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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



Study of INCB053914 in Subjects With Advanced Malignancies

This is an open-label, dose-escalation study of the proviral integration site of Moloney murine leukemia virus (PIM) kinase inhibitor INCB053914 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (monotherapy dose escalation) will evaluate safety and determine the maximum tolerated dose of INCB053914 monotherapy and the recommended phase 2 dose(s) (a tolerated pharmacologically active dose that will be taken forward into the remaining parts of the study). Part 2 (monotherapy dose expansion) will further evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of the recommended Phase 2 dose(s). Part 3 (combination dose finding) will evaluate safety of INCB053914 in combination with select standard of care (SOC) agents and will identify the optimal INCB053914 dose in combination with conventional SOC regimens to take forward into Part 4. Part 4 (combination dose expansion) will further evaluate the safety, efficacy and pharmacokinetics of the recommended Phase 2 dose combination(s).
Not Available
I/II
Savona, Michael
NCT02587598
VICCHEM1592

Methoxyamine, Cisplatin, and Pemetrexed Disodium in Treating Patients with Advanced Solid Tumors or Mesothelioma That Cannot Be Removed by Surgery or Mesothelioma That Is Refractory to Pemetrexed Disodium and Cisplatin or Carboplatin

Multiple Cancer Types

This phase I / II trial studies the side effects and the best dose of methoxyamine when given together with cisplatin and pemetrexed disodium and to see how well it works in treating patients with solid tumors or mesothelioma that have spread to other places in the body and usually cannot be cured or controlled with standard treatment (advanced), or mesothelioma that does not respond to pemetrexed disodium and cisplatin or carboplatin (refractory). Methoxyamine may shrink the tumor and may also help cisplatin and pemetrexed disodium work better by making tumor cells more sensitive to the drugs. Drugs used in chemotherapy, such as cisplatin and pemetrexed disodium, 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. Giving methoxyamine together with cisplatin and pemetrexed disodium may be a better treatment for solid tumors or mesothelioma than methoxyamine and pemetrexed disodium.
Endocrine, Lung, Non Small Cell, Ovarian, Phase I
I/II
Horn, Leora
NCT02535312
VICCTHO1722

Iodine I-131 with or without Selumetinib in Treating Patients with Recurrent or Metastatic Thyroid Cancer

This randomized phase II trial studies how well iodine I-131 works with or without selumetinib in treating patients with thyroid cancer that has returned or has spread from where it started to other places in the body. Many thyroid cancers absorb iodine. Due to this, doctors often give radioactive iodine (iodine I-131) alone to treat thyroid cancer as part of standard practice. It is thought that the more thyroid tumors are able to absorb radioactive iodine, the more likely it is that the radioactive iodine will cause those tumors to shrink. Selumetinib may help radioactive iodine work better in patients whose tumors still absorb radioactive iodine. It is not yet known whether iodine I-131 is more effective with or without selumetinib in treating thyroid cancer.
Not Available
II
Gilbert, Jill
NCT02393690
VICCHN1817

Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients with Prostate Cancer

Prostate

This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer. 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.
Prostate
III
Shinohara, Eric
NCT01368588
NRGUROR0924

Active Surveillance, Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Pediatric and Adult Patients with Germ Cell Tumors

Multiple Cancer Types

This phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, 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.
Germ Cell (Pediatrics), Gynecologic, Ovarian
III
Borinstein, Scott
NCT03067181
COGAGCT1531

Olaparib in Treating Participants with Metastatic or Unresectable Urothelial Cancer with DNA Damage Response Gene Alterations

This phase II trial studies how well olaparib works in treating participants with urothelial cancer with deoxyribonucleic acid (DNA) damage response gene alterations that has spread to other places in the body or cannot be removed by surgery. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Not Available
II
Davis, Nancy
NCT03448718
VICCURO1856

Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1 / PD-L1 Containing Therapy.

Multiple Cancer Types

This is an open-label, multi-centre, umbrella Phase II study in patients with metastatic NSCLC who have progressed on an anti-PD-1 / PD-L1 containing therapy. This study is modular in design, allowing initial assessment of the efficacy, safety, and tolerability of multiple treatment arms.
Lung, Non Small Cell
II
Horn, Leora
NCT03334617
VICCTHO1810

An Investigational Immuno-therapy Study of Nivolumab or Placebo in Patients With Resected Esophageal or Gastroesophageal Junction Cancer

Multiple Cancer Types

The purpose of this study is to determine whether Nivolumab will improve overall survival, disease-free survival, or both compared with placebo.
Esophageal, Gastric/Gastroesophageal
III
Goff, Laura
NCT02743494
VICCGI1655

Combination Chemotherapy with or without Temsirolimus in Treating Patients with Intermediate Risk Rhabdomyosarcoma

This randomized phase III trial studies how well combination chemotherapy (vincristine sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan hydrochloride or vinorelbine) works compared to combination chemotherapy plus temsirolimus in treating patients with rhabdomyosarcoma (cancer that forms in the soft tissues, such as muscle), and has an intermediate chance of coming back after treatment (intermediate risk). Drugs used in chemotherapy 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. Combination chemotherapy and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy or combination chemotherapy plus temsirolimus is more effective in treating patients with intermediate-risk rhabdomyosarcoma.
Not Available
III
Borinstein, Scott
NCT02567435
COGARST1431

DS-3201b for Acute Myelogenous Leukemia (AML) or Acute Lymphocytic Leukemia (ALL)

This research study tests an investigational drug called DS-3201b. An investigational drug is a medication that is still being studied and has not yet been approved by the United States Food and Drug Administration (FDA). The FDA allows DS-3201b to be used only in research. It is not known if DS-3201b will work or not. This study consists of two parts. The first part (Part 1) is a dose escalation that will enroll subjects with AML or ALL that did not respond or no longer respond to previous standard therapy. The purpose of Part 1 of this research study is to determine the highest dose a patient can tolerate or recommended dose of DS-3201b that can be given to subjects with AML or ALL. Once the highest tolerable dose is determined, additional subjects will be enrolled at that dose into Part 2 of the study.
Not Available
I
Oluwole, Olalekan
NCT03110354
VICCHEM1765

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