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

Genta Incorporated

Status and phase

Completed

Phase 3

Conditions

Melanoma

Treatments

Drug: dacarbazine plus placebo

Drug: dacarbazine plus Genasense

Study type

Interventional

Funder types

Industry

Identifiers

NCT00518895

AGENDA

GM307

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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