Status: Closed
Activation Date: 2002JUL04
Closing Date: 2004JUL28
Phase: II
Description: A Phase II Study of PS-341 (NSC 681239) in Patients With Untreated or Relapsed Mantle Cell Lymphoma
Eligibility: Histologically documented mantle cell lymphoma (at initial diagnosis) non-refractory to prior therapy or no prior therapy. Pathology will be reviewed by the Central Reference Pathologist at BCCA to confirm eligibility. Bidimensionally measurabe disease. O-2 prior chemotherapy regimens; not permitted: radioactive MoAb therapy, high dose chemotherapy with stem cell transplant or prior investigational therapy. Prior radiation permitted if < 25% functioning bone marrow; prior surgery permitted.
Objective: To assess efficacy of PS-341 given as a bolus IV injection twice weekly for two out of three weeks. To assess the toxicity of PS-341 when administered on this schedule in this patient group. To determine 20S proteasome levels in whole blood and correlate suppression of this marker with toxicity and response to PS-341.
Lay Description: The purpose of this study is to find out what effects the investigational agent PS-341 has on patients with mantle cell lymphoma. This research is being done to find out if PS-341 will cause the cancer to shrink.
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I150 | 30 | 2 | 4 | 4 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| IND | I150 | 30 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| IND | I150 | 30 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |