The main purpose of this study is to compare the effects of one of two different dose levels of an investigational drug called GC4419 when given with the standard radiation therapy and chemotherapy for the treatment of head and neck cancers. This study drug is not yet approved by the FDA. The study will be looking at the effect that the drug GC4419 will have on mucositis, which is a side effect of the chemotherapy and radiation therapy for the treatment of head and neck cancers.
The study is for patients 70 years and older who are newly diagnosed with suspected ovarian, fallopian tube, primary peritoneal carcinomas or advanced stage papillary serous uterine carcinoma. Using a brief modified version of the Comprehensive Geriatric Assessment Survey (CGAS) at the pre-operative stage and some blood work, Gynecologic Oncologists would derive a score from a predictive model and follow these patients prospectively through non randomized treatment (both surgery and chemotherapy).
The purpose of this study is to determine the maximum tolerated dose of RX-0201, up to a target dose of 250 mg/m^2/day, when given in combination with everolimus (Stage 1), and to assess the safety and efficacy of RX-0201 plus everolimus, in subjects with metastatic renal cell cancer (Stage 2).
The “investigational drug” AZD1775 is being combined with standard chemotherapy in subjects with TP53-mutated, advanced ovarian, fallopian tube or peritoneum cancer that no longer responds to platinum therapy. AZD1775 is also being studied in lung cancer and ovarian cancer and other solid tumors. Some ovarian cancer patients have experienced tumor shrinkage while receiving AZD1775 plus chemotherapy.
The purpose of this study screening step is to perform tests on genes and proteins produced by genes in your tumor sample for certain features that investigational targeted agents used in this study are specifically designed to work against. Then the purpose is to assign you to a treatment sub-study that is chosen based on the results (genes and proteins called “biomarkers”) of this genetic testing on your tumor sample. These study related “research tests” will be done in a special lab.
The purpose of this screening step is to perform a genetic test on your colorectal cancer tumor sample to see if it has a specific genetic mutation called BRAF. BRAF is a human gene that makes a protein called B-raf. This protein is involved in sending signals to the cells which direct cell growth. BRAF tumor testing is common for this type of cancer. The performance of the test is not part of the research question in this study. If your tissue has a BRAF mutation, you will be eligible to participate in the next part of the study.
1.1.1 To compare EFS in patients with newly diagnosed T-ALL and T-LLy who are randomized to a modified ABFM backbone versus bortezomib plus the modified ABFM backbone.
1.2 Secondary Aims
1.2.1 To determine the safety and feasibility of modifying standard therapy for T-ALL and T-LLy based on the results of UKALL 2003, which includes a dexamethasone-based Induction, additional doses of pegaspargase (PEG-ASP) during Induction and Delayed Intensification (DI), and dexamethasone pulses during Maintenance therapy
The purpose of this study is to compare the effects, good and/or bad, of temozolomide versus temozolomide plus capecitabine on the subjects and the subjects’advanced pancreatic neuroendocrine tumor cancer to find out which is better. In this study, subjects will get either temozolomide alone or temozolomide and capecitabine. Temozolomide and capecitabine are chemotherapy drugs, which have benefited some patients with pancreatic neuroendocrine tumors yet they have never been compared; both arms are considered investigational.