In this issue of The Leading Edge newsletter, we've highlighted new topics to give you the latest news on leading-edge research and therapies that SCCA physicians are offering.
- CME - Current Concepts and Challenges in Breast Cancer
- SCCA is opening a new Phase I Clinical Trials Unit later this year to house patients participating in Phase I cancer clinical trials lead by researchers from Fred Hutchinson Cancer Research Center and UW Medicine.
- Malignant glioma study seeks patients to determine whether transplanting a person’s own stem cells, that have been modified to be chemotherapy-resistant, will allow for more intense chemotherapy dosing and subsequently result in improving the overall survival.
- Cognitive functioning study open for prostate cancer patients receiving hormone therapy.
- Leukemia treatment trials newly underway at SCCA are seeking patients with acute myeloid leukemia.
- VATS lobectomy for lung cancer is now confirmed as an effictive and beneficial treatment. Adequacy of resection, number of lymph nodes resected, and cancer-specific survival are at least as good as that seen with conventional open surgery.
Phase I clinical trials for cancer drugs provide the first human testing of investigational agents typically with patients who have advanced cancer for whom all treatments have been exhausted and no further established treatment exists.
Phase I trials are critical to future patients and the health-care industry. Potentially speeding the development of new therapies, these trials require a high level of unique technical and scientific competencies, like those found at SCCA’s Phase I Cancer Clinical Trials Program, located in the Clinical Trials Unit (CTU) at SCCA.
This program’s researchers have access to leading research facilities at Fred Hutchinson Cancer Research Center, the source of multiple medical breakthroughs and home to Nobel Prize winning researchers, and University of Washington Medicine where advanced technologies such as positron emission tomography (PET) and other essential tools support thorough research studies.
Chemotherapy used to treat glioblastoma causes low blood counts, which limit the amount of chemotherapy that can be given. This study is one attempt to find a way to allow patients to receive more chemotherapy, which might be more effective in treating the disease.
Basic Eligibility Criteria Patients must be adults, 18 years or older, with newly diagnosed glioblastoma or gliosarcoma that contains high amounts of methylguanine methyltransferase (MGMT). Other criteria will be evaluated by the physician, nurse, and study coordinator.
Contact Information For more information about this study, contact Jennifer Adair at (206) 667-7110.
Since over 70 percent of all patients diagnosed with prostate cancer are over 65, cognitive difficulties from treatment are challenging to separate from cognitive changes due to normal aging. UW Medicine/SCCA researchers are looking at mood changes, anxiety, depression, fatigue, and diminished cognitive or memory abilities in this group of patients.
Once obvious medical conditions such as brain metastases, electrolyte or blood chemistry have been ruled out as potential causes for cognitive dysfunction, other methods of assessment are considered. Informal and subjective assessment for cognitive symptoms such as asking patients to give detailed examples of situations in which they are having cognitive difficulties can be useful. However, objective assessments by a professional can provide an unbiased measure of current capabilities along with norm-based comparisons and a profile of strengths and weaknesses. Assessment by a trained neuropsychologist is very helpful for individuals who want to know if their cognitive difficulties are
within the normal range for their age group or a sign of something more serious.
“Generally speaking, localized disease and treatment such as surgery for prostate cancer should not result in significant changes in cognition,” says Monique Cherrier, PhD, UW research associate professor in the Department of Psychiatry and Behavioral Sciences.
“Hormone therapy in particular may have a greater impact on quality of life compared to other treatments. One study found approximately 25 percent of men undergoing hormone therapy had reported cognitive difficulties.” Previous studies examining cognition in men undergoing androgen ablation have found impairments in verbal memory, spatial abilities, and attention. However, other studies have found no appreciable change in cognition from androgen ablation, or decline for only a subset of participants. Although the specific mechanisms that cause cognitive dysfunction in cancer patients are unknown, research has begun to address possible underlying mechanisms that might contribute to these behavioral problems. In addition to hormonal mechanisms, other factors include vascular injury and oxidative damage, inflammation, direct injury to neurons, autoimmune responses, and anemia. Chemotherapy can damage blood vessels and endothelial cells directly and there is evidence of a dosedependent effect of chemotherapy on cognition.
“Numerous health and behavioral factors can affect optimal cognitive functioning,” Cherrier says, “and
a review of medications, nutrition, sleep, stress, and mood disorders should be assessed and, if necessary, treated.”
Depending on the severity of cognitive dysfunction, treatment may range from intervention by a work coach or on-site rehabilitation specialist, to the implementation of an aide such as a memory book or hand held assistive device.
Eligibility & Contact Information
To participate in this study, eligible men must be starting hormone therapy or have undergone treatment for prostate cancer in the past and are not on hormone therapy. Contact Tom Erickson at (206) 277-1058 or email@example.com or firstname.lastname@example.org.
SCCA conducts clinical trials for leukemia on an ongoing basis. Continuing the pursuit of better treatments for its patients, four new clinical trials have recently opened and are currently accepting patients to participate.
WTI is a vaccine that may be active against acute myelogenous leukemia (AML) blasts that express WTI antigen. Patients are eligible if they are in remission but at significant risk of relapse. To inquire about this trial, contact Andrew Coveler, MD at (206) 288-7509. Study number UW# 09003.
Azacytidine + Vorinostat + Gemtuzumab is a combination therapy being studied that combines vorinostat to the other two medications that have been reported to be promising in patients over 60 years old who have AML. The addition of vorinostat may increase the effectiveness of this treatment. Patients are eligible if they are over 60 and have not responded to initial induction therapy with daunorubicin (or idarubicin) + ara-C. Contact Roland Walter, MD at email@example.com or (206) 667-3599. Study number 2288.
Oral Clofarabine + Low-dose ara-C. Intravenous clofarabine produces remissions in older patients with AML and addition of low-dose ara-C improves the response rate. Oral clofarabine, while not available commercially, is easier to administer than IV clofarabine. This trial is for patients who are over 60 years of age with AML who have not responded to drugs such as azacytidine or decitabine although patients cannot have received ara-C. Contact John Pagel, MD at firstname.lastname@example.org or (206) 667-1868. Study number 2302.
Clofarabine + ara-C for Minimal Residual AML. It’s been shown that patients who are in remission by morphologic criteria but have flow cytometric evidence of abnormal bone marrow blasts are at higher risk for relapse than patients without such evidence, even if they receive a stem cell transplant. This protocol is testing whether the use of clofarabine + ara-C will eliminate minimal residual disease. Patients are eligible if they have received one course of consolidation therapy containing ara-C, but still have minimal residual disease. Contact Pamela Becker, MD at email@example.com or (206) 288-6890. Study number 6858.
More Trial Information For information about more clinical trials for AML and all types of leukemia, please consult the Fred Hutchinson Cancer Research Center clinical trials database at www.fhcrc.org/patient/treatment/trials/index.php.
Thoracoscopic lobectomy has evolved dramatically since its introduction more than 15 years ago. Originally, Video Assisted Thoracic Surgery (VATS) was an approach that complemented or enhanced conventional open surgical approaches. Large incisions were downsized a bit but ribs were still spread and cameras were used mainly to enhance visualization through these slightly more limited exposures. The early operations did not adhere to basic oncologic surgical principles and often lung tissue, vessels, and airways were mass ligated. Later iterations of VATS lobectomy sought to precisely recapitulate the dissection sequence and approach used with conventional open surgery. This did not translate well. The operations were excessively long and patients experienced prolonged post-operative air leaks that extended their stays in the hospital. Currently an “anterior to posterior” dissection sequence is employed with VATS lobectomy. It is entirely anatomic and oncologically sound. It is foreign to many non-VATS surgeons however, likely adding to their reluctance to adopt it into their practices.
Despite criticism from those that do not perform VATS lobectomy, the medical literature now confirms its efficacy and benefits. The adequacy of resection, number of lymph nodes resected, and cancer-specific survival are at least as good as that seen with conventional open surgery. It is readily taught and is quite safe with reported complication rates that appear to be lower than those seen with open surgery. This may be particularly true for frail patients who might be overwhelmed by an open approach.
In addition, patients who have VATS have been shown to experience less pain, less of an inflammatory response, shorter duration of chest tube drainage and hospital stay, and better tolerance for adjuvant chemotherapy when indicated.
The keys to experiencing the benefits of VATS lobectomy are careful patient selection and precise performance of the appropriate techniques by an experienced VATS surgeon.
For more information go to www.seattlecca.org/VATS, or patient care coordinator Margaret O’Connor (206) 598-1980 Fax (206) 598-6608.
Dr. Michael Mulligan is director of Minimally Invasive Thoracic Surgery at University of Washington Medical Center and is available for consultation by calling (206) 598-1980.
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The SCCA Adult Bone Marrow Transplant News is a publication presenting the latest information on bone marrow transplant research at SCCA, providing up-to-date information for all health care professionals caring for transplant patients.
Read about important outcomes research at the Fred Hutch that may benefit your patients.
Each issue of Clinical Trials Monthly highlights several of the more than 200 clinical trials that are currently recruiting patients at SCCA.
Each quarterly Leading Edge newsletter will highlight a new topic to give you the latest news on leading-edge therapies that SCCA physicians are offering.