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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2005-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lymphoma, B-Cell

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A (mantle-cell lymphoma)

Group Type EXPERIMENTAL

PS341 (Bortezomib)

Intervention Type 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.

Arm B (other B-cell lymphomas)

Group Type EXPERIMENTAL

PS341 (Bortezomib)

Intervention Type 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.

Interventions

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PS341 (Bortezomib)

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.

Intervention Type DRUG

Other Intervention Names

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Velcade LPD-341 MLN341 PS-341

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No