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Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Waldenstrom's Macroglobulinemia, or Chronic Lymphocytic Leukemia Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Waldenstrom's Macroglobulinemia, or Chronic Lymphocytic Leukemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Waldenstrom's Macroglobulinemia, or Chronic Lymphocytic Leukemia Clinical research trials and Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Waldenstrom's Macroglobulinemia, or Chronic Lymphocytic Leukemia healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Waldenstrom's Macroglobulinemia, or Chronic Lymphocytic Leukemia. Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Waldenstrom's Macroglobulinemia, or Chronic Lymphocytic Leukemia Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Waldenstrom's Macroglobulinemia, or Chronic Lymphocytic Leukemia clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Waldenstrom's Macroglobulinemia, or Chronic Lymphocytic Leukemia condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Waldenstrom's Macroglobulinemia, or Chronic Lymphocytic Leukemia  Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Waldenstrom's Macroglobulinemia, or Chronic Lymphocytic Leukemia
Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Waldenstrom's Macroglobulinemia, or Chronic Lymphocytic Leukemia
For Condition: Waldenstrom's Macroglobulinemia,adult non-Hodgkin's lymphoma,AIDS-Related Lymphoma,Chronic Lymphocytic Leukemia,adult Hodgkin's lymphoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Monoclonal antibodies such as apolizumab and rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of combining apolizumab and rituximab in treating patients who have lymphoma, Waldenstrom's macroglobulinemia, or chronic lymphocytic leukemia.
Details: OBJECTIVES: - Determine the maximum tolerated dose of apolizumab when administered with rituximab in patients with relapsed CD20 and 1D10-positive B-cell lymphoma, Waldenstrom's macroglobulinemia, or chronic lymphocytic leukemia. - Determine the toxicity of this regimen in these patients. - Determine the antitumor activity of this regimen in these patients. - Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is a dose-escalation study of apolizumab. Patients receive apolizumab IV over several hours on day 1 followed 24-36 hours later by rituximab IV. Treatment repeats every 7 days for 4 weeks. At 12 weeks after completion of treatment, patients with stable disease or a complete or partial response may receive additional treatment for up to 3 courses. Cohorts of 2-6 patients receive escalating doses of apolizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 24 additional patients (12 with chronic lymphocytic leukemia or Waldenstrom's macroglobulinemia and 12 with lymphoma) are treated at the MTD. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 6-63 patients will be accrued for this study within 12 months.
Eligibility:
Study Type: Interventional,�Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically and immunophenotypically confirmed B-cell lymphoma, Waldenstrom's macroglobulinemia, or chronic lymphocytic leukemia - CD20 and 1D10-positive by immunohistochemistry or fluorescence-activated cell sorting - Received at least 1 prior systemic treatment regimen - Ineligible for potentially curative therapy (i.e., transplantation) - No active CNS lymphoma PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 500/mm^3* - Platelet count at least 75,000/mm^3* NOTE: * Unless due to lymphoma Hepatic: - Bilirubin less than 2 mg/dL (5 mg/dL in case of Gilbert's syndrome defined as more than 80% unconjugated)* - SGPT less than 5 times upper limit of normal* NOTE: * Unless due to lymphoma Renal: - Creatinine no greater than 1.5 mg/dL* OR - Creatinine clearance greater than 60 mL/min* NOTE: * Unless due to lymphoma Cardiovascular: - No active cardiac disease - No active cerebrovascular disease - No active peripheral arterial vascular disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 1 month since prior rituximab - No prior apolizumab Chemotherapy: - More than 3 weeks since prior systemic cytotoxic chemotherapy - No concurrent chemotherapy Endocrine therapy: - More than 1 week since prior systemic steroids (except stable doses of less than 10 mg/day) Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KieronDunleavy, Study Chair, National Cancer Institute (NCI)
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting John Byrd 614-293-7509
Center for Cancer Research *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Therese White 301-402-5886
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 301-496-4891
Additional Information:
Study ID Numbers: CDR0000068975; NCI-01-C-0235D,NCI-2410
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00029367
Other Chronic Lymphocytic Leukemia Studies:
1. A Pilot Trial of CP-461 in Patients with Chronic Lymphocytic Leukemia
2. Bortezomib and Fludarabine in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
3. Genasense™ (Oblimersen Sodium), Fludarabine, and Rituximab in Subjects with Chronic Lymphocytic Leukemia
4. Bortezomib in Treating Patients With Lymphoproliferative Disorders
5. Combination Antibody Therapy for Relapsed Lymphoma and Chronic Lymphocytic Leukemia
Related Studies:
Other Chronic Lymphocytic Leukemia Clinical Trials
Other Ohio Clinical Trials
Other Columbus Clinical Trials
Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Waldenstrom's Macroglobulinemia, or Chronic Lymphocytic Leukemia
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