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Flavopiridol, Fludarabine, and Rituximab in Treating Patients With Lymphoproliferative Disorders or Mantle Cell Lymphoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Flavopiridol, Fludarabine, and Rituximab in Treating Patients With Lymphoproliferative Disorders or Mantle Cell Lymphoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Flavopiridol, Fludarabine, and Rituximab in Treating Patients With Lymphoproliferative Disorders or Mantle Cell Lymphoma Clinical research trials and Flavopiridol, Fludarabine, and Rituximab in Treating Patients With Lymphoproliferative Disorders or Mantle Cell Lymphoma medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Flavopiridol, Fludarabine, and Rituximab in Treating Patients With Lymphoproliferative Disorders or Mantle Cell Lymphoma. Flavopiridol, Fludarabine, and Rituximab in Treating Patients With Lymphoproliferative Disorders or Mantle Cell Lymphoma Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Flavopiridol, Fludarabine, and Rituximab in Treating Patients With Lymphoproliferative Disorders or Mantle Cell Lymphoma clinical trial. Participants frequently obtain the most expert healthcare available for their Flavopiridol, Fludarabine, and Rituximab in Treating Patients With Lymphoproliferative Disorders or Mantle Cell Lymphoma condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "F" Clinical Trials Conditions > Flavopiridol, Fludarabine, and Rituximab in Treating Patients With Lymphoproliferative Disorders or Mantle Cell Lymphoma  Flavopiridol, Fludarabine, and Rituximab in Treating Patients With Lymphoproliferative Disorders or Mantle Cell Lymphoma
Flavopiridol, Fludarabine, and Rituximab in Treating Patients With Lymphoproliferative Disorders or Mantle Cell Lymphoma
For Condition: adult non-Hodgkin's lymphoma,Waldenstrom's Macroglobulinemia,Hairy Cell Leukemia,Chronic Lymphocytic Leukemia
Status: Recruiting
Sponsor(s): Arthur G. James Cancer Hospital & Richard J. Solove Research Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy such as flavopiridol and fludarabine use different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol, fludarabine, and rituximab in treating patients who have previously untreated or relapsedlymphoproliferative disorders or mantle cell lymphoma.
Details: OBJECTIVES: - Determine the maximum tolerated dose of flavopiridol in combination with standard-dose rituximab and fludarabine in patients with indolent B-cell lymphoproliferative disorders or mantle cell lymphoma. - Determine the toxicity of this regimen in these patients. - Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients. OUTLINE: This is a dose-escalation study of flavopiridol. Patients receive fludarabine IV over 30 minutes on days 1-5 and rituximab IV on day 1. Flavopiridol is administered IV over 60 minutes on day 1 in cohort 1; on days 1 and 2 in cohort 2; and on days 1, 2, and 3 in cohort 3. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) has been determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the MTD. PROJECTED ACCRUAL: A total of 20 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: - Histologically confirmed mantle cell lymphoma OR indolent B-cell lymphoproliferative disorders of any of the following types: - Chronic lymphocytic leukemia - Small lymphocytic lymphoma - Follicular center cell non-Hodgkin's lymphoma (grade I or II) - Marginal zone lymphoma - Waldenstrom's macroglobulinemia - Hairy cell leukemia - Previously untreated or relapsed/refractory disease - No evidence of histological transformation to an intermediate-grade or aggressive lymphoma - CD20 positive by immunoperoxidase or flow cytometry - Evaluable disease with presence of 1 of the following criteria: - Absolute lymphocyte count greater than 5,000/mm^3 - At least 1 measurable node greater than 2 cm by CT scan OR measurable disease in a lymphoid structure (spleen) - Bone marrow involvement (greater than 20% of marrow cellularity) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - See Disease Characteristics - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9.0 g/dL Hepatic - Bilirubin no greater than 2 times normal - AST no greater than 2 times normal Renal - Creatinine no greater than 2.0 mg/dL OR - Creatinine clearance at least 50 mL/min - No renal dysfunction that would impair tolerance or compliance with study therapy Cardiovascular - No cardiac dysfunction that would impair tolerance or compliance with study therapy Pulmonary - No pulmonary dysfunction that would impair tolerance or compliance with study therapy Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No chronic gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) that would impair tolerability of compliance with therapy - No neurological or psychiatric dysfunction that would impair tolerability of or compliance with study therapy PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy - At least 6 weeks since prior nitrosourea or mitomycin - No more than 6 prior courses of fludarabine Endocrine therapy - No concurrent corticosteroids as antiemetics Radiotherapy - Not specified Surgery - Not specified Other - At least 4 weeks since prior therapy for disease - No more than 3 prior treatments for disease (not including steroids alone)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasLin, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting Thomas Lin 614-293-9316
Additional Information:
Study ID Numbers: CDR0000287196; NCI-5745,OSU-0211,OSU-02H0281
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058227
Other Chronic Lymphocytic Leukemia Studies:
1. FR901228 in Treating Patients With T-Cell Lymphoma
2. 10-Propargyl-10-Deazaaminopterin in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma
3. Rituximab and Carmustine, Cytarabine, Etoposide, and Melphalan Followed By Autologous Hematopoietic Stem Cell Transplantation in Treating Patients With B-Cell Non-Hodgkin's Lymphoma
4. Biological Therapy Plus Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
5. Iodine I 131 Tositumomab Followed by Autologous Stem Cell Transplantation in Treating Older Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Related Studies:
Other Chronic Lymphocytic Leukemia Clinical Trials
Other Ohio Clinical Trials
Other Columbus Clinical Trials
Flavopiridol, Fludarabine, and Rituximab in Treating Patients With Lymphoproliferative Disorders or Mantle Cell Lymphoma
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