NEW YORKAn antisense oligonucleotide directed against Bcl-2 is yielding "remarkable" responses in specific melanoma patients enrolled in a phase III trial, according to Anna C. Pavlick, DO, assistant professor of medicine, New York University School of Medicine.
The multicenter, randomized, controlled phase III trial of the agent, known as G3139 (Genasense, Genta Inc./Aventis), is accruing patients rapidly and is near completion, Dr. Pavlick said at the Mount Sinai School of Medicine Chemotherapy Foundation Symposium XX.
"Responses have been impressive," Dr. Pavlick said. "Clearly, this is a trial that needs to be completed . . . we really need to know if the effects that I’m seeing as a single investigator are truly seen in other institutions as well."
All patients in the phase III trial are chemotherapy naïve and must have stage IV disease with no brain metastases. If they have no distant disease, they must be considered surgically nonresectable.
Arm A of the trial includes chemotherapy with dacarbazine(Drug information on dacarbazine) (DTIC), currently the only FDA-approved chemotherapy as a single agent for melanoma, at a dose of 1,000 mg/m2 on day 1 of a 21-day cycle. Arm B is the G3139 antisense protein, given as a 7 mg/kg continuous infusion on days 1 through 5, plus DTIC on day 6 of a 21-day cycle. Treatment is for up to eight cycles, although patients are allowed to remain on therapy if they are still responding.
Dr. Pavlick’s first patient on G3139 was a woman with extensive metastatic disease, with "tremendous" subcutaneous nodules along the right leg and a large pelvic mass. Imaging performed after three cycles showed complete resolution of the pelvic node.
"This patient had completed 16 cycles of chemo with G3139 and stopped treatment," she said. "It will be 1 year as of next month that she still remains disease-free off all treatment."