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

Sponsor:	Genta Incorporated
Information provided by:	Genta Incorporated
ClinicalTrials.gov Identifier:	NCT00518895

Purpose

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.

Condition	Intervention	Phase
Melanoma	Drug: dacarbazine plus Genasense Drug: dacarbazine plus placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Oblimersen sodium Dacarbazine Sodium chloride

U.S. FDA Resources

Further study details as provided by Genta Incorporated:

Primary Outcome Measures:

Progression-free survival and overall survival [ Time Frame: Every 42 days from date of randomization during protocol therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	300
Study Start Date:	July 2007
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Dacarbazine with Genasense	Drug: dacarbazine plus Genasense Protocol therapy will be administered in 21-day cycles for up to 8 cycles. Subjects in the dacarbazine plus Genasense group will receive Genasense 7 mg/kg/day by continuous intravenous infusion beginning on Day 1 and continuing for 5 days (120 hours) plus dacarbazine 1000 mg/m2 as a 60-minute intravenous infusion immediately following the conclusion of the Genasense infusion. Subjects who are responding or have stable disease after 8 cycles of therapy may, at the Investigator's discretion, continue that same therapy for up to 8 additional cycles.
B: Active Comparator Dacarbazine with placebo	Drug: dacarbazine plus placebo Protocol therapy will be administered in 21-day cycles for up to 8 cycles. Subjects in the dacarbazine plus placebo group will receive placebo (that is, locally available commercial 0.9% Sodium Chloride Injection) by continuous intravenous infusion beginning on Day 1 and continuing for 5 days (120 hours) plus dacarbazine 1000 mg/m2 as a 60-minute intravenous infusion immediately following the conclusion of the placebo infusion. Subjects who are responding or have stable disease after 8 cycles of therapy may, at the Investigator's discretion, continue that same therapy for up to 8 additional cycles.

Arms

Assigned Interventions

A: Experimental

Dacarbazine with Genasense

Drug: dacarbazine plus Genasense

Protocol therapy will be administered in 21-day cycles for up to 8 cycles. Subjects in the dacarbazine plus Genasense group will receive Genasense 7 mg/kg/day by continuous intravenous infusion beginning on Day 1 and continuing for 5 days (120 hours) plus dacarbazine 1000 mg/m2 as a 60-minute intravenous infusion immediately following the conclusion of the Genasense infusion. Subjects who are responding or have stable disease after 8 cycles of therapy may, at the Investigator's discretion, continue that same therapy for up to 8 additional cycles.

B: Active Comparator

Dacarbazine with placebo

Drug: dacarbazine plus placebo

Protocol therapy will be administered in 21-day cycles for up to 8 cycles. Subjects in the dacarbazine plus placebo group will receive placebo (that is, locally available commercial 0.9% Sodium Chloride Injection) by continuous intravenous infusion beginning on Day 1 and continuing for 5 days (120 hours) plus dacarbazine 1000 mg/m2 as a 60-minute intravenous infusion immediately following the conclusion of the placebo infusion. Subjects who are responding or have stable disease after 8 cycles of therapy may, at the Investigator's discretion, continue that same therapy for up to 8 additional cycles.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518895

Show 77 Study Locations

Sponsors and Collaborators

Genta Incorporated

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Bedikian AY, Agarwala SS, Gilles E, Itri L, Kay R, Garbe C. The AGENDA Study: A randomized, double-blind study of Genasense plus dacarbazine (DTIC) in chemotherapy-naïve subjects with advanced melanoma and low LDH. Pigment Cell Res. 2007;20:538 [Abstract T-26].

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.

Responsible Party:	Genta Incorporated ( Steven Novick, MD, PhD )
Study ID Numbers:	AGENDA, GM307
Study First Received:	August 14, 2007
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00518895 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genta Incorporated:

Melanoma
Advanced Melanoma
Malignant Melanoma
Metastatic Melanoma
Skin Cancer
Genasense

oblimersen
antisense
Bcl-2 antisense
G3139
dacarbazine

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Dacarbazine
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Pharmacologic Actions
Melanoma
Neuroendocrine Tumors

Neuroectodermal Tumors
Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on November 05, 2009