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Office of Clinical Research (OCR)

Summary:

The Office of Clinical Research (OCR) provides the necessary components for conducting high-quality clinical cancer research.

The OCR provides support for clinical trials initiated by Dartmouth investigators, as well as industrially sponsored studies and cooperative group studies. The OCR participates in the following cooperative groups:

Alliance for Clinical Trials in Oncology (ALLIANCE), which includes:
American College of Surgeons Oncology Group (ACOSOG)
Cancer and Leukemia Group B (CALGB)
North Central Cancer Treatment Group (NCCTG)

NRG which includes:
Gynecologic Oncology Group (GOG)
Radiation Therapy Oncology Group (RTOG)
National Surgical Adjuvant Breast and Bowel Project
(NSABP)

Children's Oncology Group (COG)

Cancer immunotherapy Trials Network (CITN)

Data management activities are focused around existing disease-specific clinical teams. Support is available for data collection, nursing, and pharmacy needs related to clinical research.

In addition to data management support, the OCR also coordinates the review of cancer-related clinical trials by committees that consider issues of scientific merit, ethics, safety, and patient accrual

Affiliations:

People:

      Member: Rollings, Nancy
      Role: Administrative Director, Office of Clinical Research

    Resources:

    Human Studies

    • A Multicenter, Open Label, Phase II Study of Bendamustine and Rituximab Followed by 90-yttrium (Y) Ibritumomab Tiuxetan for Untreated Follicular Lymphoma (Fol-BRITe Study)) ( Single group study )

      This study is ongoing, but not recruiting participants.
      Study # D1015
      Phase II The purpose of the study is to learn about the safety and effectiveness of treating follicular lymphoma with bendamustine and rituximab followed by radioimmunotherapy (RIT) using 90-yttrium (Y) ibritumomab tiuxetan.

      The researchers will also test blood and bone marrow for the BCL2 gene-Jh that is a commonly found in people with follicular lymphoma (FL) and look at how the BCL2 gene-Jh responds to the study treatment.

      Bendamustine is approved by the United States Food and Drug Administration (FDA) for the treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin's lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing treatment regimen. Bendamustine is not approved by the FDA to treat follicular lymphoma.

      Rituximab is approved by the FDA for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive B-cell non-Hodgkin's lymphoma.

      90-yttrium (Y) ibritumomab tiuxetan is approved by the FDA for the treatment of relapsed or refractory, low-grade or follicular B-cell NHL, including rituximab refractory follicular NHL. It is also approved for the treatment of follicular NHL that is previously untreated with radioimmunotherapy and that achieved a partial or complete response to first-line chemotherapy.

      Study participants will will receive bendamustine and rituximab for up to 16 weeks. If participants' cancer responds well to the treatment with bendamustine and rituximab, they will receive up to 12 weeks of radioimmunotherapy (RIT). After the RIT is complete, participants will be asked to return to the clinic every 3 months for a maximum of 10 years for follow-up visits.

    • A Phase I Randomized Controlled Trial Of A Problem-Solving Occupational Therapy Intervention For Older Adult Cancer Survivors ( Parallel group study )

      Active/Enrolling
      Study #D12110

      Phase I Older adults who are treated for cancer are at risk of developing disabilities due to the symptoms of cancer and the side effects of treatment. Disability occurs when a person has trouble performing the activities he or she needs to do in everyday life. For example, fatigue and pain can make it difficult for an older adult to do housework, leisure, or volunteer activities. Disability makes it harder for older adults to stay active and be productive members of the community, and it can increase the costs of healthcare.

      Current approaches to cancer rehabilitation focus on using exercise, education, and social support to reduce cancer treatment side effects. These are important strategies to reduce disability, yet some side effects persist despite best efforts to resolve them. To fully reduce disability, people often need to adapt their activities or the environments in which they are performed.

      The goal of this study is to test an occupational therapy (OT) intervention that teaches explicit problem-solving skills to foster survivors' ability to adapt activities, routines, and environments in order to minimize disability. The project targets adults over the age of 65 who have completed definitive cancer treatment, but are experiencing residual disability. The project has two stages...(see full trial info for details)

      "If the intervention is effective in reducing disability, it will give us another tool to reduce the impact of cancer on the daily lives of cancer survivors."

    • A Pilot Project to Investigate the Ability of Atomic Force Microscopy to Identify Malignant Cells in the Urine ( Feasibility study )

      Active/Enrolling
      Study #D12135

      Study Type: Diagnostic

    • A Prospective Study of Partial Breast Adjuvant Radiation Therapy After Resection of Borderline and Malignant Phyllodes Tumors ( Human Study )

      Active/Enrolling
      Study Number: D0929

      Therapeutic
      Phase II We recently completed a study which showed that treating the whole breast with radiation therapy after excising malignant phyllodes tumors is very effective: none of the 46 patients so treated had the tumor recur in their breast. Now we have begun a second study to see if focusing the radiation on just part of the breast-around the site where the tumor was removed, rather than radiating the entire breast-is equally effective in preventing the recurrence of phyllodes tumors.

    • A Randomized Phase II Study of the Effect of a Low Calorie Diet on Patients Undergoing Liver Resection ( Single blinded study )

      Active/Enrolling
      Study #D12052


      Phase II The purpose of this study is to measure the effect of a short-term low calorie diet on patients with a Body Mass Index (BMI) over 25 who are undergoing liver surgery.

    • Alternating Targeted Therapy in Patients with Metastatic Renal Cell Carcinoma: A Phase II Study of Alternating Sunitinib and Temsirolimus ( Single group study )

      In the past 5 years, treatment for metastatic Renal Cell Carcinoma (mRCC) has focused on agents directed at blocking tumor and vascular growth pathways. Sunitinib blocks the vascular endothelial growth factor receptor (VEGFr) and temsirolimus is an inhibitor of mammalian target of rapamycin (mTOR). Both sunitinib and temsirolimus are FDA approved agents for mRCC. When agents like these are given together, the toxicity increases but they can be given safely, at full doses, sequentially. We hypothesize that alternating these agents will double the progression free survival (PFS) of the agents when given sequentially. Active/Enrolling
      Study Number: D1011

      Phase II
      Therapeutic 

    • Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head and Neck Cancer ( Parallel group study )

      Purpose

      The primary objective is to determine the reduction in pain score by ketamine mouthwash compared to placebo in head and neck cancer patients with refractory mucositis.
      The secondary objectives are to describe the duration of analgesia and adverse effects associated with ketamine and placebo. Active/Enrolling
      Study #D1022
      Phase II

    • Bladder Tumor Tissue Bank ( Human Study )

      Active/Enrolling
      Study #D12035

    • Coagulation activation in brain neoplasms ( Feasibility study )

      Active/Enrolling
      Study #D12096

      Study Type:Tissue Banking or Laboratory Collection 

    • Fruits, Vegetables, Activity, and Sleep: A Dartmouth Photovoice Study ( Human Study )

      Study #D11241

      Study Type: Behavioral

    • Measurement of the Partial Pressure of Oxygen in Cancers Using Electron Paramagnetic Resonance Oximetry with Injected India Ink ( Human Study )

      Active/Enrolling
      Study Number: D0626

      Study Type: Diagnostic

    • Melanoma and Renal Tumor Tissue Bank ( Human Study )

      Active/Enrolling
      Study # D1013

      Tissue Banking or Laboratory Collection

    • MicroRNA Expression in Patients with Myelodysplastic Syndromes Treated with Hypomethylating Drugs ( Feasibility study )

      Active/Enrolling
      Study #D12010

      Pilot Feasibility

    • MicroRNA Expression Patterns in Human Breast Cancer Specimens ( Observational study )

      Active/Enrolling
      Study #D11276

      A Correlative Study

    • Monitoring of Neoadjuvant Therapy in Locally Advanced Breast Cancer ( Human Study )

      Active/ Enrolling
      Study Number D0605
      Diagnostic

    • Non-Myeloablative Chemotherapy Followed by HLA-Matched Related Allogeneic Stem Cell Transplantation for Hematologic Malignancies ( Single group study )

      OCR Study Number: D0345
      Active and Enrolling Purpose:
      The purpose of this study is to determine disease-free survival, overall survival, time to progression, regimen-related toxicity and/or treatment-related mortality in patients with hematologic malignancies treated with non-myeloablative chemotherapy followed by allogeneic stem cell transplant.

    • Outcomes of Cutaneous T-cell Lymphoma and Chronic Graft-Versus-Host Disease Patients Treated with Extracorporeal Photopheresis ( Case-only study )

      Active/Enrolling
      Study #D11271 Extracorporeal Photopheresis (ECP) is a form of apheresis and photodynamic therapy in which the peripheral blood is treated with 8-methoxypsoralen, which is then activated with UV light. ECP is currently a standard therapy for cutaneous T-cell lymphoma (CTCL) and is also effective for graft-versus-host disease (GVHD). The investigators would like to study the outcomes (response rates) of patients receiving ECP treatment and other factors relating to their disease and treatment, as well as procedural events, such as complications.

    • Pancreas Cancer Direct Xenograft Program at Dartmouth-Hitchcock Medical Center ( Feasibility study )

      Active/Enrolling
      Study #11129

      Tissue Banking or Laboratory Collection 

      Pilot/Feasibility

    • Participation Restrictions in Young-Middle Adult Rural Breast Cancer Survivors ( Single group study )

      Active/Enrolling
      Study #D1032

      Survivorship and Palliative Care This project will develop and preliminarily evaluate an intervention to assist young-middle adult rural breast cancer survivors to overcome functional impairments related to their cancer treatment. Younger breast cancer survivors (below age 60) have ongoing family, social and vocational responsibilities and recreational interests and are at increased risk of developing long-term difficulties performing these valued activities (participation restrictions). Rural cancer survivors are medically underserved and due to distance and geographic isolation face significant barriers to accessing traditional rehabilitation services. Alternative rehabilitation approaches are sorely needed for this population. Based on previous research with cancer and other medical populations a working draft of a treatment manual using a telephone-delivered Behavioral Activation and Problem Solving (BA/PS) intervention has been designed. Prior to testing the intervention in a randomized clinical trial, additional work must be completed. The specific aims of this study are to a. refine the BA/PS treatment manual, b. develop and apply treatment integrity measures for the BA/PS manual, c. assess participation restrictions and associated outcomes, d. preliminarily assess the immediate and maintenance effects of BA/PS, and e. examine mediators and moderators of BA/PS effects based on our "Self Regulation" model of functional recovery. 188 young-middle adult breast cancer survivors will be screened for participation restrictions following cancer treatment and 40 survivors with participation restrictions will receive BA/PS delivered by phone. BA/PS participants will be assessed for treatment effectiveness and interviewed regarding their experiences during treatment to provide information for refining the manual. The long-term objective of this line of research is to develop effective and feasible treatments for the medical and psychosocial consequences of cancer and its treatment in medically underserved cancer survivors (e.g., rural populations).

    • Protocol for Use of Brain Tumor Tissue for Research ( Human Study )

      Investigator Initiated Clinical study at the Norris Cotton Cancer Center (NCCC)

      Cancer Neurology

      Active and enrolling
      Correlative

      OCR Study Number: D0004

    • Surgical Margin Assessment During Radical Prostatectomy - a Deformation Study ( Feasibility study )

      Active/Enrolling
      Study Number: D1003

      Pilot/Feasibility
      Diagnostic

    • The Effect of a Goal Setting Intervention on Exercise in Women with Metastatic Breast Cancer: An Exploration of the Lipogenic Pathway ( Single blinded study )

      Active/Enrolling
      Study #D11282


      Pilot/Feasibility This study is a randomized prospective clinical trial of women and men with metastatic breast cancer. The purpose of the study is to test if an intervention of regular physical activity review and physical activity goal setting will allow the subjects to achieve a moderate increase in physical activity of 6,000 steps per week. The physical activity review will consist of weekly telephone call to inquire about symptoms and to set physical activity goals. The study will also look to see if the goal setting intervention will affect the time to progression, change in BMI, and quality of life. Quality of life will be measured by answers to questionnaires provided to subjects at regular intervals during the course of the study. Finally, the study will examine the impact of physical activity on circulating tumor cells, expression of tumor molecular molecules, insulin levels, and estradiol levels.

      Through an intervention of regular physical activity review and goal setting, the investigators hypothesize that a moderate increase in level of physical activity of 6000 steps per week or more can be obtained by patients with metastatic breast cancer who receive a goal setting intervention. The investigators propose that those who are able to achieve and maintain greater than or equal to 22500 steps per week will demonstrate biologic and molecular differences compared to those who are not able to achieve that level of physical activity. The investigators expect that people who are more active will have longer to progression.
      Performed by

    • Ultrasound Evaluation of Sentinel Lymph Nodes in Melanoma Patients and in Patients with Melanocytic Tumors of Unknown Metastastic Potential (MELTUMP) or Atypical Spitz Nevus (ASN): A Prospective Data Base ( Human Study )

      Active/Enrolling
      Study Number: D1012

      Registry

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    Last updated: 2014-06-10T18:11:24.571-04:00

    Copyright © 2016 by the President and Fellows of Harvard College
    The eagle-i Consortium is supported by NIH Grant #5U24RR029825-02 / Copyright 2016