Bortezomib in Treating Patients With Mantle Cell Lymphoma

Study Overview
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Brief Summary
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RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have previously untreated or relapsed mantle cell lymphoma.

Detailed Description
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OBJECTIVES: Determine the efficacy of bortezomib, in terms of response rate, in patients with previously untreated or relapsed mantle cell lymphoma. Determine the toxicity of this drug in these patients. Correlate suppression of 20S proteasome levels with toxicity of and response to this drug in these patients. Determine the time to progression and response duration in patients treated with this drug. OUTLINE: This is a nonrandomized, multicenter study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2 courses beyond documentation of CR. Patients with stable disease receive a maximum of 4 courses. Patients with partial response (PR) continue therapy until disease progression or for 2 courses beyond documentation of stable PR. Patients are followed at 4 weeks and then every 3 months until disease progression. PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 18-24 months.

Official Title
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A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Mantle Cell Lymphoma

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: bortezomib


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed relapsed or untreated mantle cell lymphoma No refractory disease defined as progression while on chemotherapy or within 1 month after completion of chemotherapy At least 1 bidimensionally measurable disease site* Lymph nodes at least 1.5 cm by 1.5 cm by spiral CT scan OR Non-nodal lesions (e.g., skin lesion or nodules) at least 1 cm by 1 cm by MRI, CT scan, or physical exam NOTE: *Bone lesions are not considered bidimensionally measurable disease No pre-existing ascites or pleural effusion No known CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 75,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST or ALT no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular LVEF at least 45% by echocardiogram or MUGA Pulmonary No pre-existing shortness of breath greater than grade 1 Other: No uncontrolled bacterial, fungal, or viral infections No pre-existing edema greater than grade 1 No pre-existing neuropathy greater than grade 1 No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix No other serious illness or medical condition that would preclude study compliance No geographical conditions that would preclude study compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: See Chemotherapy Prior rituximab allowed No prior radioactive monoclonal antibody therapy Chemotherapy: See Disease Characteristics No prior high-dose chemotherapy with stem cell transplantation No more than 2 prior systemic chemotherapy regimens Same chemotherapy combination given for first-line and second-line therapy is considered 2 regimens No prior flavopiridol At least 6 weeks since prior chemotherapy No concurrent cytotoxic chemotherapy Endocrine therapy: No concurrent corticosteroids Radiotherapy: No prior radiotherapy to 25% or more of functioning bone marrow At least 4 weeks since prior radiotherapy (except low-dose nonmyelosuppressive radiotherapy) and recovered No concurrent radiotherapy to the sole site of measurable disease Surgery: At least 2 weeks since prior major surgery Other: No prior investigational therapy No other concurrent anticancer therapy No other concurrent investigational anticancer therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bortezomib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I mantle cell lymphoma, contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, recurrent mantle cell lymphoma