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Phase 1-2 study of everolimus and low-dose oral cyclophosphamide in patients with metastatic renal cell cancer.

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+…

ACNS0332: Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients - A Groupwide Phase III Study

The goal of this study is to determine whether radiosensitization with carboplatin or the addition of Isotretinoin to maintenance therapy improves cure rates for children with other than average risk medulloblastoma/PNET.

SEQUENTIAL THERAPY WITH TACROLIMUS AND RITUXIMAB IN PRIMARY MEMBRANOUS NEPHROPATHY

PRINCIPAL OBJECTIVE To evaluate whether sequential therapy with tacrolimus for 9 months (6 months of full therapy and 3 months of tapering doses) followed by a dose of RTX leads to a greater increase in the proportion of primary MN patients with…

A Phase I Trial of NECTAR (Nelarabine, Etoposide and Cyclophosphamide in T-ALL Relapse): A Joint Study of TACL, POETIC and ITCC

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.

High-dose alkylating chemotherapy in oligo-metastatic breast cancer harboring homologous recombination deficiency

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…

Everolimus (RAD001, Afinitor®) and Cyclophosphamide in Castration and Docetaxel resistant Prostate Cancer, a proof of principle Phase II study.

The primary objective is to study whether treatment with the mTOR inhibitor Everolimus results in an objectable change in phosphorylation of the selected downstream effectors 4eBP1 and p70S6K in human prostate cancer biopsies. A secondary objective…

ACNS 0331: a study evaluating limited target volume boost irradiation and reduced dose craniospinal radiotherapy (18.00 Gy) and chemotherapy in children with newly diagnosed standard risk medulloblastoma: a phase III double randomized trial.

The aim of the study is to assess if a dose reduction of craniospinal irradiation in children with a medulloblastoma does not reduce event free survival (EFS) or overall survival (OS). Furthermore it will be assessed if a field reduction (only tumor…

A multi-center, randomized, open-label, mechanism of action trial on the biological effects of the therapeutic cancer vaccine Stimuvax® (L-BLP25) in rectal cancer subjects undergoing neoadjuvant chemoradiotherapy

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…

Efficacy and feasibility of first-line treatment with risk-adapted dose-adjusted EPOCH-R (DA-EPOCH-R) in patients with Burkitt lymphoma. A phase II clinical trial.

Primary objectives-Determine efficacy, defined as PFS and OS at 2 years of risk-adaptive DA-EPOCH-R in newly diagnosed Burkitt lymphoma patients 18-75 years.-Determine feasibility, defined as > 60% of cycles of the DA-EPOCH-R scheme on an out…

p53 synthetic long peptides vaccine with cyclophosphamide for ovarian cancer, a phase II trial.

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…

RANDOMIZED PHASE II/III STUDY OF INTENSIFIED ALKYLATING AGENT CHEMOTHERAPY WITH PERIPHERAL BLOOD PROGENITOR CELL SUPPORT IN THE PREOPERATIVE CHEMOTHERAPY OF BREAST TUMORS THAT ARE DEFICIENT FOR HOMOLOGOUS RECOMBINATION.

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…

Dendritic cell-based immunotherapy combined with low-dose cyclophosphamide in patients with malignant pleural mesothelioma

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…

Chemotherapy Adjuvant Study for women at advanced Age (CASA); Phase III Trial Evaluating the Role of Adjuvant Pegylated Liposomal Doxorubicin (PLD, Caelyx®, Doxil®) for Women (age 66 years or older) with Endocrine Nonresponsive Breast Cancer Who Are NOT Suitable for Being Offered a *Standard Chemotherapy Regimen*

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…

Revlimid, Endoxan, Prednisone Evaluation After prior revlimid Treatment (REPEAT):;A phase 1 and phase 2 study of lenalidomide (Revlimid) in combination with cyclophosphamide (endoxan) and prednisone (REP) in relapsed/refractory multiple myeloma

Phase 1Primary objective- To determine the maximum tolerated dose (MTD) and recommended phase 2 dose level (RDL) of lenalidomide administered during 21 days of a 4 week cycle, combined with continuous cyclophosphamide and prednisone. See paragraph…

A phase 2, single arm, multi center trial evaluating the efficacy of the combination of sirolimus and cyclophosphamide in metastatic or unresectable myxoid liposarcoma and chondrosarcoma.

- To evaluate the treatment efficiency by time to progression according to RECIST 1.1

HD 18 for advanced stages: treatment optimization trial in the first line treatment of advanced stage Hodgkin Lymphoma; treatment stratification by means of FDG-PET.

The aim of the trial is to individualize treatment for each patient by adapting it to early response and thus to continue intensive treatment only with those patients wo show an inadequate treatment response.For patients who show a good initial…

A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with
Amyloid Light Chain (AL) Amyloidosis

This study has been transitioned to CTIS with ID 2023-507069-25-00 check the CTIS register for the current data. The primary objectives for the study are: Cohort 1, to characterize cardiac safety of different Daratumumab, cyclophosphamide,…

International phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones

This study has been transitioned to CTIS with ID 2024-515499-12-00 check the CTIS register for the current data. The primary objective is reducing treatment-related morbidity and mortality without adversely impacting DFS in Ph+ ALL patients,…

Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, alone or in combination with other agents, in HLA-A2+ Participants with NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO) (study 208467)

This study has been transitioned to CTIS with ID 2024-513032-14-00 check the CTIS register for the current data. Primary:To evaluate the efficacy of NY-ESO-1-Specific (c259) T Cells, alone or in combination with other anti-cancer agents, in HLA-A*02…

Master Protocol to Assess the Safety and Recommended Phase 2 Dose of Next Generations of Autologous Enhanced NY-ESO-1/ LAGE-1a TCR Engineered T-cells, alone or in combination with other agents, in Participants with Advanced Tumors (study 209012)

Primary:To assess the safety, tolerability and determine recommended phase 2 dose (RP2D) of NY-ESO-1 and LAGE-1a specific T cells, alone or in combination with other agents, in HLA-A*02-positive participants with NY-ESO-1 and/or LAGE-1a positive…