Cancer Clinical Trials in Atlanta, GA

This is a pilot study of biomarker evaluation and safety of pre-incisional ketorolac for patients undergoing surgical resection for non-small cell lung cancer and renal cell carcinoma. There is significant promise in the use of preoperative ketorolac to decrease the inflammatory response after surgical resection of tumors, thereby potentially reducing the risk of distant metastatic tumor spread and improving survival. A total of 56 patients (28 per disease site) will be enrolled into the experimental arm and will receive ketorolac prior to surgery. About 10 patients will be allocated randomly into a control group, for each disease site, for a total of 76 patients enrolled. The research will advance scientific knowledge by studying the safety of a preoperative dose of ketorolac prior to major surgical resection, which needs to be assessed prior to proceeding with a larger phase II study designed to evaluate traditional efficacy endpoints such as recurrence and overall survival. Read Less

This prospective cluster-randomized trial examines the efficacy of a novel communication intervention delivered by trained physician and nurse dyads to parents of children with cancer within the clinicians' practice, to foster alignment of the goals of treatment. The investigators hypothesize that goal alignment will improve quality of life outcomes, in particular for those patients who reach end of life. Findings from the proposed research will provide essential information to promote communication practice standards that can be rapidly translated into practice to improve outcomes for children, particularly those who reach end of life, and parents. Read Less

Pediatric cancer survivors are at an increased risk of excessive weight gain and reduced exercise behaviors with the potential for this risk to worsen over time. With over 80% of pediatric cancer patients living to adulthood, many pediatric cancer survivors experience long-term health consequences such as heart disease - the leading cause of death in this population. The purpose of this clinical research study is to teach parents/caregivers skills that will help prevent and reduce the problems of obesity in childhood cancer survivors. In this study, parents have the opportunity to participate in one of two web-based groups in which parents in either group will learn valuable information to improve the health of their child and of themselves. Read Less

This is a Phase 1, open-label, 2-part, multi-center study evaluating the safety, tolerability, PK, pharmacodynamics (PD), immunogenicity, and antitumor activity of CUE-102 intravenous (IV) monotherapy in HLA-A*0201 positive patients with WT1 positive recurrent/metastatic solid tumors who have failed conventional therapies. Read Less

The Childhood Cancer Predisposition Study (CCPS) is a multi-center, longitudinal, observational study that will collect clinical and biological data and specimens from children with a cancer predisposition syndromes (CPS) and their relatives. The central hypothesis is that studying individuals at high risk for childhood cancer creates a unique opportunity for improving the understanding of carcinogenesis, tumor surveillance, early detection, and cancer prevention, which will collectively contribute to improving care and outcomes for pediatric patients with cancer and those with cancer predisposition syndromes (CPS). Read Less

This is a phase I, clinical research study of EPI-7386, an investigational drug being studied as a treatment for patients with prostate cancer. All patients in the study will receive EPI-7386. Since this is the first study of EPI-7386 in humans, there is no information about how it affects people or what dose should be used. Therefore, the main purpose of this study is to assess the safety (side effects) of EPI-7386 and to find a dose that can be given without unacceptable side effects. There are other important things that will be evaluated during the study: How the amount of EPI-7386 in the blood changes over time. The effect of EPI-7386 on prostate cancer. The effect of EPI-7386 on certain substances in the body. The possibility that EPI-7386 can interact with other drugs. The study will be conducted in 2 parts: Part A: To evaluate the safety and tolerability of EPI-7386 as a single agent via 2 Phases: Phase 1a: Dose Escalation (mCRPC) Phase 1b: Dose Expansion (mCRPC) Part B: To evaluate 2 parallel enrolling cohorts (Cohort 1 and Cohort 2) of EPI-7386 in combination of apalutamide acetate + prednisone (AAP) or apalutamide (APA): Cohort 1: Combination with AAP in mHSPC or mCRPC patients Cohort 2: Will evaluate the anti-tumor activity of EPI-7386 for a limited window of time (12 weeks EPI-7386 monotherapy prior to the start of combination therapy with APA) in nmCRPC patients unperturbed by previous 2nd generation anti-androgen therapies or chemotheraphy. Read Less

A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 vs Physician's Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma in Patients Who Have Failed or Progressed On or After at Least Two Lines of Therapy Read Less

Primary Objective: The primary objective of the study is to evaluate the safety of repeat administration of a dose level of Ad/PNP plus fludarabine phosphate (F-araAMP) which demonstrated anti-tumor activity in patients with advanced head and neck cancer in a completed phase I study. Secondary Objective: The secondary objective is to evaluate the antitumor activity of repeat administration of Ad/PNP plus F-araAMP. FDA Office of Orphan Drugs Division is a source of funding for the overall project. Read Less

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes non-match sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies. Read Less

This phase I trial tests the safety and effectiveness of vudalimab (XmAb20717) in combination with standard of care treatment abiraterone, enzalutamide, or abiraterone plus docetaxel in treating patients with castration sensitive prostate cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as vudalimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding vudalimab to standard of care treatments may be effective in treating metastatic castration sensitive prostate cancer. Read Less

This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading. Read Less

This phase II trial tests whether vidutolimod with nivolumab works to destroy tumor cells in patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Nivolumab is an antibody working by attaching to and blocking a molecule called PD 1. PD 1 is a protein that is present on different types of cells in the immune system and controls parts of the immune system by shutting it down. Antibodies (proteins in the immune system which act to stop infection harming the body) that block PD 1 can potentially prevent PD 1 from shutting down the immune system, thus allowing immune cells to recognize and destroy cancer cells. Vidutolimod (CMP-001) is a Toll-like receptor 9 (TLR9) agonist, with the ability to generate tumor-targeted T cells capable of killing a tumor both locally and systemically in combination with checkpoint inhibitors (nivolumab, in this case), thus potentially improving outcomes for people whose tumors are progressing. Giving nivolumab and vidutolimod may kill more cancer cells in patients with metastatic prostate cancer. Read Less