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Neoplasms clinical trials

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NCT ID: NCT00629187 Terminated - Neoplasm Metastasis Clinical Trials

Safety Study of High Dose Temozolomide to Treat Relapsed/Refractory Central Nervous System (CNS) Malignancy

CN-306
Start date: April 2004
Phase: Phase 1
Study type: Interventional

The goal of this study is to find the maximum dose of a drug, temozolomide, that can safely be given to subjects with brain tumors. Past studies showed that the maximum dose of temozolomide was limited by low blood counts. The investigators will use blood stem cells collected from bone marrow to help subjects recover their blood counts, a procedure called autologous stem cell transplant or stem cell rescue. This way, the investigators expect to be able to safely deliver very high doses of temozolomide. This study is only available at Tufts Medical Center.

NCT ID: NCT00626483 Completed - Clinical trials for Malignant Neoplasms Brain

Basiliximab in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Undergoing Targeted Immunotherapy and Temozolomide-Caused Lymphopenia

REGULATe
Start date: April 24, 2007
Phase: Phase 1
Study type: Interventional

RATIONALE: Monoclonal antibodies, such as basiliximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Vaccines may help the body build an effective immune response to kill tumor cells. Giving these treatments together may kill more tumor cells. Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) is a powerful adjuvant capable of stimulating macrophage function, inducing proliferation and maturation of DCs, and is able to enhance T-lymphocyte stimulatory function. Intradermal administration of GM-CSF enhances the immunization efficacy at the site of administration PURPOSE: This clinical trial is studying how well basiliximab works in treating patients with newly diagnosed glioblastoma multiforme and temozolomide-caused lymphopenia who are undergoing targeted immunotherapy.

NCT ID: NCT00626015 Completed - Clinical trials for Malignant Neoplasms of Brain

Chemotherapy, Radiation Therapy, and Vaccine Therapy With Basiliximab in Treating Patients With Glioblastoma Multiforme That Has Been Removed by Surgery

ZAP IT
Start date: March 2007
Phase: Phase 1
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Vaccines may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as basiliximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving chemotherapy, radiation therapy, and vaccine therapy together with basiliximab is a more effective treatment for glioblastoma multiforme than chemotherapy, radiation therapy, and vaccine therapy alone. PURPOSE: This randomized phase I trial is studying the side effects and best way to give chemotherapy and radiation therapy followed by vaccine therapy with basiliximab in treating patients with glioblastoma multiforme that has been removed by surgery.

NCT ID: NCT00625638 Completed - Advanced Cancer Clinical Trials

Interactive Voice Response System in Advanced Cancer Patients

Start date: January 28, 2008
Phase: N/A
Study type: Interventional

The goal of this research study is to learn if using an Interactive Voice Response (IVR) system can bring about better and more timely symptom control for patients with advanced cancer. Primary Objectives: - To determine whether the Interactive Voice Response (IVR) system, supplemented by Nursing Telephone Intervention (NTI), results in better symptom management and quality of life than standard care for individuals with advanced cancer as evidenced by reduced scores on symptom measures. - To determine whether the IVR system, supplemented by NTI, results in reduced caregiver burden, increased caregiver satisfaction with care, and improved coping strategies. - To determine the feasibility of using an IVR system, supplemented by NTI, for symptom assessment in individuals with advanced cancer and their caregivers by conducting a process evaluation of the system. Variables to be evaluated include rates of participant recruitment and retention, frequency of use of the system, acceptability of the system to participants, and barriers to participation. Researchers' goal is to identify and improve aspects that affect external validity (recruitment rate, cohort maintenance), internal validity (implementation, contamination), participant acceptability and satisfaction, and reaction to study procedures. The findings from this evaluation will also allow researchers to evaluate delivery of interventions in future studies.

NCT ID: NCT00625378 Completed - Neoplasms Clinical Trials

Sorafenib Long Term Extension Program

STEP
Start date: December 21, 2007
Phase: Phase 3
Study type: Interventional

The primary purpose of program was to enable patients, currently receiving sorafenib (Nexavar) in a Bayer/Onyx sponsored clinical trial, to continue sorafenib treatment after their respective study had met its primary endpoint and/or had reached the end as defined in the original protocol. Patients were able to continue treatment until (i) the treating physician felt the patient was no longer benefiting from the treatment or (ii) the treatment becomes commercially available and reimbursed for the respective indication as applicable in the country in which the patient lived and the patient could obtain suitable amounts of drug for treatment through standard mechanisms of commercial availability (ie, there should be no interruption in the patient's treatment schedule when switching to commercially available product) or (iii) the patient could join a Post-Trial-Access Program, another study or can receive sorafenib through any other mechanism (e.g. local access program) in accordance with local legal and compliance rules, with no cost to the patient with respect to sorafenib. An additional objective was the assessment of the safety of Nexavar or Nexavar combination treatment.

NCT ID: NCT00624962 Withdrawn - Leukemia Clinical Trials

Early Enteral Tube Feedings in Children Receiving Chemo for AML/MDS & High Risk Solid Tumors

Start date: March 2006
Phase: N/A
Study type: Interventional

RATIONALE: Tubefeeding may help maintain good nutrition and lessen weight loss in younger patients receiving chemotherapy for cancer. PURPOSE: This clinical trial is studying how well tube feedings work in younger patients receiving chemotherapy for newly diagnosed acute myeloid leukemia, myelodysplastic syndrome, or high-risk solid tumors.

NCT ID: NCT00624312 Withdrawn - Cancer Clinical Trials

Procrit Versus Placebo to Determine Efficacy in Pre-Operative Major Surgical Oncology Operations

Start date: February 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of a two-dose regimen of Procrit prior to a major surgical oncology operation.

NCT ID: NCT00623870 Completed - Clinical trials for Hematologic Neoplasms

A Study of RO5045337 [RG7112] in Patients With Hematologic Neoplasms.

Start date: May 2008
Phase: Phase 1
Study type: Interventional

This study will determine the maximum tolerated dose of RO5045337 and the optimal associated 4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with hematologic neoplasms. A first cohort of patients will receive the starting dose of 20mg/m2/day orally, once daily for 10 days in each 28 day cycle. Subsequent cohorts of patients will receive dose escalations, and possible changes in dosing schedule, based on tolerability and pharmacokinetic knowledge gained from prior treatment cohorts. Different formulations of RO5045337 will be tested and the food effect evaluated. The anticipated time on study treatment is until disease progression or intolerable toxicity.

NCT ID: NCT00621556 Terminated - Clinical trials for Intraductal Papillary Mucinous Neoplasms

Secretin Enhanced MRCP for Evaluation of the Known or Suspected Intraductal Papillary Mucinous Neoplasms of the Pancreas

Start date: February 2008
Phase: Phase 1
Study type: Interventional

1. To assess the effect of RG1068 at a dose of 0.2 mcg/kg intravenously (IV) on the diameter of the pancreatic duct when used during Magnetic Resonance Pancreatography 2. To demonstrate that RG1068-enhanced MRCP improves detection and characterization of intraductal papillary mucinous neoplasms (IPMN) relative to unenhanced MRCP in patients with suspected IPMN 3. To correlate findings on MRCP with histologically confirmed malignancy

NCT ID: NCT00618124 Completed - Breast Cancer Clinical Trials

A Study To Find The Best Doses Of SU011248 (Sunitinib) And Capecitabine When These Drugs Are Administered Together

Start date: May 2005
Phase: Phase 1
Study type: Interventional

This study assesses the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with capecitabine in patients with advanced solid tumors