test for human immunodeficiency virus (HIV) infection |
Study Objectives
I) Introduction Patients with cancer face difficult choices that require balancing competing priorities such as survival, functional capacity and symptom relief. Most patients with advanced cancer (\>80%) expect frank yet sensitive discussions with their physicians about prognosis and treatment choices in order to be involved in the decision-making process. Nevertheless, this kind of discussion is frequently lacking, and consequently, patients often have a biased view of their own prognosis such as an underestimation of disease severity, or unrealistic expectations for cure.
Patients with advanced hepatocellular carcinoma (HCC) may be treated with systemic therapies which may prolong survival but are not curative. Patients with advanced HCC often report expectations for survival and treatment-related side effects that differ from their treating physician. Accordingly, communication on prognostic and treatment choices is essential to obtain an accurate understanding of the disease that allows patients to make informed decisions. To the best of our knowledge, a thorough evaluation of the physician-patient communication quality has never been performed in advanced HCC patients.
The aim of our study is to assess the perception of the expected prognosis and treatment side effects by the patient and his physician during the first consultation before the initiation of a new systemic therapy.
II) Type of study:
Prospective, observational, non-interventional multicentric study
III) Outcomes III.1) Primary Outcome Evaluate the concordance between the patient's perception of his prognosis and treatment side effects with the one of his treating physician.
III.2) Secondary Outcomes
* Compare the patient's expectations for the aforementioned items to those of his physician and the degree of concordance between them.
* Evaluation of patient satisfaction with the information received during the consultation
* Assessment of patient-reported symptoms of anxiety and depression
* Evaluate the association between individual prognosis expectation (i.e., patient and physician) and data from the available literature.
IV) Recruitment All consecutive patients with a new systemic treatment prescribed for HCC in participating centres will be included for a period of 1 year.
Intervention / Treatment
BEHAVIORAL: Questionnaire
| Inclusion Criteria:
* diagnose of advanced hepatocellular carcinoma by histology or radiology using the EASL criteria
* ≥ 18 years old
* willing to participate in the study, being capable of consenting and sign the informed consent
* not candidate for curative treatment or locoregional therapy
* any line systemic therapy that has been validated by the local hepatic tumor board.
Exclusion Criteria:
* Locoregional treatment combined with systemic treatment
* Pregnancy in progress
* Candidate for surgery or locoregional therapy
* Patient with state medical aid (AME) |
Study Objectives
Neoadjuvant therapy of cisplatin-based chemotherapy has been proved to improve prognosis of muscle invasive UTUC patients in several studies. This study is designed to investigate the safety and efficacy of neoadjuvant PD-1 monoclonal antibody in patients with locally advanced upper urinary tract urothelial carcinoma (UTUC) which are ineligible for cisplatin. Tislelizumab, an anti-programmed death protein-1 (PD-1) monoclonal antibody, was engineered to minimize binding to FcγR on macrophages to abrogate antibody-dependent phagocytosis, a mechanism of T-cell clearance and potential resistance to anti-PD-1 therapy. The safety, tolerability, and efficacy of tislelizumab in patients with PD-L1 positive urothelial carcinoma who progressed during/following platinum-containing therapy was proved in a phase 2 trial (CTR20170071). This trial focuses on the efficacy of Tislelizumab to induce pathological down-staging of locally advanced UTUC in neoadjuvant setting.
Intervention / Treatment
DRUG: Tislelizumab
| Inclusion Criteria:
* * had non-metastatic high risk UTUC and planed to receive surgery(defined as high grade UTUC either by endoscopic biopsy or urinary cytology and/or any invasive aspect on radiological examination and/or hydronephrosis );
* * were ineligible for cisplatin-based chemotherapy(defined as meeting at least one of the following criteria: Eastern Cooperative Oncology Group \[ECOG\] performance status 2, creatinine clearance 30-60 mL/min, grade ≥2 audiometric hearing loss, grade ≥2 peripheral neuropathy, or New York Heart Association Class III heart failure);
* * had not received any systemic anti-tumor therapy;
* * Adequate organ function defined by study-specified laboratory tests; Hemoglobin ≥90 g/L; Hematological Absolute neutrophil count (ANC) ≥*5×109 /L; Platelets ≥100×109 /L
* * No functional organic disease: T-BIL≤*5×upper limit of normal (ULN); ALT andAST≤*5×ULN; Serum creatinine≤2×ULN; endogenous creatinine clearance rate>30ml/min
* * Agree to comply with scheduled visits, treatment plans, lab tests and any other required study procedures;
Exclusion Criteria:
* * Patients who have received prior therapy of an anti-PD-1, anti-PD-L1, or anti-PD-L2 antibody;
* * Patients who are allergic to monoclonal antibodies or any of its excipients;
* * Patients who have received other systems for anti-tumor treatment (e. g., Steroid therapy, immunotherapy) within 4 weeks or enrolled in other clinical trials;
* * Patients who are pregnant or breastfeeding, or expecting to conceive;
* * Patients who have a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies);
* * Patients who have known active Hepatitis B or Hepatitis C;
* * Patients who have active autoimmune disease that has required systemic treatment in the past 2 years;
* * Patients who have received a live vaccine within 30 days prior to the first dose of trial treatment;
* * Patients who have received prior radiation therapy to the bladder;
* *Patients who have muscle invasive bladder cancer;
* *Patients who have received allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
* *Patients who have a history of substance abuse or with a history of mental disorders;
* *Patients who had other malignant tumors in the past five years that have not recovered except for curable tumors that have been cured including basal or squamous skin cancer, localized carcinoma in situ of the cervix or the breast and low-risk prostate cancer, etc.
* *Patients who have active tuberculosis;
* *Patients who have other serious and uncontrollable accompanying diseases that may affect compliance or interfere with the interpretation of results including active opportunistic infections or advanced (severe) infections, uncontrollable diabetes, cardiovascular disease (grade III or IV heart failure defined by the New York Heart Association classification, II degree atrioventricular block and above, myocardial infarction in the past 6 months, unstable arrhythmia or instability angina, cerebral infarction within 3 months, etc.) or lung disease (interstitial pneumonia, history of obstructive lung disease and symptomatic bronchospasm); |
Study Objectives
This clinical investigation examined the effectivity 5-fluorouracil, of adding levamisol or interferon to 5-fluorouracil, and of a 5-fluorouracil/levamisol/interferon triple combination, in terms of recurrence-free and overall survival in curatively operable colon carcinoma Stage III.
Intervention / Treatment
DRUG: 5-fluorouracil, levamisol, interferon
| Inclusion Criteria:
* Patients with histologically verified, curatively operated colon carcinoma Stage III (R0, T1-4, N1-3, M0)
* Age: less than 80 years
* WHO Performace Status > 2
* Adequate bone marrow reserve
* Informed consent
Exclusion Criteria:
* Rectal cancer
* R1, R2, carcinosis peritonei
* Start of chemo- or chemo-immunotherapy > 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
* Serious concomitant disease, in particular chronically inflammatory large intestine, cardiopathic disease, malignant second carcinoma |
Study Objectives
End-of life care is one of the principle components of cancer care. Measurement of the quality of care provided for end-of-life cancer patients is an important issue. Recently there has been an increased emphasis on measuring and monitoring the quality of cancer care for the purpose of improving clinical practice. Despite increasing attention paid to end-of-life care in recent years, many studies have described difficulties in the final phase of life, including problems with access to hospice, inadequate symptom management, care giving burdens, care mismatched with patient preferences, and inappropriate resource use. Measuring quality of life is an important issue for monitoring clinical practice and improving outcome. Although patient assessment is the best quality measure, it is impractical to measure the quality of end-of-life care because of the difficulties of accurate prognostication for end-of-life and many patients are too ill to provide assessments. In contrast, several recent studies developed quality indicators (QIs) of palliative and end-of-life care, which assess the quality from existing sources such as administrative data or medical chart data.
Intervention / Treatment
OTHER: survey
| Inclusion Criteria:
* Documented confirmed cancer diagnosis.
* 18 year or older.
* Patients with advanced cancer (stage IV or with metastasis).
* Any hospital admission within the last 30 days.
Exclusion Criteria:
* Cancer patients admitted under care of other specialties other than oncology.
* Patients who had a major surgery within one month of death, which required admission for more than 1 day under general anesthesia.
* Patients who were following with other hospitals transferred and died within 3 days of admission.
* Cancer diagnosis was made only on death certificate with no prior cancer diagnosis.
* Patient died outside hospital. |
Study Objectives
The goal of this clinical research study is to learn if giving cytotoxic T lymphocytes (CTLs) can help control CMV when it reactivates (becomes active again) in patients who receive an allogeneic stem cell transplant. Researchers also want to learn about the safety of giving CTLs to patients who have had a stem cell transplant.
Intervention / Treatment
BIOLOGICAL: Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)
| Inclusion Criteria:
* STEP 1: Within 30 days of study entry: Patients with a history of bone marrow disorders including hematological malignancies and aplastic anemia, Myelodysplastic Syndrome (MDS) and Myeloproliferative disorder (MPD) planning to undergo allogeneic HSCT with reduced intensity or myeloablative conditioning regimens.
* Disease status must be complete remission by standard criteria for Lymphoma and Acute Leukemia patients.
* Patients with Myelodysplastic Syndrome (MDS) and Myeloproliferative Disorder (MPD) must have <5% blasts in the bone marrow.
* Patients with T Cell ALL must be in complete remission and MRD negative (-) by flow cytometry and molecular studies.
* Patients >/= 18 years of age.
* Karnofsky greater than or equal to 80%.
* CMV seropositive.
* Donor is either matched related, matched unrelated, mismatched unrelated, or haploidentical. Cord blood recipients are also eligible.
* Hgb greater than 10 g/L.
* Patient or patient's legal representative, parent(s) or guardian able to provide written informed consent.
* Negative pregnancy test in female patients of childbearing potential.
* STEP 2: Eligibility at time of generating and infusing CMV-specific cytotoxic T cells (adoptive immunotherapy): CMV reactivation defined as CMV DNAemia >/= 137 copies/ml.
* Evidence of neutrophil engraftment defined as the absolute neutrophil count (ANC)> *5 X 10\^3/for 3 consecutive days.
* Clinical status to allow tapering of steroids to less than *5 mg/kg/day prednisone or equivalent.
* Negative pregnancy test in female patients of childbearing potential.
Exclusion Criteria:
* STEP 1: Within 30 days of study entry: T cell leukemia or lymphoma.
* CMV seronegative.
* Positive for HIV, HBV, HCV, HTLV1 and/or HTLV*
* STEP 2: Eligibility at time of generating and infusing CMV-specific cytotoxic T cells (adoptive immunotherapy): Documented CMV end-organ disease.
* Patients receiving ATG, or Campath within 28 days of CMV reactivation.
* Patients with other uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to generating CTLs. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to generating CTLs. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
* Patients who have received donor lymphocyte infusion (DLI) within 28 days.
* Patients with active acute GVHD grades II-IV.
* Active and uncontrolled relapse of malignancy. |
Study Objectives
The purpose of this study is to determine the safety of docetaxel and CNTO 328 when given together as a treatment. The second goal of this study is to determine if a combination of docetaxel and CNTO 328 has an effect on prostate cancer.
Intervention / Treatment
DRUG: CNTO 328, DRUG: Docetaxel
| Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Radiologically documented metastatic disease
* No prior systemic chemotherapy for metastatic hormone refractory prostate cancer
* Progressive hormone-refractory disease after orchiectomy or gonadotropin-releasing hormone analog and/or anti-androgen treatment within 12 months of screening based on 1 of the following: Transaxial imaging tumor progression, Rise in 2 consecutive prostate-specifec antigen (PSA) values obtained at least 7 days apart or Radionucleotide bone scan progression
* Karnofsky performance status of greater than or equal to 60
Exclusion Criteria:
* Prostate cancer that does not express serum PSA or is less than *0 ng/mL at screening
* Received any investigational drug/agent within 30 days or 5 half-lives, whichever is longer
* Prior malignancy (other than prostate cancer) except adequately treated basal cell or squamous cell carcinoma of the skin or other cancer for which the subject has been disease-free for greater than or equal to 3 years
* Known central nervous system metastases
* Received any over-the-counter or herbal treatment for prostate cancer (eg, PC SPES \[an herbal refined powder\]) within 4 weeks prior to screening. |
Study Objectives
Objective: To explore the hypothesis that different methods of selecting and printing information for cancer patients could improve emotional support by affecting interaction with others, and so lead to improved psychological wellbeing.
Design: Randomised trial with 8 groups (three factors, 2X2X2). Data collected at recruitment and three month follow-up.
Participants: 400 patients starting radiotherapy and their 'confidant' (the person in who they confide).
Interventions: Printed booklets.
1. Half had 'general' CancerBACUP information for that cancer; half had 'personal' information from the medical record plus selected general information;
2. Half chose information by 'interacting' with the computer; half had a larger volume of material in booklets that were produced 'automatically'.
3. Half had additional 'anxiety management advice'.
Outcomes: Patients' views; use of booklet with others; change in reported social support; change in anxiety and depression.
Intervention / Treatment
PROCEDURE: Issue of information booklet
| Inclusion Criteria:
* Patients starting outpatient radiotherapy treatment with breast, prostate, cervical or laryngeal cancer
Exclusion Criteria:
* Receiving palliative care
* Severe pain or symptoms causing distress
* Having cancer at other sites
* Having no spoken English
* Receiving treatment for psychological or psychiatric problems
* Visual or mental handicap
* Having case notes not available or ambiguous or illegible. |
Study Objectives
This is a non-interventional, observational, multicentre, one-arm, non-comparative, and retrospective study.
The study is based on the collection of data about the patients treated with Durvalumab after chemoraditherapy in the real world. The patients participating in this non-interventional study will not receive treatment in relation to the study. The primary objective is to assess affectiveness of durvalumab in patients treated in real-life settings by evaluating Progression Free Survival.
Intervention / Treatment
DRUG: Durvalumab
| Inclusion Criteria:
* Patients must have histologically or cytologically documented diagnosis of NSCLC with a locally advanced, or locally recurrent, unresectable (stage III) disease (according to American Joint Committee on Cancer \[AJCC\] lung cancer edition 7 or 8).
* Age ≥ 18 years at time of study Entry
* Patients must have been treated with chemotherapy and radiotherapy concurrently or sequentially and shown no progressive disease following chemoradiation
* Patients must have been enrolled in durvalumab EAPs between 1 September 2017 and 21 December *
* Patients must have been treated with at least one dose of durvalumab within the EAP
* Alive patients must have signed, dated and IRB/EC-approved written informed consent\* form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.
Exclusion Criteria:
* Alive patients who do not want to sign and date an IRB/IEC-approved written informed consent form.
* Patients who were accepted in the EAP, but did not receive treatment.
* Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP |
Study Objectives
The blood-brain barrier (BBB) is a specialized interface allowing a unique environment for neuro-glia networks. BBB dysfunction is common in brain disorders. The Transcranial Magnetic Stimulation (TMS) is a non-invasive method of stimulating cortical motor neurons with the use of rapidly changing electromagnetic fields generated by a coil placed over the scalp. The objective of this study is to evaluate the safety and effects of the deep TMS (dTMS) on barrier integrity in patients with malignant glial tumors. BBB permeability will be quantified using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI). Permeability change will be compared between two DCE-MRI scans performed immediately after "real" and "sham" rTMS, randomly assigned within one week of each other.
Intervention / Treatment
DEVICE: Deep Transcranial Magnetic Stimulation (dTMS)
| Inclusion Criteria:
* Histological diagnosis of glioblastoma multiforme (WHO grade IV)
* Craniotomy with resection of the tumor at least one year prior to the study
* Treatment with steroids or chemotherapy stable for at least four weeks prior to study enrollment
Exclusion Criteria:
* History of epilepsy
* Presence of cardiac pacemaker
* Presence of neurostimulators
* Presence of surgical clips or medical pumps
* Allergy to contrast medium for Magnetic Resonance Imaging
* History of head injuries
* Alcoholism or drugs abuse
* State of pregnant or breastfeeding
* Severe psychiatric disorders |
Study Objectives
JS001 combined with pemetrexed plus carboplatin for treatment of recurrent or advanced non-small-cell lung cancer with EGFR-mutation positive and T790M negative after progression on EGFR-TKI treatment：a multi-center, single arm phase II study
Intervention / Treatment
COMBINATION_PRODUCT: Drug intervention
| Inclusion Criteria:
Only the patients meeting all the following criteria can be eligible to participate in the trial:
* Histologically and/or cytologically confirmed advanced or recurrent non-small cell lung cancer with EGFR sensitive mutation (exon 19 deletion, exon 21 L858R), and meeting the following conditions at the same time:
* Previous first-line EGFR-TKI monotherapy with clinical benefit, followed by progression of disease;
* No exon 20 T790M mutation after failure of EGFR-TKI therapy;
* At least one measurable lesion (in accordance with RECIST *1);
Exclusion Criteria:
Patients who fulfill any of the following criteria must be excluded from the study:
* Histologically or cytopathologically confirmed combined with small cell lung cancer component or squamous cell carcinoma component >10%;
* Combined with other driver gene mutation with known drug therapy, including but not limited to ALK rearrangement, ROS1 mutation, BRAF600E mutation etc.;
* Previous systemic chemotherapy for advanced NSCLC;
* EGFR-TKI therapy within two weeks prior to enrollment; |
Study Objectives
The primary objective of this study is to assess the overall response rate (ORR) of von Hippel-Lindau (VHL) disease-associated clear cell renal cell carcinoma (ccRCC) tumors in VHL patients treated with PT2385.
Intervention / Treatment
DRUG: PT2385 Tablets
| Inclusion Criteria:
* Has at least 1 measurable ccRCC tumor and no solid ccRCC tumor greater than *0 cm, based on radiologic diagnosis (histologic diagnosis not required); may have VHL disease-associated lesions in other organ systems
* Has a diagnosis of von Hippel Lindau disease, based on a germline VHL alteration
Exclusion Criteria:
* Has had prior radiotherapy or systemic anti cancer therapy for ccRCC (includes anti-VEGF therapy or any systemic investigational anti cancer agent)
* Has a prior or concomitant non-VHL disease-associated invasive malignancy with the exception of adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma in situ or any other malignancy from which the patient has remained disease free for more than 2 years
* Has any history of metastatic disease
* Has had radiotherapy to any non-ccRCC site within 4 weeks prior to entering the study or has not recovered from adverse events (AE)
* Has had any surgical procedure for VHL disease or any major surgical procedure completed within 4 weeks prior to entering the study or has any surgical lesions from recent major surgical procedures that are not well healed |
Study Objectives
This Trial offers a reduction in patient burden, which is especially preferable in children with a poor compliance and poor performance status. This prospective randomized trial was extension to the previous controlled prospective study performed in Children's Cancer Hospital, Egypt and registered at clinicaltrials.com (NCT01635140). The ultimate aim of this work is to demonstrate noninferiority of the hypofractionated regimens relative to the conventional regimen in a controlled randomized clinical study.
Intervention / Treatment
RADIATION: Hypofractionated Arm (1), RADIATION: Hypofractionated Arm (2), RADIATION: Conventional Arm (3)
| Inclusion Criteria:
* Newly diagnosed patients with a diffuse intrinsic brainstem glioma
* Aged 2-18years,
* Have symptoms for less than 3 months and at least two findings of the neurologic triad: cranial nerve deficits, ataxia, or long tract signs.
* No performance criteria were required for entry onto the study.
Exclusion Criteria:
* Children were not eligible if they had received any prior therapy other than steroids Treatment |
Study Objectives
Basal cell carcinomas (BCCs) are the most common form of cancer. The treatment of BCC can be surgical or topical for the low-risk subtypes. Topical treatments used for BCC are imiquimod and photodynamic therapy (PDT). Ingenol mebutate could provide a fast and easy topical therapy for BCC. Data regarding the treatment of BCC with ingenol mebutate are still limited. The investigators propose a pilot study to investigate the efficacy of 1 or 2 courses of ingenol mebutate 0,05%, on superficial and nodular BCC
Intervention / Treatment
DRUG: Picato 0.05% Topical Gel
| Inclusion Criteria:
* Age > 18 years
* Histologically confi rmed, primary, previously untreated, nodular or superfi cial basal-cell carcinoma not arising on the face or scalp, measuring 1 to 4 cm (large axis)
Exclusion Criteria:
* Basal cell carcinomas of the scalp
* Basal cell carcinomas recurrent, sclerodermiform, infiltrant, metatypic
* Allergic patient to treatment products
* Patient treated with immunosuppressants, immunomodulators, systemic cytotoxic agents or local corticosteroids applied in the CBC area during the 4 weeks prior to the screening visit |
Study Objectives
To analyse false positives in breast cancer screening with tomosynthesis versus 2D mammography. The Avellino Breast Tomosynthesis Screening Trial is a observational population-based study that analyze souspicious findings in tomosynthesis slice images.
This study is based on two years screening and tomosynthesis was analzyed by two expert breast radiologists.
Intervention / Treatment
| Inclusion Criteria:
* breast cancer screening population
Exclusion Criteria:
* previous cancer
* breast prostheses |
Study Objectives
RATIONALE: Diagnostic procedures, such as MRI and magnetic resonance spectroscopy imaging, may help in learning how well dutasteride works in patients with benign prostatic hypertrophy and low-risk prostate cancer.
PURPOSE: This clinical trial is studying MRI and magnetic resonance spectroscopy imaging in patients receiving dutasteride for benign prostatic hypertrophy and low-risk prostate cancer.
Intervention / Treatment
DRUG: dutasteride
| Inclusion criteria:
* Histologically confirmed adenocarcinoma of the prostate
* Clinical stage T1b, T1c, or T2a disease
* Gleason score ≤ 6
* Maximal prostate-specific antigen (PSA) < 10 ng/mL
* Demonstrates intra-prostatic metabolite abnormalities, consistent with adenocarcinoma of the prostate (i.e., ≥ 3 voxels with magnetic resonance spectroscopy imaging \[MRSI\] scores 4-5) by baseline MRI and MRSI
* Has symptomatic benign prostatic hypertrophy and is currently undergoing watchful waiting OR opting to undergo permanent seed implant (i.e., brachytherapy), but requires neoadjuvant androgen suppression for prostate shrinkage
* No regional lymph node involvement
* No evidence of distant metastases
* Zubrod performance status 0-1
* Able to swallow and retain oral medications
Exclusion Criteria:
* Other prior or concurrent invasive cancer, other than localized basal cell or squamous cell carcinoma of the skin
* Contraindications to MRI/MRSI, including any of the following:
* Prostate biopsy (within the past 8 weeks) and any continued post-biopsy bleeding
* Rectal bleeding
* Anal fissures
* Rectal surgery (end-to-end anastomosis)
* Inflammatory bowel disease
* Prior radical prostatectomy
* Hip replacement
* Certain types of penile implants
* Vascular clips
* Known anaphylactic reaction to latex compounds
* Anticoagulant drugs
* Severe claustrophobia
* Cardiac pacemaker
* Metal in eye
* Any other metallic or foreign object in the body
* Unstable serious co-morbidities including, but not limited to, myocardial infarction, coronary artery syndrome, cardiac arrhythmias, symptomatic congestive heart failure, or cerebrovascular accident
* Major medical or psychiatric illness that, in the investigator's opinion, would preclude the completion of treatment and interfere with follow up
* Known hypersensitivity to any 5α-reductase inhibitor or drug chemically related to the study drug
* Prior radical surgery (prostatectomy) or cryosurgery for prostate cancer
* Prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
* Prior or concurrent cytotoxic chemotherapy for prostate cancer
* Prior hormonal therapy, such as luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide acetate), antiandrogens (e.g., flutamide or bicalutamide), or estrogens (e.g., diethylstilbestrol)
* Prior or concurrent finasteride, dutasteride, other drugs with known antiandrogenic properties (e.g., spironolactone or progestational agents), or any dietary or herbal supplement (e.g., selenium, vitamin E, saw palmetto, or PC-SPES) |
Study Objectives
This study is a trial of Dexanabinol in patients with advanced solid tumours. The purposes of this protocol are to study different doses of the study drug to determine the maximum safe dose and to further understand the safety of the study drug; to understand what the body does to the study drug; to understand what the study drug does to the body and to measure any reduction in size of patients' cancer tumour(s).
Dexanabinol is a synthetic cannabinoid derivative with reduced psychotropic potential which was initially investigated as a neuroprotective agent. Because of its method of action however it is thought that it may have the effect of destroying cancer cells by reducing the level of control on networks that prevent cancer cells dying.
Intervention / Treatment
DRUG: Dexanabinol, OTHER: Cremophor
| Inclusion Criteria:
* Adult patients defined by age ≥18 years.
* Patients with histologically or cytologically confirmed solid tumours that are advanced, metastatic and or progressive, for whom there is no effective standard therapy available.
* Eastern Collaborative Oncology Group (ECOG) Performance Status of ≤*
* Any acute or chronic adverse effects of prior chemotherapy or radiotherapy have resolved to < Grade 2 as determined by Common Terminology Criteria for Adverse Events (CTCAE) v*03 criteria, with the exception of alopecia.
* Evaluable disease, either measurable on imaging, or with informative tumour marker(s), as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v*1 (Eisenhauer, et al. 2009).
* Laboratory values at Screening:
* Absolute neutrophil count ≥*5 x 109/L;
* Platelets ≥100 x 109/L;
* Total bilirubin <*5 times the upper limit of normal;
* Aspartate aminotransferase (AST) ≤*5 times the upper limit of normal;
* Alanine aminotransferase (ALT) ≤*5 times the upper limit of normal;
* Estimated glomerular filtration rate (GFR) of >50 mL/min (based on the Wright formula (Wright, et al. 2001); and
* Negative human chorionic gonadotropin (hCG) test in women of childbearing potential (defined as women ≤50 years of age or history of amenorrhea for ≤12 months prior to study entry). Sexually active male and female patients of childbearing potential must agree to use an effective method of birth control (e.g. barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices) during the entire duration of the study and for 1 month after final administration of Dexanabinol, or the patient must be surgically sterile (with documentation in the patient's medical records).
* If there is a history of treated brain metastases, these must have been clinically stable for ≥4 weeks prior to enrollment.
* Have a life expectancy of >3 months.
* Ability to give written, informed consent prior to any study-specific Screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.
* Be willing and able to comply with the study protocol procedures.
Exclusion Criteria:
* Patient is pregnant or breast feeding.
* History of clinically significant cardiac condition, including ischemic cardiac event, myocardial infarction or unstable cardiac disease within 3 months of Cycle 1, Day *
* Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to Cycle 1, Day * Localised palliative radiotherapy is permitted for symptom control.
* Major surgery within 6 weeks prior to Cycle 1, Day *
* Known human immunodeficiency virus positivity.
* Active hepatitis B or C or other active liver disease (other than malignancy).
* Use of any investigational agents within 4 weeks of Cycle 1, Day *
* Any active, clinically significant, viral, bacterial, or systemic fungal infection within 4 weeks prior to Cycle 1, Day *
* History of significant chronic or recurrent infections requiring treatment or any uncontrolled intercurrent illness that would jeopardize patient safety, interfere with the objectives of the protocol, or limit patient compliance with study requirements, as determined by the Investigator. |
Study Objectives
This study is for men who have prostate cancer that has spread outside of the prostate gland and is no longer responding to hormone removal therapy. This study is designed to determine if a new drug combination will help to control the cancer. The medicines being used, docetaxel and diethylstilbestrol (DES), have been given to patients with prostate cancer and each drug has demonstrated activity in prostate cancer, either used alone or in other combinations. The objective of this study is to determine the effect of this drug combination on the prostate cancer and its response to disease progression.
Intervention / Treatment
DRUG: Docetaxel and Diethylstilbestrol (DES)
| Inclusion Criteria:
Patients meeting all of the following criteria are eligible for the trial:
* Men 18 years of age or older with a histologically confirmed diagnosis of adenocarcinoma of the prostate consistent with stage D*
* Prior therapy with medical or surgical castration and evidence of castrate levels of testosterone
* Discontinuation of nonsteroidal antiandrogens more than 6 weeks prior to evaluation for progression. It is not a requirement that nonsteroidal antiandrogen therapy be used prior to enrollment.
* Androgen independent disease as defined by one of the following after androgen ablation and withdrawal from nonsteroidal antiandrogen if initiated (> 6 weeks after discontinuation):
* PSA must be greater than 5 ng/ml and increasing as demonstrated by two consecutive increasing PSA levels over 5 ng/ml. Each PSA measurement must be taken at least one week apart.
* Increase in measurable disease within one month of enrollment
* Worsening of bone scan abnormalities within two months of enrollment and greater than four months since initiation of luteinizing hormone-releasing hormone (LHRH) agonist.
* Performance status < 3 by the Eastern Cooperative Oncology Group (ECOG) scale.
* Patients must be informed of the investigational nature of the study and sign an informed consent form.
* Life expectancy must be >= 3 months.
* Laboratory values must be as follows:
* White blood cell count: >= 3,000/mm3
* Absolute granulocyte count: >= 1,500/mm3
* Platelets: >= 100,000/mm3
* Hemoglobin: >= 8g/dL
* Serum creatinine: <= *5 x upper limit of normal (ULN)
* AST: <= 2 x ULN
* ALT: <= 2 x ULN
* Serum calcium: <= ULN
* Total bilirubin: <= *5 x ULN
* Patient must be willing to consent to using effective contraception while on treatment and for three months after completion of therapy.
Exclusion Criteria:
Patients meeting any of the following criteria will not be eligible for the trial:
* Patients who have received PC-SPES, DES, mitoxantrone or docetaxel therapy.
* Patients who have received prior chemotherapy of any type or are receiving any other investigational therapy.
* Patients with evidence of recent deep venous thrombosis, pulmonary emboli, unstable angina or clinical congestive heart failure.
* Patients with a prior history of myocardial infarction, pulmonary embolism, cerebral vascular accident (CVA) or atrial fibrillation.
* Patients with evidence of active angina as evidenced by chest pain responsive to sublingual nitroglycerin or other anginal equivalent.
* Patients with known evidence of brain metastases or carcinomatous meningitis.
* Patients with a history of other cancers except curatively-treated non-melanomatous skin cancer. Other cured tumors may be entered after discussion with and approval of the study chair.
* Patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment.
* Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
* Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 must be excluded.
* Histologic evidence of small cell carcinoma of the prostate.
* Patients with current peripheral neuropathy of any etiology that is greater than Grade I.
* Patients with contraindications to anti-coagulation. |
Study Objectives
The well-established role of vascular endothelial growth factor (VEGF) in carcinogenesis and tumor angiogenesis has led to the development of agents that target this pathway. Anti-VEGF agents the VEGF monoclonal antibody bevacizumab, and the small molecule VEGF receptor tyrosine kinase inhibitors. Angiogenic factors play a key role in the maintenance of lung integrity and normal endothelial function. Endothelial dysfunction has been implicated in hypertension, proteinuria and retinopathy. One of the major issues of anti-VEGF agents is its long-term toxicity especially taking into account the lack of adequate knowledge in this area and the possibility of prolonged periods of therapy in non-progressing patients. Hypertension and proteinuria are commonly seen in patients treated with anti-VEGF agents. In addition, the investigators have also observed in a relatively high frequency of pulmonary air-filled lesions in patients with malignancy in the lung treated with an anti-VEGF agent. Objectives of this exploratory study are to 1) determine the effect of anti-vascular endothelial growth factor (VEGF) on endothelial function 2) determine endothelial dysfunction as a marker of early response and as an indicator for the development of hypertension and proteinuria 3) characterize the effect of anti-VEGF therapy on the pulmonary function of patients with malignancy (primary or secondary) involving the lung in patients treated with anti-VEGF agents. Pharmacodynamic endpoints to be assessed are: blood pressure, brachial artery reactivity, retinal microvessels, microalbuminuria and proteinuria, pulmonary function, assess the effects of anti-VEGF therapy by assessing brachial artery reactivity, retinal vasculature and pulmonary function in a subset of patients receiving anti-VEGF therapy. The development of markers of endothelial dysfunction may result in the early identification of patients who are non-responders or develop toxicity from anti-VEGF treatment.
Intervention / Treatment
| Inclusion Criteria:
* Eligibility
* Patients who are receiving single agent anti-VEGF therapy
* Signed written informed consent
* Patients with measurable pulmonary malignancy (primary or metastatic) as determined by RECIST will undergo assessment of pulmonary function
* Patients with a known allergy to intravenous contrast used in fluorescein and indocyanine green angiography will be exempt from these investigations but will undergo other study assessments
Exclusion Criteria:
* None |
Study Objectives
The purpose of this study is to evaluate the effect of administration of low dose of human chorionic gonadotropin (HCG) after use of clomiphene citrate (CC) for induction of ovulation in infertile women having CC resistant polycystic ovarian syndrome (PCOS).
Intervention / Treatment
DRUG: Clomiphene citrate and Human chorionic gonadotropin (HCG), DRUG: Clomiphene citrate
| Inclusion Criteria:
* Infertile lean women with PCOS as defined by the Rotterdam criteria.
* CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).
Exclusion Criteria:
* Age < 20 or > 35 years.
* Presence of any infertility factor other than anovulatory PCOS.
* Previous history of ovarian surgery or surgical removal of one ovary.
* Previous exposure to cytotoxic drugs or pelvic irradiation.
* Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
* Metabolic or hormonal abnormalities. |
Study Objectives
This study is designed to provide evidence of the safety and a preliminary understanding of the efficacy of AME 133v.
Intervention / Treatment
BIOLOGICAL: AME-133v (LY2469298)
| Inclusion Criteria:
To be included in the study protocol, subjects have to meet all of the following criteria.
* Have morphologically confirmed diagnosis of CD-20+ follicular B-cell non-Hodgkin's lymphoma;
* Have the low affinity form of FcγRIIIa (F/F or F/V at position 158) as determined by FcR genotyping;
* Have measurable disease. Measurable masses (such as enlarged lymph nodes) must have a clearly defined bi-dimensional diameter of at least *5 x *5 cm on physical examination or ≤ *5 cm in one of the dimensions by CT, MRI, or plain radiograph;
* Have received prior treatment with chemotherapy given without rituximab; OR, Have not relapsed or progressed within 120 days (inclusive) of the last infusion of rituximab;
* Be 18 years of age or greater;
* Have a negative pregnancy test, if relevant. Women of childbearing potential (not postmenopausal for at least one year and not surgically incapable of bearing children) must agree not to become pregnant for the duration of the study. To do this, they must agree to use a medically acceptable contraceptive regimen;
* Have a performance status of 0 to 2 on the ECOG performance scale;
* Have adequate hematopoietic, renal, and hepatic function defined as:
* Absolute neutrophil count greater than 1,500/mm³;
* Platelet count greater than 75,000/mm³;
* Hemoglobin at least 8 g/dL;
* Serum creatinine ≤ *5x upper limit of normal;
* Total bilirubin ≤ *5x upper limit of normal;
* ALT ≤ *5 x upper limit of normal;
* Alkaline phosphatase ≤ *5x upper limit of normal.
* No evidence of hepatitis B or C infection (no detectable HBV DNA or HCV RNA);
* Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, or other investigational therapy for at least 30 days prior to study enrollment;
* Have discontinued all high-dose corticosteroid therapy at least 30 days prior to study enrollment (≤ 10 mg/day of Prednisone or equivalent is allowable);
* Have life expectancy of more than 3 months;
* Be able to give written informed consent.
Exclusion Criteria:
Subjects with any of the following exclusions are not allowed to participate in the study.
* Allergy to monoclonal antibodies or any of the study drug components;
* Concurrent malignancy that could complicate interpretation of response evaluation, including any histologic evidence of diffuse B-cell lymphoma. Non-melanoma skin cancer and carcinoma in situ of the cervix are not exclusions;
* Significant cardiac disease (e.g. NYHA CHF of class III or IV, history of MI within one year prior to study Day 1, unstable angina, uncontrolled hypertension, clinically significant cardiac arrhythmia (CTCAE Grade 2 or higher), or clinically significant baseline ECG or MUGA abnormality.
* Positive test for serum cardiac troponins (cTnI or cTnT assay; special processing required, and the same assay must be used throughout the study; see Study Reference Manual)
* Active infection requiring oral or i.v. antibiotics;
* Administration of blood transfusions or red blood cell growth factors within 10 days preceding enrollment into the protocol;
* Administration of white cell growth factors within 28 days preceding enrollment into the protocol;
* Concomitant nonmalignant disease(s) which could interfere with implementation of the protocol, make the study results difficult to interpret, or which represent additional safety risks;
* History of HIV-associated non-Hodgkin's lymphoma. |
Study Objectives
This observational prospective single arm cohort study is designed to assess pain and bone pain related quality of life of metastatic Castration Resistant Prostate Cancer (mCRPC) patients receiving Radium-223 in a real life nuclear medicine practice setting. In addition, overall survival, time to next tumor treatment (TTNT), time to first symptomatic skeletal event (SSE), course of blood counts, and safety will be assessed.
Intervention / Treatment
DRUG: Radium-223 dichloride, (Xofigo, BAY88-8223)
| Inclusion Criteria:
* Adult male patients diagnosed with CRPC with symptomatic bone metastases without known visceral metastases
* Decision to initiate treatment with Radium-223 was made as per investigator's routine treatment practice
Exclusion Criteria:
* Patients participating in an investigational program with interventions outside of routine clinical practice or participating in another observational study with Xofigo |
Study Objectives
The primary objective is to describe the real-world clinical effectiveness of cemiplimab in patients with locally advanced cutaneous squamous cell carcinoma (laCSCC) or metastatic cutaneous squamous cell carcinoma (mCSCC) treated in routine clinical practice.
Intervention / Treatment
OTHER: No intervention
| Inclusion Criteria:
* Patients aged >=18 years at initiation of cemiplimab.
* Patients treated with >=1 dose of cemiplimab for laCSCC or mCSCC who were not suitable for curative surgery or curative radiation according to routine practice.
* Patients initiating treatment with cemiplimab in the UK between 2nd July 2019 and 30th November *
Exclusion Criteria:
* Patients who are known to have opted out of participation in any research (as required for compliance with GDPR).
* Patients participating in any form of investigative study (e.g., clinical trials) during the post-index observation period. |
Study Objectives
The primary purpose of the trial is to demonstrate that at least a 40% drop of recurrence rate can be achieve in hepatocellular carcinoma patients treated with no touch multipolar radiofrequency ablation technique compared to those treated with usual intranodular multipolar technique.
Intervention / Treatment
PROCEDURE: Radiofrequency ablation
| Inclusion Criteria:
* Adults > 18 years old, holder of up to 3 nodules less than 4 cm in diameter
* Diagnosis of hepatocellular carcinoma according to American Society of Liver Study non invasive criteria or based on histological proof
* Non invasive diagnosis of cirrhosis according to French Haute Authority of illness guideline or based on histological proof
* No previous treatment for hepatocellular carcinoma
* Multidisciplinary decision of treatment by radiofrequency ablation
Exclusion Criteria:
* Adult patient under guardianship or trusteeship, homeless
* Patient with potentially short term life-threatening serious co-infection (apart from viral B or C, or VIH co-infection)
* Pregnant or breastfeeding woman
* Patient for whom regular follow-up is impossible whatever the cause
* Contra indication to general anaesthesia
* Technical impossibility to perform the procedure under ultrasound guidance
* Boundary of the tumor located at less than 1 cm distance from colonic wall or main biliary tract (main right or left bill ducts and common bill duct)
* Tumor invisible with ultrasound
* Lack of safe percutaneous course which can be planned
* Tumor in which more than four biopsies pass were previously performed (cumulated during one or several previous biopsies sessions)
* Contra indication to perform CT or MRI with contrast medium (GADOLINITE or iodinate) intravenous injection
* Child-Pugh B or C cirrhosis (apart from the transitory liver failures in the setting of acute hepatitis related to alcohol abuse)
* Total detachment of the anterior face of the liver from internal abdominal wall due to abundant ascites.
* Prothrombin activity < 50 %
* Platelet count <40 .10 3/ml
* Platelet dysfunction or congenital impaired blood coagulating |