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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genta Incorporated
ClinicalTrials.gov Identifier:
NCT00518895
First received: August 14, 2007
Last updated: November 4, 2011
Last verified: April 2009
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma
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
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  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].

Responsible Party: Genta Incorporated
ClinicalTrials.gov Identifier: NCT00518895     History of Changes
Other Study ID Numbers: AGENDA, GM307
Study First Received: August 14, 2007
Last Updated: November 4, 2011
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:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
 Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013