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

Brain / Central Nervous System	Esophagus or Gastric	Lung	Ovarian
Breast	Head and Neck	Lymphoma	Pancreatic
Bladder	Hematology	Melanoma	Prostate
Carcinoid	Leukemia	Myeloma	Renal
Colon and Rectal

Brain / Central Nervous System

N0877 Phase I / Randomized Phase II Trial of Either Dasatinib or Placebo Combined with Standard Chemo-Radiotherapy for Newly Diagnosed Glioblastoma Multiforme (GBM)

The purpose of this research study is to:

• Add dasatinib to the standard treatment temozolomide and radiation, to see if this combination is better than the current standard treatment of radiation therapy and temozolomide. Dasatinib helps to stop signals that cause tumors to grow. Dasatinib is FDA approved for treating certain cancers but is currently not approved for use in treating brain cancer. Therefore the use of dasatinib in this study is considered investigational.

• Test the safety of the dasatinib when given in combination with temozolomide.

N0872 / Phase I/Randomized Phase II Double Blind Study of Either Dasatinib or Placebo Combined with Bevacizumab in Recurrent Glioblastoma

The purpose of this research study is to: 

• Find out what effects, good and/or bad, the combination of dasatinib and bevacizumab have on cancer.
• Find out if the combination of dasatinib and bevacizumab can help you get better.
• Find out if there are individual differences and/or tumor characteristics that will affect response to treatment.
  
  The use of dasatinib and bevacizumab in this study is considered investigational.

Breast

8129 / A Phase I/II trial of IMC-A12 in Combination with Temsirolimus in Patients with Metastatic Breast Cancer

The purpose of this study is to find out what effects, good and/or bad, IMC-A12 and temsirolimus has on you and your metastatic breast cancer. These drugs act by blocking the signals of growth in tumors. Therefore, IMC-A12 and temsirolimus may stop the growth and spread of your metastatic breast cancer.

RTOG 1005 / A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation Plus Concurrent Boost Versus Standard Whole Breast Irradiation Plus Sequential Boost for Early Stage Breast Cancer.

The purpose of this study is to compare radiation therapy given with a higher daily dose over 3 weeks with a boost given each day of radiation therapy compared with standard whole breast radiation followed by a boost given on separate days which extends over 6 to 6 ½ weeks.  It is not expected that there would be a difference in survival by changing the number of daily treatments and shortening the length of time needed for treatment.  However, shortening treatment length could be more convenient and save time and money. It is not known, but it is hoped, that the higher daily dose of radiation to the breast has the same chance or better of preventing the breast cancer returning compared to standard daily doses of radiation.

B-49 / 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

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.

11-PIR-11 / The BEACON study (Breast Cancer Outcomes with NKTR-102): A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physicians Choice (TPC) in Patients with Locally Recurrent or Metastatic Breast Cancer Previously Treated with an Anthracylcine, a Taxane, and Capecitabine

The purpose of this study is to test whether NKTR-102 compared with standard treatment for breast cancer, also called “treatment of physician’s choice”, is safe and effective in treating patients with advanced breast cancer. For the “treatment of physician’s choice”, your doctor will offer you one drug from a list of standard of care drugs available in your country for the treatment of breast cancer. This will be a drug that your doctor would prescribe for you if you were not participating in a research study. In all countries, the following standard of care drug options are available: vinorelbine (Navelbine®), gemcitabine (Gemzar®), paclitaxel (Taxol®) or docetaxel (Taxotere®). Depending on what country you live in, the following treatment options may also be available: eribulin (Halaven®), ixabepilone (Ixempra®), or nab paclitaxel (Abraxane®). If you are not randomly assigned to receive NKTR 102, your doctor will discuss the best drug option for you (including its activity in breast cancer and the drug’s side effects). You will be provided with an additional (supplemental) part of this consent to read which will give you more information about the drug your doctor offers you.

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.

B025126 (Aphinity) / A randomized multicenter, double-blind, placebo-controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive primary breast cancer. 

The aim of this study is to investigate a new drug called pertuzumab, which also acts on the HER2 marker but in a different way to trastuzumab. Pertuzumab is a research drug and is not yet licensed for HER2-positive breast cancer. 

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.

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.

Esophagus or Gastric (Stomach)

There are no current esophagus/gastric studies.

Colon and 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.

RC09C8 /  A Two-Part, Phase II Randomized Trial to Explore Topical Spironolactone to Prevent/Attenuate Rash from Epidermal Growth Factor Inhibitors (Panitumumab and Cetuximab) in Advanced Cancer Patients.

The purpose of this research study is to:
•Compare if spironolactone 5% gel is better than placebo (inactive agent) in preventing a rash that often occurs during the first 4 weeks with one of the drugs you are currently on or will be taking.  Spironolactone 5% gel is a product that has been used to treat other skin conditions in the past.  However its use in this study is not FDA approved and is therefore considered investigational.
•See what side effects may occur when you using spironolactone or the placebo in this manner.

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).

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 (Kidney)

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). 

Lymphoma

There are no current lymphoma studies.

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.

Melanoma

E1609 / A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon α-2b for Resected High-risk Melanoma

The purpose of this study is to compare the effects, good and/or bad, of ipilimumab with interferon alfa-2b on melanoma to find out which is better. In this study, you will get either ipilimumab or the interferon alfa-2b. You will not get both. We plan to determine whether ipilimumab stops or delays your cancer from returning in comparison to interferon alfa-2b

N0879 / A Randomized Phase II Trial of Carboplatin, Paclitaxel, Bevacizumab with or without Everolimus for Therapy of Metastatic Malignant Melanoma

This research study is being done to:
• Find out what effects the combination of study drugs has on melanoma
Group A: Carboplatin, paclitaxel, and bevacizumab
Group B: Carboplatin, paclitaxel, bevacizumab, and everolimus.
• Find out what effects the combination of study drugs has on the immune system and the way the tumor grows

Paclitaxel, carboplatin, bevacizumab, and everolimus are chemotherapy drugs that are FDA approved to treat certain types of cancer. However, the drugs and combinations listed above have not been approved for the treatment of melanoma; so their use in this study is considered investigational.

Head and 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

S1117 / A Randomized Phase II Study of Azacitidine in Combination with Lenalidomide vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat for Higher-Risk Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML)

The purpose of this study is to compare the effects, good and/or bad on you and your MDS or CMML, of adding either the drug lenalidomide or the drug vorinostat to the regular treatment drug azacitidine.  In this study, you will be on one of the following treatment arms:  azacitidine alone, azacitidine and lenalidomide or azacitidine and vorinostat.  The combinations of azacitidine and lenalidomide or azacitidine and vorinostat are considered investigational.

Leukemia

There are no current leukemia studies.

Myeloma

There are no current myeloma studies.

Ovarian

There are no current ovarian studies.

Pancreatic

There are no current pancreatic studies.

Control Trials

RTOG 1012 / Phase II Randomized Trial of Prophylactic Manuka Honey for the Reduction of Chemoradiation Therapy Induced Esophagitis-related Pain during the Treatment of Lung Cancer

The purpose of this study is to compare the effects, good and/or bad, of standard supportive care with honey on esophagitis-related pain to find out which is better. In this study, you will get either the standard supportive care or the honey. However, if you receive the honey and it does not prevent esophagitis-related pain, your doctor will give you medicine to help with your pain.

V212 -011-00 / Phase III Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of V212 in Adult Patients with Solid Tumor or Hematologic Malignancy

The purpose of this study is to:
• Test the safety and tolerability of the research study vaccine, V212 in the prevention of shingles in subjects with solid tumor malignancy or hematologic malignancy.
• Compare the effectiveness of the research study vaccine, V212 in the prevention of shingles in subjects with solid tumor malignancy or hematologic malignancy to placebo (a vaccine with no active ingredients).
• See how well the study vaccine works in subjects with weakened immune systems (decreased ability to fight infection), in the prevention of shingles

RC11C3 / Pilot Placebo-controlled Evaluation of Pregabalin as a Means to Prevent the Paclitaxel Associated Pain Syndrome

It is well known that paclitaxel can cause side effects on nerves that result in symptoms such as aches and pains and also tingling or numbness of fingers and toes which can interfere with activities of daily living.  In some patients, the chemotherapy has to be stopped because of these symptoms. 

The purpose of this study is to compare the effects, good and/or bad, of pregabalin with placebo (an inactive agent) on symptoms caused by paclitaxel.

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.

N07C4 / A Phase II trial evaluating two non-pharmacologic interventions in cancer survivors for the treatment of sleep-wake disturbances

The purpose of this research study is to:
• Look at the effect of two types of behavioral interventions to improve sleep.

Behavioral interventions are things people can do by themselves to try and improve a symptom, such as sleep.  Exercise is an example of a behavioral intervention that is used to improve fatigue.  The two types of behavioral interventions being tested in this study is the use of two types of pre-recorded mp3 device as well as following some rules related to sleep. 

N0574 / Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients with One to Three Cerebral Metastases

The purpose of this research study is to compare overall survival and to compare the effects of radiosurgery (SRS) to radiosurgery plus whole brain radiation therapy (WBRT) on 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.