Navigation Links
Drugs are safe, active in patients normally ineligible for clinical trial
Date:12/10/2010

ORLANDO - A two-drug combination is safe and active in newly diagnosed acute myeloid leukemia and myelodysplastic syndrome patients who are usually excluded from clinical trials because they have other illnesses or poor performance status - a measure of disease progression - researchers reported this week at the 52nd American Society of Hematology Annual Meeting.

"Our findings suggest current eligibility standards that prevent participation by these patients in phase I and phase II clinical trials might be inadequate," said Guillermo Garcia-Manero, M.D., professor in The University of Texas MD Anderson Cancer Center Department of Leukemia, who presented early results of an ongoing phase II clinical trial. Such patients also are not eligible for standard therapies.

Newly diagnosed patients with AML or MDS who have an additional disease, including a second cancer, or lack good performance status, survive for less than 60 days without treatment, Garcia-Manero said. Performance status is measured by Eastern Cooperative Oncology Group criteria, which score patients from 0 (fully active) to 4 (completely disabled).

The phase II clinical trial accepts only those with ECOG performance status higher than 2 (capable of self care, unable to work, up more than half of waking hours) and those with other diseases.

The drug combination of 5-azacitidine and vorinostat is known to be safe and active against AML and MDS among patients without the complications that participants in this trial have, Garcia-Manero said.

So far, 27 patients have been treated, nine with AML, 18 with MDS. Their median age is 69, ranging from 44 to 83. At a median follow up of 3.6 months, 20 of 24 survived past 60 days (83 percent). One patient died during therapy, two died of disease progression after going off the study.

Fifteen could be evaluated for response to the combination, seven (46 percent) had complete responses. Stable disease was noted in two patients - one with metastatic sarcoma and one with breast cancer.

Benchmarks of survival and response that would require stopping the trial have not been met and Garcia-Manero said indications are that the study will continue and not hit either measure.

"This combination is safe and active for these poor-prognosis patients at similar levels of safety and activity seen among patients who are eligible for clinical trials," Garcia-Manero said.

Garcia-Manero and colleagues also have developed a prognostic model for MDS patients that takes into account additional diseases or conditions, called co-morbidities, to help predict survival in those patients.

Azacitidine, known commercially as Vidaza, activates genes that have been silenced by stripping them of methyl groups, which protrude like bookmarks from a gene's promoter region. Vorinostat, known commercially as Zolzinza, activates genes by protecting acetyl groups that adhere to histones - proteins connected to DNA like beads on a string.

Both drugs reactivate enough tumor-suppressing genes to have an effect on AML and MDS.


'/>"/>

Contact: Scott Merville
smerville@mdanderson.org
713-792-0661
University of Texas M. D. Anderson Cancer Center
Source:Eurekalert  

Related medicine news :

1. The private sale of drugs in public hospitals
2. Social Anxiety and Panic - Alternative Treatment to Drugs and Therapy
3. Adapting to clogged airways makes common pathogen resist powerful drugs
4. Diabetes Drugs Avandia, Actos Tied to Fractures in Women
5. Drugs That Shift Cells Energy Find New Purpose
6. FDA Tightens Controls on Anemia Drugs
7. FDA Issues Warning on Key Asthma Drugs
8. Two Tulsa Pharmacies Penalized for Missing Prescription Drugs
9. Tests to Measure Safety of Anti-Clotting Drugs of Limited Value
10. Notch-blocking drugs kill brain cancer stem cells, yet multiple therapies may be needed
11. Scans Might Monitor Success of Alzheimers Drugs
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Drugs are safe, active in patients normally ineligible for clinical trial
(Date:3/27/2017)... ... March 27, 2017 , ... ... facility from 8:00am-10:00am on Monday, April 3rd to commemorate the two-year anniversary of ... opportunity for area-residents to celebrate two great years while also familiarizing themselves with ...
(Date:3/27/2017)... HOUSTON, Texas (PRWEB) , ... March 27, 2017 , ... ... and hard of hearing, is bringing its latest products to the Deaf Seniors of ... attendees will have the opportunity to meet with knowledgeable ASL friendly staff from Harris ...
(Date:3/25/2017)... ... 2017 , ... Norland at Swissray is pleased to announce the release of the ... ELITE DXA has an active scan window, which is more than double that of existing ... scan area could not undergo an accurate total body bone density or body composition study. ...
(Date:3/24/2017)... ... March 24, 2017 , ... ... will spark a conversation on the current obstacles facing infection prevention and offer ... preventable deaths caused by these infections. , The print component of “Fighting ...
(Date:3/24/2017)... ... 2017 , ... The Radiology Business Management Association (RBMA) has named ... in their 12th year, are among the most prestigious in radiology marketing because a ... were retooled to recognize achievements in both large budget (over $5,000) and small budget ...
Breaking Medicine News(10 mins):
(Date:3/27/2017)... BOSTON , March 27, 2017 ... pharmaceutical company and Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), ... commercialization of innovative therapies based upon tetracycline chemistry, ... sarecycline for the treatment of moderate to severe ... Sarecycline is a once-daily, oral, narrow spectrum tetracycline-derived ...
(Date:3/27/2017)... NEW YORK , March 27, 2017 ... and technology platform for value-based precision medicine, ... multi-year collaboration with Novartis Pharmaceuticals Corporation to ... breast cancer patients. As part ... the previous announced collaboration entered into January ...
(Date:3/27/2017)... 2017 Arena Pharmaceuticals, Inc. (NASDAQ: ... small molecule drugs across multiple therapeutic areas, today announced that ... will present a corporate update at the 16th Annual Needham ... conference will take place April 4-5, 2017 at the Westin ... , NY.  A live audio webcast of ...
Breaking Medicine Technology: