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
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)

Vitamin D3 Supplementation for Low-Risk Prostate Cancer, A Randomized Trial Save

Date Added
August 18th, 2015
PRO Number
Pro00019745
Researcher
Sebastiano Gattoni-celli
Keywords
Cancer, Prostate, Vitamin D
Summary

This randomized clinical trial will enroll 136 men recently diagnosed with Early-Stage prostate cancer. Men must be 19 or older with a prostate biopsy Gleason score ? 6 and PSA ?10 who have decided that active surveillance is their present treatment option. Study visits will be every 4 months for just over a year in Charleston, S.C. There will be two groups, one taking vitamin D3 supplement and the other taking a placebo. Assigment to each group will be by chance and neither the particpant nor the study team will know to which group they are assigned. Blood and urine samples will be collected at each visit for research purposes. A survey relating to the subjects' decision making about their biopsies will be completed at the baseline and final visits. Waist/hip ratio and blood pressure measurements will also be obtained at the baseline and final study visits. Each participant will be in the study until a repeat prostate biopsy is performed by their own Urologist as Standard of Care for Active Surveillance regimen.

Institution
MUSC
Recruitment Contact
Linda Ambrose
843-792-8303
ambrosel@musc.edu

Assessing The Impact Of A Simplified Patient Care Strategy To Decrease Early Deaths In Acute Promyelocytic Leukemia (APL) By Maintaining A Database Save

Date Added
August 12th, 2015
PRO Number
Pro00026587
Researcher
Robert Stuart
Keywords
Cancer, Cancer/Other
Summary

This registry study is for patients with acute promyelocytic leukemia, a subtype of acute leukemia. This particular subtype of leukemia is curable in the majority of the patients. Most of the patients die in the first month after diagnosis from bleeding, infection or lung problems that are a result of the disease itself or a complication after the treatment is started. The study team would like to collect information about participants, the disease, the treatment and the response
to treatment and store the information in a database that will allow them to assess the importance of various factors that lead to early mortality and study the early intervention that prevent these early deaths. There are no new treatment interventions being proposed as part of this study. Once the consent is signed, participants' information will be collected. After the identifying markers are removed, participants' information will be stored in a secure location permanently.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

Phase II Trial of Intravenous Fenretinide (N-(4-hydroxyphenyl) retinamide, 4-HPR) Emulsion for Patients with Relapsed/Refractory Peripheral T-cell Lymphomas (PTCL) Save

Date Added
August 11th, 2015
PRO Number
Pro00045977
Researcher
Saurabh Chhabra
Keywords
Cancer, Cancer/Lymphoma, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with cancer, specifically a T-cell lymphoma. The investigational drug in this study is 4-HPR. The purpose of this study is to see what effects fenretinide will have on your tumor. Participants can expect to be in this study for up to two years.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

A phase 2 study of brentuximab vedotin in combination with standard of care treatment (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [RCHOP]) or RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) as front-line therapy in patients with diffuse large B-cell lymphoma (DLBCL) Save

Date Added
July 28th, 2015
PRO Number
Pro00045219
Researcher
Saurabh Chhabra
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with diffuse large B-cell lymphoma (DLBCL), which has never been treated. The drug in this study is brentuximab vedotin. The purpose of the first part of the study was to test the safety and effectiveness of 2 different doses of brentuximab vedotin when given with a combination of drugs called RCHOP [rituximab, cyclophosphamide, hydroxydaunorubicin (also called doxorubicin), vincristine (Oncovin), and prednisone]. The purpose of the second part of the study is to test the safety and effectiveness of brentuximab vedotin when given with a combination of drugs that does not include vincristine called RCHP [rituximab, cyclophosphamide, hydroxydaunorubicin (also called doxorubicin), and prednisone]. Participants can expect to be in this study for up to 2-3 years.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

A PHASE III TRIAL OF ADJUVANT CHEMOTHERAPY AS PRIMARY TREATMENT FOR LOCALLY ADVANCED CERVICAL CANCER COMPARED TO CHEMORADIATION ALONE: THE OUTBACK TRIAL (ANZGOG 0902/GOG-0274/RTOG 1174) Save

Date Added
December 18th, 2013
PRO Number
Pro00016094
Researcher
Jennifer Young
Keywords
Cancer, Cancer/Gynecological
Summary

The objectives of this trial are to find out whether adjuvant chemotherapy (using two other drugs) after chemo-radiation will increase the chances of survival and reduce the risk of tumor recurrence in the pelvis and other places. The risk and severity of side effects and quality of life during and after treatment will also be evaluated and compared. This trial will help the researchers understand the safety and effectiveness of this new treatment regimen for cervical cancer.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High-Risk Prostate Cancer: A Phase III Randomized Trial Save

Date Added
November 7th, 2013
PRO Number
Pro00028856
Researcher
David Marshall
Keywords
Cancer, Cancer/Genitourinary, Prostate
Summary

The purpose of this study is to compare the effects of hormone therapy (androgen deprivation) and radiation therapy to the prostate gland and seminal vesicles with hormone therapy and radiation therapy to the whole pelvic body area to determine which is better.

There are 2 treatment groups in this study:
1) Patients who receive hormone therapy plus radiation therapy to the prostate gland and seminal vesicles
2) Patients who receive hormone therapy plus radiation therapy to the whole pelvis

Institution
MUSC
Recruitment Contact
Kelly Hawthorne
864-725-4111
khawthorne@selfregional.org

ANHL1131: INTERGROUP TRIAL FOR CHILDREN OR ADOLESCENTS WITH B-CELL NHL OR B-AL: EVALUATION OF RITUXIMAB EFFICACY AND SAFETY IN HIGH RISK PATIENTS Save

Date Added
October 10th, 2013
PRO Number
Pro00021704
Researcher
Jacqueline Kraveka
Keywords
Adolescents, Cancer, Pediatrics
Summary

A large randomized trial is necessary to evaluate whether rituximab can add benefit to the current chemotherapy regimen. Two pilot studies in children provide preliminary evidence of safety and activity of rituximab in this disease setting that support such a study. A Berlin-Frankfurt-M

Institution
MUSC
Recruitment Contact
Jacqueline Kraveka
843.792.2957
kravekjm@musc.edu

A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer Save

Date Added
October 3rd, 2013
PRO Number
Pro00017993
Researcher
Frank Brescia
Keywords
Cancer, Cancer/Breast, Drug Studies, Women's Health
Summary

This study is being done for the following reasons:
?This study is being done to find out if a combination of just two chemotherapy drugs, docetaxel and cyclophosphamide, is as good as using different combinations of the chemotherapy drugs doxorubicin and cyclophosphamide, given with either docetaxel or paclitaxel, in treating your type of breast cancer. All of these drugs are used in standard combinations of chemotherapy for breast cancer.
?The researchers also want to learn about the side effects of the combinations of drugs used in this study. Side effect information will also be studied to see if there are any differences between the two-drug and three-drug chemotherapy combinations.
?In order to learn more about cancer tumors, this study includes special research tests that will be done on tumor tissue that was removed during your breast cancer surgery. Information about this study requirement will be explained to you in more detail later in this consent form.

Institution
MUSC
Recruitment Contact
Katherine Halloran
843-792-7035
halloran@musc.edu

ASCT1221: A Randomized Phase II Study Comparing Two Different Conditioning Regimens Prior to Allogeneic Hematopoietic Cell Transplantation (HCT) for Children with Juvenile Myelomonocytic Leukemia (JMML) Save

Date Added
September 20th, 2013
PRO Number
Pro00027972
Researcher
Jacqueline Kraveka
Keywords
Adolescents, Cancer, Pediatrics
Summary

Although JMML is an uncommon disease, it occurs exclusively in very young
children (median age ~ 2.5 years) indicating an increased risk for TRM and late
effects associated with maximum intensity conditioning regimens. Moreover, there is currently no agreed upon standard of care preparative regimen in use for
patients with JMML. Previous studies suggest that there are significant toxicities
associated with conditioning regimens currently in use today. Moreover, the
relapse rates were fairly high and it appears that further escalation of the
conditioning regimens is unlikely to produce significant improvements in EFS or
relapse rates without unacceptable TRM. Therefore, it is essential that novel
strategies be developed to reduce the high rates of relapse that have been
observed.

Institution
MUSC
Recruitment Contact
Jacqueline Kraveka
843-792-2957
kravekjm@musc.edu

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