<Cancer> The NBTF is teaching patients how to read clinical trial abstracts..
The National Brain Tumor Foundation (NBTF) strives to provide you with important information about the latest brain tumors research. NBTF recently attended the American Society of Clinical Oncology (ASCO) 2006 Annual Meeting and we wanted to provide you with a summary of what was presented. To read the complete abstracts please visit What?s New.
How to Best Understand Clinical Trial Abstracts
The following summaries below represent the results of clinical trials. When reading these summaries, we suggest you think about the following questions to help you understand the study and its significance to you.
How many people participated?
Who participated? (what type of tumors and what grade)
What were the researchers trying to figure out?
What were the conclusions?
NBTF has published two fact sheets on clinical trials that you may find helpful if you would like to learn more. You can find them on our web site by clicking the links below, or contact us at nbtf@braintumor.org or 1.800.934.2873.
Fact Sheet: Overview of Clinical Trials for Brain Tumors
Fact Sheet: How to Access Clinical Trials
Abstract # 1503
What: Can the drug Provigil (modafinil) be used to treat neurobehavioral dysfunction (problems with memory, cognition, and mood) and fatigue in adult patients with brain tumors?
Where: UCLA School of Medicine, Los Angeles, CA
Who: 30 patients total. Patients were 21-65 years old with primary malignant or nonmalignant brain tumors treated with surgery, radiotherapy, and/or chemotherapy who had mild to severe attention/memory impairment and/or fatigue.
Conclusion: This study examined the effectiveness and safety of the drug modafinil (Provigil) for treating neurobehavioral dysfunction (problems with memory, cognition, and mood) and fatigue in brain tumor patients. Results showed improvement in cognition, mood, and fatigue in the study participants. Also, modafinil was generally well tolerated, and the greatest improvements were observed 8 weeks after baseline.
Abstract # 1504
What: What is the impact of whole brain radiation therapy on neurocognitive function (thinking/memory problems) in relation to tumor shrinkage in metastatic brain tumor patients?
Where: University of Wisconsin, Madison, WI; Pharmacyclics, Sunnyvale, CA
Who: 135 patients total. Patients were selected from the WBRT alone arm of a phase III clinical trial (PCYC-9801) evaluating motexafin gadolinium in brain metastases.
Conclusion: The impact of whole brain radiation therapy on neurocognitive function (memory, decision-making/planning, and small muscle movements) was explored in this study in relation to tumor shrinkage. Patients were observed for 15 months, and results showed that neurocognitive function was stable or improved in the long-term brain metastases survivors (15 months). The adverse impact of tumor growth on neurocognitive function appeared greater than that of whole brain radiation therapy.
Abstract # 1506
What: Is the combination of the drugs Avastin (Bevaciszumab) and Camptosar (irinotecan) safe and effective in treating malignant glioma tumors?
Where: Duke University Medical Center, Durham, NC
Who: 32 patients total. 23 patients had a grade IV Glioblastoma Multiforme tumor, and 9 patients had a grade III tumor (either anaplastic astrocytoma or oligodendroglioma).
Conclusion: The study is a phase II clinical trial examining the effectiveness and safety of a combination of the drugs bevacizumab (Avastin) and irinotecan (Camptosar) for the treatment of recurrent malignant gliomas. The prognosis for recurrent malignant gliomas is usually poor, with a median progression-free survival (length of time a patient lives with no tumor growth) less than 12 weeks. In this study, the combination of Avastin and Camptosar led to a median progression-free survival of 24 weeks. The combination of Avastin and Camptosar was shown to be well tolerated, safe, and active against malignant glioma tumor growth.
Abstract # 1507
What: Is the combination of drugs Iressa (gefitinib) and RAD-001 (everolimus) safe and effective in treating glioblastoma multiforme tumors?
Where: Memorial Sloan-Kettering Cancer Center, New York, NY
Who: 19 patients total. 11 men and 8 women aged 22-72 years (median age range of 53 years). Patients included those with a GBM tumor who were enrolled in a phase I/II study open to patients with either hormone refractory prostate cancer or recurrent GBM.
Conclusion: The most frequent grade 1 and 2 toxicities (side effects that negatively impact health) in this study were reduced platelet count, elevated ALT enzyme (indicating possible liver damage), rash, anemia (low red blood cells), leukopenia (low white blood cells), and diarrhea. Grade 3 lymphopenia (low lymphocyte cells such as T cells) occurred in 8 patients (42%), and two patients had grade 4 seizures unrelated to the study drugs. The combination of RAD-001 and gefitinib (Iressa) demonstrated anti-tumor activity in 37% of the patients. Most patients were heavily pre-treated and expected to have resistant disease.
Abstract # 1516
What: Can taking Temodar (temozolomide) on a different schedule still be effective?
Where: Genom Cooperative Group; Hospital General Universitario de Valencia, Valencia, Spain; Hospital Clinico de San Carlos, Madrid, Spain; Hospital Germans Trias i Pujol, Badalona, Spain; Instituto Valenciano de Oncologia, Valencia, Spain; Hospital de Sondureta, Palma de Mallorca, Spain; Hospital La Fe, Valencia, Spain; Hospital Ramon y Cajal, Madrid, Spain; Hospital Santa Creu I San Pau, Barcelona, Spain
Who: 29 patients, average age 51.3 yrs, 76% male, 24% female. Patients had high grade glioma brain tumors that were resistant to temozolomide (Temodar)
Conclusion: The goal of this study was to assess whether Temodar administration over an extended schedule (3 weeks of medication every 4 weeks) can overcome tumor resistance to the drug. The study is still underway, but preliminary data show that the extended schedule Temodar administration may reverse tumor resistance.
Abstract # 1519
What: Is the combination of the drugs Temodar (temozolomide) and Celebrex (celecoxib) safe and effective in treating relapsed malignant glioma tumors?
Where: Staten Island University Hospital, Staten Island, NY; New York Presbyterian Hospital-Weill Cornell University, New York, NY; J.F.K. Medical Center, Edison, NJ; New York Presbyterian Hospital-Columbia, New York, NY
Who: 46 patients total with recurrent/progressive Grade III or Grade IV astrocytoma brain tumors. Age ranged from 34-74 years.
Conclusion: Taking the drugs temozolomide (Temodar) and celecoxib (Celebrex) in combination twice a day was shown to be safe and potentially effective for the treatment of recurrent Grade III or IV astrocytoma brain tumors. These results warrant further study of this drug combination, especially in newly diagnosed patients.
Abstract # 1538
What: What is the incidence of blood clots (venous thromboembolisms) in glioma brain tumor patients, and what risk factors and outcomes are associated with blood clots?
Where: University of California, Davis, Sacramento, CA
Who: 9,489 cases total. Patients were diagnosed with a glioma brain tumor in California between 1993-1995 and 1997-1999.
Conclusion: Venous thromboembolism (VTE), also known as a blood clot, is a commonly reported complication of brain tumors. This retrospective study examined incidence, risk factors, and outcomes of VTE in patients with a glioma brain tumor. Two-thirds of all VTE cases occurred early after the diagnosis of the glioma, and most of these occurred within 2 months of a surgical procedure in the brain. In this study, a diagnosis of VTE was not associated with an increased risk of death within 1 year.
Abstract # 1539
What: Is the drug Tinzapain safe and effective in preventing blood clots (venous thromboembolisms) in brain tumor patients?
Where: Duke University Medical Center, Durham, NC
Who: 27 total newly diagnosed brain tumor patients.
Conclusion: Venous thromboembolism (VTE), also known as a blood clot, is a commonly reported complication of brain tumors. This phase II prevention trial is in the process of examining the drug tinzapain to see if it is effective in preventing VTE in brain tumor patients and to further evaluate its safety. Preliminary results show that tinzapain at a dose of 4500 IU is safe and may decrease the incidence of VTE in brain tumor patients. If the completed study concludes similar results, the drug will be able to enter a phase III study to further examine its effectiveness, monitor side effects, and compare it to other drugs.
Abstract # 1573
What: Is the combination of the drugs Gleevac (imatinib mesylate) and hydroxyurea safe and effective in treating malignant grade III glioma tumors?
Where: Duke University Medical Center, Durham, NC
Who: 39 patients total. Patients had grade III malignant astrocytoma (anaplastic astrocytoma) brain tumors with prior radiation therapy and chemotherapy. Median age 29 yrs.
Conclusion: This phase II clinical trial assessed whether the combination of the drugs imatinib mesylate (Gleevec) and hydroxyurea was safe and effective in halting tumor growth in anaplastic astrocytoma patients. Patients who were not taking enzyme-inducing anti-seizure medication received 400 mg daily of Gleevec, and patients who were on enzyme-inducing anti-seizure medication received 500 mg daily of Gleevec. Hydroxyurea was given to all patients at 500 mg twice a day. Results were that daily Gleevec and hydroxyurea drugs demonstrated encouraging antitumor activity, and the drugs were well tolerated among the patients in the study. Patients taking enzyme-inducing anti-seizure medication seemed to demonstrate a better response.
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