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.
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.
NRG-BN001 Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation with Concomitant and Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma
The purpose of this study is to compare a different radiation therapy schedule and higher radiation dose [higher dose group] to the standard dose of radiation therapy [standard dose group]
NRG-CC001 A Randomized Phase III Trial of Memantine and Whole-Brain Radiotherapy with or without Hippocampal Avoidance in Patients with Brain Metastases
The purpose of this study is to compare any good and bad effects of avoiding the hippocampus during whole-brain radiation plus memantine to using the usual whole-brain radiation plus memantine. The hippocampus is a brain structure that is important for memory. The addition of the hippocampal avoidance technique to the usual whole-brain radiation plus memantine will decrease the dose of radiation to your hippocampus
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.
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
PALLAS AFT-05 A Randomized Phase III Trial of Palbociclib with Standard Adjuvant Endocrine Therapy versus Standard adjuvant Endocrine Therapy Alone for hormone receptor (HR+)/human epidermal growth factor receptor 2 (HER2) negative early breast cancer.
The purpose of this study is to compare any good and bad effects of using 2 years of Palbociclib in combination with standard anti-hormone therapy to using standard anti-hormone therapy alon and to evaluate the likelihood that invasive breast cancer returns.
B-55/A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant Chemotherapy
The purpose of this study is to compare the addition of olaparib after the usual care of chemotherapy, surgery, and radiation for your type of cancer.
A011401Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer
This study is being done to see if losing weight may help prevent breast cancer from coming back (recurring). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed.
S1416 Phase II Randomized Placebo-Controlled Trial of Cisplatin with or without ABT-888(Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer
The main purpose of this study is to compare any good and bad effects of using ABT-888 (Veliparib) (a “PARP” inhibitor) along with cisplatin to using cisplatin alone. The drug being tested in this study is called ABT-888.
EA1131 A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy vs. Observation in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy
The main purpose of this study is to compare getting more treatment with capecitabine (i.e. one of the usual approaches), to any good and bad effects of getting more treatment with a platinum-based chemotherapy (cisplatin or carboplatin), after surgery.
B-51 A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axiallary Nodes After Neoadjuvant Chemotherapy
The main purpose of this clinical trial is to study women like you 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
A011502 A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive HER2 Negative Breast Cancer: The ABC trial
This study will evaluate whether patients taking aspirin once per day will have a lower rate of cancer recurrence than patients taking a placebo
There are no current bladder studies.
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.
NRG GI002 A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer
The purpose of this study is to learn if adding an experimental drug, veliparib (also known as ABT-888), to a usual treatment is better than the usual treatment alone.
Esophagus or Gastric
There are no current studies.
Head & Neck
There are no current studies.
There are no current studies.
ACE-CL-006 A Randomized, MultiCenter, Open-Label, Non-Inferiority, Phase 3 Study of ACP-196 Versus Ibrutinib in Previously Treated Subjects with High Risk Chronic Lymphocytic Leukemia
The purpose of this study is to determine if the experimental drug ACP-106 is safe and effective for this disease.
ACE-Cl-309 A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACE-196) Versus Investigator’s Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia
The purpose of this study, which involves research, is to determine if the experimental drug acalabrutinib is safe and effective in the treatment of this disease in comparison with the approved treatment of rituximab with either idelalisib or bendamustine.
Non-Small Cell Lung
There are no current non-small cell lung studies.
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.
EA5142 Adjuvant Nivolumab in Resected Lung Cancers (ANVIL)- A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers.
The purpose of this study is to find if adding the study drug, nivolumab (also known as OPDIVO®), will limit lung cancer from growing back in patients with early stage non-small cell lung cancer.
E4512 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 Lymphona 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.
There are no current lymphoma studies.
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.
A061202 A Phase I/II Study of Pomalidomide, Dexamethasone and Ixazomib vs. Pomalidomide and Dexamethasone for Patients with Multiple Myeloma Refractory to Lenalidomide and Proteasome Inhibitor-Based Therapy.
The purpose of this study is to compare the effects, good and/or bad, of the study drugs pomalidomide, ixazomib and dexamethasone, or the study drugs pomalidomide and dexamethasone, on you and your multiple myeloma to find out which is better.
NRG-GY004 A Phase III Study Comparing Single- Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women with Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
The purpose of this study is to compare the effect on your cancer of using either olaparib by itself or the combination of cediranib and olaparib to the usual chemotherapy given for your cancer
NRG GY005; RP2/3 Cediranib and Olaparib vs. Cediranib or Olaparib alone, or Standard of Care chemotherapy in Women with Recurrent Platinum-resistant or refractory ovarian, fallopian tube or primary peritoneal
This study has two parts: A Phase II part and a Phase III part. You are being asked to participate in the Phase II part of the study. The purpose of the Phase II part of the study is to compare any good and bad effects of using a combination of the investigational agents cediranib and olaparib, to using the standard chemotherapy, or cediranib alone, or olaparib alone. Cediranib is an experimental drug that may help keep cancer cells from growing by affecting their blood supply. Olaparib is a drug that may stop cancer cells from growing abnormally. Olaparib by itself has been approved by the Food and Drug Administration (FDA) for use in women with advanced ovarian cancer with BRCA1 and BRCA2 mutation who have been treated with three or more different chemotherapy treatments. The combination of olaparib and cediranib is investigational.
S1513 Randomized Phase II Study of 2nd Line FOLFIRI vserus Modified FOLFIRI with PARP inhibitor ABT-888 (Veliparib) in Metastatic Pancreatic Cancer
The purpose of this study is to compare any good and bad effects of using the investigational drug ABT-888 (Veliparib) with modified FOLFIRI compared to using FOLFIRI alone. ABT-888 is an investigational drug that targets cancer cells differently from chemotherapy. ABT-888 blocks a protein called PARP that may make cancer treatment more effective. The addition of ABT-888 to modified FOLFIRI could shrink your cancer, but it could also cause side effects.
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.
ONC-MA-1004 Trumpet A Prospective Observational Cohort Study of Patients with Castration-Resistant (CRPC) in the United States
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).