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Trial of Dacarbazine With or Without Genasense in Advanced Melanoma (AGENDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00518895
Recruitment Status : Completed
First Posted : August 21, 2007
Last Update Posted : November 6, 2011
Sponsor:
Information provided by (Responsible Party):
Genta Incorporated

Study Description
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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.

Condition or disease Intervention/treatment Phase
Melanoma Drug: dacarbazine plus Genasense Drug: dacarbazine plus placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : July 2007
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Dacarbazine

Arms and Interventions
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Arm Intervention/treatment
Experimental: A
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.
Other Name: dacarbazine plus Genasense (oblimersen, G3139)
Active Comparator: B
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.
Other Name: dacarbazine plus placebo (0.9% Sodium Chloride Injection)


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival and overall survival [ Time Frame: Every 42 days from date of randomization during protocol therapy ]

Secondary Outcome Measures :
  1. Response rate, durable response rate, duration of response, safety [ Time Frame: Response and progression every 42 days from date of randomization during protocol therapy ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518895


Locations
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Sponsors and Collaborators
Genta Incorporated
More Information
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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].

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Responsible Party: Genta Incorporated
ClinicalTrials.gov Identifier: NCT00518895    
Other Study ID Numbers: AGENDA
GM307
First Posted: August 21, 2007    Key Record Dates
Last Update Posted: November 6, 2011
Last Verified: April 2009
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:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Dacarbazine
Oblimersen
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents