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Home > "B" Clinical Trials Conditions > Bortezomib in Treating Patients With Advanced Cancer and Kidney Dysfunction  Bortezomib in Treating Patients With Advanced Cancer and Kidney Dysfunction
Bortezomib in Treating Patients With Advanced Cancer and Kidney Dysfunction
For Condition: refractory plasma cell neoplasm,adult solid tumor,Multiple Myeloma,adult non-Hodgkin's lymphoma
Status: Recruiting
Sponsor(s): University of Wisconsin Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase I trial to study the effectiveness of bortezomib in treating patients who have advanced cancer and kidney dysfunction.
Details: OBJECTIVES: - Determine the pharmacokinetics and pharmacodynamics of bortezomib in patients with advanced malignancies and renal insufficiency. - Determine the safety and tolerability of this drug in these patients. - Determine the maximum tolerated dose of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to most recent creatinine clearance (greater than 60 mL/min vs 40-59 mL/min vs 20-39 mL/min vs less than 20 mL/min vs any creatinine clearance and undergoing renal dialysis). Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional cohort of up to 6 patients is treated at the MTD. PROJECTED ACCRUAL: A total of 60-69 patients (at least 12 per stratum) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed malignancy (including non-Hodgkin's lymphoma and multiple myeloma) for which there is no known potentially curative or definitely life-extending therapy - No symptomatic CNS metastases - Brain metastases previously treated with radiotherapy and/or surgery and stable for at least 8 weeks are eligible PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 50,000/mm^3 Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST no greater than 2.5 times ULN (5 times ULN if liver involvement present) Renal - Abnormal kidney function allowed - No dialysis within 4 hours of study drug Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - No New York Heart Association class III or IV heart disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception during and for 30 days after study participation - No other uncontrolled illness - No psychiatric illness or social situation that would preclude study compliance - No ongoing or active infection - No preexisting neuropathy grade 2 or greater PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior immunotherapy - More than 4 weeks since prior biologic therapy - No concurrent immunotherapy - No concurrent thalidomide Chemotherapy - More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered - No concurrent chemotherapy Endocrine therapy - Concurrent steroids for CNS metastases allowed provided dose is stable Radiotherapy - See Disease Characteristics - More than 2 weeks since prior radiotherapy - No prior radiotherapy to more than 50% of the bone marrow - Prior total body irradiation for bone marrow or stem cell transplantation allowed - No concurrent radiotherapy Surgery - See Disease Characteristics Other - No prior bortezomib - No concurrent antiretroviral therapy for HIV-positive patients - No concurrent enzyme-inducing anticonvulsants for patients with brain metastases - No other concurrent investigational agents - Bisphosphonates (e.g., pamidronate or zoledronate) not considered investigational - No concurrent bisphosphonates on days 1, 4, 8, and 11 of course 1
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DanielMulkerin, Study Chair, University of Wisconsin Comprehensive Cancer Center
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Anna Pavlick 212-263-6485
Albert Einstein Clinical Cancer Center *Recruiting*
Bronx, New York, 10461
United States
Recruiting Sridhar Mani 718-904-2488
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting Robert Morgan 626-359-8111
Sydney Cancer Centre at Royal Prince Alfred Hospital *Recruiting*
Sydney, New South Wales, 2050
Australia
Recruiting Anne Hamilton 61-2-9515-5494
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15232
United States
Recruiting Ramesh Ramanathan 412-648-6507
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Chris Takimoto 210-562-1725
University of California Davis Cancer Center *Recruiting*
Sacramento, California, 95817
United States
Recruiting Angela Davies 916-734-3771
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792
United States
Recruiting Daniel Mulkerin 608-262-9653
USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Heinz-Josef Lenz 323-865-3955
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5065
United States
Recruiting Scot Remick 216-844-1196
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting Patricia LoRusso 313-745-8860
Additional Information:
Study ID Numbers: CDR0000270687; CWRU-1Y03,CWRU-040315,NCI-5874,WCCC-CO-02903
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054483
Other Multiple Myeloma Studies:
1. Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Other B-cell Cancers
2. Bone Marrow and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
3. Mycophenolate Mofetil, Tacrolimus, Daclizumab, and Donor Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
4. PS-341 in Treating Patients With Advanced Cancer
5. CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation
Related Studies:
Other Multiple Myeloma Clinical Trials
Other New York Clinical Trials
Other Bronx Clinical Trials
Bortezomib in Treating Patients With Advanced Cancer and Kidney Dysfunction
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