30 results
Primary objectives:- To improve the clinical effectiveness of the p53 synthetic long peptides vaccine by pre-administration of cyclophosphamide.- To evaluate the immunogenicity of a p53 synthetic long peptide vaccine when preceded by administration…
We estimate that the anthracycline and cyclophosphamide dose could be significantly (>=15%) increased in at least 15% of ACC-treated patients. Therefore, in order to diminish the risk of under-dosing ACC, we aim to develop a neutrophil-guided…
To determine a safe dose combination of carboplatin-cyclophosphamide combined with atezolizumab fixed dose in advanced breast cancer and gynaecologic cancer (ovarian, cervical and endometrial cancer).
Primary objective:To determine the effect of obesity (BMI > 35 kg/m2) on the pharmacokinetics of posaconazole and develop a dosing regimen for obese patients. Secondary objective:• To describe the pharmacokinetics of the augmented dose of 400…
This study will investigate whether oligometastatic triple negative or BRCA1/2 related breast cancer can be treated effectively with a multimodality approach including induction chemotherapy, and whether high dose alkylating chemotherapy can improve…
Primary: Phase I part 1) Assessment of the recommended dosing and schedule for metronomic cyclophosphamide when administered in combination with fixed dose (10 mg) oral everolimus in patients with mRCC with respect to the selective induction of CD4+…
• To determine the pharmacokinetics of posaconazole (new solid oral and IV) given as prophylaxis to patients who are at risk for developing fungal infections after receiving conditioning therapy (except strictly non myeloablative (NMA)) for…
The primary objective of the trial is to evaluate whether L-BLP25 administered as weekly subcutaneous vaccinations with or without pretreatment with intravenous cyclophosphamide (CPA) induces a change in immune response parameters (ELISpot against…
To determine the maximum tolerated doses (MTDs) and dose-limiting toxicities (DLTs) of nelarabine, etoposide and cyclophosphamide when given in combination to children with T-ALL and bone marrow relapse or T-LL.
The primary objective of this study is to evaluate the PK of POS administered orally at three dosage levels to immunocompromised children with expected neutropenia (selected oncology patients, aplastic anemia patients and patients which undergo a…
Primary: To determine the influence of posaconazole on unboosted fosamprenavir pharmacokinetics, and vice versa, in healthy volunteersSecondary: To determine the safety of combined use of fosamprenavir with posaconazole in healthy vol-unteers
We expect to finalize the current phase I study by the May 2008 demonstrating that injection of tumor lysate-pulsed autologous DCs injected in patients with MM after chemotherapy is safe and well tolerated with induction of immune responses. New…
Primary: Dose finding for a twice daily regimen for PSZ as prophylactic treatment in children with CGD, based on the exposure to PSZ measured by PSZ trough levels.Secondary:To determine the tolerability of PSZ as prophylactic treatment in children…
The overall aim of the CASA trial is to investigate the role of PLD as adjuvantchemotherapy for older postmenopausal women for whom chemotherapy is indicated, but standard regimens, derived from trials in younger women, are assumed to be too toxic…
Nearly all patients who die from breast cancer die from the consequences of distant metastases. Adjuvant chemotherapy, either administered before or after surgery, has been shown to reduce the risk of metastases and death. Four main groups of…
The main goal of neoadjuvant therapy should be a pathological complete response (pCR), because pCR more accurately predicts improved patient outcome and prolonged survival. In the present study, pathological response will be evaluated by The Miller…
During the course of the study 2 randomisation questions will be adressed. Both questions concern patients in the high risk group.Randomisation question 1: Will the addition of Doxorubicin to the first 4 standard IVA chemotherapy courses lead to a…
- To evaluate the treatment efficiency by time to progression according to RECIST 1.1
To deliver proof of concept that antifungal prophylaxis with posaconazole in addition to standard of care (SOC) can reduce the incidence of IAA in ICU patients with severe influenza, in comparison with SOC alone.To assess differences in cytokine…
The main objectives are to evaluate the efficacy (as measured byprogression free survival at 6 months) of pertuzumab combined withtrastuzumab (PH) or PH plus metronomic chemotherapy (PHM) in anelderly metastatic breast cancer population, and to…