The GW Cancer Center is proud of its physician scientists and their commitment to medical research. These clinical studies are designed to add to the medical knowledge base and relate to the treatment, diagnosis, and prevention of diseases or conditions.

Clinical Program Title Description
Breast Cancer Program Combination immunotherapy with Herceptin and theHER2 vaccine E75 in low and intermediate HER2-expressing breast cancer patients to prevent recurrence

This is a randomized trial for after all neo or adjuvant therapy is complete for women are Her2 1+ or HER2 2+

Breast Cancer Program A Open-Label, Multicenter, Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination with Letrozole for The Treatment of men and Pre/Postmenopausal Women With Hormone Receptor-Positive (HR+) HER-Negative (HER2-) Advanced Breast Cancer (aBC) with No Prior Hormonal Therapy for Advanced Disease

The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer.

Breast Cancer Program Comparing Group Approaches to Improve Insomnia Symptoms Among Breast Cancer Survivors

We are inviting women diagnosed with stage I-III breast cancer who have completed active treatment (e.g. surgery, chemotherapy, radiation) to participate in this research study. Through this study we will examine if our mind and body programs improve some of the long term effects of breast cancer treatment such as insomnia. This is a pilot phase of the study. This means that we are interested in feasibility of the program and will ask for your feedback about things you like and do not like about the program.

Breast Cancer Program Combination immunotherapy with Herceptin and the HER2 vaccine E75 in low and intermediate HER2- expressing breast cancer patients to prevent recurrence

This is a randomized trial for after all neo or adjuvant therapy is complete for women are Her2 1+ or HER2 2+

Breast Cancer Program A Randomized Phase III Trial of Palbociclib with Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+)/ Human Epidermal Growth Factor Receptor 2 (HER2)-Negative early Breast Cancer (PALLAS Study)

The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer.

Malignant Hematology Program A Global, Prospective, Non-Interventional, Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Patients-the INSIGHT-MM study

The objective of this study is to describe contemporary, real-world patterns of patient characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in patients with newly diagnosed multiple myeloma and patients with relapsed/refractory multiple myeloma.

Malignant Hematology Program A Global, Prospective, Non-Interventional, Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Patients-the INSIGHT-MM study

The objective of this study is to describe contemporary, real-world patterns of patient characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in patients with newly diagnosed multiple myeloma and patients with relapsed/refractory multiple myeloma.

Neuro Oncology Program Malignant Brain Tumors

A Multicenter Study of 5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Malignant Tumor in Patients with Newly Diagnosed or Recurrent Malignant Gliomas: A Safety, Histopathology, and Correlative Biomarker Study This single arm trial is being conducted to establish the safety and efficacy of Gliolan-Æ (5-ALA) in patients undergoing resection of newly diagnosed or recurrent malignant gliomas. The rationale for the study is that Gliolan-Æ (5-ALA), as an adjunct to tumor resection, is safe and will provide surgeons with real-time visualization of malignant tumor.

Urological Oncology Program A Phase 3 Randomized Study Comparing Perioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)

This randomized phase III trial compares nephrectomy (surgery to remove a kidney or part of a kidney) with or without nivolumab in treating patients with kidney cancer that is limited to a certain part of the body (localized). Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving nivolumab before nephrectomy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed, and after nephrectomy to increase survival. It is not yet known whether nivolumab and nephrectomy is more effective than nephrectomy alone in treating patients with kidney cancer.