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Lymphoma SPORE

Lymphoma SPORE
Stephen, J. Forman, M.D.
Principal Investigator

Andrew Raubitschek, M.D.
Co- Principal Investigator
The overall goal of the City of Hope Lymphoma Specialized Program of Research Excellence (SPORE) is to develop translational studies to improve the detection and therapy of Hodgkin’s and non-Hodgkin’s Lymphoma. This grant consists of four translational research projects and five cores developing novel approaches that are derived from molecular and immunologic studies of T-cell and antibody based therapies. An important theme of the translational studies in this grant is to develop lymphoma therapies that will reduce toxicities associated with current treatment regimens for Hodgkin’s and non-Hodgkin’s Lymphoma which can then be translated to the older patient population.
City of Hope is pursuing four main projects through its Lymphoma SPORE:
T-cells engineered to fight non-Hodgkin lymphoma

T-cells are powerful immune system cells that fight disease. City of Hope scientists aim to re-engineer some of a lymphoma patient’s T cells so they target lymphoma cells and overcome the defenses that keep the lymphoma safe from the immune system. The treatment uses central memory T-cells, which potentially can provide a life-long immunity against lymphoma, preventing any relapse of the disease.
Avoiding treatment-related leukemia

Sometimes lymphoma treatment can put a patient at risk of developing leukemia later. Better understanding how a patient’s genetic profile may influence that cancer risk could help physicians tailor lymphoma treatment to minimize the chance of developing therapy-related leukemia.
Strategies for overcoming relapsed disease

Non-Hodgkin follicular lymphoma doesn’t give up easily; patients can have a high relapse rate and often must undergo many difficult treatments. Researchers are studying a protein that may help the immune system specifically target non-Hodgkin follicular lymphoma cells and protect patients against relapse.
Nanoparticles to infiltrate lymphoma cells

Minute tubes of carbon atoms called nanoparticles — each a tiny fraction of a hair’s width — can carry a therapeutic molecule to lymphoma cells to block cancer-boosting genes. Turning off those genes may kill the cancer, but making sure those nanoparticles can get into cancer cells and drop off the therapy is tricky. This project aims to make delivery more certain.

This Lymphoma SPORE also supports a Developmental Research Program and a Career Development Program to foster the advancement of pilot translational research projects and young investigators focused on lymphoma. City of Hope remains one of only five centers in the country who have been awarded a Lymphoma SPORE grant.

Administrative Core

Stephen J. Forman, M.D.

Eileen Smith, M.D.

The Administrative Core provides for the administration of the Lymphoma SPORE including administrative and budget support for all the SPORE investigators.

In addition, this Core provides communication with the National SPORE Program Staff, coordination with City of Hopes’s Comprehensive Cancer Center Administrative Office, preparation of progress reports, management of financial and reporting obligations, organization of the weekly research meetings of the basic science and clinical research staff, coordination of intra- and inter-institutional and inter-SPORE projects, as well as organizing the attendance and presentations at the annual City of Hope Lymphoma SPORE retreat, the annual SPORE meeting, and SPORE workshops at the National Cancer Institute.

Importantly, this core is responsible for the oversight of the Developmental Research and Career Development Programs in the City of Hope Lymphoma SPORE. Publications, grant submissions and INDs are also coordinated and supported through this Core.

In addition, the Administrative Core arranges the Executive and Steering Committee meetings that reviews the progress of the work and organize the annual External Advisory Board meetings.



Biostatistics and Data Management

Joyce C. Niland, Ph.D.

The Biostatistics Core provides its statistical expertise across all SPORE research activities, including study design, safety monitoring, data collection, data quality assurance, and data analysis. The Biostatistics Core ensures that the proposed research hypotheses will be measured, tested, and interpreted, independent of whether the data will come from epidemiological studies, basic science, translational or immunologic studies, imaging, or clinical trials.

The centralized, comprehensive framework of the Biostatistics Core assures each SPORE investigator access to statistical expertise that includes collaborative development of study designs and analysis plans, data analysis and interpretation, data management resources, and abstract and manuscript preparation. The Biostatistics Core also provides infrastructure for the management and integration of both existing and newly collected data through consistent and compatible data handling. The Core has an integral role in the scientific development, execution, and analysis of all projects in the SPORE, including the clinical trials.
Core investigators have extensive experience in quantitative methods for biomedical applications, including clinical, basic, and translational science studies. The Core is committed to taking a leadership role in the scientific integrity of the SPORE investigations, to participating in regular project and program meetings, and to providing rigorous and innovative input on all quantitative matters arising in the projects. Their contribution to each project places them in a unique position to promote interdisciplinary interactions and innovative hypotheses for exploration.

Biological Materials Production Core

David DiGiusto Ph.D.

David Colcher, Ph.D.

Core D is the biologic materials production (manufacturing) core. Core D activities, the production of plasmid DNA, ex-vivo genetic modification and expansion of T-cell products and production and conjugation of monoclonal antibodies (Projects 1, 2 and 4), performed in The Center for Biomedicine and Genetics (CBG) on the campus of City of Hope's National Medical Center.

The CBG is a fully licensed biologics manufacturing facility operated under the principles of current Good Manufacturing Practices (cGMP) and Good Tissue Practices (cGTP) commensurate with Phase I/II clinical trials. The facility consists of controlled access Class 10,000 manufacturing suites, quarantined and released material areas, Quality Control laboratory, continuous process monitoring, USP purified water production, USP process gas farm, fully validated preparative equipment (autoclave, glasswash, depyrogenation oven) and biologics production equipment as required (incubators, centrifuges, bioreactors, chromatography equipment, etc.) The CBG is staffed with fully trained professionals who perform manufacturing, quality assurance and quality control functions as well as management staff with extensive biotechnology and pharmaceutical industry experience.

The CBG provides cGMP/cGTP quality clinical trials material for Projects 1, 2 and 4 of the SPORE. All manufacturing and release testing is performed according to standard operating procedures using materials that are inspected and released by the Quality Assurance Department. Manufacturing staff produces batch records of manufacturing runs that are reviewed by Quality Assurance prior to the release of any clinical materials. The Quality Control department performs raw material and release testing on drug intermediates and final products. Some testing (i.e. sterility, endotoxin) is performed by qualified third party providers including City of Hope's Microbiology and General Clinical Research Center laboratories.

The CBG is also capable of plasmid DNA production (to be used in Project 2) and has experience with the manufacturing of monoclonal antibodies (Projects 1 and 4) and T-cell products (Project 2). The staff of the CBG manages all support services such as equipment maintenance and calibration, cleaning, gowning, environmental monitoring and other facility-related activities

Career Development

Stephen J. Forman, M.D.

John Rossi, Ph.D.
Review Committee Members
Andrew Raubitschek, M.D.
John Zaia, M.D.

The Career Development Program is devised to attract, train, and facilitate the success of young investigators pursuing careers in translational lymphoma research as well as provide a support mechanism for established investigators to refocus their work on lymphoma. This program provides fiscal support for one to three years to two individuals per year.

The program is implemented through the Administrative Core with SPORE Steering Committee, Executive Committee and External Advisory Board oversight. This program has well delineated processes for candidate recruitment, including an intensive effort to recruit women and minorities, an application, review, and selection process, a mentoring plan, a program of educational activities, and an evaluation process. In aggregate, this program insures that City of Hope is productive in contributing to the next generation of highly trained and lymphoma focused investigators that will contribute to translational lymphoma research.

Career Development Application Process
To apply for grant funds under the Career Development Program:

Contact Maggie Vigil at mvigil@coh.org to request the Pilot Grant Application.
You will then be emailed a Pilot Grant Application (Part One), along with a tracking number and instructions. To complete the application, you must include a brief program description.
Submit the completed Pilot Grant Application (Part One) as directed. You will need your tracking number to submit the application. 

All applications will undergo committee review, and selected applicants will be asked to submit additional program information. These selected applicants will be notified by email. The email notification will include using Pilot Grant Application (Part Two), and instructions for submitting this second application section. After committee review of Part Two applications, applicants whose requests are accepted will be notified.

Developmental Research

Stephen J. Forman, M.D.

John A. Zaia, M.D.

Review Committee Members
David Colcher, Ph.D.
Michael Jensen, M.D.
Andrew Raubitschek, M.D.
John Rossi, Ph.D.

The primary objective of City of Hope ’s Cancer Center Lymphoma SPORE Developmental Research Program is to support high quality, innovative translational research projects that are not yet sufficiently mature for full program status despite having outstanding potential.

This goal is accomplished through the Developmental Research Program's capacity to identify conceptually novel and innovative hypothesis-driven projects spanning the spectrum of basic to medical science and clinical research pertaining to lymphoma, to provide fiscal support to allow sufficient development of these projects for subsequent funding as full SPORE projects or as independent projects funded by an independent peer-reviewed mechanism, and to provide intellectual/practical advice to Developmental Project leaders and foster collaborations to facilitate the translational process. This program imparts flexibility to the SPORE, allowing it to respond quickly to the latest developments in translational lymphoma research and to take maximal advantage of new technologies, opportunities for new collaborations, and novel ideas and approaches.

Under the auspices of the Administrative Core, Dr. Stephen Forman, SPORE PI, directs the Program in conjunction with the Developmental Research Program Committee, made up of highly regarded scientists and clinicians with interest and expertise in evaluating the translational potential of evolving lines of query pertaining to improving early detection, diagnosis, treatment or prevention of lymphoma.

The Administrative Core provides:

Dissemination of information about the Developmental Research Program within and outside City of Hope’s Comprehensive Cancer Center
Solicitation of applications
Organization of the activities of the Developmental Research Program Committee.

The Program provides up to $50,000 for one year per developmental project throughout the duration of the SPORE. Funds in this program can also be used to develop a new shared resource or establish a new technology within an existing shared resource, to support short-term collaborations with investigators in other institutions, or to purchase services for the SPORE in response to a recognized need. Developmental research projects from investigators within City of Hope’s Research community, as well from established collaborators outside the institution, are eligible for support.

Developmental Research Application Process

To apply for grant funds under the Developmental Research Program:

Contact Maggie Vigil at mvigil@coh.org to request the Pilot Grant Application.
You will then be emailed a Pilot Grant Application (Part One), along with a tracking number and instructions. To complete the application, you must include a brief program description.
Submit the completed Pilot Grant Application (Part One) as directed. You will need your tracking number to submit the application.

All applications will undergo committee review, and selected applicants will be asked to submit additional program information. These selected applicants will be notified by email. The email notification will include using Pilot Grant Application (Part Two), and instructions for submitting this second application section.

After committee review of Part Two applications, applicants whose requests are accepted will be notified.

Animal Models and Assays Core

David Colcher, Ph.D.

Core E is the Animal Models and Assay Core. This core has two main functions: a) to help evaluate the materials that are intended for clinical studies, in a number of model systems, using the advanced animal imaging instrumentation available at City of Hope ; and b) the analysis of clinical blood, urine, bone marrow, and tissue biopsy samples.

The Specific Functions are:

To provide the needed facilities and expertise for evaluating the biodistribution and imaging cells and antibody constructs in small animals, and

To perform core studies on clinical samples obtained from patients entered on imaging and therapy trials.

Core E is a critical component of Projects 1, 2 and 4. All antibody and T-cell constructs are evaluated in vitro and in vivo prior to translation into the clinic. The in vivo analysis are performed as part of this Core using the expertise of the Cores personnel. Animal biodistribution and imaging studies are performed using the Core personnel with help as needed from the individual projects. Luciferase transfected tumor cell lines and T-cells that are generated as part of the projects and antibodies and their engineered constructs are radiolabeled as part of the individual projects.

The in vivo studies are performed in City of Hopes Animal Resource Center in the Parvin building. City of Hopes National Medical Center and Beckman Research Institute has developed an animal imaging facility. It has two Xenogen in vivo biophotonic imaging system (IVIS), a Biospace Instruments animal gamma scintillation camera, a Concorde Microsystems microPETÆ R4 and a Siemens MicroCAT for small animals imaging.

This core also analyzes clinical samples from patients participating in the clinical trials included as part of Projects 1, 2 and 4. Analysis of blood and urine samples to determine the pharmacodynamics of the radiolabeled antibodies and their engineered constructs will be performed by this Core. Samples are counted to determine the pharmacokinetics and selected samples are analyzed by high performance liquid chromatography to evaluate the status of the labeled construct. In vitro assays to determine circulating levels of infused antibodies and constructs, as well as their immunogenicity, are also performed by this Core. Immunoassays will be performed by ELISA or using methods developed using the PerkinElmer VICTOR3 plate reader using time-resolved fluorometry.

Tissue Bank for Cellular and Molecular Studies

Ravi Bhatia, M.D.

Smita Bhatia , M.D.
Karen Chang, M.D.

The tissue core facilitates research on lymphoid malignancies by members of City of Hope's Comprehensive Cancer Centerand supports two tissue banks.

The Pathology tissue bank core provides services in the following areas:
  • Acquisition and banking of fresh and paraffin-fixed tissues of lymphoma patients at City of Hope, including specimens obtained prospectively and retrospectively obtaining specimens from patients previously biopsied elsewhere;
  • Comprehensive work-up of lymphoma specimens to ensure correct diagnosis and classification, including immunohistochemical, molecular pathologic, and cytogenetic studies.

Performance and assistance in routine histologic processing and immunohistochemical staining of lymphoma tissues, including paraffin embedding, sectioning and H&E staining of human tissue, animal tissue, and preparations from cell lines, as well as specialized histologic services such as preparation of multitumor blocks or tissue microarrays to the specifications of researchers;
Performance and assistance in Laser Capture microdissections from paraffin or frozen sections to obtain enrichment of specific cell types including isolation of malignant cells for analysis of proteins, RNA and/or DNA content.
Consultation services to other SPORE investigators.

The Hematopoietic cell tissue bank collects bone marrow, peripheral blood and peripheral blood stem cell samples from lymphoma patients undergoing autologous peripheral stem cell transplant (aPBSCT). This core prospectively collects and stores fresh blood and marrow samples from patients undergoing aPBSCT for lymphoma. Samples are obtained pre-transplant and post-transplant at 100 days, 6 months, 1 year, and then annually through 5 years after transplant. In addition, aliquots of the PBSC autograft are also banked. The core also collects and enters follow up outcome information for all patients.

The core uses an IRB approved protocol for sample and data collection. The core also follows patients who have received their initial transplant treatment but who are not under current follow-up at City of Hope, by contacting the treating physician, and if necessary, recalling the patient to City of HopesGeneral Clinical Research Centerfor clinical evaluation, blood draw and bone marrow biospy. 
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