New Clinical Trials Under Way

The following clinical trials are currently recruiting patients with various types of cancer for inclusion in several investigations. Each trial description includes the NLM Identifier to use as reference with clinicaltrials.gov.

1 Genomic Testing for Primary Breast Cancer

This research study will help researchers to determine if genetic testing done on tumor samples will be able to predict whether the tumor responds to treatments for breast cancer. Researchers will test tumor samples to see if certain genes are activated, with the hope that such activation may predict if the tumor will be sensitive or resistant to routine chemotherapy or hormonal treatments for breast cancer.

To be eligible for inclusion, female patients with cancer must be aged 18 years or older. The study will enroll 500 patients, and will be conducted at The University of Texas M.D. Anderson Cancer Center in Houston, TX. For more information, contact Stacy Moulder, MD, at 713-792-2817. The NLM Identifier is NCT01334021.

2 Spray Cryotherapy for Esoph­ageal Cancer (ICE-CANCER)

This study will evaluate the safety and efficacy of endoscopic spray cryotherapy in patients with previously untreated early-stage esophageal cancer using the truFreeze System (CSA Medical, Inc). The patients in this study will not be eligible for or have refused conventional therapy, including surgery, chemotherapy, radiation therapy, or endoscopic resection.

The study will be conducted at the University of Maryland Medical Center, Baltimore. For more information, contact Bruce D. Greenwald, MD, principal investigator, at 410-328-8731 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01868139.

3 Specimen and Data Study for Early Detection and Prevention of Ovarian Cancer

The objectives for this study are to identify and develop highly sensitive and specific tumor markers that can detect and help to manage ovarian cancer and other gynecologic cancers, identify new approaches to prevention and therapy, and identify measures to improve the quality of life for women who have been diagnosed with ovarian cancer, as well as women at increased risk for the disease.

Women aged 18 to 80 years who are at high risk for ovarian cancer due to family or personal medical history, or because of a gynecologic abnormality, are eligible for inclusion in this study. The study will be conducted at the Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago IL. Lee Shulman, Chief, Division of Clinical Genetics, Northwestern University, is the study chair, and can be reached at 312-695-1301 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT00005095.

4 Study of Carfilzomib with Irinotecan in Irinotecan-Sensitive Malignancies and Patients with Lung Cancer

This study aims to determine a well-tolerated dose of carfilzomib in combination with irinotecan in patients with relapsed small-cell and non–small-cell lung cancer or with other irinotecan-sensitive cancers. It will also assess the 6-month survival rate of relapsed disease in patients with small-cell lung cancer who have received this combination therapy.

Patients aged 18 years or older with a histologically or cytologically confirmed diagnosis of progressive or recurrent malignancy may be eligible for inclusion if several other criteria are met. For a full list of inclusion criteria, contact Susanne M. Arnold, MD, at 859-323-8043 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The University of Kentucky Markey Cancer Center Lexington, is currently recruiting patients. The NLM Identifier is NCT01941316.

5 Comprehensive Gene Sequenc­ing in Guiding Treatment Rec­om­mendations for Patients with Metastatic or Recurrent Solid Tumors

This pilot clinical trial is studying comprehensive gene sequencing in patients with metastatic or recurrent solid tumors. Studying samples of blood and tissue from patients with cancer in the laboratory may improve the ability to plan their treatment. The primary objectives of the study are to assess the feasibility and logistics that are associated with a clinical trial using the Foundation Medicine, Inc (FMI) test in an academic therapeutic setting, and to determine the proportion of patients who will receive a cancer-related therapy based on the results of the FMI test.

Patients must be aged 18 years or older to participate in this study. Patients must have been diagnosed with a recurrent or metastatic solid tumor cancer. The first patients to be enrolled will have a diagnosis of breast cancer (Cohort 1) or colorectal cancer (Cohort 2). Furthermore, at the time of inclusion, patients are within 10 weeks of starting their current line of therapy and are enrolled before their first computed tomography scan.

The study is being conducted at the Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center in Columbus. For more information and a full list of inclusion criteria, contact Erin M. Olson, principal investigator, at 614-366-8541 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01987726.

6 Trametinib, Fluorouracil, and Radiation Therapy Before Surgery in Patients with Stage II or Stage III Rectal Cancer

This phase 1 trial investigates the side effects and best dose of trametinib when given together with fluorouracil and radiation therapy before surgery for the treatment of patients with stage II or stage III rectal cancer. Giving trametinib together with fluorouracil and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

For a full list of inclusion criteria, contact Evan J. Wuthrick, MD, principal investigator, at 614-293-3422 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The study will be conducted at the Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus. The NLM Identifier is NCT01740648.

7 Low-Dose Naltrexone for Metastatic Melanoma, Castrate-Resistant Prostate Cancer, and Renal Cancer

This phase 2 clinical trial will evaluate whether low-dose naltrexone has activity in refractory solid tumors. Melanoma, castrate-resistant prostate cancer, and kidney cancer will be studied. Patients who are aged 18 years or older who meet all of the inclusion criteria will be considered for participation in the study. Inclusion criteria include histologically or pathologically confirmed melanoma, renal cancer, or prostate cancer; patients with melanoma or renal cancer must have metastatic disease and radiographically measurable advanced disease. Patients with prostate cancer must be castrate refractory and must have radiographically assessable metastatic disease or must have rising prostate-specific antigen on 2 sequential measurements.

For a full list of inclusion criteria, contact Maureen Jean at 401-793-4283 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The study will be conducted at Miriam Hospital, Providence, RI. The NLM Identifier is NCT01650350.

8 2B3-101 Open-Label Study for Patients with Solid Tumors and Brain Metastases

The safety, tolerability, and pharmacokinetics of 2B3-101 as a single agent and in combination with trastuzumab will be evaluated in this phase 1/2a dose-escalating, open-label study. Patients with solid tumors and brain metastases or recurrent malignant glioma, as well as patients with various forms of breast cancer with and in combination with trastuzumab in patients with HER2-positive breast cancer and brain metastases are also eligible for inclusion. Other criteria include age 18 years or older, measurable intracranial disease by magnetic resonance imaging, and estimated life expectancy of at least 8 weeks.

For more information, contact Rachel Phipps, RN, at 919-966-4432 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The study will be conducted at the UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC. The NLM Identifier is NCT01386580.

9 New Delivery System for Mar­qibo Drug to Be Put to the Test

This study aims to evaluate the safety, activity, and pharmacokinetics of Marqibo, a new anticancer drug that combines vincristine sulfate, a widely used anticancer drug, packaged in a liposome to improve the drug’s ability to destroy cancer cells and reduce treatment-related adverse events. Children and adolescents between ages 2 years and 21 years diagnosed with solid tumors, primary brain tumors, leukemias, or lymphomas, who did not respond to standard treatment, are eligible for inclusion.

The principal investigator of this study, Alan S. Wayne, MD, can be contacted at 301-496-426 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The study will be conducted at the National Institutes of Health Clinical Center, Bethesda, MD. The NLM Identifier is NCT01222780.

10 Safety and Efficacy of Cediranib Maleate with or without Lenalidomide in Patients with Thyroid Cancer

A randomized phase 1/2 study will evaluate the safety and efficacy of cediranib maleate with or without lenalidomide in patients with thyroid cancer. Adverse events and best dose of cediranib will be evaluated. To be elegible for inclusion, patients should be aged 18 years or older, have radiographically measurable disease, evidence of disease progression, and a life expectancy of more than 12 weeks.

For the full list of inclusion criteria, contact Jonas De Souza, principal investigator, at 773-834-1736 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The study will be conducted in multiple states, including California, Colorado, Florida, and Illinois. The NLM Identifier is NCT01208051.

11 Genetic Epidemiology Stud­ies to Evaluate Genetic Causes of Cancer

This observational study will evaluate the genetic causes of cancer and the inherited tendency to develop cancer by collecting blood specimens and/or saliva samples and/or tumor and normal tissue blocks from patients and families of patients with cancer. Eligibility criteria include patients with a referral to the Cancer Family Clinic of the Department of Medicine at Memorial Sloan-Kettering Cancer Center, as well as a history of cancer including breast, ovary, and colon, in first-degree relative or successive generations in a suspected cancer family syndrome.

Contact Kenneth Offit, MD, principal investigator, at 646-888-4050, for a full list of inclusion criteria and/or more information. The study will be conducted at the Memorial Sloan-Kettering Cancer Center, New York, NY. The NLM Identifier is NCT00579163.

12 Sirolimus, Cisplastin, and Gemcitabine Hydro­chlor-ide in Patients with Bladder Cancer

This phase 1/2 clinical trial will be evaluating the adverse events, optimal dosage, and efficacy of sirolimus in combination with cisplatin and gemcitabine hydrochloride in patients with blader cancer. Patients aged 18 years or older, with a signed informed consent form, histologically or cytologically confirmed carcinoma of the bladder of all histologies, except neuroendocrine differentiation or squamous-cell histology, will be included in the study.

For a full list of inclusion criteria, contact Robert B. Montgomery, principal investigator, at 206-616-8289. This study will be conducted at Fred Hutchinson Cancer Research Center/Universty of Washington Cancer Consortiun, Seattle. The NLM Identifier is NCT01938573.

13 Collecting Data for Early- Onset and Familial Gastric Cancer Registry

This gastric cancer registry is recruiting patients to learn more about the genetic causes of gastric cancer and develop methods for early diagnosis, prevention, and treatment. Study participants will be asked to join a registry of families who are affected by various forms of gastric cancer. Participants have to be aged 18 years or older. To be eligible for the study, participants must have (1) a diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma, or (2) have/had a first-degree relative with early-onset gastric cancer or with familial gastric cancer, and/or (3) has a personal familial history of a genetic mutation associated with gastric or GEJ adenocarcinoma.

For more information, contact David Kelsen, MD, principal investigator, at 646-888-4179. This study will be conducted in multiple locations by the Memorial Sloan-Kettering Cancer Center. The NLM Identifier is NCT00582257.

14 Testing a New Delivery System for Smoking Ces­sation in Patients with Lung Cancer

This trial is seeking to evaluate the feasibility of delivering a Quitline-based smoking-cessation intervention in patients with lung cancer who are receiving treatment in the outpatient setting. To be included in this randomized, parallel, open-label study, patients must be aged 18 years or older, and must have American Joint Committee on Cancer stage 0, I, II, or III lung, breast, colorectal, bladder, head and neck, or cervical cancer; have reported any amount of smoking in the past 7 days; and be scheduled to receive or are currently undergoing surgery, radiation, or chemotherapy, or have undergone surgery, last radiation treatment, and/or last chemotherapy treatment in the past 6 months. Participants must also be willing to consider smoking and able to understand/sign an informed consent and have a Karnofsky performance status of 70 to 100.

To receive a full list of inclusion criteria, contact Robin Rosdhal, RN, at 336-713-6519 or This email address is being protected from spambots. You need JavaScript enabled to view it.. W F Baptist Health Winston-Salem, NC, is currently recruiting patients, The NLM Identifier is NCT01434342.

15 Pilot Study to Evaluate Renal Lesions via Accuracy Contrast-Enhanced Ultra­sound in Patients with and at Risk for Renal Malignancy

To evaluate the accuracy of con­trast-enhanced ultrasound in patients with renal tumors or patients at risk for renal malignancy (ie, if a screening ultrasound indicates the possibility of a malignant renal mass), this study is recruiting approximately 48 patients. The criteria for inclusion are age 18 years or older, ability to provide written informed consent, willingness to comply with protocol requirements, eligibility to receive radical or partial nephrectomy or ablative therapy (Cohort 1) or be at high risk and have at least 1 kidney lesion identified by incompletely characterized at screening (Cohort 2).

For more information, contact Gayle Grigson, RN, at 919-966-4432 or This email address is being protected from spambots. You need JavaScript enabled to view it.. This study will be conducted at the Linenberg Comprehensive Cancer Center, Chapel Hill, NC. The NLM Identifier is NCT01751529.

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