Proteasome Inhibitor PS-341 Relapsed or Refractory B Cell Lymphomas Previously Treated With Chemotherapy

Phase II Study of Proteasome Inhibitor PS-341 For Patients With Relapsed or Refractory B Cell Lymphomas Previously Treated With Chemotherapy

Purpose of Phase II study for B-cell lymphoma using PS341: Evaluate efficacy and toxicity of bortezomib in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.

Patients were stratified, based on preclinical data, into arm A (mantle-cell lymphoma) or arm B (other B-cell lymphomas) without limitation in number of prior therapies. Bortezomib was administered as an intravenous push (1.5 mg/m2) on days 1, 4, 8, and 11 every 21 days for a maximum of six cycles.

INCLUSION:

• Relapsed or Refractory B cell lymphoma.
• Zubrod status </= 3.
• Measurable disease.
• No anti-cancer treatment within past 3 weeks.
• ANC >= 1500/uL, Plt >/= 50,000, Bilirubin <2 mg/dL, SGPT <2.5xULN, creatinine <2. Patients with ANC>/1000, PLT>/30000 will be eligible if due to massive splenomegaly and/or BM involvement.
• HIV negative.
• No active CNS lymphoma.
• No serious intercurrent illness, active infections or cancer except basal cell carcinoma of the skin or in situ cervical carcinoma.
• Not eligible for treatment of a higher priority. Patients may be entered before BMT.
• No pregnancy & age bearing females must be practicing adequate contraception.
• Age > 16.

EXCLUSION:

• Patients with platelets <30x10(9)/L within 14 days before enrollment.
• Patients with ANC<1.0 x10(9)/L within 14 days before enrollment.
• Patients with peripheral neuropathy >/= grade 3 within 14 days before enrollment.