A Phase II Study of Sodium Cridanimod in Conjunction With Progestin Therapy in Patients With Progesterone Receptor Negative Recurrent or Persistent Endometrial Carcinoma
This is an open label, multi-center, single arm phase II study. The study will investigate
the efficacy of sodium cridanimod in conjunction with progestin therapy in a population of
patients with recurrent or persistent PrR-negative endometrial cancer.
Eligible patients will be enrolled into the study and administered sodium cridanimod in
combination progestin therapy. Objective responses will be assessed at 12 week intervals.
Patients will be treated for a 12 month period, followed by an additional 12 month follow up
period or to disease progression whichever occurs first.
Important objectives of the study are to investigate the effect of sodium cridanimod in
conjunction with progestin therapy on the level of PrR in tumor tissue and how this
correlates to efficacy. To accomplish this objective, some of the patients enrolled in the
study will undergo two tumor biopsies that will allow measurement of PrR levels in the tumor
tissue before the treatment and after 4 weeks of therapy.
A Phase III Randomized Trial of Adding Vincristine-Topotecan-Cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-Metastatic Ewing Sarcoma
OBJECTIVES:
Primary
- Compare the event-free and overall survival of patients with newly diagnosed localized
Ewing's sarcoma treated with doxorubicin hydrochloride, cyclophosphamide, vincristine,
etoposide, and ifosfamide with vs without topotecan hydrochloride.
- Compare the side effects of these regimens in these patients.
Secondary
- Evaluate initial tumor size as a prognostic factor for event-free survival of these
patients.
- Evaluate histological response as a prognostic factor for event-free survival of these
patients.
- Continue evaluation of biologic markers both as related to prognosis and as eventual
therapeutic targets via encouraging concurrent enrollment on COG-AEWS02B1.
- Evaluate radiologic response by positron emission tomography as a prognostic factor for
event-free survival.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
(≤ 17 vs ≥ 18 years of age) and primary tumor site (pelvic vs nonpelvic [including
extra-osseous Ewing's sarcoma]). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive vincristine IV over 1 minute once a week on day 1 in weeks 1-3,
7-9, and 13-15; doxorubicin hydrochloride IV over 15 minutes on days 1 and 2 in weeks
1, 7, and 13; cyclophosphamide IV over 1 hour on day 1 in weeks 1, 7, and 13; and
ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 in weeks 4, 10, and
16. Patients undergo local therapy comprising surgical resection in approximately week
18 and/or radiotherapy beginning in approximately week 19. Patients then receive
vincristine as above in weeks 19-21, 28-30, 34-36, 40-42, and 46-51; dexrazoxane
hydrochloride IV over 15 minutes on days 1 and 2 and doxorubicin hydrochloride as above
in weeks 19 and 28; cyclophosphamide as above in weeks 19, 28, 34, 40, 46, and 49; and
ifosfamide and etoposide as above in weeks 22, 25, 31, 37, and 43.
- Arm II: Patients receive vincristine IV over 1 minute once a week on day 1 in weeks
1-3, 7-9, and 13-16; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1
and 13; cyclophosphamide IV over 30 minutes on days 1-5 in weeks 1 and 13 and IV over 1
hour on day 1 in weeks 7 and 16; ifosfamide IV over 1 hour and etoposide IV over 1 hour
on days 1-5 in weeks 4 and 10; and doxorubicin hydrochloride IV over 15 minutes on days
1 and 2 in weeks 7 and 16. Patients undergo local therapy comprising surgical resection
in approximately week 18 and/or radiotherapy beginning in approximately week 19.
Patients then receive vincristine as above in weeks 19-21, 28-33, 37-42, and 46-48;
topotecan hydrochloride as above in weeks 19, 31, and 40; cyclophosphamide IV over 30
minutes in weeks 19, 31, and 40 and IV over 1 hour in weeks 28, 37, and 46; ifosfamide
and etoposide as above in weeks 22, 25, 34, 43, and 49; dexrazoxane hydrochloride IV
over 15 minutes on days 1 and 2 in weeks 37 and 46; and doxorubicin hydrochloride as
above in weeks 28, 37, and 46.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 528 patients will be accrued for this study.
Join a USC Study on Vaping and E-Cigarette Use for Cigarette Smokers
The number of people who vape and use e-cigarettes has been increasing, particularly among young adults. We want to examine how factors associated with vaping and e-cigarette use, such as flavoring and nicotine level, effect people's thoughts, feelings, and behaviors.
ENRICH: A Multi-center, Randomized, Clinical Trial Comparing Standard Medical Management to Early Surgical Hematoma Evacuation Using Minimally Invasive Parafascicular Surgery (MIPS) in the Treatment of Intracerebral Hemorrhage (ICH).
The ENRICH trial will compare the outcomes between early surgical intervention using the
BrainPath® Approach (i.e., MIPS) and a medically managed cohort. The integrated surgical
approach includes a combination of available technologies, including the FDA-cleared NICO
BrainPath® for non-disruptive access and NICO Myriad® to achieve the goal of maximum clot
evacuation. The medically managed cohort will be treated according the Clinical
Standardization Guidelines (CSG) as adapted by Emory University from the 2015 AHA/ASA
Guidelines for the Management of Spontaneous Intracerebral Hemorrhage. Clinical efficacy
will be determined by demonstrating a 10% improvement in functional outcome, as determined
by a blinded-assessment of the 180-day utility-weighted modified Rankin Scale (mRS).
Data suggests improved mortality rates and potential functional benefits of surgical ICH
evacuation. The methodology proposed for this trial was tested in a preliminary series of 39
patients treated for supratentorial spontaneous ICH and retrospectively reviewed (Labib et
al.). These results were replicated in a single center retrospective series of 18 patients
(Bauer et al.). Despite positive results of both studies and the widely accepted benefit of
the BrainPath Approach (i.e., MIPS) for subcortical lesions, stronger evidence supporting
the use of these techniques in ICH is needed for the technique to become universally
validated.
Recruiting | Subcortical Intracerebral Hemorrhage | Site Unknown
ST Monitoring to Detect ACS Events in ICD Patients
This is a prospective, non-randomized, multicenter, pivotal IDE study. The intent of this
study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in the
Fortify® ST, Fortify Assura® ST, and Ellipse® ST family of devices, as well as any future St
Jude Medical devices with the same ST Monitoring Feature capabilities. Effectiveness of the
device will be evaluated by analyzing the sensitivity of the ST Monitoring Feature to detect
clinical events. In addition, safety of the ST Monitoring Feature will be evaluated by
demonstrating a low percentage of patients with false positive events.
Active, not recruiting | Atherosclerosis | Multisite
A Mobile Mindfulness App for U.S. Veterans: Mind Guide (Beta-Test Phase)
The purpose of this study is to examine how mobile apps that focus on mindfulness techniques and stress reduction skills can help post-9/11 veterans. Several stand-alone apps for phones have been developed, but they have yet to be tested to see if they are helpful for veterans who may living with stress or may be drinking alcohol at levels higher than they would like.
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