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Current Cancer Clinical Trials

The Cancer Research Department at the Coborn Cancer Center opens new clinical trials on a regular basis. Please contact the research staff at 320-229-4907 for information on these or additional studies that may be open and available to treat, control or prevent cancer. A sample of cancer research trials currently open to enrollment at the Coborn Cancer Center is listed below.

Treatment Trials, Control Trials, Prevention Trials, Registry Trials

For a listing of additional trials, visit the web site of the National Cancer Institute.

Treatment Trials

Brain/Central Nervous System

 N1174 Phase I / Comparative Randomized Phase II Trial of TRC105 Plus Bevacizumab versus Bevacizumab in Bevacizumab-Naive Patients with Recurrent Glioblastoma Multiforme                                                       This study is for patients with recurrent glioblastoma multiforme, a kind of brain tumor. People who are not in a study are usually treated with bacacizumab, an FDA approved chemotheraphy drug. For patients who receive bavacizumab chemotheraphy, on average 50 out of 100 have not had further progression of the cancer again at 3.5 months. The purpose of this study is to compare any good and bad effects of using a combination of the chemotherapy drug, TRC105, with the usual approach chemotherapy drug bevacizumab to using the usual approach bevacizumab drug alone. The addition of TRC105 with bavacizumab could shrink the cancer but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same or worse than the usual approach. To be better, the TRC105 should increase life by six months or more compared to the usual approach. This chemotherapy drug Bevacizumab is already FDA approved for use in treating glioblastoma multiforme.                                         

Breast

E1Z11 / A Cohort Study to Evaluate Genetic Predictors for Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS)

The purpose of this study is to find out what effects, good and/or bad, that anastrozole has on you, and whether your genes and blood can help explain how the study drug, anastrozole, affects you. Specifically, many women who take anastrozole report muscle and joint aches, however, the reasons that lead to these symptoms are not known. These symptoms have been designated aromatase inhibitor-associated musculoskeletal syndrome (AIMSS). Small studies have suggested that a person’s genetic information may help us to develop a way to predict who would develop side effects and how best to treat them. In addition, we hope to look at how the side effects from hormone therapy influence quality of life and a patient’s willingness to continue hormonal treatment.

Z11102 / Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients with Multiple Ipsilateral Breast Cancers (MIBC)

The purpose of this research study is to determine whether breast conservation surgery, also called lumpectomy, the removal of only the tumor tissues from the breast, is as effective as mastectomy, or the removal of the entire breast, at keeping the cancer from returning.

B-47 / A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer

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.

S1007 / A Phase III Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/ Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and
HER2-Negative Breast Cancer with Recurrence Score of 25 or Less.

We are using the Oncotype DX® to determine whether patients are eligible to continue to the treatment part of this clinical trial. We are asking that you give permission for your breast cancer tissue to be tested.

If the recurrence score is higher than 25, the risk that the cancer may come back is higher than the limit we will be testing in the treatment part of this study. In this case, we ask that you discuss other treatment studies with your study doctor.

If the recurrence score is 25 or lower, we ask that you discuss participation in this study with your study doctor and consider joining the study. If you choose not to join the study, we will also ask you to let us know what kind of treatment you have chosen.

B-43 / A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER-2 Positive Ductal Carcinoma in Situ Resected by Lumpectomy

This study is being done to compare the effects, good and/or bad, of adding the drug trastuzumab (also called Herceptin®) to breast radiation therapy. Radiation therapy is the standard treatment for patients with DCIS.

This study will find out if adding trastuzumab to breast radiation therapy is more effective than radiation therapy without trastuzumab in preventing occurrence of breast cancer in the same breast, in the other breast, or in other parts of the body in patients with HER2-positive DCIS.

S1207, "Phase III Randomized, Placedbo-Controlled Clinical Trial Evaluation the use of Adjuvant Endocrine Therapy +/- one year of Everolimus in patients with high-risk hormone receptor-positive and her2/neu negative Breast Cancer." e3 Breast Cancer Study - evaluation everolimus with endocrine therapy."

The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without your cancer returning.  The current standard treatment after chemotherapy is hormone treatment alone.  Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney or breast cancer.   It is considered investigational for non-metastatic breast cancer patients.   In this study you will get hormone treatment with either everolimus or with placebo (a pill with no medication). The combination of hormone-treatment and everolimus is experimental in patients with breast cancer.

2011014 Randomized, Phase 2 Study to Estimate the Effect of Prophylactic Intervention with Naproxen or Loratadine On Bone Pain in Breast Cancer Subjects Receiving Chemotherapy and Pegfilgrastim
The purpose of this study is to learn more about whether taking naproxen, a non-steroidal anti-inflammatory (NSAID) or loratidine (an anti-histamine) can lessen any bone pain subjects may have during chemotherapy treatment.  Participants in this study will have breast cancer, and be receiving a certain type of chemotherapy and a drug known as pegfilgrastim, which helps strengthen your immune system during chemotherapy. A side-effect of pegfilgrastim is bone pain and this study will see if naproxen or loratadine can help lessen any bone pain participants may have.  The use of naproxen and loratadine in this study is considered investigational. 

RU011201I A Randomized Phase III Trial of Eribulin Compared to Standard Weekly Paclitaxel as First or Second Line Therapy for Locally Recurrent or Metastatic Breast Cancer
The purpose of this research study is to determine of Halaven will work better than paclitaxel for persons with breast cancer who have developed another tumor in breast area that cannot be removed surgically or who have spread of the breast cancer to another part of the body. 

A011202 A RANDOMIZED PHASE III TRIAL EVALUATING THE ROLE OF AXILLARY LYMPH NODE DISSECTION IN BREAST CANCER PATIENTS  WHO HAVE POSITIVE SENTINEL LYMPH NODE DISEASE AFTER NEOADJUVANT CHEMOTHERAPY
The purpose of this study is to examine whether removing some of the lymph nodes from the arm pit, but not removing them all followed with radiation therapy (experimental) will be as good as having the majority of the lymph nodes from the arm pit removed during breast surgery followed with radiation (standard of care).

B-51  A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chest Wall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

The main purpose of this clinical trial is to study women who have cancer cells in the lymph nodes at the time that the breast cancer is diagnosed and have chemotherapy before surgery that clears the cancer cells from the lymph nodes.  This study asks 1) if, after lumpectomy, radiation to the breast and lymph nodes will be better than radiation only to the breast at keeping breast cancer from returning, and 2) if, after mastectomy, radiation to the area where the breast used to be and to the lymph nodes is better than no radiation at keeping breast cancer from returning.

Bladder

C90601 / A Randomized Double-Blind Phase III Comparing Gemcitabine, Cisplatin and Bevacizumab to Gemcitabine, Cisplatin and Placebo in Advanced Transitional Cell Carcinoma

The purpose of this study is to compare the effects of the combination of the chemotherapy drugs gemcitabine and cisplatin (chemotherapy) with the combination of gemcitabine, cisplatin, and the experimental drug bevacizumab on transitional cell cancer to find out which is better. Bevacizumab is an antibody that we think can block a protein called VEGF and inhibit the growth of new blood vessels. Bevacizumab has been approved by the FDA for the treatment of metastatic colorectal, lung, and breast cancer, but for transitional cell carcinoma, it is not FDA-approved and should be considered experimental.

Carcinoid

There are no current carcinoid studies.

Colon & Rectal

S0820 / A Double Blind Placebo-Controlled Trial of Elfornithine 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

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. Sulindac is commercially available but is not approved for this indication. Oral eflornithine is an investigational agent and not approved by the FDA.

N1048 / A Phase II/III Trial of Neoadjuvant FOLFOX, with Selective Use of Combine Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision

The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy using a combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin and leucovorin) and selective use of the standard treatment, depending on response to the FOLFOX. The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved and have been used routinely since 2002 to treat patients with advanced colorectal cancer.

C80702 / A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer

This study is being done to evaluate the effects of different chemotherapy treatments. One of the common combinations of chemotherapy drugs used to treat your type of cancer includes 5-fluorouracil (also called 5-FU), leucovorin and oxaliplatin, and is also called “FOLFOX”. At the present time, 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).

Esophagus or Gastric

RTOG 1010 A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma

This study is being done to compare the effects, good and/or bad, of the addition of trastuzumab to standard chemotherapy, radiation, and surgery for patients with HER2 positive esophageal cancer.

Head & Neck

E1305 / A Phase III Randomized Trial of Chemotherapy with or without Bevacizumab In Patients with Recurrent Or Metastatic Head and Neck Cancer

The purpose of this study is to compare the effects of the addition of a drug called bevacizumab to the standard chemotherapy to see which works better. We will determine if the combination of standard chemotherapy (cisplatin and docetaxel or cisplatin and 5-FU) and bevacizumab can increase the effectiveness of treatment for head and neck cancer. This combination is experimental. We will determine if the adding bevacizumab to standard therapy produces results that are better than those we would ordinarily expect. Currently, we do not know whether using bevacizumab will be effective. This is a subject of this study. Bevacizumab is approved by the Food and Drug Administration (FDA) for another type of cancer, colorectal cancer, but is not approved for head and neck cancer.

Hematology

 There are no current hematology studies.

Leukemia

A041202 A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients ( ≥ 65 Years of Age) with Chronic Lymphocytic Leukemia (CLL)
The purpose of this study is to compare the effects, good and/or bad, of the drug ibrutinib, either alone or in combination with the drug rituximab, with the standard treatment for this disease. The standard treatment is chemotherapy with the drug bendamustine in combination with the drug rituximab. The effects on leukemia will be looked at to find out which treatment is better. Both bendamustine and rituximab are approved by the FDA to treat chronic lymphocytic leukemia. Ibrutinib is FDA approved for patients who have received previous treatment for CLL. For this study, ibrutinib is considered investigational. The combination of the drugs ibrutinib and rituximab (Arm 3) is also considered investigational. In this study, you will get either the drug ibrutinib alone, or ibrutinib with rituximab, or bendamustine with rituximab.

Lung

Non-Small Cell Lung

RC1126 / A Randomized Phase II Trial of Erlotinib Alone or in Combination with Bevacizumab in Patients with Non-Small Cell Lung Cancer and Activating Epidermal Growth Factor Receptor Mutations

The purpose of this research study is to:

Find out if erlotinib alone or erlotinib along with bevacizumab will work better for patients with non-small lung cancer. 
Find out what effects, good and/or bad, erlotinb alone or erlotinib along with bevacizumab has on you and your non-small cell lung cancer.
Small Cell Lung

There are no current small cell lung studies.

Lymphoma

E1412 Randomized Phase II Open Label Study of Lenalidomide R-CHOP (R2CHOP) vs RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) in Patients with Newly Diagnosed Diffuse Large B Cell Lymphoma
The purpose of this study is to find out what effects, good and/or bad, the addition of lenalidomide to standard chemotherapy (RCHOP) has on lymphoma. Everybody in this study will receive standard chemotherapy. In addition to standard chemotherapy randomly chosen half of the patients will receive a medication called lenalidomide. Adding lenalidomide to the standard chemotherapy RCHOP is considered experimental in diffuse large B cell lymphoma, and is not FDA approved. There is NO placebo (“sugar pill”) in this study, and everybody selected will receive an active medication.             

CC-5013-NHL-007  A Phase 3, Double-Blind Randomized Study to Compare The Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Placebo in Subjects with Relapsed/ Refractory Indolent Lymphoma

The purpose of this study is to find out if a drug called lenolidomide when given along with Rituximab can help to control the disease and also increase the length of remission. 

Melanoma

 There are no current melanoma studies.

Myeloma

There are no current myeloma studies.

Ovarian

There are no current ovarian studies.

Pancreatic

There are no current pancreatic studies.

Prostate

S1216 / A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer"

The purpose of this study is to find out what effects (good and/or bad) there are to adding the new investigational drug TAK-700 (also called orteronel) to standard hormone therapy which is used to treat prostate cancer as compared to the standard of hormone therapy alone.  The combination of TAK-700 and standard hormone therapy is considered experimental.

TAK-700 is a pill that works by reducing the levels of testosterone and other male hormones that help your prostate cancer grow.  TAK-700 acts on the adrenal glands and inside the prostate tumors and slows the amount of male hormones being produced.  By lowering the amount of male hormones in your body, TAK-700 is expected to control the growth of your prostate cancer.

C70807 / The Men’s Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance

The purpose of the study is to find out more about how diet may prevent prostate cancer from getting worse.

RTOG 0534 / Phase III Trial of Short Term Androgen Deprivation with Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPORT) in Prostatic Cancer Patients with a Rising PSA After Radical Prostatectomy

The purpose of this study is to compare the effects of three treatment methods on participants and their cancer. 

There are 3 treatment groups in this study:

  1. Patients who receive radiation therapy to the prostate bed only;
  2. Patients who receive hormone therapy for 4 to 6 months plus radiation therapy to the prostate bed;
  3. Patients who receive hormone therapy for 4 to 6 months plus radiation therapy to the prostate bed and to the pelvic lymph nodes.

CALBG 90203 / 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

The purpose of this study is to compare the effects (good and bad) of the combination of chemotherapy and hormone therapy followed by radical prostatectomy (surgery to remove your prostate) with radical prostatectomy alone to see which is better.

Renal

E2810 / Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients with Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastatectomy

The purpose of this study is to determine whether taking an oral drug known as pazopanib (Votrient®) will reduce the risk of the cancer recurring in the future.

Pazopanib is approved by the FDA for patients who have metastatic renal cell carcinoma.  However, it has not been tested in patients who have had all visible areas of their cancer removed surgically, and is considered experimental in this situation. We don’t know if pazopanib will be helpful to patients in this scenario.  There is currently no standard of care for patients in this situation but careful observation without treatment is considered reasonable

S0931/ "EVEREST:  EVErolimus for Renal Cancer Ensuing Surgical Therapy, a Phase III Study"

The purpose of this study is to see whether treatment with everolimus after surgery for kidney cancer will increase the time without cancer returning.  The current standard treatment after surgery is careful monitoring with no immediate treatment.  Studies suggest that one way kidney cancer may grow is through chemical signaling through a protein named “mTOR”.  Everolimus is a drug that stops signaling through mTOR and may therefore stop the growth of kidney cancer.  Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney cancer.  It is considered investigational for use after surgery.  In this study, you will get either everolimus or placebo (a pill with no medication).

A031203 Randomized Phase II study comparing cabozantinib with commercially supplied sunitinib in patients with previously untreated locally advanced or metastatic renal cell carcinoma

The purpose of this study is to find out what effects, good and/or bad, two study drugs called sunitinib and cabozantinib have on you and on advanced or metastatic kidney cancer. Sunitinib has been approved by the FDA and cabozantinib is an investigational drug. Both medications target special proteins that are on the surface of the kidney cancer cell and both drugs are taken by mouth.

 

Control Trials

N107C / A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared with Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease

The purpose of this research study is to compare overall survival and to compare the effects (good and bad) of stereotactic radiosurgery (SRS) to whole brain radiation therapy (WBRT) on you and your brain metastases.

 

Prevention Trials

There are no current prevention trials.

 

Registry Trials

AIMMS / Adults in MN with Myelodysplastic Syndrome

This study is being done to learn more about myelodysplastic syndrome. Myelodysplastic syndrome (MDS) is a blood cancer that affects about 10,000 people in the United States each year. Little is known about why MDS happens or why some people with MDS eventually develop leukemia. We are proposing one of the largest epidemiological studies of MDS ever conducted, with the goal of being able to identify risk factors that could lead to prevention.  This case-control epidemiology study was designed to investigate the causes of MDS in Minnesota.

20130110 Prospective Study of the Relationship between Chemotherapy Dose Intensity and Mortality in Early-Stage (I-III) Breast Cancer Patients

This is an observational research study. This means that patients in this study will receive regular medical care from their doctors. Information about your regular medical care will be copied from your medical chart and used for this study. This study will look at how the dose of chemotherapy women with breast cancer receive is related to how long they live. This study will also look at how medicines to prevent febrile neutropenia are being used in women receiving chemotherapy for breast cancer. Febrile Neutropenia is fever in conjunction with low white blood cell count that is sometimes caused by chemotherapy treatment. For this study, you will not be asked to do any extra medical tests or receive extra medications. Your doctor will provide routine care as he/she normally would for your condition. In addition, you might be asked to answer some questions in the form of a survey / questionnaire.

20130110 Prospective Study of the Relationship between Chemotherapy Dose Intensity and Mortality in Early-Stage (I-III) Breast Cancer Patients

 This is an observational research study. This means that patients in this study will receive regular medical care from their doctors. Information about your regular medical care will be copied from your medical chart and used for this study. This study will look at how the dose of chemotherapy women with breast cancer receive is related to how long they live. This study will also look at how medicines to prevent febrile neutropenia are being used in women receiving chemotherapy for breast cancer. Febrile Neutropenia is fever in conjunction with low white blood cell count that is sometimes caused by chemotherapy treatment. For this study, you will not be asked to do any extra medical tests or receive extra medications. Your doctor will provide routine care as he/she normally would for your condition. In addition, you might be asked to answer some questions in the form of a survey / questionnaire.

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