PS-341 in Treating Patients With Advanced Cancer
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ClinicalTrials.gov Identifier: NCT00006362 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : August 3, 2011
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Precancerous Condition Unspecified Adult Solid Tumor, Protocol Specific | Drug: bortezomib | Phase 1 |
OBJECTIVES:
- Determine the maximum tolerated dose and toxicity of PS-341 in patients with advanced malignancies.
- Determine, in a preliminary manner, the therapeutic activity of this regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
- Regimen A: Patients receive PS-341 IV twice weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
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.
- Regimen B: Once the MTD has been determined in regimen A, patients receive PS-341 IV twice weekly for 2 weeks. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for 3 months.
PROJECTED ACCRUAL: A maximum of 78 patients will be accrued for this study within 14 months.
Study Type : | Interventional (Clinical Trial) |
Primary Purpose: | 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 |
Actual Primary Completion Date : | August 2003 |
Actual Study Completion Date : | August 2003 |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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
- Patients with B-cell lymphoproliferative disorders and a leukemic phase are eligible once the maximum tolerated dose is established
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NHL patients must meet the following conditions:
- No greater than 25% of bone marrow involved
- No symptomatic brain metastases
- Prior brain metastases allowed if definitively treated (radiotherapy and/or surgery) and stable for at least 8 weeks
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST or ALT no greater than 2.5 times ULN (5 times ULN if liver involvement)
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No New York Heart Association class III or IV heart disease
Other:
- No uncontrolled infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior biologic therapy or immunotherapy
- No concurrent immunotherapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
- No other concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy to greater than 30% of bone marrow
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
Other:
- No concurrent antiretroviral therapy (HAART) for HIV positive patients

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006362
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, Wisconsin | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-6164 |
Study Chair: | Alex A. Adjei, MD, PhD | Mayo Clinic |
Responsible Party: | Alex A. Adjei, M.D., Mayo Clinic Cancer Center |
ClinicalTrials.gov Identifier: | NCT00006362 |
Other Study ID Numbers: |
CDR0000068233 U01CA069912 ( U.S. NIH Grant/Contract ) P30CA015083 ( U.S. NIH Grant/Contract ) 980111 ( Other Identifier: Mayo Clinic Cancer Cancer ) 1443-99 ( Other Identifier: Mayo Clinic IRB ) |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | August 3, 2011 |
Last Verified: | August 2011 |
monoclonal gammopathy of undetermined significance isolated plasmacytoma of bone extramedullary plasmacytoma refractory multiple myeloma Waldenstrom macroglobulinemia stage III multiple myeloma stage IV chronic lymphocytic leukemia refractory chronic lymphocytic leukemia unspecified adult solid tumor, protocol specific B-cell chronic lymphocytic leukemia untreated hairy cell leukemia progressive hairy cell leukemia, initial treatment refractory hairy cell leukemia stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma |
stage IV grade 3 follicular lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV adult Burkitt lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma |
Lymphoma Leukemia Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Precancerous Conditions Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bortezomib Antineoplastic Agents |