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What are Clinical Trials?

Clinical trials are systematic studies designed to find new and better ways to help patients. Using a formal study plan of people with a particular disease or class of diseases, investigators evaluate treatment methods such as surgery, drugs, or radiation techniques. Methods of prevention, detection, or diagnosis also may be the subject of such studies. Cancer clinical trials offer patients what are often the most innovative and ground breaking treatments available.

Every drug used to treat cancer first undergoes extensive laboratory testing. When laboratory tests show that a drug or other form of therapy has either slowed or stopped the growth of cancer in laboratory settings, the Federal Drug Administration allows researchers to see how well it works for people with cancer. When first available, those treatments-which become part of clinical trials- are offered for sale only in designated medical centers across the county, where oncology specialists supervise the treatment under study. Clinical trials help researchers determine how well a drug combats a particular form of cancer while allowing patients the opportunity to benefit from what may be the most promising treatment option available.


How do Clinical Trials Advance Medical Knowledge?

The University Hospital and Medical Center at Stony Brook is the leading center for clinical trials in Suffolk County. Our facility physicians share in evaluating and developing the treatment methods doctors throughout the nation may later recommend for patients with cancer.

Stony Brook oncologists belong to various cooperative research groups sponsored by the National Cancer Institute and other leading research institutions throughout the country.

Via sophisticated computer programs, Stony Brook's oncology teams share the most up-to-the-minute information about cancer treatments with their colleagues throughout the United States. By caring for cancer patients, analyzing and summarizing treatment results, Stony Brook's clinical investigators are at the forefront of cancer treatment and prevention.


How Is a Clinical Trial Conducted?

Doctors who conduct a clinical trial follow a carefully designed treatment plan called a protocol. This spells out what will be done and why. Studies are planned to safeguard the medical and psychological health of patients as well as to answer research questions. Some clinical trials test one research treatment in one group of patients. Other trials compare two or more treatments in separate groups of patients who are similar in certain ways, such as the extent of their disease.

One of the groups may receive standard treatment (the most accepted) treatment so the new treatments can be directly compared to it. The group receiving the standard treatment is called the control group. For example, one group of patients (the control group) may receive the usual surgical treatment for a certain cancer, while another patient group with the same type of cancer may receive surgery plus radiation therapy to see if this improves disease control.

Sometimes, no standard treatment yet exists for certain cancer patients. In drug studies for such cases, one group of patients might receive a new drug and the control group, none. But no patient is placed in a control group without treatment if there is any known treatment that would benefit that patient. The control group is followed as often and carefully as the treatment group.

If the treatment in a trial is not helping the patient, the patient's doctor can decide to take him or her out of the study. Of course, the patient can decide to leave, as well, and still receive other available care. There are regular reviews for the results a trial and the information is shared. This is important, because if a treatment is found to be too harmful or not effective, it is stopped. Also, when there is firm evidence that one method is better than the others in a study, the trial is stopped and all patients in the trial are given the benefit of the new information. Such information may help present and future patients.


What are the Benefits of participating in Clinical Trials at Stony Brook?

The patients in a clinical trial are among the first to receive new research treatments before they are widely available. Those who take part in clinical trials have the first chance to benefit from treatments that can be more effective.

Many patients, even those who feel frightened when beginning clinical trials, say they enjoy the warm and caring, team-management approach at Stony Brook. Patients benefit from more extensive medical attention and observation than usual. Expertise is provided by a research team of doctors, nurses, data mangers, and other professional health care staff who watch carefully over patient progress and collaborate to make sure all needs are met.

Each patient is assigned a highly skilled research nurse who becomes closely involved with the patient's care. The research nurse maintains telephone contact with the patient to answer any questions or concerns the patients may have about their care.

As part of the screening process that determines if a patient is a good candidate for a particular study, each patient receives a thorough physical examination by a clinical oncologist who reviews the patient's medical history and diagnosis, and supervises that patient's care if he or she is accepted into the study. When the treatment ends, this supervision continues with follow-up care and monitoring.

In response to the urgent needs of our cancer patients and their families. Stony Brook's research clinicians are pressing to find cures for cancer. As they do, Stony Brooks offers the most advanced treatment options for cancer patients and allows many patients the option to receive that care in a setting located conveniently close to home.

Stony Brook's clinical research teams are funded in part by grants from the National Cancer Institute and other benefactors. These awards offset many of the costs of drugs and other cancer care. Some services provided through clinical trials are also covered by health insurance plans.


What Is Happening in Cancer Research at Stony Brook?

The Cancer Center at Stony Brook combines the most advanced cancer treatment options with a multidisciplinary approach to care. As Stony Brook researchers link the molecular characteristics of tumors with clinical outcomes, such as response to therapy and overall survival rates, they discover which cancers respond best to particular forms of treatment.

Stony Brook's Frontline Research Initiatives Form the Base for Clinical Trials.
Gene Therapy. This technique of inserting specialized genes into a patient's cells to modify cell function has future applications in cancer treatment. Stony Brook researchers are preparing to explore this modality in several areas of chemotherapy.

Tumor Control. Researchers at Stony Brook are among those investigating p53, a gene known to play an important role in suppressing tumor growth. By inserting the p53 gene into tumor cells, scientists expect p53 to multiply, restoring the ability to impede tumor growth.

Immunotherapy. Cytokines, produced by the white blood cells, are proteins that regulate our immune system in various ways. Stony Brook researchers are investigating the interaction of cytokines with tumor cells as a biological approach to treating cancer.

Stony Brook--Leading the Way
Biochemical modulation. Clinical investigators in our Medical Oncology Division led the world in developing biochemical modulation, a technique that uses drug combinations to enhance the effectiveness of chemotherapy. Their work in the 1980's resulted in today's accepted therapy for advanced colorectal carcinoma and, subsequently, in treatment that prevents or delays the recurrence of colon cancer after it is surgically removed. Medical oncologists at Stony Brook are presently testing the next generation of biochemical modulation therapies.

Stony Brook investigators are currently working on trials that offer new and novel approaches to cancer treatment:

Monoclonal antibodies for breast and colon carcinomas. These antibodies act as "magic bullets" specifically designed to target or kill tumor cells while sparing normal cells. Stony Brook has been selected as one of the international sites to conduct these trials.

Intracarotid chemotherapy for brain tumors. This novel approach delivers chemotherapy directly into the brain tumor. Nationwide, there are only a few institutions capable of conducting this type of study.

Study of the cancer language. Cancer occurs when cells are triggered to reproduce in an abnormal and uncontrolled way. The mechanism of cancer cell growth--the language--is under investigation by Stony Brook researchers as they identify and therapeutically target growth receptors on cancer cells with somatostatin. This new approach is currently underway in treating brain tumors and will soon target breast and prostate tumors, as well.

Bone marrow transplantation. Physicians at Stony Brook are active participants in nationwide bone marrow transplantation trials for malignancies such as breast and ovarian cancers, multiple myeloma, lymphoma and sarcomas.

Prevention of Secondary Cancers. Clinical trials are underway at Stony Brook to evaluate drugs that have shown promise in preventing the recurrence of lung, and head and neck cancers.

Chemotherapy. Our researchers are currently investigating a variety of new drugs from the National Cancer Institute for carcinomas of the head and neck, lung, breast, colon as well as sarcomas and lymphomas.


Why Choose Stony Brook's Research Team?

Stony Brook physicians are strongly committed to offering patients the option to pursue the latest cancer treatment and prevention protocols because, someday, they may be the therapies of choice. This commitment to innovative medicine and our concern for patient dignity provides a thoughtful and meaningful approach to cancer care.

Cancer Clinical Trials at Stony Brook address the needs of a broad spectrum of cancer patients. To best meet those needs, Stony Brook physicians focus their talents in specific areas. With specialists in gynecologic oncology, medical oncology, pediatric oncology, radiation oncology and surgical oncology, Stony Brook offers caring physicians with extensive knowledge of a variety of cancers. Our cancer clinical trials specialists treat brain tumors, breast cancers, gastrointestinal carcinomas, melanomas, and soft tissue sarcomas, ovarian and endometrial cancers. They also treat lung and prostate cancers, leukemias and lymphomas. And our team is active in trials focused on preventing cancer.

True to the Stony Brook tradition of excellence, our University researchers are designated as principal investigators of many nationwide research studies. They design protocol for single-and multi-institution clinical trials and conduct investigations for several national research organizations. In fact, the early work of a Stony Brook faculty member contributed significantly to what is now the standard treatment for colon cancer. Our physicians also provide medical expertise for research at Brookhaven National Laboratories, such as Phase I and Phase II clinical trials of boron neutron capture therapy.

Stony Brook's clinical research faculty help advance the care of patients with cancer. Through their research, they serve as advocates for all those with cancer.


How Can I Enroll in a Clinical Trial?

If you are interested in enrolling in one of the several clinical trials underway at the Stony Brook University Hospital and Health Sciences Center, please ask your primary care physician to refer you for treatment. If you need more information about clinical trials, you may call the Cancer Helpline at Stony Brook directly at 1-800-UMC-2215.