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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

A071102 A Phase II/III Randomized Trial Of Veliparib Or Placebo In Combination With Adjuvant Temozolomide In Newly Diagnosed Glioblastoma With MGMT Promoter Hypermethylation

The purpose of this study is to compare the effects, good or bad of the usual treatment (temozolomide) with or without the addition of the investigational drug veliparib for people whose brain tumors show a change in a small region of DNA (gene) called O6-methylguanine methyltransferase (MGMT). Your tumor showed this change, called MGMT methylation, and researchers want to see if veliparib combined with temozolomide has an effect in your particular type of brain tumor.  Veliparib is not approved by the FDA for any type of cancer at this time.  There will be approximately 440 participants in this study.

The use of TMZ is the standard of care. The combination of veliparib with TMZ is experimental. Veliparib is an investigational drug that has not been approved by the FDA for any indication.

Breast

A011203A Randomized Phase II Trial of Tamoxifen Versus Z-Endoxifen HCl in Postmenopausal Women with Metastatic, Estrogen Receptor Positive, HER2 Negative Breast Cancer

The purpose of this study is to compare any good and bad effects of using Z-Endoxifen HCL to using tamoxifen. Z-Endoxifen HCL could shrink your cancer and prevent it from spreading, but it could also cause side effects. This study will allow the researchers to know whether this new approach is better, the same, or worse than the usual approach of using tamoxifen. To be better, the study approach should increase the time to cancer progression by 3 months or more compared to the usual approach.

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.

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.

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.

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).

BR003 A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or Without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

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).

S1406 Randomized Phase II Study of Irinotecan and Cetuximab with or without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer

BRAF is a human gene that makes a protein called B-raf. This protein is involved in sending signals to the cells which direct cell growth. BRAF tumor testing is common for this type of cancer. The performance of the test is not part of the research question in this study. If your tissue has a BRAF mutation, you will be eligible to participate in the next part of the study.

The purpose of the treatment part of the study is to compare any good and bad effects of using vemurafenib along with the usual chemotherapy approach alone. The addition of vemurafenib to the usual chemotherapy could shrink your 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.

Esophagus or Gastric

There are no current studies. 

Head & Neck

 There are no current studies.

Hematology

E2905 Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment with Lenalidomide (Revlimid®) Alone and in Combination with Epoetin Alfa (Procrit®) in Subjects with Low- or Intermediate-1 Risk MDS and Symptomatic Anemia

The purpose of this study is to compare how a drug called lenalidomide affects (good or bad) you and your condition when given alone compared with when given with another drug called epoetin alfa (Procrit). We want to find out which is better. 

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.

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

The purpose of this research study is to examine lung cancer patients’ surgically removed tumors for certain genetic changes, and to possibly refer these patients to a treatment study with drugs that may specifically target tumors that have these genetic changes.

A genetic test will be done to learn if your tumor has any of these genetic changes. This test will look at the genetic material of the tumor cells. All tissues in the body are made up of cells.  Those cells contain DNA, which is your unique genetic material that carries the instructions for your body’s development and function.  Cancer can develop when changes in certain genes cause those cells to divide in an uncontrolled way and, sometimes, to travel to other organs.

We are interested to see if your tumor tissue might have one of the following two genetic changes:

•          Genetic changes in ALK (this will be referred to as ALK )

•          Genetic changes in EGFR (this will be referred to as EGFR)

ALK and EGFR are both proteins found on the surface of cells. If your tumor is found to have one of these genetic changes you may be invited to participate on a trial that will look at drugs which may target tumors that have these specific genetic changes. 

A081105  Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)

The purpose of this study is to compare any good and bad effects patients may have when treated with the standard treatment against patients who are treated with the standard treatment plus erlotinib (an investigational drug). You are being asked to take part in this research study because you have early stage non-small cell lung cancer that was surgically removed and may have been treated with chemotherapy and/or radiation. The tumor removed has a mutation of a gene called EGFR (Epidermal Growth Factor Receptor). We are trying to find out if this mutation could help us make decisions about which type of treatment is best for people with your type of cancer.

A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

The purpose of this research study is to compare any good and bad effects of using the study drug, crizotinib (also known as XALKORI®), after completion of surgery and, in some cases, after chemotherapy and/or radiation therapy for ALK-positive non-small cell lung cancer. The addition of crizotinib may help prevent your cancer from returning, but it could also cause side effects.

U31287-A-U301 Phase 3, Randomized, Placebo Controlled, Double Blind Multicenter, Two-Part Study of Patritumab in Combination with Erlotinib in EGFR Wild-Type Subjects with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSLC) Who Have Progressed on at Least One Prior Systemic Therapy.

Lymphoma

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

E3612 A Randomized Phase II Trial of Ipilimumab with or Without Bevacizumab in Patients with Unresectable Stage III or Stage IV Melanoma

The purpose of this research study is to compare the good and bad effects of using the study drug called ipilimumab either alone or in combination with the study drug called bevacizumab.

Myeloma

There are no current myeloma studies.

Ovarian

NRG-CC002 Pre-operative evaluation for older women undergoing surgery for gynecologic cancer.

The purpose of this study is to see if a geriatric assessment tool in the form of a series of questions and lab work, given before surgery, will help predict complications from surgery in older women undergoing surgery for gynecologic cancers

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.

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.

ONC-MA-1004 Trumpet A Prospective Observational Cohort Study of Patients with Castration-Resistant (CRPC) in the United States

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

 

 

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.

REVEAL (INCB-MA-PV-401) Prospective, Non-interventional Study of Disease Progression and Treatment of Patients with Polycythemia Vera (PV) in United States Academic or Community Clinical Practices

The purpose of this study is find out more information about people with PV, follow the course of the disease in these people and find out how the disease and standard medical care affect the daily life people being treated for PV.

ONC-MA-1004  A Prospective Observational Cohort Study of Patients with Castration-Resistant (CRPC) in the United States

The main reason why this registry is being set up is to describe patterns of care, disease assessment methods, treatment decisions, treatment settings, physician referral patterns and to find out how your CRPC symptoms have improved while on CRPC therapy.