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 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 12th, 2013
PRO Number
Pro00015882
Researcher
Andrew Kraft
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
Jessica Salamacha
843-792-7030
salamach@musc.edu

Phase II Study Evaluating the Role of Pazopanib in Angiosarcoma + save

Date Added
March 7th, 2013
PRO Number
Pro00016682
Researcher
Andrew Kraft
Keywords
Cancer, Cancer/Sarcoma
Summary

This study is for subjects with Angiosarcoma that cannot be treated with surgery. The goal of this study is to find out what effects, good and/or bad, pazopanib has on you and your angiosarcoma. We do not know if treatment will help you.
• Your condition could get better
• There may be no effect on your condition
• Your condition may get worse
We can use what we learn from this study to help other people with the same disease. Screening procedures will be done to determine if subjects may be enrolled in the study. If subjects are eligible and are willing to participate, then subjects may begin treatment on the study. Subjects will be given the study drug in pill form and will take it every day with food. Subjects will take the study drug until their disease progresses, they have side effects or they decide to stop therapy. once subjects stop treatment, they will be followed for 2 or 3 months to see how they are doing.

Institution
MUSC
Recruitment Contact
Mohanasundari Pajaniappan
843-792-1507
pajaniap@musc.edu

A Randomized Controlled Study of Yondelis (Trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma. + save

Date Added
February 26th, 2013
PRO Number
Pro00010186
Researcher
Andrew Kraft
Keywords
Cancer, Cancer/Sarcoma
Summary

There are 2 treatment groups in this study. You will either receive dexamethasone followed by Yondelis or dacarbazine. Both are given about every 3 weeks. Each patient who is allowed to join the study is put into a group by chance (randomly). To be part of this study, you must agree to provide a tumor sample. This study contains 3 phases: a screening phase, a treatment phase and a follow up treatmetn phase. If you agree, an extra 2 teaspoonfuls (10 ml) of blood will be collected during this study. This blood will be used for DNA research.

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

A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination with Doxorubicin vs. Doxorubicin Alone in Subjects with Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma + save

Date Added
November 13th, 2012
PRO Number
Pro00014235
Researcher
Andrew Kraft
Keywords
Cancer, Cancer/Sarcoma
Summary

Subjects enrolled in this clinical trial have advanced soft tissue sarcoma that their doctor plans to treat with doxorubicin (a chemotherapy drug). Researchers want to find out if an investigational drug called TH-302 can help patients with advanced soft tissue sarcoma when it is combined with doxorubicin.

The purpose of this study is to gather information on the safety and effect on this cancer of TH-302 in combination with doxorubicin. The study will also look at how the drug is processed in the body. Participants will undergo a screening process to determine if he or she is eligible to participate in the study. If a subject is eligible and chooses to participate, he or she may receive treatment for approximately 6 months or 23 weeks. The treatment period is divided into 3-week periods called “cycles.” Subjects will be randomly assigned (like flipping a coin) to one of the following treatment arms:

A)TH-302 plus doxorubicin: TH-302 once a week for 2 weeks followed by one week off. Subjects will receive doxorubicin on the first day of each 3-week cycle.

B) Doxorubicin alone: Doxorubicin only on the first day of the 3-week cycle.

Subjects may receive up to 6 cycles of treatment. A end of study visit will be completed once the subject stops study treatment.

Institution
MUSC
Recruitment Contact
Mary Shannon
843-792-9251
shannsu@musc.edu

A Phase I Safety and Tolerability Study of LBH589 in Combination with Sorafenib in Patients with Advanced Renal Cell Carcinoma and Non-small Cell Lung Carcinoma (NSCLC) of Non-squamous Histologies + save

Date Added
February 16th, 2011
IRB Number
18864
Researcher
Harry Drabkin
Keywords
Cancer, Cancer/Genitourinary, Cancer/Lung, Cancer/Other, Cancer/Sarcoma, Drug Studies, Kidney, Lung, Urinary
Summary

The purpose of this study is to determine if a new investigational drug called LBH589, which has not yet been approved by the Food and Drug Administration (FDA), is safe and tolerable when given in combination with Sorafenib for the treatment of certain types of lung kidney and soft tissue cancers. Sorafenib is a medication approved by the FDA and used in treating kidney cancer. This study is investigational because the combination of these two drugs LBH589 and Sorafenib have not yet been approved by the FDA for use in these types of cancer. Sorafenib works by slowing the spread of cancer cells. LBH589 slows the growth of the enzyme histone deacetylase (a protein that speeds up chemical reactions in the body), which causes cancerous cells to die. Patients will be asked to take 2 tablets of Sorafenib by mouth twice a day along with the study drug LBH589 that will be given by tablet as well on certain days during your study cycle. The first dose of LBH589 that patients receive has been determined as a safest dose based on previous study information. Increasing doses of LBH589 will then be given depending on how you and other study participants are reacting to the drug. LBH589 will increase until it is determined that the highest dose given is causing too many side effects. At that point, it may also be possible for the dose of Sorafenib that you receive to be reduced if it is also causing too many side effects in combination with the highest dose of LBH589. You will receive the combination of study drugs for a maximum of 24 months.

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

A Multicenter, Open-Label, Single-Arm Study of YONDELIS (trabectedin) for Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Relapsed or Are Refractory to Standard of Care Treatment + save

Date Added
October 5th, 2009
IRB Number
15603
Researcher
Andrew Kraft
Keywords
Cancer, Cancer/Sarcoma, Drug Studies
Summary

The purpose of this study is to provide an experimental drug called Yondelis to eligible patients who have not responded to previous treatment. This drug has not been approved for sale by the FDA for use with your type of cancer. Safety evaluation of this drug will also occur during this study that will include physical exams, monitoring of your vital signs and side effects, and performing laboratory tests.

Patients who participate in this study will receive Yondelis as a 24-hour infusion. You may be hospitalized only for the first cycle of this treatment. You will receive treatment on day 1 of every 17 to 49 day cycle. You will visit your doctor on day 1 of each cycle and blood will be taken during the middle of each cycle and at the end of treatment.

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