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
May 14th, 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

Phase 1/2 Study of PX-866 and Docetaxel in Patients with Solid Tumors + save

Date Added
May 14th, 2013
PRO Number
Pro00017009
Researcher
Keisuke Shirai
Keywords
Cancer, Cancer/Head & Neck, Drug Studies
Summary

The purpose of the phase 2 part of the study is to find out whether PX-866 in combination with docetaxel is better than docetaxel alone at treating patients with locally advanced, recurrent, or metastatic non-small cell lung cancer or squamous cell cancer of the head and neck.

Institution
MUSC
Recruitment Contact
Adam Fiebelkorn
843-792-6349
fiebelko@musc.edu

A Phase I/II Trial of Vorinostat (SAHA) (NSC-701852) In Combination With Rituximab-CHOP in Patients With Newly Diagnosed Advanced Stage Diffuse Large B-Cell Lymphoma (DLBCL) + save

Date Added
May 7th, 2013
PRO Number
Pro00013879
Researcher
James Bearden
Keywords
Cancer, Cancer/Lymphoma, Drug Studies
Summary

The standard therapy of large cell lymphoma uses a combination of the drugs
cyclophosphamide, doxorubicin, vincristine, and prednisone (called "CHOP") with the rituximab antibody. CHOP is a common chemotherapy for lymphoma. The rituximab antibody is a protein that targets specific cells that are related to your cancer.

The combination of rituximab-CHOP chemotherapy has been used to treat patients with lymphoma and has been shown to be active against lymphoma. This experimental study is being done to test the best dose and safety for using vorinostat (SAHA) together with rituximab-CHOP. It is also being done to see if patients treated with the vorinostatrituximab-CHOP chemotherapy will have longer lasting tumor shrinkage than patients treated with CHOP chemotherapy and rituximab alone.

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

A Feasibility Trial using Molecular-Guided Therapy for the Treatment of Patients with Relapsed and Refractory Childhood Cancer + save

Date Added
May 7th, 2013
PRO Number
Pro00024968
Researcher
Jacqueline Kraveka
Keywords
Cancer
Summary

This study will look at experimental technologies to determine a tumor's molecular makeup (gene expression profile) and mutations in order to develop a personalized treatment plan to treat children with relapsed or refractory neuroblastoma, brain tumor or rare tumors.

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

Phase II Randomized Study of Whole Brain Radiotherapy in Combination with Concurrent Lapatinib in Patients With Brain Metastasis From HER2-Positive Breast Cancer – A COLLABORATIVE STUDY OF RTOG AND KROG + save

Date Added
May 7th, 2013
PRO Number
Pro00025233
Researcher
Patricia Griffin
Keywords
Cancer, Cancer/Brain, Drug Studies
Summary

The purpose of this study is to compare the effects of adding lapatinib to standard whole brain radiation therapy (WBRT). The study will try to find out whether WBRT or lapatinib plus WBRT is better at safely improving tumor control. In this study, subjects will receive either lapatinib plus WBRT or WBRT alone.

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

A PHASE III TRIAL OF 6 VERSUS 12 TREATMENTS OF ADJUVANT FOLFOX PLUS CELECOXIB OR PLACEBO FOR PATIENTS WITH RESECTED STAGE III COLON CANCER + save

Date Added
April 30th, 2013
PRO Number
Pro00024065
Researcher
Melanie Thomas
Keywords
Cancer, Cancer/Gastrointestinal, Men's Health, Women's Health
Summary

This study is for subjects who have cancer of the colon, which has been surgically removed, but has spread to lymph nodes. This study is being done to evaluate the effects (good and bad) of different chemotherapy treatments. One of the common combinations of chemotherapy drugs used to treat this type of cancer includes 5-fluorouracil (also called 5-FU), leucovorin and oxaliplatin, and is also called “FOLFOX”. The Food and Drug Administration (FDA) has approved each of these drugs as treatment for colon cancer. FOLFOX is a standard treatment used to prevent colon cancer from coming back (recurrence).
In this study, researchers will evaluate the effects (good and bad) of an oral drug called celecoxib when given in combination with FOLFOX chemotherapy. Celecoxib is approved by the FDA to treat arthritis and some other painful conditions. The addition of celecoxib to FOLFOX chemotherapy is considered investigational. One of the purposes of this study is to determine if giving subjects celecoxib (by mouth) and chemotherapy decreases the risk of colon cancer recurrence.
This study will also look at whether receiving FOLFOX chemotherapy for 6 treatments (12 weeks) is as good as 12 treatments (24 weeks) in preventing recurrence of colon cancer. Currently, the standard of care is 12 treatments with FOLFOX. In this trial, researchers will explore whether 6 treatments are as effective as 12 treatments and whether side effects can be reduced with fewer treatments. It expected that subjects will be enrolled in this trial for up to 3 years.

Institution
MUSC
Recruitment Contact
Andie Adelman
843-792-1507
adelman@musc.edu

Ofatumumab versus Rituximab Salvage Chemoimmunotherapy followed by ASCT in Relapsed or Refractory DLBCL + save

Date Added
April 23rd, 2013
PRO Number
Pro00009358
Researcher
Luciano Costa
Keywords
Blood Disorders, Cancer, Cancer/Lymphoma
Summary

This study will compare the use ofatumumab to rituximab in subjects that have diffuse large B-cell lymphoma (DLBCL) . Standard of care chemotherapy will be given with DHAP (Cisplatin, Cytarabine, Dexamthasone) and either ofatumumab or rituximab. If the disease responds well to treatment, stem cells, will be collected and stored. After BEAM (Carmustine, Etoposide, Cytarabine, and Melphalan) treatment, the stem cells would be re-injected and should start to make blood. The purpose of this study is to test how well ofatumumab works, and how safe it is, as a treatment.

Institution
MUSC
Recruitment Contact
Jessica Simons
843-792-8856
simonsjl@musc.edu

Circulating Fibroblast Precursors in Metastatic Sarcoma + save

Date Added
April 22nd, 2013
PRO Number
Pro00010978
Researcher
Amanda Larue
Keywords
Cancer, Cancer/Sarcoma
Summary

The purpose of this project is to determine the role of fibroblasts in sarcoma metastasis. Fibroblasts are cells that are major component of the supporting and connecting structures of the body. Precursors to these tissue fibroblasts are found in our bone marrow and in our circulating blood. The study doctor will grow fibroblasts from blood samples in culture and determine the role that they play in promoting tumor cell invasion and metastasis.

Institution
MUSC
Recruitment Contact
Sara Rothmyer
843-792-1507
rothmyer@musc.edu

A PHASE II, OPEN-LABEL, RANDOMIZED STUDY OF MEHD7945A VERSUS CETUXIMAB IN PATIENTS WITH RECURRENT/METASTATIC SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK WHO HAVE PROGRESSED DURING OR FOLLOWING PLATINUM-BASED CHEMOTHERAPY + save

Date Added
April 22nd, 2013
PRO Number
Pro00016993
Researcher
Paul O'brien
Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Minorities, Women's Health
Summary

The main purpose of this study is to find out what effects, good and/or bad, MEHD7945A has on you and your cancer. In this study there will be two treatment arms. You will be treated with either MEHD7945A or cetuximab, a drug that is commonly used for your type of cancer. You will not be treated with both drugs at the same time.

Institution
MUSC
Recruitment Contact
Adam Fiebelkorn
843-792-6349
fiebelko@musc.edu

ACNS0821: Temozolomide with Irinotecan versus Temozolomide, Irinotecan plus Bevacizumab (NSC# 704865, BB-IND# 7921) for Recurrent/Refractory Medulloblastoma/CNS PNET of Childhood, A COG Randomized Phase II Screening Trial + save

Date Added
April 19th, 2013
PRO Number
Pro00024598
Researcher
Jacqueline Kraveka
Keywords
Adolescents, Cancer, Pediatrics
Summary

There is no current standard treatment for recurrent/refractory
medulloblastoma/PNET. The combination of the drugs temozolomide and
irinotecan has been used to treat adults and children with other types of cancer.
The combination has also been used in previous studies to treat a small number
of children with recurrent or refractory medulloblastoma/PNET as well as other
recurrent tumors, with encouraging results. This study uses the results of these
earlier studies, and looks at how well giving temozolomide and irinotecan daily
for 5 days every 28 days works when given to children and young adults with
recurrent or refractory medulloblastoma/PNET.

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