Track topics on Twitter Track topics that are important to you
Rationale: Interferon has long been used as a therapy for renal cell carcinoma. However, optimal dosing schedules have not been identified and patients have been relegated to receiving the highest possible doses for prolonged periods of time. This high-dose approach often leads to serious adverse effects from toxicity that limits the usefulness and patient tolerance of this treatment. No formal study has determined the relationship if any between the maximal tolerated dose (MTD) and the biological effective dose of interferon alpha-2b. The current study seeks to fill that gap by gathering research information about different doses of interferon alpha-2b and correlating with measurements of JAK/STAT in the blood. Validation of correlative studies to determine optimum biologic dosing are needed so that therapy may be adjusted appropriately rather then the current approach of maximizing dose. In addition, a trial of low dose daily administered interferon-2b has not been carried out in the current era with refined histologic classification and modern CT imaging scanning. As this therapy potentially has wide applicability, definite response rates need to be documented.
Purpose: The purpose of this study is to assess the response rate of daily low dose interferon-2b in patients with metastatic or unresectable clear cell renal carcinoma. The duration of the response and overall survival will be determined in study participants. This study will also evaluate JAK/STAT, two types of kinases or enzymes involved in an intracellular signaling process associated with cancer growth, in peripheral blood mononuclear cells over the course of interferon alpha-2b dose escalation. Researchers will examine in a preliminary manner the correlation between clinical response, toxicity, and JAK/STAT signal transduction. Progression free survival and rate of stable disease will also be determined in a preliminary manner.
Treatment: Study participants will receive interferon alpha-2b. This drug will be self-administered daily through injections into the skin. The dose level of interferon alpha-2b will be increased each week into study treatments. For the first three weeks and approximately monthly thereafter, patients will have blood drawn three hours following interferon alpha-2b administration to measure JAK/STAT. Toxicity from study treatments will be closely monitored in patients during clinics visits. Supportive care therapies will be given throughout the study. Treatments will be discontinued due to disease growth or unacceptable side effects.
Allocation: Non-Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Ohio State University
Ohio State University Comprehensive Cancer Center
Published on BioPortfolio: 2014-08-27T03:46:03-0400
Patients with metastatic renal cell cancer will be enrolled to receive either Trovax® alone or Trovax® plus Interferon Alfa. The study will try to determine whether the use of Trovax® ...
This is a non-interventional, multicenter study to evaluate efficacy and safety of intravenous Avastin in combination with interferon alpha-2a for first-line treatment of participants with...
This prospective observational study will evaluate the efficacy and safety of Av astin (bevacizumab) in combination with interferon alpha 2a in patients with pre viously untreated metastat...
When administered simultaneously, interferon-alpha 2b + interferon-gamma result in dramatic antiviral synergy.Ribavirin has shown to enhance interferon-gamma levels in patients with chroni...
The treatment response with conventional interferon alpha alone in patients with end stage renal disease and chronic hepatitis C is about 33-39%. However, the drop-out rate is 17-29.6%. Pe...
To report the results of tocilizumab (TCZ) treatment in patients with Behçet uveitis (BU) who had failed conventional, interferon alpha, and anti-Tumor necrosis factor-alpha therapy.
HEV infection can lead to chronic hepatitis in immunosuppressed patients; extrahepatic manifestations are rarely seen. Here, we report a 13-year-old renal transplant patient with chronic hepatitis E a...
To assess the efficacy and tolerability of interferon (IFN) alpha-2a in post-infectious uveitis secondary to presumed intraocular tuberculosis (IOTB).
For pregnant women with essential thrombocythemia (ET), no standard approach for managing the platelet count has been established. We present the cases of two pregnant women with ET treated with inter...
Interferon secreted by leukocytes, fibroblasts, or lymphoblasts in response to viruses or interferon inducers other than mitogens, antigens, or allo-antigens. They include alpha- and beta-interferons (INTERFERON-ALPHA and INTERFERON-BETA).
A ubiquitously expressed heterodimeric receptor that is specific for both INTERFERON-ALPHA and INTERFERON-BETA. It is composed of two subunits referred to as IFNAR1 and IFNAR2. The IFNAR2 subunit is believed to serve as the ligand-binding chain; however both chains are required for signal transduction. The interferon alpha-beta receptor signals through the action of JANUS KINASES such as the TYK2 KINASE.
An interferon regulatory factor that binds upstream TRANSCRIPTIONAL REGULATORY ELEMENTS in the GENES for INTERFERON-ALPHA and INTERFERON-BETA. It functions as a transcriptional activator for the INTERFERON TYPE I genes.
A DEAD box RNA helicase that contains two N-terminal CASPASE ACTIVATION AND RECRUITMENT DOMAINS. It functions as a sensor of viral NUCLEIC ACIDS such as DOUBLE-STRANDED RNA and activates the INNATE IMMUNE RESPONSE by inducing the expression of INTERFERON-ALPHA and INTERFERON-BETA. It may also regulate cell growth and APOPTOSIS.
A multimeric complex that functions as a ligand-dependent transcription factor. ISGF3 is assembled in the CYTOPLASM and translocated to the CELL NUCLEUS in response to INTERFERON signaling. It consists of ISGF3-GAMMA and ISGF3-ALPHA, and it regulates expression of many interferon-responsive GENES.
Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...
Renal Cell Carcinoma
Renal cell cancer (renal adenocarcinoma or hypernephroma) is the most common type of kidney cancer in adults. More than 8 in every 10 (80%) kidney cancers diagnosed in the UK are this type. In renal cell cancer the cancerous cells start in the lini...