Cancer and Leukemia Group B
Encyclopedia
Cancer
Cancer , known medically as a malignant neoplasm, is a large group of different diseases, all involving unregulated cell growth. In cancer, cells divide and grow uncontrollably, forming malignant tumors, and invade nearby parts of the body. The cancer may also spread to more distant parts of the...
research cooperative group in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
.
CALGB research is focused on seven major disease areas: leukemia
Leukemia
Leukemia or leukaemia is a type of cancer of the blood or bone marrow characterized by an abnormal increase of immature white blood cells called "blasts". Leukemia is a broad term covering a spectrum of diseases...
, lymphoma
Lymphoma
Lymphoma is a cancer in the lymphatic cells of the immune system. Typically, lymphomas present as a solid tumor of lymphoid cells. Treatment might involve chemotherapy and in some cases radiotherapy and/or bone marrow transplantation, and can be curable depending on the histology, type, and stage...
, breast cancer
Breast cancer
Breast cancer is cancer originating from breast tissue, most commonly from the inner lining of milk ducts or the lobules that supply the ducts with milk. Cancers originating from ducts are known as ductal carcinomas; those originating from lobules are known as lobular carcinomas...
, lung cancer
Lung cancer
Lung cancer is a disease characterized by uncontrolled cell growth in tissues of the lung. If left untreated, this growth can spread beyond the lung in a process called metastasis into nearby tissue and, eventually, into other parts of the body. Most cancers that start in lung, known as primary...
, gastrointestinal malignancies, genito-urinary malignancies, and melanoma
Melanoma
Melanoma is a malignant tumor of melanocytes. Melanocytes are cells that produce the dark pigment, melanin, which is responsible for the color of skin. They predominantly occur in skin, but are also found in other parts of the body, including the bowel and the eye...
. In each of these areas, multi-modality treatment programs are designed by national experts in an attempt to cure more patients with cancer. Treatment protocols are carefully developed and monitored and are often coupled with studies of cancer biology, quality of life, pharmacology and cost-effectiveness measures so that improvements in therapy can be placed in the proper clinical perspective in today's health care marketplace.
The CALGB pays particular attention to the rights of cancer patients participating in clinical research studies by working with the Department of Health and Human Services' Office for Human Research Protection (OHRP). CALGB is headquartered at the University of Chicago
University of Chicago
The University of Chicago is a private research university in Chicago, Illinois, USA. It was founded by the American Baptist Education Society with a donation from oil magnate and philanthropist John D. Rockefeller and incorporated in 1890...
in Chicago, Illinois and maintains its statistical center at Mayo Clinic
Mayo Clinic
Mayo Clinic is a not-for-profit medical practice and medical research group specializing in treating difficult patients . Patients are referred to Mayo Clinic from across the U.S. and the world, and it is known for innovative and effective treatments. Mayo Clinic is known for being at the top of...
in Rochester, Minnesota
Rochester, Minnesota
Rochester is a city in the U.S. state of Minnesota and is the county seat of Olmsted County. Located on both banks of the Zumbro River, The city has a population of 106,769 according to the 2010 United States Census, making it Minnesota's third-largest city and the largest outside of the...
.
History
The group that was to become known as the CALGB got its roots when James F. Holland initiated a clinical trialClinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
for acute leukemia
Acute leukemia
Acute leukemia or acute leukaemia is a generic term used to describe a family of serious medical conditions relating to an original diagnosis of leukemia...
in 1953 while at the National Cancer Institute
National Cancer Institute
The National Cancer Institute is part of the National Institutes of Health , which is one of 11 agencies that are part of the U.S. Department of Health and Human Services. The NCI coordinates the U.S...
. In 1954, before the trial was complete, Holland moved to Roswell Park Memorial Institute
Roswell Park Cancer Institute
The Roswell Park Cancer Institute is a comprehensive cancer research and treatment center located in Buffalo, New York. Founded in 1898 by Dr. Roswell Park, it was the first dedicated medical facility for cancer treatment and research in the United States. The facility is involved in drug...
, but the new chief of oncology Gordon Zubrod
Gordon Zubrod
Dr Charles Gordon Zubrod was an American oncologist who played a prominent role in the introduction of chemotherapy for cancer. He was one of the recipients of the 1972 Albert Lasker Awards in recognition of his contributions to the field, amongst many other doctorates and awards.-Life and work:Dr...
at the NCI agreed to continue the trial, and a multicenter trial was thus born.
In 1955, Congress granted $5 million for the study of chemotherapy and began the Chemotherapy National Service Center which was headquartered at the NCI. An interinstitutional protocol for the treatment of leukemia was started by Tom Frei at the NCI, involving 3 groups: NCI, RPMI, and Children's Hospital in Buffalo
Buffalo, New York
Buffalo is the second most populous city in the state of New York, after New York City. Located in Western New York on the eastern shores of Lake Erie and at the head of the Niagara River across from Fort Erie, Ontario, Buffalo is the seat of Erie County and the principal city of the...
.
In 1956, this group was designated the Acute Leukemia Group B by the Chemotherapy National Service Center, and Frei became its chairman. (There was also an Acute Leukemia Group A, which later became the Children's Cancer Study Group
Children's Cancer Study Group
The Children's Cancer Study Group was a U.S. and Canadian clinical trial cooperative group created with the mission of studying childhood cancers. The CCG was originally known as Cancer and Leukemia Group A when it was associated with CALGB. In 2000, the CCG merged with several other pediatric...
.) During this time, the group expanded to a national level. Holland became the new chairman in 1962 after Frei resigned.
The group changed its name to Cancer and Leukemia Group B in 1976 to reflect its role with solid tumors as well as leukemia.
Function
CALGB Research Objectives- To answer important therapeutic questions through large clinical trials
- To develop a strong multidisciplinary approach to cancer treatment and prevention
- To integrate information obtained from basic science and from economic and psychosocial investigations with information from clinical trials
- To explore the relationship between dose density and therapeutic outcome
- To systematically explore methods of optimizing treatment for individual patients
- To introduce novel therapies and treatment approaches for patients with poor prognoses
- To study quality of life and impact of cost on cancer patients
- To encourage fresh and innovative ideas of new investigators
- To involve community hospitals in CALGB cancer research
- To maintain a high degree of quality control in all CALGB science
- To increase participation of minority populations, the elderly and women in clinical trials
- To collect, analyze, and publish the results of CALGB studies
Multimodality Studies of Adult Solid Tumors
The number of CALGB protocols involving multimodality treatment has increased steadily over the years. Areas of particular interest within CALGB are the role of minimally invasive surgery in patients receiving state-of-the-art multimodality therapy as well as neoadjuvant therapy prior to surgery.
Correlative Sciences
During the 1970s, the CALGB initiated the application of immunologic methods for the study of leukemia and lymphoma. Continuing with progressively more sophisticated studies, interest has expanded to include the application of molecular-genetic techniques to characterize leukemias, lymphomas, and solid tumors at the gene level. This information is providing dramatic insights into relationships between gene mutation and treatment outcome and allowing better treatment selection for individual patients.
Pharmacology Studies
Pharmacokinetic data are important for determining the optimal dose or schedule of a drug. The Pharmacology & Experimental Therapeutics Committee has increasingly focused on pharmacogenetics, the study of how genetic variation may impact on the toxicity or efficacy of drug therapy.
Studies of New Agents
The CALGB has a long history of accomplishments in evaluating new therapeutic agents. The Group has developed innovative strategies for testing new agents while allowing patients to receive standard therapies.
Cancer Control and Health Outcomes
The CALGB has pioneered the use of telephone interviews for data collection concerning quality of life in cancer patients. Studies exploring the relationship between therapy and quality of life and the economic impact of new treatments are underway.
Cancer in the Elderly
CALGB has been among the leaders in designing studies specifically assess the pharmacology and tolerance of chemotherapy in older patients, barriers to treatment of older patients on clinical trials and therapeutic options for older women with early stage breast cancer.
Study Development and Monitoring
The concept for a new study originated by a CALGB member is discussed by the Disease Committee and Modality Committee core; it is then discussed by the full committee. The committee chairs bring the concept to the Executive Committee and, if approved, the Study Chair develops a draft protocol. The relevant Committee Chair, the responsible Statistician, appropriate chairs of other Disease and Modality committees, patient advocates, and the Principal Investigators at the main member institutions are involved in the protocol design. After CALGB review and NCI approval, the Central Office officially activates the protocol. A Data and Safety Monitoring Board (DSMB) periodically reviews interim reports prepared by the Statistical Center for all Phase III studies. When the required number of patients has been entered on a study, the study is closed. The DSMB may elect to terminate a protocol early or to continue a study beyond its intended accrual. Final analysis of the data is the responsibility of the Statistical Center and the Study Chair.
Study Analysis
The Statistical Center is responsible for all database management and statistical activities within the Group. Statisticians and Data Coordinators are members of all Disease and Modality committees. Each Group research study is assigned to a Statistician / Data Coordinator team, which actively collaborates in the design, implementation, interim and final analyses, and publication of Group research. Study Chairs are required to formally evaluate each patient record at key points in the patient's progress. Quality control checks are done on all data submission forms.
Data Management
The Clinical Research Associates promote efficient and accurate documentation and collection of data. Data audits are conducted on-site at the member institutions of the CALGB, along with their affiliates and CCOPs. These audits are performed to confirm the data reported on the clinical research forms.
Radiation Therapy Quality Assurance
The CALGB Radiation Oncology Quality Assurance Subcommittee reviews CALGB data under the auspices of the Quality Assurance Review Center
Quality Assurance Review Center
The Quality Assurance Review Center is a research program within the University of Massachusetts Medical School that provides radiotherapy quality assurance , diagnostic imaging data management, and clinical research support...
(QARC) in Lincoln, Rhode Island
Lincoln, Rhode Island
Lincoln is a town in Providence County, Rhode Island, United States. The population was 21,105 at the 2010 census. Lincoln is located in northeastern Rhode Island, north of Providence....
. QARC was organized to monitor radiotherapy quality assurance programs for several cooperative groups and is supported independently of the CALGB. Today QARC provides radiotherapy quality assurance and diagnostic imaging data management to all of the National Cancer Institute
National Cancer Institute
The National Cancer Institute is part of the National Institutes of Health , which is one of 11 agencies that are part of the U.S. Department of Health and Human Services. The NCI coordinates the U.S...
(NCI) sponsored cooperative groups. These groups include CALGB, the Children's Oncology Group
Children's Oncology Group
The Children’s Oncology Group , a National Cancer Institute supported clinical trials group, is the world’s largest organization devoted exclusively to childhood and adolescent cancer research...
(COG), the Eastern Cooperative Oncology Group
Eastern Cooperative Oncology Group
The Eastern Cooperative Oncology Group began in 1955 as one of the first publicly-funded cooperative groups to perform multi-center clinical trials for cancer research. A cooperative group in oncology constitutes a large network of private and public medical institutions that work toward...
(ECOG), the Southwest Oncology Group (SWOG), and others. Although QARC is largely supported by grants from the NCI and NIH (National Institutes of Health
National Institutes of Health
The National Institutes of Health are an agency of the United States Department of Health and Human Services and are the primary agency of the United States government responsible for biomedical and health-related research. Its science and engineering counterpart is the National Science Foundation...
), the center also contracts privately with the pharmaceutical industry so as to offer its services in clinical trials for anti-cancer drugs. Lastly, QARC maintains a strategic affiliation with the University of Massachusetts Medical School
University of Massachusetts Medical School
The University of Massachusetts Medical School is one of five campuses of the University of Massachusetts system and is home to three schools: the School of Medicine, the Graduate School of Biomedical Sciences, the Graduate School of Nursing; a biomedical research enterprise; and a range of...
(UMMS) in Worcester, Massachusetts
Worcester, Massachusetts
Worcester is a city and the county seat of Worcester County, Massachusetts, United States. Named after Worcester, England, as of the 2010 Census the city's population is 181,045, making it the second largest city in New England after Boston....
.
Institutional Performance Evaluation Committee
The Institutional Performance Evaluation Committee (IPEC) develops and implements standards of performance for the CALGB and reviews performance of protocol requirements and quality of data submitted by individual institutions on a semi-annual basis. The Committee evaluates institutional audit reports from the Data Audit Committee and quality control data from the Radiation Oncology Quality Assurance Subcommittee, the Surgery Quality Assurance Committee, the PET Committee, and other sources.
OHRP Assurances
The CALGB works with the Department of Health and Human Services' Office for Protection for Human Research Protection (OHRP). This office is responsible for assuring that the rights of patients participating in clinical research studies are protected amend the patient informed consent is documented. The CALGB audit teams evaluate institutional performance with respect to OHRP regulations.
Patient Confidentiality Right to Privacy Act
The CALGB has instituted procedures designed to protect the privacy of patients participating in clinical trials. Although there are some limits to nondisclosure of information to federal regulatory agencies, the CALGB protects the privacy of our clinical trial participants as required by law. The CALGB consent form fully describes the confidentiality policy of the CALGB. Information that would allow identification of study participants is not included in any reports or publications of the CALGB.
Policies Concerning Women and Minorities
The CALGB recognizes the importance of policies and procedures that encourage women and minority participation in CALGB clinical trials; currently, more than 50% of CALGB study patients are women.
Minority Initiative Program
The Minority Initiative program was created to increase the number of minority patients participating in CALGB studies. Particular attention is directed toward developing protocols that focus on diseases that exact a heavy toll on minority populations.
Whom Do We Serve?
The constituencies to which the CALGB is responsible include:
- The public whose taxes, in part, support the CALGB
- The patients who agree to participate in our clinical trials
- The academic institutions and their community affiliates that support our research investigators