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

M.D. Anderson Cancer Center

Status and phase

Completed

Phase 2

Conditions

Lymphoma, B-Cell

Treatments

Drug: PS341 (Bortezomib)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00038571

ID01-596

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 patients

Sex

All

Ages

17+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.