Bortezomib in Treating Patients With Lymphoproliferative Disorders

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase II trial to study the effectiveness of bortezomib in treating patients who have low-grade lymphoproliferative disorders. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Bortezomib

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed lymphoproliferative disorder of 1 of the following subtypes:

• * Relapsed or refractory grade I, II, or III follicular center cell lymphoma

• Relapsed or refractory mantle cell lymphoma

• Measurable disease for non-Hodgkin's lymphoma (NHL) only

• At least 1 unidimensionally measurable lesion

• At least 2 cm by conventional techniques OR at least 1 cm by spiral CT scan

• Lymph nodes no greater than 1 cm in short axis considered normal

• Absolute lymphocytosis greater than 5,000/mm^3 with B-cell phenotype (CD19, 20,or 23 positive) with more than 30% bone marrow lymphocytes for CLL or other leukemic forms of NHL

• No known brain metastases

• Performance status - Karnofsky 70-100%

• At least 3 months

• See Disease Characteristics

• Absolute neutrophil count greater than 1,500/mm^3 (500/mm^3 if lymphomatous involvement of bone marrow)

• Platelet count greater than 50,000/mm^3

• Bilirubin less than 1.5 times upper limit of normal (ULN)

• AST and ALT no greater than 2.5 times ULN (4 times ULN in case of liver metastases)

• Creatinine less than 1.5 times ULN

• No symptomatic congestive heart failure

• No New York Heart Association class III or IV heart disease

• No unstable angina pectoris

• No cardiac arrhythmia

• No myocardial infarction within the past 6 months

• No cerebrovascular accident or transient ischemic attack within the past 6 months

• No history of orthostatic hypotension

• No evidence of acute ischemia or significant conduction abnormality (left anterior hemiblock in the presence of right bundle branch block or second or third degree atrioventricular blocks) on electrocardiogram

• No uncontrolled hypertension requiring antihypertensive medication

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Febrile episodes up to 38.5°C allowed if no evidence of active infection

• No other uncontrolled concurrent illness

• No known or active HIV infection

• No ongoing or active infection

• No psychiatric illness or social situation that would preclude study entry

• At least 3 months since prior monoclonal antibody therapy (e.g., rituximab)

• No more than 3 prior regimens of conventional cytotoxic chemotherapy

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

• At least 1 week since prior steroid therapy

• At least 4 weeks since prior radiotherapy and recovered

• At least 4 weeks since prior major surgery

• No other concurrent investigational agents