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

Study Overview
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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.

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.

Official Title
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Phase II Study of Proteasome Inhibitor PS-341 For Patients With Relapsed or Refractory B Cell Lymphomas Previously Treated With Chemotherapy

Conditions
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Lymphoma, B-Cell

Intervention / Treatment
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* Drug: PS341 (Bortezomib)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A (mantle-cell lymphoma)<br> | Drug: PS341 (Bortezomib)<br>* 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.<br>* Other names: PS-341;|
| Experimental: Arm B (other B-cell lymphomas)<br> | Drug: PS341 (Bortezomib)<br>* 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.<br>* Other names: PS-341;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Every two 21-day cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Relapsed, Refractory, B cell lymphoma, Proteasome Inhibitor, PS-341