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Cancer Clinical Research Trials

Many of the standard cancer treatments used today are the result of clinical trials. Clinical trials are an integral part of cancer research because they focus on finding new, and sometimes improved, ways to prevent, diagnose, treat and manage cancer. You deserve personalized treatment plans that maximize results and minimize side effects. Participating in a clinical trial f a new treatment or procedure may be an option for you.

Norton Cancer Institute offers more than 50 innovative National Cancer Institute and industry-sponsored clinical trials in which you may qualify to participate. Our participation in these research studies allows us to offer many patients the latest, most advanced therapies for cancer – and often those that are unavailable elsewhere.

The Norton Cancer Institute Research Program has made remarkable strides and discoveries through participation in clinical trials. These breakthroughs hold promise for patients by improving the ability of our specialists to target and detect cancers early, while they are the most treatable.

Research Program

Norton Cancer Institute
315 E. Broadway
Louisville , KY 40202

For more information on available studies, call (502) 629-3449.

Brain Cancer

1. Title: Phase III trial on concurrent and adjuvant temozolomide chemotherapy in non-1p/19q deleted anaplastic glioma: the catnon intergroup trial

Sponsor: Radiation Therapy Oncology Group (RTOG)

Physician Investigator: Aaron Spalding, M.D., Ph.D.

Research Details: This study will find out what effects, good and/or bad, the addition of temozolomide has when it is given at the same time as radiotherapy, after radiotherapy, or both.



2. Title: Natural history of postoperative cognitive function, quality of life, and seizure control in patients with supratentorial low-risk grade II glioma

Sponsor: Radiation Therapy Oncology Group (RTOG)

Physician Investigator: Aaron Spalding, M.D., Ph.D.

Research Details: The purpose of this study is to understand the effects of the brain tumor and surgery on cognitive function (thinking abilities, memory), quality of life, and seizures.



3. Title: A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared with Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease

Sponsor: North Central Cancer Treatment Group (NCCTG)

Physician Investigator: Aaron Spalding, M.D., Ph.D.

Research Details: The purpose of this study is to compare stereotactic radiosurgery (SRS) to whole brain radiation therapy (WBRT).



4. Title: An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma. The “ACT IV” Study

Sponsor: Celldex

Physician Investigator: Renato V. LaRocca, M.D.

Research Details: The purpose of this research study is to find out whether adding the investigational drug rindopepimut to the commonly used chemotherapy drug called temozolomide helps to shrink brain tumors or prevents brain tumors from growing and possibly help patients with brain tumors live longer than treatment with temozolomide alone.


Brain Tumor

1. Title: Southeastern Study of Cancer and the Environment

Sponsor: Moffitt

Physician Investigator: Renato V. LaRocca, M.D.

Research Details: This information from this study could help prevent brain tumors in the future. It may also lead to earlier detection and better treatments for the disease.The study is also intended to help doctors find better ways to treat brain tumors and to find the best treatments for individual patients.


Breast Cancer

1. Title: A phase III clinical trial comparing Trastuzumab given concurrently with radiation therapy alone for women with HER2 positive ductal carcinoma in situ resected by lumpectomy.

Sponsor: National Surgical Adjuvant Breast and Bowel Project (NSABP)

Physician Investigator: Janell Seeger, M.D.

Research Details: 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 subjects with DCIS.



2. Title: A randomized, double-blind, placebo controlled, phase II study of BKM120 plus paclitaxel in patients with HER2 negative inoperable locally advanced or metastatic breast cancer, with or without PI3K pathway activation.

Sponsor: Novartis Pharmaceuticals Corp

Physician Investigator: Janell Seeger, M.D.

Research Details: The main purpose of this study is to determine whether the addition of the investigational agent BKM120 to a commonly used standard therapy (paclitaxel) is beneficial to subjects with locally advanced or metastatic breast cancer, and compare the safety profile of the combination with the standard therapy (paclitaxel).



3. Title: An open-label, phase II, single-arm study of everolimus in combination with letrozole in the treatment of postmenopausal women with estrogen receptor positive metastatic breast cancer

Sponsor: Novartis Pharmaceuticals Corp

Physician Investigator: Janell Seeger, M.D.

Research Details: This study aims to find out:

  • If the study drug everolimus (Afinitor®) combined with letrozole (Femara®) is safe and has beneficial effects in postmenopausal women with your same diagnosis.
  • If everolimus plus exemestane (Aromasin®) is safe and has beneficial effects in women after treatment with everolimus plus letrozole.
  • If a prescription mouth rinse can help reduce the severity of mouth sore/blisters (oral stomatitis), a common side effect of everolimus.



4. Title: 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

Sponsor: National Surgical Adjuvant Breast and Bowel Project (NSABP)

Physician Investigator: Janell Seeger, M.D.

Research Details: 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. A second purpose of this study is to learn if adding trastuzumab to treatment with chemotherapy will help women with HER2-low breast cancer live longer.



5. Title: A randomized, multicenter, open-label phase III study to evaluate the efficacy and safety of trastuzumba emtansine versus trastuzumba as adjuvant therapy for patients with HER2-positive primary breast cancer who have residual tumor present pathologically in the breast or axillary lymph nodes following preoperative therapy

Sponsor: Genentech, Inc.

Physician Investigator: Janell Seeger, M.D.

Research Details: The purpose of this study is to compare the effects, good or bad, of the study drug trastuzumab emtansine when compared to the drug trastuzumab (Herceptin®) on you and your breast cancer to find out which may be better in cases where there is cancer found.



6. Title: 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 Axillary Nodes After Neoadjuvant Chemotherapy

Sponsor: National Surgical Adjuvant Breast and Bowel Project (NSABP)

Physician Investigator: Janell Seeger, M.D.

Research Details: 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.


Cancer Pain

1. Title: A double blinded, randomized,placebo-controlled, parallel group of Sativex oromucosal spray as adjunctive therapy in relieving uncontrolled persisten chronic pain in patients with advanced cancer who experience inadequate analgesia during optimized chronic opioid therapy.

Sponsor: GW Pharmaceuticals

Physician Investigator: Don A. Stevens, M.D.

Research Details: Sativex may help in relieving cancer-related pain and how it compares to placebo. Sativex is an investigational drug, which means that it has not been approved by the Food and Drug Administration (FDA).



2. Title: Extension Study to 12N0112: A multicenter, non-comparative, open-label extension study to assess the long term safety of Sativex oromucosal spray (Sativex®;Nabiximols) as adjunctive therapy in patients with uncontrolledpersistent chronic cancer related pain.

Sponsor: GW Pharmaceuticals

Physician Investigator: Don A. Stevens, M.D.

Research Details: The purpose of this extension study is to investigate the safety of the drug Sativex, when used over a long period of time to relieve cancer-related pain.


Cancer Risk

1. Title: Total Cancer Care Consortium: A Lifetime Partnership with Patients Who Have or May be at Risk of Having Cancer

Sponsor: Moffitt

Physician Investigator: John T. Hamm, M.D.

Research Details: The study is designed to help find ways to prevent cancer in the future.


Cervical Cancer

1. Title: A phase III trial of adjuvant chemotherapy following chemo-radiation as primary treatment for locally advanced cervical cancer compared to chemo-radiation alone: The OUTBACK Trial

Sponsor: Gynecologic Oncology Group (GOG)

Physician Investigator: Mary E. Gordinier, M.D.

Research Details: The purpose of this study is to compare the standard treatment to the standard treatment plus additional chemotherapy.


Endometrial Carcinoma-Gynecology

1. Title: A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma

Sponsor: Gynecologic Oncology Group (GOG)

Physician Investigator: Mary E. Gordinier, M.D.

Research Details: The study is being conducted to determine if radiation therapy combined with chemotherapy administered for a total of 4 cycles offers a benefit over chemotherapy alone administered over 6 cycles.


Glioblastoma-Cental Nervous System

1. Title: EF-14 - A Prospective, Multi-center Trial of NovoTTF-100A Together With Temozolomide Compared to Temozolomide Alone in Patients with Newly Diagnosed GBM

Sponsor: NovoCure

Physician Investigator: Renato V. LaRocca, M.D.

Research Details: The purpose of this trial is to determine how well this device works compared to standard treatment, and there may be no direct benefit to you from participating in this study.



2. Title: Randomized Phase II Trial of Concurrent Bevacizumab and Re-Irradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma

Sponsor: Radiation Therapy Oncology Group (RTOG)

Physician Investigator: Aaron Spalding, M.D., Ph.D.

Research Details: The purpose of this study is to determine whether adding radiation to bevacizumab is more effective than using bevacizumab alone to treat recurrent glioblastomas.



3. Title: A phase II randomized trial comparing the efficacy of heat shock protein-peptide complex-96 (HSPPC-96) (NSC #725085, ALLIANCE IND #15380) vaccine given with bevacizumab versus bevacizumab alone in the treatment of surgically resectable recurrent glioblastoma multiforme (GMB)

Sponsor: Alliance / RTOG

Physician Investigator: David A. SunM.D.,Ph.D.

Research Details: The purpose of this study is to compare the effects on your brain tumor with a vaccine called heat shock protein peptide complex 96 (HSPPC-96) given with a drug called bevacizumab or bevacizumab alone.


Leukemia-Hematology

1. Title: An open label randomized phase III study of Inotuzumab Ozogamicin compared to a defined investigator's choice in adult patients with relasped or refractory CD22-positive acute Lymphoblastic Leukemia (ALL)

Sponsor: Pfizer

Physician Investigator: Don A. Stevens, M.D.

Research Details: The main purpose of this research study is to learn if using the study drug, inotuzumab ozogamicin, is more or less effective when compared to standard chemotherapy regimens for your disease.



2. Title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma

Sponsor: Janssen Research & Development

Physician Investigator: Don A. Stevens, M.D.

Research Details: The purpose of this study is to compare the effects (both good and bad) of an investigational drug, Ibrutinib, when it is given along with Bendamustine and Rituximab as compared to Bendamustine and Rituximab alone.



3. Title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor,PCI-32765 (Ibrutinib), in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

Sponsor: Janssen Research & Development

Physician Investigator: Don A. Stevens, M.D.

Research Details: The purpose of this study is to determine the effects (both good and bad) of ibrutinib when it is given in combination with the drugs normally used to treat this cancer: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (abbreviated as ?R-CHOP?) as compared to the use of R-CHOP and placebo (looks just like ibrutinib and is given the same way but has no active drug in it).


Myeloid Leukemia-Hematology

1. Title: Phase III Randomized Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin & Cytarabine Induction and Intermediate Dose Cytarabine Post-Remission Therapy, Followed by Decitabine Maintenance vs. Observation in Newly-Diagnosed Acute Myeloid Leukemia in Older Adults (Age ≥ 60 Years)

Sponsor: National Surgical Adjuvant Breast and Bowel Project (NSABP)

Physician Investigator: Don A. Stevens, M.D.

Research Details: This study is being done to determine which treatment is best for older patients with newly diagnosed AML.


Non-Hodgkin Lymphoma-Hematology

1. Title: A Phase 2 Study of IPI-145 in Subjects with Refractory Indolent Non-Hodgkin Lymphoma

Sponsor: Infinity Pharmaceuticals

Physician Investigator: Don A. Stevens, M.D.

Research Details: The purposes of this study are to:

  • Find out if IPI-145 is effective in stopping the growth and spread of cancer cells in the body
  • Find out the safety and tolerability of IPI-145,3 including what side effects it may cause
  • Measure the amount of IPI-145 and its components in your body at different times to learn how IPI-145 is processed by your body (this is called pharmacokinetics)
  • Monitor the changes (if any) to genes, proteins, or other cells in the body to understand how IPI-145 is working (pharmacodynamics).
  • Find out if we can identify certain genes and/or proteins in cancer cells and/or blood that might predict whether certain people may be more or less likely to respond to IPI-145 or experience certain side effects (predictive biomarkers).
  • Find out if your inherited genes have an effect on how IPI-145 is broken down or moved throughout the body. This is called pharmacogenomics, and is an optional portion of this study). This analysis may also help to understand how cancer cells respond to the study drug.

Ovarian Cancer

1. Title: Can diet and physical activity modulate ovarian, fallopian tube and primary peritoneal cancer progression-free survival?

Sponsor: Gynecologic Oncology Group (GOG)

Physician Investigator: Mary E. Gordinier, M.D.

Research Details: The purpose of this study is to find out if a change in diet and exercise in women with your type of cancer has an effect on the length of time you are cancer free following your initial treatment.



2. Title: A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients with BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer following First Line Platinum Based Chemotherapy Study D0818C00001/GOG-3004

Sponsor: AstraZeneca

Physician Investigator: Mary E. Gordinier, M.D.

Research Details: This study is being carried out to see if using a drug called olaparib can delay any return or progression of ovarian cancer as compared to the current practice of not taking further anti-cancer medication until the cancer returns or progresses.


Pancreatic Cancer

1. Title: A Phase 2, Randomized, Multicenter Study of PEGPH20 (PEGylated Recombinant Human Hyaluronidase) Combined with nab-Paclitaxel Plus Gemcitabine Compared With nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Previously Untreated Pancreatic Cancer

Sponsor: Halozyme, Inc.

Physician Investigator: John T. Hamm, M.D.

Research Details: The purpose of both parts is to evaluate PEGPH20 in combination with 2 chemotherapy drugs: a standard dose of gemcitabine, plus a dose of nab-paclitaxel that has been tested in pancreatic cancer subjects as compared to gemcitabine and nab-paclitaxel alone. The first part of this study, called the run-in phase, will study the safety and tolerability of these combinations. The second part, called Phase 2 will continue to study the safety of these combinations but also look at how well each combination works.


Small Cell Lung Cancer (SCLC)

1. Title: Phase 1b/II Trial of Carfilzomib with Irinotecan in Irinotecan-Sensitive Malignancies (Phase Ib) and Small Cell Lung Cancer Subjects (Phase II) Who Have Progressed on Prior Platinum-based Chemotherapy (IND Number: 117350)

Sponsor: Cancer Research And Biostatistics (CRAB)

Physician Investigator: John T. Hamm, M.D.

Research Details: The primary purpose of the Phase Ib portion of this study is to determine the safest dose of Carfilzomib. This study will also evaluate the effects (good and bad) of Carfilzomib in combination with Irinotecan on cancer. The purpose of the Phase II portion of this study is to evaluate the effects (good and bad) of Carfilzomib and Irinotecan on your cancer.


Soft Tissue Sarcoma

1. Title: A Multicenter, Open-Label, Single-Arm Study of YONDELIS (trabectedin) for Subjects with Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Relapsed or Are Refractory to Standard of Care Treatment AMENDMENT 6: A Multi-center, Open-Label Single-Arm Study of YONDELIS® (trabectedin) for Subjects with Locally Advanced or Metastatic Soft Tissue Sarcoma Excluding Leiomyosarcoma and Liposarcoma who have Relapsed or are Refractory to Standard of Care Treatment

Sponsor: Janssen Research & Development

Physician Investigator: John T. Hamm, M.D.

Research Details: The purpose of the study is to provide an experimental drug to eligible previously treated people with soft tissue sarcoma. The study will measure the safety and how well Yondelis is tolerated.


Specimen/Tissue

1. Title: Analytical Biological Services Inc. & Norton Healthcare Agreement regarding The Cancer Genome Atlas (TCGA) March 2012 The Cancer Genomic Atlas (TCGA) project with the National Cancer Institute

Sponsor: Analytical Biological Services, Inc (ABS)

Physician Investigator: Shawn D. Glisson, M.D.

Research Details: The purpose of this study is to provide researchers with biological specimens and information that may help discover new ways to diagnose and treat disease.


Urothelial Bladder Cancer

1. Title: A phase II, multicenter, single-arm study of MPDL3280A in patients with locally advanced or metastatic urothelial bladder cancer

Sponsor: Genentech, Inc.

Physician Investigator: Arash Rezazadeh, M.D.

Research Details: The purpose of this study is to look at the effects, good or bad, of MPDL3280A on bladder cancer. MPDL3280A is an experimental drug, which means that health authorities have not approved MPDL3280A for the treatment of bladder cancer.


Research Leadership

 

John T. Hamm, M.D.
Medical Director, Research Program

Dr. Hamm is one of the four founders of Norton Cancer Institute. A Louisville native, he received his medical degree at Vanderbilt University and completed his formal training in Louisville. Dr. Hamm is board certified in internal medicine with a subspecialty in medical oncology. He is chairman of the Norton Hospital Cancer Committee.

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