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Home > "P" Clinical Trials Conditions > PS-341 in Treating Patients With Advanced Cancer  PS-341 in Treating Patients With Advanced Cancer
PS-341 in Treating Patients With Advanced Cancer
For Condition: Multiple Myeloma,Lymphoma,Leukemia
Status: No longer recruiting
Sponsor(s): Mayo Clinic Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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. - 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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 - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AlexAdjei, Study Chair, Mayo Clinic Cancer Center
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
Additional Information:
Study ID Numbers: CDR0000068233; MAYO-980111,WCCC-CO-99904,NCI-T99-0071
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006362
Other Multiple Myeloma Studies:
1. Comparing Treatments for Multiple Myeloma
2. Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Other B-cell Cancers
3. Total Therapy II
4. Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer
5. Chemotherapy, Stem Cell Transplantation and Donor and Patient Vaccination for Treatment of Multiple Myeloma
Related Studies:
Other Multiple Myeloma Clinical Trials
Other Wisconsin Clinical Trials
Other Madison Clinical Trials
PS-341 in Treating Patients With Advanced Cancer
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