A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating with Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864, IND# 122782) in Patients with Intermediate Risk (IR) Rhabdomyosarcoma (RMS) Save

Date Added
April 17th, 2018
PRO Number
Pro00076211
Researcher
Jacqueline Kraveka

Silhouette
Keywords
Cancer, Cancer/Sarcoma, Pediatrics
Summary

This study is for patients that have been diagnosed with rhabdomyosarcoma (RMS). The investigational drug in this study is Temsirolimus. The purpose of this study is to find out if we can improve the treatment for subjects with intermediate risk RMS by adding temsirolimus to VAC/IV therapy. Participants can expect to be in this study for approximately 1 year and would like to continue to follow-up with the patient every year for about 10 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Reduced Pressure Reaming versus Standard Reaming for the Treatment of Impending Pathologic Femur Fractures Save

Date Added
January 16th, 2018
PRO Number
Pro00063851
Researcher
Lee Leddy

Silhouette
Keywords
Bone, Cancer, Cancer/Lymphoma, Cancer/Myeloma, Cancer/Other, Cancer/Sarcoma, Surgery
Summary

This study is for patients that have suffered a femur fracture due to metastatic cancer. The standard of care for this type of fracture is to stabilize the bone with an intramedullary nail. When preparing the femur for the nail, pressure can cause fat to enter the bloodstream and travel to the heart, causing heart and lung complications. The procedure being investigated in this study is called reduced pressure reaming. In this procedure the surgeon will use a device with suction when preparing the bone for the nail in order to decrease pressure and decrease the amount of fat that enters the bloodstream. Patients will be randomly assigned to either the standard preparation (standard reaming), or the reduced pressure preparation (reduced pressure reaming). After surgery, both treatment groups will followed according to standard practices at 2 weeks, 6 weeks, 3 months, and 6 months.

Institution
MUSC
Recruitment Contact
Robert McClam
843-792-7238
mcclamr@musc.edu

URCC 14040: A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral therapy for Treating Insomnia in Cancer Survivors Save

Date Added
March 15th, 2016
PRO Number
Pro00053106
Researcher
Jeffrey Giguere
Keywords
Cancer, Cancer/Brain, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Leukemia, Cancer/Lung, Cancer/Lymphoma, Cancer/Myeloma, Cancer/Other, Cancer/Sarcoma, Cancer/Skin, Education, Exercise, Sleep Disorders
Summary

This research study is for patients who have completed all scheduled surgery, chemotherapy and/or radiation therapy for their cancer within the last 6-12 months and are currently having some type of sleep disturbance. While there is no standard treatment for sleep disturbance for cancer survivors, people who do not take part in this study may take over-the-counter or prescription medications, receive cognitive behavioral therapy, or exercise as a means of attempting to manage their sleep problems.

Sleep disturbance, particularly insomnia, is a common problem for cancer survivors. Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty staying asleep, or waking up earlier than you would like. Insomnia can increase fatigue, impair physical function, impair immune function, cause circadian rhythms (known as your biological clock) to be disrupted and decrease quality of life.

Because there is no ideal standard of care for effectively treating sleep problems in cancer survivors, the purpose of this study is to compare the effectiveness of three different treatments for improving sleep problems and determine which is best. The three treatments are yoga, survivorship health education, and cognitive behavioral therapy (CBT-I).

Study participation will be approximately 8 months.

Institution
Greenville
Recruitment Contact
Gina Norris
864-242-2762
gnorris@ghs.org

Incisional negative pressure wound therapy for preoperatively irradiated lower extremity soft tissue sarcoma wounds. A prospective randomized clinical trial. Save

Date Added
August 18th, 2015
PRO Number
Pro00028423
Researcher
Lee Leddy

Silhouette
Keywords
Cancer, Cancer/Sarcoma, Infectious Diseases
Summary

This is a study comparing two methods of dressing a post operative wound that are currently in practice. One method is a traditional dry gauze dressing. The other method is using a negative pressure dressing that provides gentle suction on the wound.

We will attempt to determine how well the use of post-operative negative pressure dressing reduces wound healing problems in patients who have surgery after radiation for a sarcoma in the thigh or leg.

Institution
MUSC
Recruitment Contact
Jennifer Philp
843 8462210
Philp, Jennifer (philpj@musc.edu)

Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI) Save

Date Added
May 20th, 2014
PRO Number
Pro00034264
Researcher
Steven Carroll

Silhouette
Keywords
Cancer, Cancer/Sarcoma
Summary

This study is for adult males and females who are being treated for cancer. This study inovlves collecting samples and saving them for future research.

Institution
MUSC
Recruitment Contact
Scott Landreth
843-792-6429
landrets@musc.edu

A Randomized, Open-label, Phase II, Multi-center Trial of Gemcitabine (G) with Pazopanib (P) or Gemcitabine (G) with Docetaxel (T) in Previously Treated Subjects with Advanced Soft Tissue Sarcoma. Save

Date Added
March 13th, 2012
PRO Number
Pro00015882
Researcher
Daniel Reuben

Silhouette
Keywords
Cancer, Cancer/Sarcoma
Summary

The purpose of this study is to test the effectiveness and safety of Gemcitabine and Pazopanib compared with Gemcitabine and Docetaxel in participants with soft tissue sarcoma. Screening tests will be done to ensure subjects are eligible to participate in this study. If the exams, tests and procedures show that subjects can be in the study, and they choose to take part, then they will be "randomized" into one of the two study groups: Group 1 or Group 2. Subjects in Group 1 will receive Gemcitabine 1000 mg/m2 intravenously (directly into a vein) on Day 1 and Day 8 and Pazopanib 800mg by mouth daily. Subjects in Group 2 will receive Gemcitabine 900 mg/m2 intravenouslyon Day 1 and Day 8 and Docetaxel 100 mg/m2 intravenously on Day 8. Both groups will be in 21 day cycles. Both groups will be asked to complete 2 "quality of life" questionnaires, on their first visit, then at 6 weeks (2nd cycle), 18 weeks (6th cycle) and at the end of study treatment. Subjects will be followed for up to 2 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

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