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| Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006362 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of PS-341 in treating patients who have advanced cancer.
| Condition | Intervention | Phase |
|
Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Precancerous/Nonmalignant Condition Unspecified Adult Solid Tumor, Protocol Specific |
Drug: bortezomib |
Phase I |
| Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma |
| ChemIDplus related topics: | Bortezomib |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I and Pharmacologic Study of the Proteasome Inhibitor PS-341 in Patients With Advanced Solid Tumors and B-Cell Lymphoproliferative Disorders |
| Study Start Date: | November 1999 |
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study.
Cohorts of 3-6 patients receive escalating doses of PS-341 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3-4 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed for 3 months.
PROJECTED ACCRUAL: A maximum of 78 patients will be accrued for this study within 14 months.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven advanced malignancy, including non-Hodgkin's lymphoma (NHL), for which there is no known standard therapy that is potentially curative or definitely capable of extending life expectancy
NHL patients must meet the following conditions:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Minnesota | |||||
| Mayo Clinic Cancer Center | |||||
| Rochester, Minnesota, United States, 55905 | |||||
| United States, Wisconsin | |||||
| University of Wisconsin Comprehensive Cancer Center | |||||
| Madison, Wisconsin, United States, 53792-6164 | |||||
| Mayo Clinic |
| National Cancer Institute (NCI) |
| Study Chair: | Alex A. Adjei, MD, PhD | Mayo Clinic |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068233, MAYO-980111, WCCC-CO-99904, NCI-T99-0071 |
| First Received: | October 4, 2000 |
| Last Updated: | August 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006362 |
| Health Authority: | United States: Federal Government |
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