Trial of Dacarbazine With or Without Genasense in Advanced Melanoma
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.
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