Clinical Trials

4 studies in Cancer

1. Study of Kidney Tumors in Young Patients Rochester, MN View Summary
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   Study of Kidney Tumors in Young Patients

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   OBJECTIVES: Primary - Classify patients with renal tumors by histological categorization, surgico-pathological stage, presence of metastases, age at diagnosis, tumor weight, and loss of heterozygosity for chromosomes 1p and 16q, to define eligibility for a series of therapeutic studies. - Maintain a biological samples bank to make specimens available to scientists to evaluate additional potential biological prognostic variables and for the conduct of other research by scientists. Secondary - Monitor outcome for those patients who are not eligible for a subsequent therapeutic study. - Describe whether the pulmonary tumor burden correlates with outcome in patients with stage IV disease. - Describe the sensitivity and specificity of abdominal CT scan by comparing it with surgical and pathologic findings for identification of local tumor spread beyond the renal capsule to adjacent muscle and organs, lymph node involvement at the renal hilum and in the retroperitoneum, preoperative tumor rupture, and metastases to the liver. - Compare the sensitivity and specificity of pre-operative abdominal CT scan and MRI for the identification and differentiation of nephrogenic rests and Wilms' tumor in children with multiple renal lesions. - Correlate the method of conception (natural vs assisted reproductive technology) with the development of Wilms' tumor. OUTLINE: This is a multicenter study. Tumor tissue, blood, and urine samples are collected for research studies, including immunohistochemistry. CT scans and MRIs are also performed. Loss of heterozygosity analyses (chromosome 1p and 16q) are performed by extraction of DNA. DNA polymorphisms are assayed by polymerase chain reaction using standard methodology. Leftover specimens are archived for future studies. Patients are followed periodically for 5 years. PROJECTED ACCRUAL: There are no sample size goals for this study.

   NCT ID:

   NCT00898365

   IRB Number:

   07-000195

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   Who can I contact for additional information about this study?

   Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   
   
   

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2. Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer Rochester, MN View Summary
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   Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   PRIMARY OBJECTIVES: I. To assess the safety and feasibility of short-term fasting prior to administration of chemotherapy. SECONDARY OBJECTIVES: I. To evaluate weight changes in patients who are exposed to short-term fasting prior to chemotherapy. II. To get a preliminary estimate of the longest feasible fasting period prior to chemotherapy. III. To evaluate the toxicity profile of systemic chemotherapy treatment in patients who undergo short-term fasting prior to treatment. IV. To investigate changes in plasma glucose, insulin, IGF-1 and IGF-1BP in patients who undertake short-term fasting. OUTLINE: COHORT I: Patients fast 24 hours before day 1 of course 2 of chemotherapy. If fast is well tolerated, patients may escalate fasting by 12 hours for each subsequent course of chemotherapy for up to 3 courses in the absence of unacceptable toxicity. COHORT II: Patients fast at the longest fasting regimen found to be safe and tolerable in cohort I before day 1 of each course of course of chemotherapy for up to 4 courses in the absence of unacceptable toxicity.

   NCT ID:

   NCT01175837

   IRB Number:

   10-002451

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   Who can I contact for additional information about this study?

   Rochester: Mayo Clinic Clinical Trials Office 507-538-7623
                       
   
   
   

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3. Safety and Efficacy of VB-111 in Subjects With Advanced Differentiated Thyroid Cancer Jacksonville, FL Rochester, MN View Summary
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   Safety and Efficacy of VB-111 in Subjects With Advanced Differentiated Thyroid Cancer

   Location:

   Jacksonville, FL Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   The purpose of this study is to examine the safety and evaluate the response of VB-111 on DTC.

   NCT ID:

   NCT01229865

   IRB Number:

   10-001281

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   Who can I contact for additional information about this study?

   Rochester: Keith Bible, MD 507-284-8440
                       
   
   Jacksonville: Robert Smallridge, MD 904-953-6824
                       
   

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4. Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance Scottsdale and Phoenix, AZ Rochester, MN View Summary
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   Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance

   Location:

   Scottsdale and Phoenix, AZ Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   OBJECTIVES: Primary - To determine if a telephone-based dietary intervention compared to no intervention will decrease clinical progression in AS patients. Secondary - To compare the incidence of active treatment (surgery, irradiation, local ablation, or androgen deprivation) in AS patients receiving dietary intervention compared to no intervention. - To compare prostate cancer-related anxiety in AS patients receiving dietary intervention compared to no intervention. - To compare health-related quality of life in AS patients receiving dietary intervention compared to no intervention. OUTLINE: This is a multicenter study. Patients are stratified according to age (≤ 70 years vs > 70 years), race (African American vs other), and time of baseline prostate biopsy (0-12 months before registration vs > 12-24 months before registration). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive the MEAL program intervention with dietary education and telephone counseling sessions for 24 months. Patients receive the "Participant Notebook", which provides written material describing the counseling program. It also outlines the dietary targets, offers supporting information on strategies to achieve these targets, supplies referent tools to help patients accurately estimate servings of target foods, and offers recipes and articles about diet and prostate cancer. The counseling sessions are divided into 4 phases, with the first three phases completed in 7 months and the fourth phase continuing for 17 months. The first phase comprises 6 counseling calls focusing on education and the rapid development of self-efficacy, the second phase comprises 4 calls over a 2-month period focusing on practical and consistent implementation of the dietary pattern, the third phase comprises 4 calls over a 4-month period helping patients habituate to the dietary pattern by providing regular performance reviews, and the fourth phase comprises 8 calls over a 17-month period and is a maintenance phase. Patients are encouraged to achieve 7 servings per day of vegetables (2 cruciferous, 2 tomato products, 3 other vegetables), 2 servings per day of whole grains, 1 serving per day of beans or other legumes, and 2 servings per day of fruit. Patients also receive 8 regularly scheduled newsletters over the course of 24 months. The newsletters focus on study goals and progress and provide tips on achieving and maintaining diet change. They also include information on diet and cancer, the challenges of diet change, the advances in prostate cancer control, and new recipes. - Arm II: Patients receive standard United States Department of Agriculture dietary guidelines for Americans. Patients also receive 8 regularly scheduled newsletters over the course of 24 months. The newsletters contain general information about diet and healthy lifestyle. Blood (plasma and serum) and tissue samples are collected at baseline and at 12 and 24 months for biomarker and pharmacogenomic studies. Patients complete quality-of-life assessments (Personal Habits Questionnaire, Functional Assessment of Cancer Therapy Scale-Prostate (FACT-P), Memorial Anxiety Scare for Prostate Cancer (Max-PC), International Prostate Symptom Score (IPSS), Expanded Prostate Cancer Index Composite 26 (EPIC-26), and Nutrition Self-Efficacy and Satisfaction with the MEAL Program) at baseline and at 6, 12, 18, and 24 months. After study entry, patients are followed up every 3 months for 2 years.

   NCT ID:

   NCT01238172

   IRB Number:

   12-000517

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   Who can I contact for additional information about this study?

   Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   Scottsdale: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   
   

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