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

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Millennium Pharmaceuticals, Inc.
• Treatments: Bortezomib; Proteasome Inhibitors

Criteria

INCLUSION:

• Relapsed or Refractory B cell lymphoma.

• Zubrod status
• 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.