Trial of Dacarbazine With or Without Genasense in Advanced Melanoma - Tabular View

Tracking Information
First Received Date ^ICMJE	August 14, 2007
Last Updated Date	April 7, 2009
Start Date ^ICMJE	July 2007
Estimated Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 9, 2008)	Progression-free survival and overall survival [ Time Frame: Every 42 days from date of randomization during protocol therapy ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: August 17, 2007)	Co-primary: progression-free survival; overall survival
Change History	Complete list of historical versions of study NCT00518895 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 9, 2008)	Response rate, durable response rate, duration of response, safety [ Time Frame: Response and progression every 42 days from date of randomization during protocol therapy ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE (submitted: August 17, 2007)	response rate; safety

Descriptive Information
Brief Title ^ICMJE	Trial of Dacarbazine With or Without Genasense in Advanced Melanoma
Official Title ^ICMJE	A Multicenter, Randomized, Double-Blind Study of Dacarbazine With or Without Genasense in Chemotherapy-Naive Subjects With Advanced Melanoma and Low LDH (The AGENDA Trial)
Brief Summary	This study is being performed to prospectively determine whether dacarbazine plus Genasense is significantly better than dacarbazine plus placebo in chemotherapy-naive patients with advanced melanoma and low baseline LDH (LDH less than or equal to 0.8 times the upper limit of normal). LDH is a biomarker strongly associated with improved outcomes in a recent trial of dacarbazine plus Genasense.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Melanoma
Intervention ^ICMJE	Drug: dacarbazine plus Genasense Drug: dacarbazine plus placebo
Study Arms / Comparison Groups	Experimental: Dacarbazine with Genasense Active Comparator: Dacarbazine with placebo
Publications *	Bedikian AY, Millward M, Pehamberger H, Conry R, Gore M, Trefzer U, Pavlick AC, DeConti R, Hersh EM, Hersey P, Kirkwood JM, Haluska FG; Oblimersen Melanoma Study Group. Bcl-2 antisense (oblimersen sodium) plus dacarbazine in patients with advanced melanoma: the Oblimersen Melanoma Study Group. J Clin Oncol. 2006 Oct 10;24(29):4738-45. Epub 2006 Sep 11.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	300
Estimated Completion Date	March 2011
Estimated Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Histologically confirmed diagnosis of melanoma Progressive disease that is not surgically resectable, or metastatic Stage IV Low-normal LDH, defined as ≤ 0.8 times the upper limit of normal No prior chemotherapy Measurable disease ECOG performance status ≤ 1 At least 4 weeks and recovery from effects of major prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy Prior immunotherapy allowed Adequate organ function Exclusion Criteria: Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense treatment Primary ocular or mucosal melanoma Bone-only metastatic disease History or presence of brain metastasis or leptomeningeal disease Significant medical disease other than cancer Organ allograft
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Australia, Austria, Canada, Czech Republic, France, Germany, Italy, Poland, Spain, Switzerland, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00518895
Responsible Party	Steven Novick, MD, PhD, Genta Incorporated
Study ID Numbers ^ICMJE	AGENDA, GM307
Study Sponsor ^ICMJE	Genta Incorporated
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Genta Incorporated
Verification Date	April 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP