An Open-Label, Multicenter Phase Ib/2 Stndy of E7080 Alone, and in Combination with Everolimus in Subjects with Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment + save

Date Added
May 28th, 2013
PRO Number
Pro00013342
Researcher
Harry Drabkin
Keywords
Cancer, Cancer/Genitourinary, Kidney
Summary

This study is for subjects that have have been diagnosed as having advanced renal cell carcinoma that has been treated previously, but has not responded or got worse despite treatment. E7080 is an investigational drug that is in development for the treatment of cancer, including renal cell carcinoma. E7080 is thought to work by stopping the formation of new blood vessels that help cancer cells grow and spread. Everolimus is also used in this study and is a drug approved by the FDA and other Health Authorities for the treatment of advanced renal cell carcinoma. Subjects will either receive E7080, Everolimus or both drugs together. Also being studied is how your genetic make up affects how your body absorbs, distributes, breaks down and excretes the study drugs. There will be a screening visit to determine subjects eligibility and a baseline visit that will determine is subjects are still eligible to participate in this study. If subjects are eligible and choose to participate, then subjects will be assigned to one of three study groups. Each treatment cycle is 28 days long. Subjects are expected to be on this study for approximately 24 months or 2 years.

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-9007
brisend@musc.edu

A Phase 2 Assessment of the Diagnostic Accuracy of 99mTc-MIP-1404 Imaging in Men with High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to Histopathology + save

Date Added
May 28th, 2013
PRO Number
Pro00017217
Researcher
Thomas Keane
Keywords
Cancer, Cancer/Genitourinary
Summary

The research study will determine whether an investigational drug 99mTc-MIP-1404 is effective in detecting prostate cancer tissue within the prostate gland and elsewhere in your body when used with imaging techniques. This study will be for patients that will be undergoing a Radical Prostatectomy with extended pelvic lymph node dissection as treatment for prostate cancer. This is not a treatment based study.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
843-876-0630
jenkijn@musc.eud

Phase I/II Study of BNC105P in Combination with Everolimus or Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma Following Prior Tyrosine Kinase Inhibitors + save

Date Added
April 9th, 2013
PRO Number
Pro00016841
Researcher
Harry Drabkin
Keywords
Cancer, Cancer/Genitourinary, Cancer/Other, Kidney
Summary

Subjects are being asked to take part because they have clear cell renal cancer that has spread to other organs in their body. Renal cell carcinoma is the cancer that develops in the kidneys.
The purpose of this study is to test a new cancer treatment drug called BNC105P in combination with everolimus to see what effects (good and bad) it has on subjcets and their cancer. BNC105P is a drug that causes changes in the lining of the blood vessels nourishing the tumor cells more than the lining of the blood vessels nourishing the normal cells. These changes in the lining of the blood vessels reduces blood flow to the tumor causing reduced blood supply/nourishment to the tumor resulting in death of the tumor cells and reduction of the tumor size.
This study will be done in 2 parts; Phase I and Phase II.
The purpose of the Phase I part of the study is to:
• test the safety of BNC105P (a new type of drug used to treat cancer) when given together with Everolimus
• find the highest dose of BNC105P that can be given together with Everolimus without causing severe side effects
• see what effects (good and bad) BNC105P has on you and your cancer

The purpose of the Phase II part of the study is to:
• Evaluate if adding BNC105P to the Everolimus is better than Everolimus treatment when given alone and see what effect (good or bad) BNC105P will have when given following Everolimus treatment.

Subjects will have screening procedures to determine if he or she is eligible to participate in this study. If he or she is eligible and agrees to participate, subjects will either participate in Phase I or Phase II. Subjects in Phase I will receive EVEROLIMUS at 10 mg by mouth daily and BNC105P by IV.

If subjects are in the Phase II portion of the study, they will be randomized in to either Group A or Group B. Group A subjects will also receive EVEROLIMUS at 10 mg by the mouth daily and BNC105P by IV. Subjects in Group B will receieve EVEROLIMUS at 10 mg by mouth daily only.

Subjects will be followed by study team members for the rest of their lives to look at the long term effects of the study treatment.

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-9007
brisend@musc.edu

A Randomized Phase II Dose Finding Study of ArginMax for Its Effect on Erectile Function and Quality of Life in Survivors of Prostate Cancer Previously Treated with Radiotherapy + save

Date Added
April 5th, 2013
PRO Number
Pro00008414
Researcher
Drew Monitto
Keywords
Cancer, Cancer/Genitourinary, Prostate
Summary

The purpose of this research study is to find what effects (good and bad) ArginMax has on erectile dysfunction in prostate cancer survivors treated with radiotherapy.

ArginMax is a dietary supplement that contains extracts of L-arginine, ginseng, ginkgo biloba, multivitamins, and minerals and has been taken for erectile dysfunction. This supplement is not approved by the Food and Drug Administration (FDA).

In this study, participants will receive a low or high dose of the study medication given twice a day. Active drug will be compared to a placebo also taken twice a day.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
800-486-5941
research@srhs.com

A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients With Advanced Transitional Cell Carcinoma + save

Date Added
March 21st, 2013
PRO Number
Pro00019955
Researcher
Charles Bowers
Keywords
Cancer, Cancer/Genitourinary, Cancer/Other, Drug Studies
Summary

The purpose of this study is to compare the effects, good and/or bad, of the combination of the chemotherapy drugs gemcitabine and cisplatin (chemotherapy) with the combination of gemcitabine, cisplatin, and the experimental drug bevacizumab on subjects and their transitional cell cancer to find out which is better.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, a Phase III Study + save

Date Added
March 7th, 2013
PRO Number
Pro00019129
Researcher
James Bearden
Keywords
Cancer, Cancer/Genitourinary, Drug Studies
Summary

The primary objective of this study is to compare recurrence-free survival in patients with kidney cancer randomly assigned to one year of everolimus versus one year of placebo after nephrectomy or partial nephrectomy.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

A Phase III Trial Of Short Term Androgen Deprivation With Pelvic Lymph Node Or Prostate Bed Only Radiotherapy (SPORT) In Prostate Cancer Patients With A Rising PSA After Radical Prostatectomy + save

Date Added
March 7th, 2013
PRO Number
Pro00020946
Researcher
Patricia Griffin
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Prostate
Summary

The primary study objectives are to determine if the following improve disease outcomes in men with prostate cancer who will be receiving radiation treatment to the prostate bed because they have a rising PSA level following a radical prostatectomy:
• addition of hormonal therapy to radiation treatment of the prostate bed
• addition of radiation treatment of the pelvic lymph nodes AND hormonal therapy to radiation treatment of the prostate bed

The secondary study objectives include comparisons of quality of life, toxicity, cost effectiveness, and future biological correlative studies among the different treatment groups.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer + save

Date Added
February 16th, 2013
PRO Number
Pro00021027
Researcher
Patricia Griffin
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Prostate
Summary

The primary objective of this study is to demonstrate an overall survival advantage for the addition of short-term (6 months) hormone therapy to dose-escalated radiation therapy for patients with intermediate-risk prostate cancer. In this study, patients with intermediate-risk prostate cancer will receive one of two treatments for it--Dose-escalated radiation therapy alone OR Dose-escalated radiation therapy combined with short-term (6 months) hormone therapy.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

A Randomized, Phase 2, Open-label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects with High Risk HER2+ Urothelial Carcinoma. + save

Date Added
February 12th, 2013
PRO Number
Pro00017877
Researcher
Thomas Keane
Keywords
Bladder, Cancer, Cancer/Genitourinary
Summary

This study is for an immune system treatment for urothelial cancer called DN24-02. This study compares patients who receive DN24-02 to patients who do not receive DN24-02 for treatment of high risk HER2+ Urothelial Carcinoma (cancer of the bladder, renal pelvis {area of the kidneys that acts like a funnel for urine flow to the ureter} , urethra {tube that connects the bladder to the reproductive organs} or ureter { tubes that propel urine from the kidneys to the bladder}). The main purpose of the study is to learn if DN24-02 helps patients to live longer. Other purposes of the study are to learn about the safety of DN24-02, to learn if it delays the time until urothelial cancer returns, and to learn if the immune system will responds to treatment with DN24-02. DN24-02 uses cells, called antigen presenting cells, which are prepared from your own blood. An antigen is a substance, in this case a protein, which may be able to stimulate the body’s immune system. Antigen presenting cells are a type of white blood cell (cells that fight cancer and infections), and they are important to the immune system because they teach other white blood cells to how to recognize diseased cells in your body. These blood cells are removed from your body, cultured with an antigen in the laboratory, and then put back into your body. Training your white blood cells to recognize these diseased cells may help your immune system find and attack cancer cells.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
843-876-0630
jenkijn@musc.edu

Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer + save

Date Added
February 7th, 2013
PRO Number
Pro00019953
Researcher
Charles Bowers
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Prostate
Summary

The purpose of this study is to determine whether:
• The combination of chemotherapy and hormone therapy followed by radical prostatectomy (surgery to remove the prostate) or
• Radical prostatectomy alone will better decrease the chance of recurrence, increase life expectancy, and improve quality of life for men with prostate cancer who are at risk of cancer recurrence after surgery to remove their prostate.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com