UAMS - Translational Research Institute

The purpose of this study is to describe contemporary, real-world patterns of patient characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in participants with newly diagnosed [ND] multiple myeloma (MM) and participants with relapsed/refractory [R/R] MM.

Type: Observational

Start Date: Jul 2016

open study

The Total Therapy treatment regimens developed at the Myeloma Institute have demonstrated great improvement in treatment outcomes for multiple myeloma patients. However, some patients still relapse early during maintenance treatment meaning that better options are still needed. This study will evaluate a treatment regimen that alternates two different 3-drug regimens every eight weeks for patients that have previously completed autologous stem cell transplant. The two regimens are bortezomib, lenalidomide, and dexamethasone (VRD) which will be alternated with Elotuzumab, lenalidomide, and dexamethasone (Elo RD). Effectiveness will be measured by the depth of response (i.e., whether or not minimal residual disease (MRD) negative status is achieved). The rate of MRD negativity from this study will be compared to historical control data from the Total Therapy 4 trial which used continuous VRD maintenance therapy after stem cell transplant(s).

Type: Interventional

Start Date: Oct 2017

open study

There have been four previous Total Therapy (TT1 through IIIB) studies for multiple myeloma at the MIRT from 1989 to present. Results have shown that participants treated on these studies had better outcomes (meaning they have lived longer and had better responses to treatment) when compared to individuals treated with standard chemotherapy. Past studies conducted at the MIRT and at other institutions have shown that participants with high-risk features by gene array studies tend to have shorter remissions (disappearance of signs and symptoms of myeloma) and do not survive as long as participants with low-risk myeloma. Researchers at MIRT think that one reason for this is that the myeloma cells re-grow in the time when participants are not receiving treatment because they are recovering from high-dose chemotherapy. In this study, participants will receive several chemotherapy drugs previously shown to be effective in myeloma, but in lower doses and in shorter cycles. It is hoped that by giving the drugs in this way, myeloma cells will not have time to re-grow between cycles, therefore resulting in longer remissions. This study is being done in an attempt to improve the remission rate and the survival time for participants with high-risk myeloma.

Type: Interventional

Start Date: Oct 2008

open study

Toward improving the therapeutic index of standard TT3 (S-TT3), the investigators will employ a randomized Phase III trial design to determine whether S-TT3 treatment-related toxicities can be reduced by 50% in TT3-Lite (L-TT3). Note: Randomization has been discontinued and accrual is closed to the L-TT3 arm. This trial is currently enrolling as a single-arm trial for patients to receive S-TT3.

Type: Interventional

Start Date: Jul 2008

open study

A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.

Type: Interventional

Start Date: Jun 2015

open study

This multicenter, open-label, Phase I study will evaluate the safety, efficacy, and pharmacokinetics of atezolizumab alone or in combination with daratumumab and/or various immunomodulatory agents in participants with MM who have relapsed or who have undergone autologous stem cell transplantation (ASCT). Cycle length will be 21 days in Cohorts A to C and 28 days in Cohorts D to F.

Type: Interventional

Start Date: Jul 2015

open study

The purpose of this study is to improve the clinical outcomes of research subjects with high-risk multiple myeloma in the context of the immediately preceding Total therapy 5 trial 2008-02 and Total therapy 3 trials 2003-33 and 2006-66.

Type: Interventional

Start Date: Aug 2014

open study

A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects Who Previously Received Talimogene Laherparepvec in Amgen or BioVEX-Sponsored Clinical Trials

Type: Observational [Patient Registry]

Start Date: Apr 2010

open study

One out of every five people experiences tinnitus (a ringing, buzzing, or roaring sound in the ear) ranging from mild to severe impairment. To date, there are no effective therapies available that have been shown to decrease tinnitus loudness. The purpose of this study is to develop a new treatment option for tinnitus using a technique called Repetitive Transcranial Magnetic Stimulation (rTMS), which will hopefully prove to be an effective means of alleviating or reducing the symptoms of tinnitus.

Type: Interventional

Start Date: Jan 2009

open study

The Fabry Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Fabry disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician. The objectives of the Registry are: - To enhance the understanding of the variability, progression, and natural history of Fabry disease, including heterozygous females with the disease; - To assist the Fabry medical community with the development of recommendations for monitoring patients and reports on patient outcomes to help optimize patient care; - To characterize and describe the Fabry population as a whole; and - To evaluate the long-term safety and effectiveness of Fabrazyme®

Type: Observational

Start Date: Jul 2001

open study

A Phase 2, open-label, dose escalation study to evaluate the safety and efficacy of venetoclax in combination with carfilzomib-dexamethasone (Kd) in participants with relapsed or refractory MM and have received 1 to 3 prior lines of therapy.

Type: Interventional

Start Date: Jan 2017

open study

This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells that remain after surgery and have fewer side effects.

Type: Interventional

Start Date: Feb 2018

open study

The purpose of this research study is to look at the effect of a treatment regimen called CACTUX on head and neck cancer. The CACTUX regimen is a combination of three drugs called cisplatin, nab-paclitaxel, and cetuximab (although carboplatin may be given in place of cisplatin if participants have previously had problems receiving cisplatin). The use of nab-paclitaxel in this combination is different from routine care, in which a drug called 5FU is often given instead, but the investigators group has conducted previous research where the investigators incorporated nab-paclitaxel into routine treatment with cisplatin, 5FU, and cetuximab. The investigators are looking at the incidence of side effects with the CACTUX regimen as well as response of the disease and health status.

Type: Interventional

Start Date: Feb 2015

open study

The study is performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care

Type: Interventional

Start Date: Jun 2017

open study

The primary objective of this study is to evaluate the toxicity profile of GRID therapy using dose levels of 10Gy, 15 Gy and 20Gy in pediatric osteosarcoma of the extremity.

Type: Interventional

Start Date: Jul 2017

open study

This is a 5-year, longitudinal, observational study of patients with PBC designed to specifically address important clinical questions that remain incompletely answered from registration trials. In addition to the study database, a bio specimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.

Type: Observational

Start Date: Oct 2016

open study

This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy in treating patients with node-positive breast cancer treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate whether radiation therapy is as effective as lymph node dissection.

Type: Interventional

Start Date: Feb 2014

open study

The purpose of this study is to determine the clinical efficacy of MV-NIS (measles virus-sodium iodide symporter) therapy for people with relapsed/refractory myeloma when given with cyclophosphamide

Type: Interventional

Start Date: Mar 2015

open study

This randomized phase II/III trial studies how well giving maintenance chemotherapy with or without stereotactic body radiation therapy works in treating patients with stage IV non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel, pemetrexed disodium, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving maintenance chemotherapy and stereotactic body radiation therapy together may work better than maintenance chemotherapy alone in treating patients with stage IV non-small cell lung cancer.

Type: Interventional

Start Date: Apr 2017

open study

The purpose of this study is to determine the safety profile and maximum tolerable dose (MTD) of single-agent GBR 1342 in subjects with multiple myeloma who have received prior therapies.

Type: Interventional

Start Date: Oct 2017

open study

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? (S1400). 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 a ?non-match? sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.

Type: Interventional

Start Date: Jun 2014

open study

This partially randomized clinical trial studies surgery or non-surgical management in treating patients with intra-abdominal cancer and bowel obstruction. Bowel obstruction is a common problem for advanced cancer patients and can negatively affect quality of life. It is not yet known whether surgery or non-surgical management is the best treatment option for bowel obstruction and can lead to better quality of life.

Type: Interventional

Start Date: Mar 2015

open study

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.

Type: Interventional

Start Date: Jul 2011

open study

This randomized phase III trial studies how well stereotactic body radiation therapy works compared to intensity-modulated radiation therapy in treating patients with stage IIA-B prostate cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Stereotactic body radiation therapy may work better in treating patients with prostate cancer.

Type: Interventional

Start Date: Nov 2017

open study

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer. PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.

Type: Interventional

Start Date: Apr 2013

open study