View clinical trials related to Solid Tumors.
Filter by:Background: - CDDO is a novel synthetic triterpenoid which is a potent multifunctional molecule. It induces apoptosis in vitro in malignant cells through both intrinsic and extrinsic pathways, and it controls cellular differentiation, apoptosis, and growth inhibition by serving as a ligand for the transcription factor peroxisome proliferator activator receptor-gamma (PPAR gamma). - Based on in vitro activity, it holds considerable promise as a novel anti-tumor agent against a wide range of malignancies by concurrently targeting multiple pathways leading to oncogenesis. - In vivo data demonstrates that the drug is well tolerated in dogs, and has anti-tumor effects, dependent upon dose schedule. Objectives: Primary: - To determine the dose limiting toxicities, toxicity profile, and maximum tolerated dose of CDDO when administered in adult patients with solid tumors and lymphomas. - To characterize the pharmacokinetics of CDDO. Secondary: - To obtain preliminary evidence of anti-tumor activity of CDDO in this population. - To evaluate the in vivo molecular and biological effects of CDDO by assessing changes in biomarkers of apoptosis and cell cycle arrest. Eligibility: - Patients with advance, histological-confirmed malignancies refractory to standard therapy or for which no standard therapy exist. - Patients should have adequate liver, renal and bone marrow function. Study Design: - Accordingly with the accelerated titration design 4B, dose levels will initially be increased at 100% increments, and one new patient per dose level will be treated per 4-week course. - The accelerated phase ends when one patient experiences DLT during any course of treatment or when two different patients experience grade 2 toxicity during first course of treatment. - When the first instance of grade 2 toxicity is observed two additional patients must have been treated at that dose, or a higher dose, (during any course) without experiencing moderate or worse toxicity, in order that the accelerated phase continue. - When the accelerated phase ends, dose-escalation will revert to a more conservative modified Fibonacci scheme with 40% dose-step increments, with at least 3 patients treated per dose level.
Melanoma is the main cause of death in patients with skin cancer. Once it has metastasized, this cancer has been shown to respond to chemotherapy only in rare cases. Immunotherapy represents an approach to treatment based on the immune response to cancer antigens. The long-term objective of this study is to develop a therapeutic approach for the treatment of cancer in general, and melanoma in particular, based on immunotherapy, using a combination of local tumor irradiation followed by injection of immature dendritic cells (iDC).The treatment will be followed by the injection of interferon alpha, which we expect will induce activation of the iDC. This trial is based on the hypothesis that local radiation, which causes destruction of the tumor, in combination with injection of the patient's own iDC and the activation of these cells with interferon alpha, will induce an effective immune response against the tumor. In order to test the suggested approach, we propose a 20-patients clinical trial that will evaluate the objective clinical and immunological response to the proposed treatment in patients with malignant melanoma and other solid tumors.
1. To determine the safety and feasibility of administering Capecitabine with the combination of Cisplatin and Irinotecan. 2. To determine the Phase II recommended dose and toxicity profile of Capecitabine with the combination of Cisplatin and Irinotecan. 3. To study the biologic effect of pyrimidine inhibition on DNA repair after camptothecin therapy.
Hypothesis: Radiosensitization using Xeloda should improve the rate of complete pain relief. Primary Objective: - To determine the frequency of pain relief for the proposed regimen. Secondary Objective(s): - To determine the duration of pain relief and narcotic relief for the proposed regimen. - To determine the frequency of narcotic relief for the proposed regimen. - To determine the toxicity of concurrent UFT and radiotherapy in patients with bone metastases.
The purpose of this protocol is to estimate the maximum tolerated dose of gefitinib in combination with fixed dose of irinotecan and vincristine in patients with refractory solid tumors.
The purpose of this study is to assess the safety of rhEndostatin, to determine how much of the drug stays in the patients blood (pharmacokinetics), to assess the development of proteins in the blood that are produced by the body (antibodies)using rhEndostatin, to determine the effect of rhEndostatin on the formation of new blood vessel factors, and to perform an analysis of the effect of rhEndostatin on circulating endothelial precursor cells (cells in the body that help the tumor build more blood vessels).
The goal of this clinical research study is to find the highest safe dose of AMG 531 that will decrease the risk and severity of thrombocytopenia (low platelet counts) in patients who have received chemotherapy. Researchers will also look at the safety and effectiveness of AMG 531 (Romiplostim). Primary Objectives: 1. To determine the clinical safety and tolerability of AMG 531 administered following chemotherapy in patients with advanced malignancy 2. To determine an optimal biologic dose (OBD) of AMG 531 administered in patients receiving chemotherapy known to cause severe thrombocytopenia 3. To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and platelet recovery following chemotherapy Secondary Objective: 1. To evaluate limited pharmacokinetics of AMG 531 administered by S.C. route post-chemotherapy
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This research study of clofarabine will be used for advanced cancer in persons in which drugs are no longer effective or no reliable effective treatment is available. The purpose of this study is to find the answers to the following research questions: 1. What is the largest dose of clofarabine that can be safely administered as an IV infusion (over at least 2 hours) once a week for 3 weeks (days 1, 8 and 15) followed by 1 week of rest and repeated every 28 days? 2. What are the side effects of clofarabine when given on this schedule? 3. How much clofarabine is in the blood at specific times after administration and how does the body get rid of the drug? Once the MTD/RP2D is established, patients will be enrolled at the MTD/RP2D regardless of the PK data with cardiac assessments done every other cycle. 4. Will clofarabine help treat a specific cancer?
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This is a research study of clofarabine that will be given to patients (orally) with advanced cancerous tumors or cancerous tumors that have spread in which standard drugs are no longer effective or no reliable effective treatment is available. The purpose of this study is to find the answers to the following research questions: 1. What is the largest dose of oral clofarabine that can be safely given daily for 5 days followed by 23 days of rest and repeated every 28 days? 2. What are the side effects of clofarabine when given on this schedule? 3. How much oral clofarabine is in the blood at specific times after administration and how does the body get rid of the drug? 4. Will oral clofarabine help treat solid tumor cancer?
The purpose of this research study is to test the safety and effectiveness of palifermin to determine if weekly doses can be safely administered to reduce the incidence (occurrence of), duration (length of time) and severity (amount of pain) of oral mucositis (painful sores in the mouth). Mucositis is a common side effect for patients receiving chemotherapy (cancer-killing drug) and radiotherapy (cancer-killing x-rays) for the treatment of head and neck cancer (HNC).