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.
- 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.
- 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.