Track topics on Twitter Track topics that are important to you
RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system and stop cancer cells from growing. Interferon alfa may interfere with the growth of cancer cells. Combining these therapies may be an effective treatment for bladder cancer.
PURPOSE: Phase II trial to study the effectiveness of BCG plus interferon alfa 2b in treating patients who have bladder cancer.
OBJECTIVES: I. Compare the efficacy of BCG combined with interferon alfa 2b in patients with superficial bladder cancer. II. Determine the relative local and systemic toxicities of this regimen and its effect on quality of life in these patients. III. Evaluate the effect of BCG dose reduction during therapy on symptom tolerance and ability to maintain an extended treatment plan in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior BCG exposure and BCG tolerance (no prior BCG exposure vs prior BCG exposure, BCG tolerant vs prior BCG and interferon alfa treatment failure, BCG intolerant). Patients receive induction therapy consisting of varying strengths of BCG plus interferon alfa intravesically weekly for 6 weeks. Patients with disease recurrence which is resectable and/or amenable to intravesical therapy following the first induction course may receive an additional course of induction therapy. At 3 months, patients undergo evaluatory cystoscopy and cytology. At 4 months, patients with no evidence of disease receive varying strengths of maintenance therapy consisting of BCG and interferon alfa intravesically weekly for 3 weeks. Treatment repeats every 6 months for 3 courses. Quality of life is assessed within 1 week following the last induction and maintenance treatment and prior to cystoscopy. Patients are followed every 3 months for 6 months, every 6 months for 1.5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 660 patients will be accrued for this study within 2.5 years.
Primary Purpose: Treatment
BCG vaccine, recombinant interferon alfa
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:58:21-0400
RATIONALE: Interferon alfa may interfere with the growth of cancer cells.Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether melanoma vacci...
RATIONALE: Interferon alfa may interfere with the growth of tumor cells and slow the growth of urothelial cancer. PURPOSE: This randomized phase I trial is studying how well low-dose inte...
This phase I trial is studying the side effects and best dose of interferon alfa-2b when given together with vaccine therapy and GM-CSF in treating patients with locally advanced or metast...
RATIONALE: Vaccines made from a person's melanoma cells may make the body build an immune response to kill tumor cells. Interferon alfa may interfere with the growth of the cancer cells. ...
RATIONALE: Vaccines made from a patient's dendritic cells and tumor cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's lymphocytes...
Intravesical instillation of bacillus Calmette-Guérin (BCG) has been a first-line therapy for non-muscle-invasive bladder cancer for the last 4 decades. However, this treatment causes serious adverse...
Bladder cancer is the most common urogenital tumor with substantial morbidity, high recurrence rate and mortality. miRNAs, a class of endogenous noncoding RNA, were found to involve in the genesis, ma...
Bladder cancer is a serious cancer in the world, especially in advanced countries. Bladder cancer stem cells (CSCs) drive bladder tumorigenesis and metastasis. Circular RNAs (circRNAs) are involved ...
The breakage of matrix metalloproteinases (MMPs) has been reported to be one of the mechanisms required for tumor invasion, and the expression of MMP-7 in serum is correlated with poor prognosis of ur...
Bladder cancer has numerous genomic features that are potentially actionable by targeted agents. Nevertheless, both pre-clinical and clinical research using molecular targeted agents have been very li...
A recombinant alfa interferon consisting of 165 amino acids with arginine at positions 23 and 34. It is used extensively as an antiviral and antineoplastic agent.
A recombinant alfa interferon consisting of 165 amino acids with lysine at position 23 and histidine at position 34. It is used extensively as an antiviral and antineoplastic agent.
A recombinant alfa interferon consisting of 165 amino acid residues with arginine in position 23 and histidine in position 34. It is used extensively as an antiviral and antineoplastic agent.
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).
Tumors or cancer of the URINARY BLADDER.
Biological therapy involves the use of living organisms, substances derived from living organisms, or laboratory-produced versions of such substances to treat disease. Some biological therapies for cancer use vaccines or bacteria to stimulate the body&rs...
Head and neck cancers
Cancer can occur in any of the tissues or organs in the head and neck. There are over 30 different places that cancer can develop in the head and neck area. Mouth cancers (oral cancers) - Mouth cancer can develop on the lip, the tongue, the floor...
Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...