View clinical trials related to Neoplasms.
Filter by:The purpose of this study is to assess the ability of darbepoetin alfa to maintain hemoglobin concentrations greater than or equal to 10 g/dL when administered every 3 weeks (Q3W).
The purpose of this study is to evaluate the efficacy of darbepoetin alfa as 500ug once every 3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid malignancies.
The purpose of this trial is to assess the effectiveness of Aranesp® administered at 300 mcg every 3 weeks (q3w) in achieving therapeutic objectives of anemia treatment (achieving and maintaining hemoglobin levels consistent with the National Comprehensive Cancer Network (NCCN) guidelines).
Background: HIF-1 is a common mediator of hypoxic and non-hypoxic pathways that affects a transcriptional program leading to survival, angiogenesis, migration and invasion of cancer cells. We have demonstrated that chronic administration of topotecan inhibits HIF-1alpha expression, angiogenesis and tumor growth in human xenografts. Notably, the mechanism by which topotecan inhibits HIF-1alpha protein expression is independent of replication-mediated DNA damage, suggested a mechanism of action distinct from its cytotoxic effects. Objectives: This clinical trial is designed to explore the hypothesis that chronic administration of topotecan (TPT) inhibits Hypoxia Inducible factor 1alpha (HIF-1alpha) expression and angiogenesis in patients with metastatic tumors over-expressing HIF-1alpha. Eligibility: Adult patients with metastatic solid tumors expressing HIF-1alpha, for whom standard therapy does not exist or would likely not be effective, will be evaluated for study eligibility. Due to safety concerns, pregnant women and HIV-infected individuals are excluded from this study. Prior to enrollment, archival tumor tissue wil be evaluated for the expression of HIF-1alpha as assessed by IHC. Only patients who have tumors that express HIF-1alpha and who meet all eligibility criteria will be enrolled on this study. Patients will be asked to undergo a biopsy to evaluate HIF-1alpha expression before starting treatment and at the end of treatment on cycle 2 (day 12 or 13 cycle 2). Design: Topotecan at the dose of 1.2 mg/m(2) will be administered orally daily x 5 for 2 weeks, during a 28 days cycle. Imaging studies including CT, FDG-PET and DCE-MRI will be performed at baseline, at the end of treatment on cycle 1 (day 9 or 10), end of treatment on cycle 2 (day 12 or 13) and then every 2 cycles and will provide information on clinical response as well as tumor metabolism and angiogenesis. The repeat scans on day 9 or 10 of cycle 1 will be performed solely for research purposes to evaluate for early changes in tumor metabolism and angiogenesis. Additional correlative studies include evaluation of mRNA expression of HIF-1 target genes in tumor tissue, circulating markers of angiogenesis, and measurement of circulating endothelial precursor cells (CEP). The goal of this trial is to establish whether topotecan inhibits HIF-1alpha and angiogenesis in human cancers....
Tapestry Pharmaceuticals, Inc. has developed a novel taxane analog, TPI 287. TPI 287 is synthetically manufactured from naturally occurring taxanes extracted from yew starting material. The synthesis involves modification to the taxane side chain to overcome multidrug resistance and to achieve mutant tubulin binding. This study will be a multi-center, dose escalation, sequential group, phase I study evaluating the intravenous administration of TPI 287, a novel third generation taxane.
The primary goal of this pilot study is to assess the feasibility of using magnetic resonance (MR) imaging guidance in the Magnetic Resonance Therapy (MRT) unit at the Brigham and Women's Hospital during the implantation of brachytherapy applicators in patients with gynecologic malignancies. Patients with gynecologic malignancies requiring brachytherapy are currently treated under either fluoroscopic or CT visualization of the brachytherapy applicator. Magnetic resonance imaging has been shown in many studies to provide superior visualization of the cervix, vagina and uterus compared to CT. However no prior study has examined the feasibility of using real-time magnetic resonance imaging to assist in the guidance of gynecologic brachytherapy applicators
A feasibility study of neoadjuvant chemotherapy (NAC) followed by interval cytoreductive surgery (ICS) and postoperative chemotherapy for stage III/IV mullerian carcinomas such as ovarian, tubal and peritoneal carcinomas.
The purpose of this study is to compare the effect of darbepoetin alfa administered in a weight based versus fixed dosing for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.
The purpose of this study is to compare the time to hematopoietic response (hemoglobin correction to 12 g/dL or a greater than or equal to 2 g/dL increase from baseline) for subjects randomized to receive darbepoetin alfa with a front load dosing regimen to those receiving recombinant human erythropoietin (rHuEPO) with a weekly dose regimen during the 12-week comparative treatment period.
The purpose of this study is to compare the effect of darbepoetin alfa against placebo for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.