Bortezomib in Treating Patients With Lymphoproliferative Disorders
Completed · Phase 2
Conditions studied: Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma
In brief
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.
Key facts
- Study ID
- NCT00023764
- Run by
- National Cancer Institute (NCI)
- People needed
- 103
- Starts
- 2001-06-01
- Expected to finish
- 2009-03-01
- Last updated by the study team
- 2015-12-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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