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Clinical Trials
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Trinitas Cancer Center Announces Clinical Trial To Begin For Previously Untreated Patients With Multiple Myeloma |
Location And Directions... |
The Trinitas Comprehensive Cancer Center is located at our Williamson
St. Campus.
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As part of our commitment to providing the most thorough care, Trinitas
Comprehensive Cancer Center participates in clinical trials to test new
medications and other advances in treatment and technology. Because we
believe that patients should have access to as many treatment options as
possible, our highly accomplished and board certified oncologists encourage patients to participate in clinical trials when the
most appropriate treatment is a trial with a new compound.
As part of the Eastern Cooperative Oncology Group (ECOG), our Comprehensive
Cancer Center is part of a larger network of cancer centers that partake in
clinical research being conducted by major pharmaceutical and biotechnology
companies. The range of choices has expanded dramatically for patients who
want to evaluate every possible option available to them. New drugs, updated
drug delivery methods and immunotherapy are part of what we offer at the
Trinitas Comprehensive Cancer Center.
Trinitas staffs medical oncologists that are experienced in most forms of
cancer. These oncologists work with a team of professionals including
radiation oncologists when appropriate, advanced practice nurses, oncology
certified and trained nurses, a clinical research manager, nutritionists and
social workers in order to provide accessible, personalized and
compassionate care for all of our patients.
What are Clinical Trials?
Also called research studies, clinical trials are designed to assess
potential new treatment or prevention opportunities with the goal of better
outcomes. Clinical trials test the safety and efficiency of new or
transformed cancer drugs, doses, unique approaches to surgery or radiation
therapy, and diversified treatment combinations. The goal of a clinical
trial may be to cure more patients, to prolong the lives of more patients,
to prevent the spread or recurrence of cancer, or to achieve the same
outcome as previous therapies with fewer side effects.
Clinical trials are a significant component for enhancing the treatment of
medical conditions because they lead to exceeding standards of care. Every
current medical treatment was a clinical trial at one point. In fact,
current standard treatments for particular cancers may not be what is
optimal for you, so always discuss with your oncologist about what clinical
trial might be appropriate to consider for your specific cancer.
What are the Benefits of Clinical Trials?
Designed to evaluate the effectiveness of new treatment interventions,
clinical trials have several benefits such as:
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Exceptional cancer care |
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The possibility of benefiting from a new drug or treatment procedure |
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The opportunity to help other patients and improve cancer treatment |
It has been proven that clinical trials have offered some of the most effective cancer treatments currently available today.
What are the types of Clinical Trials?
Also known as "research protocols" clinical trials evaluate the effectiveness of new interventions. The following are the various types of cancer clinical trials:
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Prevention trials constructed to keep cancer from developing in patients who have not previously had the disease |
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Prevention trials designed to prevent a new type of cancer from developing in those who have had cancer |
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Early detection trials to discover cancer in its early stage |
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Treatment trials to examine new therapies in people who have cancer or to compare new, promising treatment to customary, established treatment |
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Quality-of-life studies to enhance comfort and quality of life for people with cancer |
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Studies to evaluate ways of altering cancer-causing behaviors such as tobacco use |
Who Can Participate in Clinical Trials?
Trinitas Cancer Center has many clinical trials available for patients with various types and stages of cancer. Any patient interested in participating in one of these trials is carefully screened. In order to take part in the study, the patient must have specific medical conditions as well as meet particular standards to qualify for treatment in the protocol.
These standards, referred to as eligibility criteria, are for the patient's safety. These criteria will ensure that the results of the study will be useful when selecting treatments for other patients with similar diseases.
Trinitas Cancer Center Announces Clinical Trial To Begin For Previously Untreated Patients With Multiple Myeloma
A Phase II Trial with VELCADE® (PS-341), Cytoxan (cyclophosphamide), Dexamethasone and Thalomid® (VEL-CTD)
Aptium Oncology Research Network Protocol* #05-MM-01
Trinitas Comprehensive Cancer Center (Trinitas CCC) announced today its participation in a nationwide, multi-center clinical trial for previously untreated patients with multiple myeloma. As part of the Aptium Oncology Research Network, Trinitas CCC is working in partnership with several U.S. cancer centers and principal investigators. Dr. Gerardo Capo is serving as the principle investigator locally at Trinitas CCC. Participation in the 05-MM-01 study is currently available in NJ through the Trinitas Comprehensive Cancer Center, which is currently one of 10 medical facilities in the United States accepting volunteers for this Phase II study.
Heading the study for the Aptium Oncology Research Network is Dr. Brian Durie from the Cedars Sinai Outpatient Cancer Center in Los Angeles. Dr. Durie is the National Director for Hematology Malignancies for Aptium Oncology and Chairman of the International Myeloma Foundation. Also leading this study and collaborating with Trinitas CCC is Dr. Sundar Jagannath, Chief of the Multiple Myeloma Program and Bone Marrow and Stem Cell Transplantation Program at St. Vincent’s Comprehensive Cancer Center in New York City and Editor-in-Chief of Clinical Lymphoma & Myeloma.
Trinitas CCC researchers hope to move rapidly to begin this clinical trial. The Phase II study is open label, single arm and multi-institutional. It will evaluate an investigational* treatment regimen that includes sequential use of multiple myeloma drugs. The drugs in this study consist of VELCADE® (developed and provided by Millennium Pharmaceuticals, Inc.), Cytoxan (commercially available), dexamethasone (commercially available), and Thalomid® [provided by Celgene Corporation through the PTAP (Protocol Treatment Assistance Program)] and will be administered in varying doses and combinations in six treatment cycles.
Over the past three decades, the treatment for multiple myeloma has been mainly palliative with a median life expectancy of 3 years and less than 10% living 10 years or longer. "Nearly all patients experience a relapse after their initial treatment, and unfortunately, there is still no cure,” said Gerardo Capo, Medical Oncology and Hematology specialist at the Trinitas Comprehensive Cancer Center. “The best therapies we have still only provide a controlled remission in the most successful instances. There is clearly an urgent need for more therapies. This clinical trial may offer an option for multiple myeloma.”
Participants in the 05-MM-01 clinical trial must meet the following eligibility:
• A confirmed diagnosis of multiple myeloma requiring treatment
• No prior chemotherapy, immunotherapy, vaccine, or other agents for the treatment of active multiple myeloma
• Adequate cardiac, liver and kidney function
• Age 18 or older
"We have some of the best minds in Multiple Myeloma research working on this clinical trial," said Gary Horan, President of Trinitas Hospital. "Cancer is a major focus of our clinical research activities at Trinitas and this clinical trial is a prime example of our commitment to discover possible ways to fight cancer."
For additional information on this clinical trial, please visit our web site at www.trinitasccc.org or contact Maria Serrano, Clinical Research Manager at 908-994-8539.
* The treatment regimens in this study are considered investigational due to the fact that there has not been FDA approval of the use of the drugs in these combinations for the treatment of newly diagnosed multiple myeloma. VELCADE® is currently approved by the United States Food and Drug Administration (US FDA) and it is registered in Europe for the treatment of multiple myeloma patients who have received at least one prior therapy.