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Completed

NCT Number: NCT00518895

Trial of Dacarbazine With or Without Genasense in Advanced Melanoma

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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sydney Cancer Center, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dacarbazine plus Genasense

Drug

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 names: dacarbazine plus Genasense (oblimersen, G3139)

dacarbazine plus placebo

Drug

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 names: dacarbazine plus placebo (0.9% Sodium Chloride Injection)

Primary outcomes

  1. Progression-free survival and overall survival

    Time frame: Every 42 days from date of randomization during protocol therapy

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Genta Incorporated

Industry

Registry information

Official study 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)

Acronym: AGENDA

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Aug 21, 2007
Registry last updated
Nov 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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