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HOVON 80 NHL: Phase II study on the feasibility and efficacy of R-DHAP + HD-MTX, combined with intrathecal rituximab, followed by autologous stem cell transplantation in patients with a recurrent aggressive B-cell lymphoma with CNS localisation

Evaluation of intensive therapy for relapsed B-cell lymphoma with CNS localisation. Treatment includes:a. intrathecal administration of rituximab, B. combining R-DHAP with high dose methotrexate intravenously.The following endpoints will be…

A phase II study of isolated lung perfusion with melphalan followed by pulmonary metastasectomy in patients with resectable pulmonary metastases of colorectal carcinoma, soft tissue sarcoma and osteosarcoma

The main objective of the study is to determine time to progression of the primary malignancy (locally advanced or metastatic) in patients treated with ILuP and pulmonary metastasectomy. Secondary objectives are to assess pulmonary toxicity by…

Evaluation of the oral uracil loading test as a sensitive, simple and cheap method to detect DPD deficiency.

The primary objective of this study is to establish the sensitivity and specificity of an oral uracil loading test as a potential screening tool for DPD deficiency

The long-term immune response after HPV16 peptide vaccination in woman with low-grade pre-malignant disorders of the uterine cervix, a placebo controlled phase II study

Evaluation of the capacity of a HPV 16 peptide vaccine to install a long term HPV-specific T cell response, to define the importance of a booster vaccine after 1 year, the induction of Cytotoxic T lymphocyte (CTL) immunity against HPV16E6 and E7 and…

A Phase 2 Trial of Single-Agent Amrubicin in Patients with Extensive Disease Small Cell Lung Cancer that is Refractory or Progressive within 90 Days of Completion of First Line Platinum-based Chemotherapy

The primary objective is the Objective tumor response rate (RECIST). Secondary objectives are: duration of overall response, time to tumor progression (TTP), progression free survival (PFS), overall survival, toxicity profile, incidence of…

A Multicenter, Open Label, Randomized Study of AMG 951 in Subjects with Previously Untreated Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Treated with Chemotherapy with or without Bevacizumab

Objectives:Phase 1b: To determine the maximum tolerated dose (MTD) (up to 8mg/kg/day) through safety and tolerability of multiple doses of AMG 951 administered by intravenous (IV) infusion to subjects with NSCLC in combination with chemotherapy and…

Bortezomib re-induction therapy combined with donor lymphocyte infusion in patients with relapsed Multiple Myeloma following allogeneic stem cell transplantation

Primary objectives:Efficacy of bortezomib combined with DLI in patients with relapse myeloma following (non) myeloablative allo-SCT as measured by- response rate including percentage of complete remission according to EBMT criteria (appendix A)-…

The effect of HPV16 peptide vaccination on the local immune response in woman with high grade HPV16+ pre-malignant disorders of the uterine cervix, a placebo controlled phase II study

This study aims to reveal whether vaccination of women with HPV 16+ cervical intraepithelial neoplasia not only results in a strong systemic T-cell response, but also endows these T-cells with the capacity to infiltrate HPV16-induced lesions.…

Intensive five day intravenous insulin treatment combined with enteral feeding in hyperglycemic ischemic stroke patients: a feasibility study

To optimize a safe five-day intensive intravenous insulin treatment post stroke and to assess glucose profiles in patients with stroke and HG on admission, receiving standard continues enteral tube feeding.

A Phase II Study of Concurrent Radiation and Temozolomide Followed by Temozolomide and Lomustine (CCNU) in the Treatment of Children with High Grade Glioma

Determine whether temozolomide given during radiation therapy followed by the combination of temozolomide and CCNU as adjuvant therapy results in an improvement in event-free survival compared to historical control cohorts.To further assess the…

A parallel phase II study of Tarceva®(Erlotinib) in patients with advanced non-small cell lung cancer (Stage IIIB/IV) not pre-treated by chemotherapy including dose escalation to toxicity in current and former smokers

To estimate the efficacy of erlotinib administered as a single agent to chemo-naïve NSCLC patients as determined by the non progression rate (NPR) at 8 weeks.

153Sm-EDTMP versus docetaxel for multiple painful osseous metastases in prostate cancer

The sequential application of chemotherapy and radionuclide treatment in patients with symptomatic osseous metastasized prostate cancer. Patients with more than one painful osseous metastasis will be randomized between 153Sm-EDTMP or docetaxel 3…

The effect of glycopyrronium bromide on hypersalivation in patients with Parkinson's disease: a randomised, cross-over, double-blind, placebo controlled trial.

The aim of this study is to prove the efficacy of 3 times daily 1 mg glycopyrronium bromide versus placebo in patients with PD with hypersalivation. Furthermore, the safety of glycopyrronium bromide used in the mentioned dosage will be further…

An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis

Primary: To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage therapy (see Definitions).Subjects will be…

A randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation and Dose-Confirmation Study to Evaluate the Safety and Efficacy of Rivaroxaban in Combination with Aspirin Alone or with Aspirin and a Thienopyridine in Subjects with Acute Coronary Syndromes

There are two phases in this trial with 2 objectives:In phase I of the trial it will be assessed which dose of rivaroxaban is the most safe and effective (most optimal benefit:risk profile). In phase II this dose will be further investigated to…

Phase II Study of Combination Bortezomib, Dexamethasone, and Rituximab in previously untreated Patients with Waldenstrom*s Macroglobulinemia: A multicenter Trial of the European Myeloma Network

The primary objective of this study is:To determine the response rate [the combined complete response (CR) + partial response (PR) + minimal response (MR)] following treatment with BDR in patients with previously untreated WM.Secondary objectives…

A MULTI-CENTER, RANDOMIZED, CROSS-OVER, DOUBLE-BLIND, THIRD PARTY OPEN, PLACEBO CONTROLLED, PILOT STUDY TO ASSESS THE URODYNAMIC EFFECTS OF MODIFIED RELEASE UK-369,003 IN MEN WITH LOWER URINARY TRACT SYMPTOMS (LUTS)

A pilot study to:1. assess the urodynamic changes induced by 100mg MR formulationof UK-369,003 vs. placebo in men with LUTS;2. Assess the safety and tolerability of UK-369,003 in men with LUTS

LIMIT: Lowering the Incidence of vascular complications with Metformin in patients with Impaired glucose tolerance and a recent TIA or minor ischemic stroke: a phase 2, randomized, controlled trial

To examine the safety, tolerability, and effect on glucose metabolism of metformin treatment in non-diabetic patients with TIA or minor ischemic stroke and impaired glucose tolerance.

A randomized, double-blind, parallel-group, placebo-controlled, multinational clinical trial to evaluate the efficacy of Aliskiren and valsartan versus placebo in lowering levels on NT-proBNP in stabilized patients post acute coronary syndromes

The primary objective of the study is to evaluate the efficacy of aliskiren, valsartan and a combination of both drugs versus placebo in lowering levels of NT-proBNP in stabilized patients post ACS

A randomized, double-blind, placebo-controlled, phase 2a study of the efficacy, safety, and pharmacokinetics of MLN3897 in patients with rheumatoid arthritis taking methotrexate.

This is the first study of MLN3897 in any disease population. It seeks to establish:1) The ability of MLN3897 to modify the signs and symptoms of RA.2)The safety and tolerability of MLN3897 in combination with MTX.3)The PK/PD profile of MLN3897 in…