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Bortezomib and Fludarabine in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Bortezomib and Fludarabine in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Bortezomib and Fludarabine in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Clinical research trials and Bortezomib and Fludarabine in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Bortezomib and Fludarabine in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia. Bortezomib and Fludarabine in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Bortezomib and Fludarabine in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia clinical trial. Subjects often receive the most expert healthcare possible for their Bortezomib and Fludarabine in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > Bortezomib and Fludarabine in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia  Bortezomib and Fludarabine in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Bortezomib and Fludarabine in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
For Condition: adult non-Hodgkin's lymphoma,Waldenstrom's Macroglobulinemia,Chronic Lymphocytic Leukemia
Status: Recruiting
Sponsor(s): Ireland 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. Drugs used in chemotherapy such as fludarabine work in different ways to stop cancer cells from dividing so they stop growing or die. Combining bortezomib with fludarabine may kill more cancer cells. PURPOSE: Phase I trial to study the safety and effectiveness of combining bortezomib with fludarabine in treating patients who have relapsed or refractoryindolentnon-Hodgkin's lymphoma or chronic lymphocytic leukemia.
Details: OBJECTIVES: - Determine the safety and toxicity of bortezomib and fludarabine in patients with relapsed or refractory indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia. - Determine the maximum tolerated dose of bortezomib in combination with fludarabine in these patients. - Determine the biological effect of this regimen on apoptotic markers, cell cycle kinase inhibitors, and DNA repair in these patients. OUTLINE: This is a multicenter, dose-escalation study of bortezomib. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and fludarabine IV over 30 minutes on days 1-3. Treatment repeats every 3 weeks for up to 8 courses 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 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 3-12 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of chronic lymphocytic leukemia OR indolent non-Hodgkin's lymphoma of any of the following subtypes: - Follicular lymphoma - Grade I follicular small cleaved cell - Grade II follicular mixed cell - Grade II follicular large cell - Diffuse small cleaved cell - Small lymphocytic lymphoma - Lymphoplasmacytic lymphoma (Waldenstrom's macroglobulinemia) - Extranodal marginal zone B-cell lymphoma (mucosa-associated lymphoid tissue [MALT] lymphoma) - Nodal marginal zone B-cell lymphoma (monocytoid B-cell lymphoma) - Splenic marginal zone lymphoma (splenic lymphoma with villous lymphocytes) - Mantle cell lymphoma - No blastic phase mantle cell lymphoma - Relapsed or refractory, progressive disease - First, second, or third relapse - Not a candidate for potentially curative transplantation - At least 1 unidimensionally measurable lesion - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - No brain metastases - No evidence of CNS lymphoma PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - More than 12 weeks Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 75,000/mm^3 (greater than 50,000/mm^3 if lymphomatous bone marrow involvement is present) Hepatic - Bilirubin no greater than 2.0 mg/dL - AST/ALT no greater than 4 times normal Renal - Creatinine clearance greater than 40 mL/min Cardiovascular - No history of uncontrolled orthostatic hypotension - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No uncontrolled concurrent illness - No grade 2 or greater neuropathy - No history of allergy or anaphylaxis to mannitol, bortezomib, fludarabine, or boron - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - At least 3 months since prior antibody therapy - No prior allogeneic stem cell transplantation Chemotherapy - More than 4 weeks since prior chemotherapy - Prior fludarabine allowed Endocrine therapy - At least 1 week since prior steroids Radiotherapy - At least 3 months since prior radioimmunotherapy - More than 4 weeks since prior radiotherapy Surgery - Not specified Other - No prior bortezomib - No other concurrent investigational agents or treatments for the malignancy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NizarBahlis, Principal Investigator, Ireland Cancer Center
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15232
United States
Recruiting Ramesh Ramanathan 412-648-6507
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-4937
United States
Recruiting Nizar Bahlis 216-844-7649
Additional Information:
Study ID Numbers: CDR0000321394; CWRU-ICC-3402,NCI-6126
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068315
Other Chronic Lymphocytic Leukemia Studies:
1. Epirubicin and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
2. Dose-Escalating and Safety Study of CP-461 in Patients with Chronic Lymphocytic Leukemia
3. Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults
4. Campath-1H Plus Rituximab for CD52- and CD20- Positive Refractory or Relapsed Chronic Lymphoid Disorders
5. Megadose CD34 Selected Progenitor Cells for Transplantation in Patients with Advanced Hematological Malignant Diseases
Related Studies:
Other Chronic Lymphocytic Leukemia Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Bortezomib and Fludarabine in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
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