Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in the Treatment of Hodgkin's Lymphoma
Status:
Completed
Trial end date:
2008-11-01
Target enrollment:
Participant gender:
Summary
Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow
unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis
through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process
of cell death that is often inhibited in cancer cells.
This is a multi-center, open-label, Phase II study of single-agent obatoclax administered in
2-week cycles as a 24-hour infusion every 2 weeks at a fixed dose of 60 mg to patients with
relapsed or refractory Hodgkin's Lymphoma. Infusions may be administered on an out-patient
basis. No investigational or commercial agents or therapies other than those described in the
protocol may be administered with the intent to treat the patient's malignancy. Supportive
care measures including those directed at controlling symptoms resulting from Hodgkin's
Lymphoma (blood products, growth factor, etc.) are allowed.