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NCT ID: NCT00078598 Recruiting - Clinical trials for Non-Hodgkin's Lymphoma

A Study of Rituximab Versus Iodine I 131 Tositumomab Therapy for Patients With Non-Hodgkin's Lymphoma

Start date: April 2004
Phase: Phase 3
Study type: Interventional

A total of 506 patients, 253 per arm, will be enrolled at 30 to 40 sites in the United States and Europe. Patients will be randomly assigned to one of two treatment arms. In Arm A, patients will receive 375 mg/m2 of rituximab (US, Canada – Rituxan®; EU - Mabthera®), given as an IV infusion once weekly for 4 weeks. In Arm B, patients will receive Iodine I 131 Tositumomab therapy. For Arm B, patients undergo a two-phase treatment. In the first phase, termed the “dosimetric dose,” patients will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of Tositumomab (35 mg) that has been labeled with 5 mCi (0.18 GBq) of iodine 131. Whole body gamma camera scans will be obtained three times (Day 0, Day 2, 3, or 4, and Day 6 or 7) following the dosimetric dose. Using the dosimetric data from these three imaging timepoints, the patient’s weight, and platelet count, a patient-specific administered activity of iodine I 131 Tositumomab (expressed in mCi or GBq) will be calculated to deliver the desired total body dose of radiation (65 or 75 cGy). In the second phase, termed the “therapeutic dose,” patients in Arm B will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of the patient-specific administered activity of Iodine 131–conjugated Tositumomab (35 mg). Patients on study will be followed for response and safety at Week 7, Week 13, and every 3 months for the first and second years, every 6 months for the third year, and then annually for the fourth and fifth years. Patients will be followed for safety only annually for years 6-10.

NCT ID: NCT00107367 Recruiting - Metastatic Cancer Clinical Trials

Radiation Therapy in Treating Patients Who Are Undergoing Surgery to Remove a Metastatic Brain Tumor

Start date: April 2004
Phase: Phase 1/Phase 2
Study type: Interventional

RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a tumor was surgically removed may kill any remaining tumor cells and cause less damage to normal tissue. PURPOSE: This phase I/II trial is studying radiation therapy to see how well it works in treating patients who are undergoing surgery to remove a metastatic brain tumor.

NCT ID: NCT00136370 Recruiting - Sepsis Clinical Trials

Prevention of Perinatal Sepsis (PoPS): Evaluation of Chlorhexidine Wipes of Birth Canal and Newborn

Start date: April 2004
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate whether use of the disinfectant chlorhexidine administered to the birth canal during labour and newborn at delivery can protect a woman and her baby from bacterial infections after birth. If effective, this could be used as an inexpensive alternative to antibiotics to prevent newborn infections in resource-poor countries.

NCT ID: NCT00151723 Recruiting - Hyperthyroidism Clinical Trials

Does Radioiodine Treatment Prevent Atrial Fibrillation and Bone Loss in Endogenous Subclinical Hyperthyroidism?

Start date: April 2004
Phase: N/A
Study type: Interventional

Subclinical hyperthyroidism is defined as the presence of serum free thyroxine (T4) and triiodothyronine (T3) levels within the reference range and a reduced serum thyrotrophin (TSH) level. Evidence is accumulating that it has important clinical effects. The SUBstudy is a randomised, Dutch multicenter trial to study whether radioiodine treatment prevents the development of atrial fibrillation and prevents decreases in bone mineral density in patients with endogenous subclinical hyperthyroidism.

NCT ID: NCT00153608 Recruiting - Clinical trials for WT1 Expressing Carcinoma

WT1 Peptid Vaccination in Carcinomas

Start date: April 2004
Phase: Phase 2
Study type: Interventional

In this trial HLA-A2+ patients with WT1 expressing carcinomas are vaccinated with a peptide from the leukemia associated antigen WT1 together with immunological adjuvants KLH as T-helper protein and GM-CSF

NCT ID: NCT00155168 Recruiting - Clinical trials for Spinal Muscular Atrophy

Quantitative Analysis of SMN1 and SMN2 Gene Based on DHPLC System

Start date: April 2004
Phase: N/A
Study type: Observational

In this project, we will establish the efficient and accurate gene dose determination system by combining the heterodulex analysis and gene dose analysis on DHPLC platform based on various quantitative and multiplex PCR strategies and applying on detecting the carriers- in- risk and patients with spinal muscular atrophy.This method is, therefore, based on the observation that the amount of PCR product generated from each site of amplification is proportional to the amount of starting template. Detection of PCR products is carried out on DHPLC, which provide the sensitivity required for the detection of the single-copy dosage changes.

NCT ID: NCT00155194 Recruiting - Biliary Atresia Clinical Trials

Evaluation of Immune Function in Biliary Atresia Children With Prolonged Jaundice

Start date: April 2004
Phase: N/A
Study type: Observational

Null hypothesis of this study: Biliary atresia patients with cholestatic jaundice do not have systemic immunity defect.

NCT ID: NCT00178893 Recruiting - Hepatocytes Clinical Trials

Hepatocellular Research Registry

Start date: April 2004
Phase:
Study type: Observational

This is a registry of human hepatocytes (liver cells) for research purposes.

NCT ID: NCT00217295 Recruiting - Multiple Sclerosis Clinical Trials

A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis

Start date: April 2004
Phase: Phase 2
Study type: Interventional

This is a clinical trial in relapsing-remitting Multiple Sclerosis to determine if Topamax added to Avonex has a neuroprotective effect as measured by the brain parenchymal fraction ( a measure of brain shrinkage) and by clinical assessment scores to evaluate disease progression.

NCT ID: NCT00228124 Recruiting - Prostate Cancer Clinical Trials

PR.7 Companion Trial: Effect of Intermittent Versus Continuous Androgen Suppression on Bone Loss and Body Composition

Start date: April 2004
Phase: Phase 3
Study type: Observational

The purpose of this study is to determine, in patients entered on the National Cancer Institute of Canada (NCIC)-PR.7 trial of intermittent versus continuous androgen ablation, whether the rates of osteoporosis, fractures, and alteration in body composition are reduced by intermittent androgen ablation. There will be two groups of patients: 1. A cross-sectional group of 150 patients registered in PR.7 prior to January 1, 2002, randomized between intermittent androgen suppression (IAS) and continuous androgen suppression (CAS) (75 from each group). Patients who have definite bone metastases are excluded from this study. Biochemical failure does not exclude the patient. 2. A longitudinal study of 150 newly accrued patients randomized between IAS and CAS (75 from each group). These patients will have baseline evaluation of bone loss and body composition, longitudinal monitoring and follow-up on an annual basis for patients on CAS and at the end of each “off cycle” of IAS. Patients taking bisphosphonates are excluded from this study.