Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Bevacizumab

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Bevacizumab in monotherapy or in association to other anticancer agents pharmacokinetic assessment with blood sample with additional blood sample

Trastuzumab in monotherapy or in association to other anticancer agents pharmacokinetic assessment with blood sample with additional blood sample

additional blood sample

This Study evaluates covariables being able to potentially influence the elimination of the monoclonal antibodies (trastuzumab, bevacizumab and denosumab).

Monoclonal antibodies are very widely used in cancer treatment . Certain patients benefit from these antibodies for several years and it is conceivable to wonder about the evolution of the pharmacokinetics of these antibodies.

Monoclonal Antibodies Elimination in Breast Cancer Patient

Study of the Relative Impact of the Neonatal Fc Receptor (FcRn) and the Therapeutic History on Monoclonal Antibodies Elimination. Proof of the Concept on Patients Treated by Bevacizumab or Trastuzumab in Breast Cancer

Centre Hospitalier Universitaire de Besancon

Rare Diseases

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

1 additional blood sample for patients with glioma and without treatment

2 additional blood samples for patients with localized brest cancer, metastatic breast cancer in 1st line of treatment and breast cancer in second line of treatment.

1 additional blood sample for patients with metastatic breast cancer with HER2 surexpression

1 additional blood sample for patients with breast cancer HER2 + or HER2 triple negative treated by neo adjuvant

This study evaluates the frequency of the spontaneous T cells specific CD4 answers of tumoral antigens breast cancer and glioma.

Study of the Anti-tumoral Immune Response

Study of the Anti-tumoral Immune Response T Cells Cluster of Differentiation 4 (TCD4): Proof of the Concept in Breast Cancer and Glioma

Blood and Lymph Conditions

Symptoms and General Pathology

Wounds and Injuries

Hematologic Neoplasms

Hyperthermia

Neutropenia

Fever

Febrile Neutropenia

Hematologic Diseases

Agranulocytosis

Leukopenia

Cytopenia

Leukocyte Disorders

Granulocytopenia

Anti-Infective Agents

Vancomycin

Subjects with hematologic cancer who received intravenous vancomycin for a suspected or confirmed infection.

Included subjects will provided three blood samples to follow vancomycin concentration

Additional blood sample

Annie Brisebois-Boyer, Pharm.D, M. Sc

TEAM HEMATO-VANCO, Pharm. D

This is a single-center prospective pharmacokinetic study. The principal objective is to collect new data among patients with hematologic cancer to develop a Bayesian population pharmacokinetic model and to improve dose adjustment of intravenous vancomycin. Approximately 40 subjects meeting the inclusion and no exclusion criteria will be enrolled in the study. Vancomycin blood concentration will be measured at steady-state at three different moment for each participant : immediately before the infusion, 1 hour after the infusion and during the elimination phase (at 3, 4 or 5 hours after the infusion). This additional vancomycin serum concentration in the elimination phase will be used to estimate more precisely the vancomycin pharmacokinetic parameters in this specific population including the distribution volume and the elimination of the molecule. Ultimately, the purpose of this study is to create a nomogram to predict the optimal initial vancomycin dosing in adult patients with a hematologic cancer.

STUDY DESIGN:

Prospective, monocentric, pharmacokinetic study.

Adults who have been diagnosed with a hematologic malignancy, are hospitalized at Maisonneuve-Rosemont hospital and received at least 3 doses of intravenous vancomycin.

Pharmacokinetic parameters: Serum vancomycin concentration measured at steady state just before the beginning of the infusion (trough), 1 hour after completion of the infusion (peak) and between 3 to 5 hours after the end of the infusion (additional blood draw during the elimination phase).

RECRUITMENT PROCESS:

A systematic daily screening of hospitalized patients diagnosed with a hematologic cancer will be made by the research team and the pharmacists 7 days a week. An information sheet will be given to all potential eligible patients at their admission. When intravenous vancomycin is prescribed, a member of the research team will explain the study and present the Information and Consent Form (ICF) to the potential participant to obtain his/her official informed consent.

DATA COLLECTION:

Three blood draws will be planned around the fourth or fifth dose of vancomycin and collected by the nursing team. The sampling scheme is as follows: just before the beginning of the infusion (trough), 1 hour after completion of the infusion (peak) and 3, 4 or 5 hours after the end of the infusion (additional blood draw during the elimination phase) according to the assigned time of the participant. The assigned time of the additional blood draw will be randomized at the inclusion of the subject in the study. A member of the research team will provide the tubes to the nurse, will write and save sampling times and will ship the blood samples to the laboratory.

Optimal Dosing of Vancomycin in an Adult Population of Hemato-oncology

Optimal Dosing of Vancomycin in an Adult Population of Hemato-oncology: a Nomogram Based on a Bayesian Population Model to Predict Initial Dosage of Vancomycin

Estimated from vancomycin serum concentrations and patient characteristics

Vancomycin concentration measured just before the next infusion

Vancomycin concentration measured 1 hour after the end of vancomycin infusion

Vancomycin concentration measured 3 to 5 hours after the end of vancomycin infusion

Ciusss de L'Est de l'Île de Montréal

Everolimus

Elsa CURTIT

Elise ROBERT

This study evaluates the immune response for patients affected by metastatic breast cancer treated by everolimus

Immune Response for Patients With Metastatic Breast Cancer Treated by Everolimus

Study of the Immune Response T Anti-tumoral Cluster of Differentiation 4 (CD4) for Patients Treated for a Metastatic Breast Cancer by Everolimus Within the Framework of Its Marketing Authorization

evaluation by Enzyme-Linked Immunospot (ELIspot) and by Enzyme-Linked Immunosorbent Assay (ELISA test)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Monoclonal Antibodies Elimination in Breast Cancer Patient	NCT02855775	Breast Cancer	additional bloo...	18 Years - 80 Years	Centre Hospitalier Universitaire de Besancon
Study of the Anti-tumoral Immune Response	NCT02854644	Breast Cancer Glioma	additional bloo...	18 Years -	Centre Hospitalier Universitaire de Besancon
Study of the Anti-tumoral Immune Response	NCT02854644	Breast Cancer Glioma	additional bloo...	18 Years -	Centre Hospitalier Universitaire de Besancon
Optimal Dosing of Vancomycin in an Adult Population of Hemato-oncology	NCT04758442	Vancomycin Hematologic Mal... Febrile Neutrop...	Additional bloo...	18 Years -	Ciusss de L'Est de l'Île de Montréal
Immune Response for Patients With Metastatic Breast Cancer Treated by Everolimus	NCT02854618	Breast Cancer	additional bloo...	18 Years - 85 Years	Centre Hospitalier Universitaire de Besancon
Optimal Dosing of Vancomycin in an Adult Population of Hemato-oncology	NCT04758442	Vancomycin Hematologic Mal... Febrile Neutrop...	Additional bloo...	18 Years -	Ciusss de L'Est de l'Île de Montréal

Spots Global Cancer Trial Database for additional blood sample