Trial of Dacarbazine With or Without Genasense in Advanced Melanoma

Completed · Phase 3 · Has a placebo group

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT00518895

Run by

Genta Incorporated

People needed

300

Starts

2007-07-01

Expected to finish

2011-05-01

Last updated by the study team

2011-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• San Diego Pacific Oncology and Hematology Associates Inc. — Encinitas, California, United States
• Redwood Regional Medical Group, Inc. — Santa Rosa, California, United States
• Siouxland Hematology Oncology Associates — Sioux City, Iowa, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Hematology Oncology Centers of the Northern Rockies — Billings, Montana, United States
• Morristown Memorial - Atlantic Healthcare System — Morristown, New Jersey, United States
• Cancer Care Associates — Oklahoma City, Oklahoma, United States
• Cancer Care Associates, Site 1 — Tulsa, Oklahoma, United States
• St. Luke's Cancer Center — Bethlehem, Pennsylvania, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• The West Clinic — Memphis, Tennessee, United States
• Texas Oncology - Sammons Cancer Center — Dallas, Texas, United States
• MD Anderson Cancer Center at University of Texas — Houston, Texas, United States
• Sydney Cancer Center, Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
• Calvary Mater Newcastle — Newcastle, New South Wales, Australia
• Westmead Hospital — Westmead, New South Wales, Australia
• Universitatsklinik fur Dermatologie und Venerologie, Medizinische Universitat Innsbruck — Innsbruck, Austria
• Landesklinikum St. Polten — Sankt Pölten, Austria
• Medical University of Vienna, Vienna General Hospital — Vienna, Austria
• London Regional Cancer Program — London, Ontario, Canada
• Princess Margaret Hospital — Toronto, Ontario, Canada
• Charles University, Dermatology Department — Prague, Czechia
• CHU Saint Jacques — Besançon, France
• Hopital Saint-Andre — Bordeaux, France
• University of South Alabama Hospital, Mitchell Cancer Institute — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.