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:6/27/2016)... ... 27, 2016 , ... The OSHA Training Center at ... Center headquartered in Northern California, has issued an important reminder to employers to ... Employers with workers exposed to high temperatures should establish a complete heat ...
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal ... Final Cut Pro X," said Christina Austin - CEO of Pixel Film Studios. ... Cut Pro X users can now reveal the media of their split screens ...
(Date:6/27/2016)... (PRWEB) , ... June 27, 2016 , ... ... for mental health professionals, announced today its affiliation with Tennessee Counseling Association. ... solutions to the network of the Tennessee Counseling Association, adding exclusive benefits and ...
(Date:6/27/2016)... ... June 27, 2016 , ... ... today announced its strategic partnership with Connance, a healthcare industry leader providing ... companies’ proven, proprietary technology combine to provide health systems, hospitals and ambulatory ...
(Date:6/27/2016)... ... June 27, 2016 , ... A revolution is underway. ... ambulance transport experience for the millions of people who require these medical transport ... taxi industry through the use of technology. Now, SmartEMS has put forth an ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... June 26, 2016 One of Australia,s ... the formation of a new biotechnology company, Noxopharm Limited [ABN 50 ... an IPO and to list on the ASX. Noxopharm ... ready to enter a Phase 1 clinical study later this year. ... address one of the biggest problems facing cancer patients - the ...
(Date:6/26/2016)... , June 27, 2016 Jazz Pharmaceuticals ... waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of ... acquisition of Celator Pharmaceuticals, Inc. ("Celator"; Nasdaq: ... p.m. (Eastern Daylight Time). As previously announced ... into a definitive merger agreement under which Jazz Pharmaceuticals ...
(Date:6/26/2016)... -- VMS Rehab Systems, Inc. ( www.vmsrehabsystemsinc.com ) reported today ... to build a strong and stable market for trading ... the OTC Markets-pink current trading platform. Explains ... seeing an anomaly in market trading activities that may ... Company, but shareholders and market players as well. I ...
Breaking Medicine Technology: