Track topics on Twitter Track topics that are important to you
The study is being conducted to demonstrate that CNTO 328 in combination with best supportive care is superior to best supportive care in terms of durable tumor and symptomatic response (reduction in tumor size and the symptoms for at least 18 weeks) and has an acceptable benefit risk profile in among patients with multicentric Castleman's disease.
CNTO 328 is an experimental drug that is not approved in any country. CNTO 328 is being tested to see if it may be useful in treating Multicentric Castleman's Disease. This study will compare the effects (both good and bad) of CNTO 328 to those of placebo. Placebo looks like the drug being studied but has no active ingredients (for example a sugar pill). The purpose of this study is to show that receiving CNTO 328 with best supportive care (BSC) will provide benefit compared to patients receiving BSC alone in patients with Multicentric Castleman's Disease (MCD). Safety assessments will be performed throughout the study and include laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of side effects. At predefined timepoints the efficacy will be assessed (measures of drug working). Also, blood levels of CNTO 328 will be studied. At the beginning of the study, two-thirds of patients (52 in total) will be randomly selected (like the flip of a coin) to receive the study drug CNTO328, while the remaining group (26 patients) will receive placebo. Patients who initially get placebo may be given study drug if their disease worsens. Patients will receive study drug (active or placebo) every 3 weeks until treatment failure, treatment discontinuation, withdrawal from study, or until 48 weeks after the last patient starts study treatment. Treatment in this study will end 48 weeks after the last patient starts treatment. If the patient is benefitting at the time of study end, patients may continue to receive treatment in an extension protocol. Patient follow up will occur 3 months after last dose of study drug along with survival follow up until the study ends including extension treatments. Patients will be randomly assigned to 2 treatment groups. Group A will receive placebo (intravenously,through the vein) plus best supportive care. Group B will receive 11 mg/kg of CNTO 328 (intravenously, through the vein) plus best supportive care. Both groups will receive treatment every 3 weeks for up to 48 weeks after the last patient starts study treatment. Patients who do not respond to placebo treatment may be eligible to be treated with CNTO 328 every 3 weeks.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
CNTO 328, Placebo
Published on BioPortfolio: 2014-08-27T03:17:37-0400
The purpose of this study is to evaluate of the study of different CNTO 328 doses and schedules and to see if CNTO 328 has any effect on Non-hodgkin's Lymphoma, Multiple Myeloma or Castlem...
The purpose of this study is to collect clinical, laboratory, and patient survey data from patients with Castleman disease to improve understanding, diagnosis, and treatment of the disease...
The purpose of this study is to study stained Castleman's Disease lymph nodes and perform flow cytometry and cell culture experiments on Castleman Disease blood samples to determine which ...
The purpose of this study is to assess the effectiveness and safety of CNTO 1275 in patients with moderate to severe plaque type psoriasis in subcutaneous administration of 45 and 90 mg at...
The experimental drug CNTO 888 is currently being studied in cancer patients with solid tumors and this study is the first to use this drug for patients with idiopathic pulmonary fibrosis ...
To determine the tentative diagnostic criteria and disease severity classification for Castleman disease (CD) and describe the clinical and pathologic features among human herpesvirus 8 (HHV-8) negati...
Castleman disease is a rare lymphoproliferative disorder which etiology is unknown. It is divided into 2 subtypes: the plasma cell variant and the hyaline vascular variant. The most common site is the...
We report a 73-year-old female patient with Castleman's disease coexistent with large B cell type non-Hodgkin's lymphoma in a right axillary lymphadenopathy. An excisional biopsy was performed: micros...
A 36-year-old woman suffering from oral ulcerations, skin rash, and dyspnea was suspected of having paraneoplastic pemphigus. An F-FDG PET/CT was performed to detect the underlying neoplasms and revea...
Castleman's disease is a rare benign lymphoproliferative disorder of unknown etiology. The disease occurs in two clinical forms with different prognoses, treatments and symptoms: a unicentric form (UC...
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Animate or inanimate sources which normally harbor disease-causing organisms and thus serve as potential sources of disease outbreaks. Reservoirs are distinguished from vectors (DISEASE VECTORS) and carriers, which are agents of disease transmission rather than continuing sources of potential disease outbreaks.
Analyses for a specific enzyme activity, or of the level of a specific enzyme that is used to assess health and disease risk, for early detection of disease or disease prediction, diagnosis, and change in disease status.
The worsening of a disease over time. This concept is most often used for chronic and incurable diseases where the stage of the disease is an important determinant of therapy and prognosis.
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...