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Clinical Trials


At Thompson Cancer Survival Center we’re more than a cancer center, we’re a cancer survival center. We are committed to our community, and determined to deliver the most advanced cancer care available.  Thompson was the first to bring cancer clinical trials to East Tennessee more than 25 years ago. Clinical trials are research studies designed to answer specific questions and find better ways to treat different types of cancer.  In fact, the reason why we have seen dramatic progress in recent years and treatments are continually getting better is because there are new drugs available as a direct result of clinical trials.


Today’s clinical trials are tomorrow’s standard of cancer care.

Thompson participates in clinical trials of new cancer-fighting medicines and treatments. We work with multiple Cooperative Groups funded by the National Cancer Institute. In addition, we partner with pharmaceutical companies in order to give our patients access to new treatments that are not otherwise available.

At Thompson, we’re committed to not only providing each patient with the most advanced cancer care available, but also to finding a cure. We offer clinical trials because they often lead to better ways to diagnose, treat, and prevent cancer, allowing people to live healthier and longer lives. Ask your doctor if a clinical trial might be right for you.

To learn more about clinical trials at Thompson Cancer Survival Center, call the Clinical Trials Office at (865) 541-1812.

BRAIN
CTSU N107C     Post-Surgical Stereotactic (SRS) Radiation Therapy Compared with Whole Brain Radiation Therapy (WBRT) for Resected Metastatic Brain Cancer
Eligibility: Must have four or fewer metastatic brain tumors, and at least one of the tumors must have been surgically removed
 RTOG 1205  The purpose of this study is to determine whether adding radiation to bevacizumab is more effective than using bevacizumab alone to treat recurrent glioblastoma. 
Eligibility:  Diagnosis of glioblastoma that has recurred
BREAST
NSABP B-43

A study for Stage 0 breast cancer called ductal carcinoma in situ (DCIS).  It is for patients who have undergone a lumpectomy to remove the DCIS.  This study is being done to compare the effects of adding the drug trastuzumab (also called Herceptin®) to breast radiation therapy. Radiation therapy is the standard treatment for patients with DCIS.   
Eligibility:  Patients with HER2 positive DCIS

NSAB B-47

The main purpose of this study is to learn if adding a targeted therapy, trastuzumab (Herceptin®), to standard treatment with chemotherapy for early stage, HER2-low breast cancer, will prevent breast cancer from returning.   
Eligibility: Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer

Roche B027938/NSABP B50/GBG 77    The purpose of this study is to compare the effects of trastuzumab emtansine (T-DM1) versus trastuzumab (Herceptin®) on HER2-positive primary non-metastatic breast cancer to find out which is better. In this study, the patient will get either trastuzumab emtansine or trastumuzab alone.   
Eligibility:  Patients with HER2-Positive Primary Breast Cancer who have evidence of cancer in the breast and lymph nodes after chemotherapy and trastuzumab
SWOG S1007  The purpose of this study is to find out if the Oncotype DX® Recurrence Score can help decide whether patients should receive chemotherapy or not. The Oncotype DX® is a test that looks at multiple genes related to breast cancer. The combination of the test results produces a score that is useful in guiding treatment choices for patients with node-negative breast cancer. The higher the score is, the more likely that the patient’s breast cancer will come back after surgery. 
Eligibility:  Patients
with 1-3 positive lymph nodes, hormone receptor-positive, HER2-negative invasive breast cancer who have lower Recurrence Scores (25 or less)
GASTROINTESTINAL
CALGB 80702 This study is evaluating the effects of an oral drug called celecoxib when given in combination with FOLFOX chemotherapy in patients who have been diagnosed with colon cancer.  FOLFOX is a standard treatment used to prevent colon cancer from coming back (recurrence).  One of the purposes of this study is to determine if giving patients 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 for stage III colon cancer is 12 treatments with FOLFOX.   
Eligibility:  Patients with Resected Stage III Colon Cancer
 RTOG 1201
(Pancreatic)
The purpose of this study is to compare three different ways to treat pancreatic cancer to determine if one increases survival better than another. Treatment includes chemotherapy and radiation therapy.
Eligibility:  Patients with adenocarcinoma of the pancreas that cannot be removed by surgery and that has not spread to other parts of the body.
GENITOURINARY
RTOG 0815

The purpose of this study is to compare the effects of dose-escalated radiation therapy (higher total dose of radiation to the prostate) with or without hormone therapy on intermediate risk prostate cancer.  In current clinical practice, either radiation therapy alone  or radiation therapy combined with hormone therapy would be considered an acceptable standard treatment for patients with a newly diagnosed intermediate risk prostate cancer. 
Eligibility:  Patients with intermediate risk (organ confined, unilateral or bilateral disease without extraprostatic extension; PSA >10 but <20; or Gleason score of 7 prostate cancer

GYNECOLOGIC
 None available at this time.
HEAD AND NECK
 ECOG E1311

The purpose of this study is to find out whether the drug afatinib can improve survival in patients who have cancer remaining in their lymph nodes at the time of surgery after they have been treated with combined chemotherapy and radiation therapy. 
Eligibility:  Squamous Cell Head and Neck Cancer that is at high risk for coming back after treatment with chemotherapy, radiation therapy and surgery.

LEUKEMIA/LYMPHOMA
SWOG S1117 The purpose of this study is to compare the effects of adding either the drug lenalidomide or the drug vorinostat to the standard treatment drug azacitidine for patients diagnosed with higher risk myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML).
Eligibility:  Patients with morphologically confirmed diagnosis of myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML)
 ECOG 2905  The purpose of this study is to compare how a drug called lenalidomide affects myelodysplastic syndrome (MDS) and anemia when given alone compared with when given with another drug called epoetin alfa (Procrit).  It may be helpful in determining if the combination of treatment with epoetin alfa (Procrit) and lenalidomide is better than lenalidomide alone in improving red blood cell production and in relieving the need for red blood cell transfusions in patients with MDS (myelodysplastic syndrome).   
Eligibility:  Patients with Low- or Intermediate-1 Risk MDS and Symptomatic Anemia
GSK OMB 113676

The purpose of this study is to test the safety and effectiveness of a study drug called ofatumumab compared to a drug that is already approved to treat follicular lymphoma, named rituximab (also called Rituxan or Mabthera).   
Eligibility:  Patients with relapsed Follicular Lymphoma who have previously been treated with rituximab therapy

GSK OMB 112517 The purpose of this study is to test the safety of the study drug ofatumumab as a maintenance (continued) treatment for chronic lymphocytic leukemia (CLL) and see how well it lengthens response to re-treatment. The study drug ofatumumab will be compared to the usual standard CLL re-treatment which is to simply watch (no treatment) and re-treat again at the time of disease relapse (re-treat when sick). 
Eligibility: Patients with relapsed chronic lymphocytic leukemia (CLL) who have responded to induction therapy
LUNG: NON-SMALL CELL
SWOG S0819 The purpose of this study is to compare the effects of a drug by the name of cetuximab, on advanced non-small cell lung cancer. It is being done to determine if adding cetuximab to the current standard treatment (carboplatin and paclitaxel, with or without bevacizumab) increases overall survival and time to progression (called progression-free survival) compared to standard treatment alone.   
Eligibility:  Patients with advanced non-small cell lung cancer (Stage IV disease)
BMS CA184104 The purpose of this study is to see if a drug by the name ipilimumab given in addition to paclitaxel and carboplatin versus placebo given in addition to paclitaxel (Taxol®) and carboplatin (Paraplatin®) is safe and useful in patients with advanced non-small cell lung cancer. 
Eligibility:  Patients with Stage IV or Recurrent (untreated with prior systemic therapy)  Non-Small Cell Lung Cancer (NSCLC) of squamous histology
LUNG: SMALL CELL
CALGB 30610

The purpose of this study is to compare the effects of 2 different ways to give radiation therapy to patients diagnosed with limited stage small cell lung cancer.  In addition every patient will get chemotherapy with cisplatin and etoposide, which has been established through clinical trials to be standard drugs (chemotherapy) for this type of lung cancer. 
Eligibility:  Patients with limited stage (cancer that has not been detected outside of the chest) small cell lung cancer who will also receive chemotherapy

BMS CA184156

The purpose of this study is to see if the study drug ipilimumab given in addition to etoposide and platinum (cisplatin or carboplatin) versus placebo given in addition to etoposide and platinum (cisplatin or carboplatin) is safe and useful in patients with extensive stage small cell lung cancer. 
Eligibility:  Patients with extensive stage (cancer that has spread to other parts of the body such as another lobe of the lung or the brain) small cell lung cancer

MELANOMA
ECOG 1609

The purpose of this study is to compare the effects of ipilimumab (given at 2 different doses, 10 mg/kg or 3 mg/kg) with interferon alfa-2b on melanoma to find out which is better. In this study, patients will get ipilimumab (either at 10 mg/kg or 3 mg/kg) or the interferon alfa-2b.  Interferon alfa-2b is currently the standard treatment for patients with melanoma who are free of disease but at high risk for recurrence.
Eligibility:  Patients with completely resected high-risk (Stage IIIB, IIIC, or IV with mets only to skin, lymph node or lung) primary cutaneous melanoma

MULTIPLE MYELOMA
None available at this time.