View clinical trials related to Neoplastic Disease.
Filter by:This is an open label, single arm, parallel-group, multicentre, and dose finding study to evaluate the safety of ascending radioactive dose levels of 131I-TLX101 administered intravenously in combination with best standard of care in newly diagnosed GBM patients.
This is a study to assess the ability of Indocyanine Green (ICG) to identify neoplastic disease. For many pediatric solid tumors, complete resection of the primary site and/or metastatic deposits is critical for achieving a cure. An optimal intra-operative tool to help visualize tumor and its margins would be of benefit. ICG real-time fluorescence imaging is a technique being used increasingly in adults for this purpose. We propose to use it during surgery for pediatric malignancies. All patients with tumors that require localization for resection or biopsy of the tumor and/or metastatic lesions will be eligible. Primary Objective To assess the feasibility of Indocyanine Green (ICG)-mediated near-infrared (NIR) imagery to identify neoplastic disease during the conduct of surgery to resect neoplastic lesions in children and adolescents. NIR imaging will be done at the start of surgery to assess NIR-positivity of the lesion(s) and at the end of surgery to assess completeness of resection. Separate assessments will be made for the following different histologic categories: 1. Osteosarcoma 2. Ewing Sarcoma 3. Rhabdomyosarcoma (RMS) 4. Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) 5. Neuroblastoma 6. Renal tumors (Only bilateral Wilms Tumor patients will be included.) 7. Metastatic pulmonary deposits 8. Liver tumors, lymphoma, other rare tumors, and nodules of unknown etiology Exploratory Objectives 1. To compare the ICG uptake by primary vs metastatic site and pre-treated (chemotherapy, radiation, or both) vs non-pre-treated. 2. Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified by standard of care intraoperative inspection and tactile feedback. 3. Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified on preoperative diagnostic imaging. 4. Assess the sensitivity and specificity of NIR imagery for identifying residual disease at the conclusion of a tumor resection.
The main goal of the study is to provide a unique multidimensional picture of the health of the population with simultaneous optimal standards of sampling, processing and storing of data and biomaterial that will allow discovering novel mechanisms in the development and progression of common civilization diseases. In the effect it will improve prevention, diagnosis and treatment.
The primary objective of study CA601.2 is to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of ABI-011 when administered by intravenous (IV) infusion on Days 1, 8, and 15, followed by a week of rest, in patients with advanced solid tumor malignancies or lymphomas. The MTD will be determined using a standard 3+3 design. The secondary objectives are to evaluate the safety and toxicity profile, to evaluate the plasma pharmacokinetics (PK), to assess the biological activity and pharmacodynamics, and to make a preliminary assessment of tumor response in patients with advanced solid tumors or lymphomas. The exploratory objectives are to determine the genomic and proteomic profile of patients' tumors to identify gene mutations, gene amplifications, levels of protein expression, and pinpoint oncoproteins. Correlations between genomic/proteomic profiles and efficacy outcomes will be assessed and principal metabolites of ABI-011 will be determined, if possible. Approximately 45-60 patients will be treated to determine dose limiting toxicities (DLTs), the MTD, and/or RP2D of ABI-011. Once the RP2D is identified, expansion of this cohort (up to 10 patients) will occur.
From 1996-present, we have used photodynamic therapy (PDT) to treat a number of neoplastic diseases both on prospective research protocols (for head and neck cancer, pleural malignancies, peritoneal carcinomatosis or sarcomatosis and prostate cancer) as well as for FDA approved and off label or compassionate exemption indications (neoplasms of the skin, bronchus, esophagus, head and neck and pleura). The goal of this treatment is to maximize quality of life and organ function while minimizing the chance of tumor recurrence. As such, we would like to retrospectively review the treatment parameters of all patients who undergo/underwent PDT (including operative notes and photodynamic therapy records) and treatment outcomes (including all organ functions, performance status, tumor recurrence, laboratory values and any other data present in the routinely documented follow up visits). For patients who have died or were lost to follow-up prior to initiation of this study, a retrospective review of available data will be performed. For patients who are still being actively followed after PDT or who receive PDT after the initiation of this study, informed consent will be obtained for obtaining continued follow-up data prospectively and any previous data will be collected retrospectively.. These subjects will continue to receive care from their current physicians according to standard medical practice and no attempt will be made to alter the types of follow-up, radiologic or other diagnostic studies or medical treatment as a result of enrollment in this study. All data will be de-identified and added to our already existing PDT treatment outcome databases for outcomes analysis, quality improvement and reporting of results in abstract and manuscript forms.