A PhaseI/II Adaptive Randomized Trial of Bevacizumab versus Bevacizumab plus Vorinostat in Adults with Recurrent Glioblastoma + save

Date Added
October 8th, 2013
PRO Number
Pro00020172
Researcher
Scott Lindhorst
Keywords
Cancer, Men's Health, Women's Health
Summary

The goal of this Phase II part of this clinical research study is to learn if bevacizumab when given with or without vorinostat can help to control malignant gliomas. The safety of these drug combinations will also be studied. Vorinostat is designed to cause chemical changes in different groups of proteins that are attached to DNA (the genetic material of cells), which may slow the growth of cancer cells or cause the cancer cells to die. Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.
If the participants are found to be eligible to take part in this study, they will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. If they are in Group 1, they will take bevacizumab.If the participants are in Group 2, they will take vacizumab and vorinostat
The participant may take the study drug(s) for up to 1 year. Participation on this study will end once the participant completes the end-of-dosing visit and long-term follow-up.

Institution
MUSC
Recruitment Contact
John Keller
843-792-1286
kellej@musc.edu

A Phase I/II, Multi-Center, Open-Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR610 Given Weekly in Subjects with Solid Tumors + save

Date Added
October 4th, 2013
PRO Number
Pro00023126
Researcher
Keisuke Shirai
Keywords
Cancer, Cancer/Lung, Lung
Summary

The purpose of this research study is to review the effectiveness and safety of PR610, including the dose level and side effects, for the treatment of adults diagnosed with non-squamous, nonsmall cell lung cancer (NSCLC).

Institution
MUSC
Recruitment Contact
Jessica Salamacha
843-792-6429
salamach@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

A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon Cancer, Phase III – Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES) + save

Date Added
September 26th, 2013
PRO Number
Pro00011314
Researcher
James Bearden
Keywords
Cancer, Cancer/Gastrointestinal, Colonoscopy, Drug Studies
Summary

Colorectal adenomas are tiny growths in the colon that may eventually lead to cancer. The purpose of this study is to determine if eflornithine and sulindac, taken alone or in combination, can decrease the risk of high-risk adenomas or second primary colorectal cancers in patients who have been treated for Stage 0, I, II, or III colon cancer. ("Second primary colorectal cancer" means a new colorectal cancer developing within the colorectum.)

The study drugs eflornithine and sulindac are tablets which are taken orally (by mouth). Sulindac is FDA approved and is commercially available but is not approved for this indication. Eflornithine cream is FDA approved, but oral eflornithine is an investigational agent and not approved by the FDA.

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

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

A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil(Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with High Grade Glioma + save

Date Added
September 19th, 2013
PRO Number
Pro00029068
Researcher
James Bearden
Keywords
Cancer, Cancer/Brain, Drug Studies
Summary

The purpose of this study is to:
• See if taking the study agent, armodafinil, at a dose of 150mg or 250mg, will improve problems with fatigue in patients who have been diagnosed with cancer and are experiencing fatigue.
• See the effects (good and bad) of taking Armodafinil compared to placebo (an inactive agent) on cancer related fatigue.

In this study, subjects will take either the study agent, armodafinil, or the placebo (inactive agent). They will not take both.

Armodafinil (Nuvigil®) is a medicine that is currently FDA approved to promote wakefulness in people who have sleep disorders. However, it is not been studied in people with cancer related fatigue.

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

Phase III Trial of Dose Escalated Radiation Therapy and Standard Androgen Deprivation Therapy (ADT) with a GnRH Agonist vs. Dose Escalated Radiation Therapy and Enhanced ADT with a GnRH Agonist and TAK-700 for Men with High Risk Prostate Cancer + save

Date Added
September 19th, 2013
PRO Number
Pro00018969
Researcher
David Marshall
Keywords
Cancer, Prostate
Summary

The purpose of this study is to compare the effects of hormone therapy (androgen deprivation) and TAK-700 plus radiation therapy with hormone therapy (androgen deprivation) and radiation therapy on patients with prostate cancer.
There are 2 treatment groups in this study. Group 1will receive hormone therapy plus radiation therapy only and Group 2 will receive hormone therapy and TAK-700 plus radiation therapy.
Subjects will receive hormone therapy for 24 months. Radiation will be given in 44 treatments over approximately 2 months. If the subject is in Group 2 they will take TAK-700 for 24 months. After the subject is finished receiving therapy, the study doctor will ask the subject to visit the office for follow-up exams every 6 months for 3 years and then once a year.

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

"A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon Cancer, Phase III - Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES)" + save

Date Added
September 17th, 2013
PRO Number
Pro00027914
Researcher
Joanna Metzner-sadurski
Keywords
Cancer, Cancer/Gastrointestinal
Summary

Colorectal adenomas are tiny growths in the colon that may eventually lead to cancer. The purpose of this study is to determine if eflornithine and sulindac, taken alone or in combination, can decrease the risk of high-risk adenomas or second primary colorectal cancers in patients who have been treated for Stage 0, I, II, or III colon cancer. ("Second primary colorectal cancer" means a new colorectal cancer developing within the colorectum.) This is a randomized study involving four study groups, or arms.

Institution
MUSC
Recruitment Contact
Kelly Hawthorne
864-725-7129
khawthorne@selfregional.org

Improving Resection Rates among African Americans with NSCLC (Southeastern Lung Cancer Study) + save

Date Added
September 17th, 2013
PRO Number
Pro00029265
Researcher
Marvella Ford
Keywords
Cancer, Cancer/Lung, Minorities, Stage I, Stage II, Surgery
Summary

The goal of this study is to improve rates of lung-directed therapy with curative intent (LDTCI) among African Americans with probable or proven early stage non-small cell lung cancer via a patient navigation intervention. Study participants will be recruited from study sites across the Southeastern US, including the Medical University of South Carolina Hollings Cancer Center (MUSC HCC). Participants will be randomized by study site. This study does not include blood draws or therapeutic interventions. During the one-year follow-up period, each participant will complete 4 telephone surveys.

Institution
MUSC
Recruitment Contact
Dana Burshell
843-876-2452
burshell@musc.edu

A Multi-Arm Phase 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Dual PI3K/mTOR Inhibitors PF-04691502 and PF-05212384 in Combination with Experimental or Approved Anticancer Agents in Patients with Advanced Cancer. + save

Date Added
September 10th, 2013
PRO Number
Pro00028355
Researcher
Carolyn Britten
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for adult males and females who have been diagnosed with cancer. This study involves a new investigational drug called PF-05212384 that is currently not FDA-approved for sale in this country. The first goal of this study is to determine the highest dose of PF-05212384 that can be tolerated without endangering the patients (MTD). When the MTD is found, additional patients will be enrolled to the study to examine the safety and tolerability of PF-05212384 in combination with other study drugs. Each participant will receive only one of the two possible combinations described below of study drugs while in this study. Patients may be in this study for approximately up to 1 year. Depending on the treatment he/she is given, he/she may need to visit the clinic daily, after the initial dose period. The visits to the clinic may then be as much as every 4-6 days during the first 6 “cycles” (each cycle is approximately 28 days) of treatment.

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