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

M.D. Anderson Cancer Center60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoma, B-Cell

Interventions

PS341 (Bortezomib)DRUG

1.5 mg/m2 intravenous (IV) bolus push over 3 to 5 seconds on days 1, 4, 8, and 11, followed by a 10-day rest for a 21-day cycle.

Eligibility

Sex: ALLMin age: 17 Years

Medical Language ↔ Plain English

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.

Locations (1)

UT MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Number of Patients with Response to PS-341

Patient response evaluated according to criteria of Cheson et al. Endoscopy obtained every two cycles to evaluate response using Complete Response (CR), Partial Response (PR), Progressive Disease, or Stable Disease.

Time frame: Every two 21-day cycles

Data from ClinicalTrials.gov

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