Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Carcinoma

Cholangiocarcinoma

Urinary Bladder Neoplasms

Disease Progression

Gallbladder Neoplasms

Bile Duct Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Gallbladder Diseases

Bile Duct Diseases

Bile Duct Cancer

Gallbladder Cancer

Intrahepatic Cholangiocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Gemcitabine

Oxaliplatin

Leucovorin

Fluorouracil

Levoleucovorin

Cisplatin

Immunomodulating Agents

Durvalumab

Folic Acid

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Immunological

Folinic Acid

Folate

Vitamin B9

LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given

LSTA1

1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles

cisplatin 25 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles

gemcitabine 1000 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles

The following will be given every 14 days:

* oxaliplatin 85 mg/m² and l-folinic acid 175 mg or d,l-folinic acid 350 mg concurrently, as a 2-hour IV infusion
* fluorouracil (5-FU) 400 mg/m² will be given as an IV bolus over 5 minutes
* fluorouracil (5-FU) 2400 mg/m² will be administered over 46 hours (via home-infusion pump)

FOLFOX regimen

Placebo given as a slow IV push over 1 minute when standard treatment(s) are given

Placebo

Kathryn Shantz

Madappa Kundranda, MD, PhD

Clinical Trials Referral Office

Bassam Sonbol, MD

Prisca Zimmerman

Rachna Shroff, MD

Linda Gozar

David Park, MD

Taylor Atkinson

Richard Kim, MD

Shannon Bradbury

Anup Kasi, MD, MPH

Sarah Howard

Susanne Arnold, MD

Michael Driscoll, MD

Nguyen Tran, MD

Jenna Battaglia

Anna Levy, DO

Sumbul Yousafi

Roger Keresztes, MD

Demetria Jacks, MD

Lindsey Ferry

Charles Kuzma, MD

Abby Reed, RN

Alexander Starodub, MD, PhD

Kristen Ford

Vikas Dembla, MD

VUMC Patient Recruitment Office

Thatcher Heumann, MD

Ellen Siglinsky

David Hsieh, MD

Ian Hu, MD, PhD

Stephanie Van Bebber

Raymond Wadlow, MD

Kristen K Buck, MD

The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in patients with previously untreated cholangiocarcinoma or those that have progressed after first-line treatment for cholangiocarcinoma.

The main questions it aims to answer are:

* is the new drug plus standard treatment safe and tolerable
* is the new drug plus standard treatment more effective than standard treatment

This is a Phase 2a, double-blind, placebo-controlled, multi-center, randomized study of LSTA1 when added to standard of care (SoC) versus SoC alone in patients with advanced solid tumors. The study will include patients with previously untreated cholangiocarcinoma or those that have progressed after first-line treatment for cholangiocarcinoma.

The study will consist of a screening period, a run-in period, a treatment period, an end-of-treatment follow-up visit, and a long-term follow up period.

Participants who provide informed consent will be screened for eligibility within 28 days prior to beginning the study treatment run-in period. Once eligibility is confirmed, participants will be randomized to one of the two treatment groups (SoC + placebo vs. SoC + LSTA1).

During the 3-day run-in period, participants will only receive the LSTA1 or placebo components of their randomized treatment regimen. After the 3-day run-in, Cycle 1 of treatment will commence. Tumor scans will be performed every 8 weeks (56 days ± 7 days) while on treatment.

A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors

A Phase 2a, Double-blind, Placebo-controlled, Multi-center, Randomized Study Evaluating LSTA1 When Added to Standard of Care (SoC) Versus Standard of Care Alone in Subjects With Advanced Solid Tumors (BOLSTER)

The National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE) will be used to grade the intensity of adverse events throughout the study

Lisata Therapeutics, Inc.

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Myotonic Dystrophy Type 1

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

Ado-Trastuzumab Emtansine

Trastuzumab

Capecitabine

Adenosine

Tubulin Modulators

Antimitotic Agents

Immunotoxins

Immunoconjugates

T-DM1/ trastuzumab emtansine infusion along with radiation to the breast or chest wall and lymph nodes

T-DM1/trastuzumab emtansine infusion along with radiation to the whole breast or chest wall

oral capecitabine twice per day along with radiation to the breast or chest wall and lymph nodes

oral capecitabine twice per day along with radiation to the whole breast or chest wall

Dosed at 3.6 mg/kg of body weight every 3 weeks for Her2/neu+ patients for a total duration of 14 cycles.

T-DM1

Dosed at 825 mg/m2 +/- 150mg twice per day for a total duration of 6 months

Dose of 40 Gy in 15 fractions to the whole breast or chest wall followed by consideration of a 10 Gy in 4 fraction boost to the lumpectomy cavity for a total duration of 15-19 days. Internal mammary nodal, dissected axilla coverage, and boost will be at the radiation oncologist's discretion.

External Beam Radiation Therapy 0

Dose of 40 Gy in 15 fractions to either the breast or chest wall along with comprehensive nodal radiation followed by consideration of a 10 Gy in 4 fraction boost for a total duration of 15-19 days. Internal mammary nodal, dissected axilla coverage, and boost will be at the radiation oncologist's discretion.

External Beam Radiation Therapy 1

Song Wood

Einsley Janowski, Md, PhD

Einsley Janowski, MD, PhD

The goal of this study is to evaluate the safety and effectiveness of adjuvant chemoradiation therapy in high-risk breast cancer patients who had received neoadjuvant chemotherapy before their lumpectomy and/or mastectomy and were found to have residual disease. As well as examine the effects of this treatment combination on the immune system.

Breast cancer is often treated with a combination of surgery, chemotherapy and radiation. In patients with advanced breast cancer, (neoadjuvant) chemotherapy is often given prior to surgical removal (lumpectomy and/or mastectomy). Neoadjuvant chemotherapy has been consistently shown to down-stage primary breast tumors and convert positive underarm lymph nodes to pathologically negative nodes. Residual disease discovered after receiving neoadjuvant chemotherapy indicates an increased risk for recurrence and poor overall survival. The combination of concurrent chemotherapy and radiation after surgery (adjuvant chemoradiation) may improve local and distant recurrence outcomes in high risk breast cancer patients. Chemoradiation is a standard treatment for many cancers and is universally associated with improvements in local recurrence, however, it has not historically been given as post-surgery breast cancer treatment.

The study will evaluate the safety, feasibility, and effectiveness of chemoradiation therapy in high-risk breast cancer patients. Radiation has been associated with various effects on immune cells. The study will also examine the effects of this combination on the immune cells.

Participants on this trial will be treated (per approved clinical guidelines) with capecitabine or Trastuzumab emtansine (T-DM1) depending on Her2 status while receiving radiation at the same time. Participants will have their blood drawn at various timepoints during treatment and follow up. Participants will also be asked to complete surveys asking about overall health and wellbeing.

Non-randomized assignment based on Her2/neu status and lymph node involvement

Participants, clinical research staff, and treating clinicians will be aware of arm assignment. The labels on research blood will not include the treatment arm on which the participant is assigned and this information will not be provided to lab investigators and staff.

Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer

A Study of Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer

Recurrence-free survival after 1 year of adjuvant chemoradiation therapy.

Lab analysis (CBC w/ Differential and ELISA assays) of blood to characterize and count leukocyte populations (neutrophils, monocytes, lymphocytes) throughout adjuvant chemoradiation treatment and follow up.

RAND SF-36 survey assesses feelings on overall health and activity level during follow up after adjuvant chemoradiation treatment.

Functional Assessment of Cancer Therapy- Breast (FACT-B) survey generally assess physical wellbeing, Social wellbeing, emotional wellbeing and functional well being during follow up after adjuvant chemoradiation treatment.

Assessment of toxicity frequency and severity using CTCAE v5.0 adverse event grading scale throughout chemoradiation treatment and follow up.

Percent of participants completing adjuvant chemoradiation therapy and percent of participants requiring radiation or chemotherapy dose delays.

Assessment of chronic radiation-related cosmetic outcomes (e.g. dermatitis, telangiectasia, pigmentation, and radiation fibrosis) using "Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA)" scale throughout chemoradiation treatment and follow up. Each side effect is graded on a scale of 0 to 4, with higher scores meaning more severe outcome.

Assessment of overall acute radiation related skin changes using the "Toxicity Criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC)" grading scale throughout chemoradiation treatment and follow up. Each side effect is graded on a scale of 0 to 4, with higher scores meaning more severe outcome.

Measurement of breast tissue size by measuring tape/ruler.

University of Virginia

Assistant Professor

Heart and Blood Diseases

Thrombosis

Venous Thrombosis

Thromboembolism

Venous Thromboembolism

Embolism

Embolism and Thrombosis

Vascular Diseases

Lipid Regulating Agents

Bone Density Conservation Agents

Rosuvastatin Calcium

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Calcium

Calcium, Dietary

Anticholesteremic Agents

Hypolipidemic Agents

Enzyme Inhibitors

This arm will receive rosuvastatin during the first treatment period followed by placebo in the second treatment period after washout.

This arm will receive placebo during the first treatment period followed by rosuvastatin in the second treatment period after washout.

Rosuvastatin

Steven Ades, MD, MSc

Patients with cancer have a high risk of developing venous blood clots or thromboembolism (VTE). In an effort to target patients at highest risk of VTE for thromboprophylaxis (protective treatment for blood clots), numerous studies have identified serum biomarkers for risk of future VTE. There is also increasing evidence pointing to a prophylactic effect of statin therapy on the risk of developing VTE in high-risk populations including patients with advanced cancer. The purpose of this research study is to find out whether treatment with rosuvastatin (the study drug) reduces the risk of VTE in patients with cancer receiving chemotherapy. This study is specifically investigating the impact of rosuvastatin therapy on serum biomarkers (D-dimer and others) that indicate a risk for VTE, as well as safety and tolerance of rosuvastatin therapy in this population.

This is a phase II randomized crossover study with two 3-4 week treatment periods during which all enrolled patients will receive 20 mg of rosuvastatin once a day by mouth or a matching placebo tablet. Approximately two tablespoons of blood will be collected for biomarker analysis at the beginning and end of each treatment period. After the first treatment period there will be a 3-5 week break where subjects will undergo a washout. Following this washout period every subject will "crossover" or begin taking the alternative therapy so everyone enrolled will receive the study drug either during the first or the second treatment period. Biomarker levels will be analyzed in both treatment periods and compared to baseline, with every patient acting as their own control.

Detecting the Impact of Statin Therapy On Lowering Risk of Venous Thrombo-Embolic Events (DISOLVE)

Impact of Rosuvastatin on Risk Markers of Venous Thromboembolism During Systemic Therapy for Advanced Cancer

University of Vermont

Assistant Professor of Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors	NCT05712356	Cholangiocarcin... Gallbladder Can... Gallbladder Car... Intrahepatic Ch... Extrahepatic Ch... Bile Duct Cance... Gall Bladder Ca... Gall Bladder Ca...	LSTA1 Durvalumab Cisplatin Gemcitabine FOLFOX regimen Placebo	18 Years -	Lisata Therapeutics, Inc.
Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer	NCT05288777	Breast Cancer Breast Cancer S... Breast Cancer S... Breast Cancer S...	T-DM1 Capecitabine External Beam R... External Beam R...	18 Years -	University of Virginia
Detecting the Impact of Statin Therapy On Lowering Risk of Venous Thrombo-Embolic Events (DISOLVE)	NCT01524653	Venous Thromboe... Deep Vein Throm... Neoplasms	Rosuvastatin Placebo	18 Years -	University of Vermont

Spots Global Cancer Trial Database for chemo

Every month we try and update this database with for chemo cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for chemo

Every month we try and update this database with for chemo cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for chemo cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.