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Home > "C" Clinical Trials Conditions > Combination Chemotherapy and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma  Combination Chemotherapy and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Combination Chemotherapy and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
For Condition: recurrent diffuse small lymphocytic/marginal zone lymphoma,recurrent grade 1 follicular lymphoma,recurrent grade 2 follicular lymphoma,Waldenstrom's Macroglobulinemia
Status: Recruiting
Sponsor(s): Theradex ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with rituximab may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combining pixantrone, fludarabine, and dexamethasone with rituximab in treating patients who have relapsed or refractorynon-Hodgkin's lymphoma.
Details: OBJECTIVES: - Determine the maximum tolerated dose and recommended dose of pixantrone when administered with fludarabine, dexamethasone, and rituximab in patients with relapsed or refractory indolent non-Hodgkin's lymphoma. - Determine the safety of this regimen in these patients. - Determine the dose-limiting toxic effects of this regimen in these patients and the relationship between toxicity and systemic exposure. - Evaluate the efficacy of this regimen in these patients. - Evaluate the pharmacokinetics of pixantrone in these patients. OUTLINE: This is a multicenter, dose-escalation study of pixantrone. Patients receive oral dexamethasone on days 1-5, fludarabine IV over 30 minutes on days 2-4, and pixantrone IV over 1 hour on day 2. Patients also receive rituximab IV on day 1 for courses 1-6. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of pixantrone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the recommended dose, which is the dose preceding the MTD. Patients are followed every 3 months. PROJECTED ACCRUAL: Approximately 3-30 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 relapsed or refractory indolent non-Hodgkin's lymphoma including the following: - Follicular center cell lymphomas grade I (formerly known as follicular small cleaved) - Follicular center cell lymphomas grade II (formerly known as follicular mixed) - Small lymphocytic lymphoma - Lymphoplasmacytoid lymphoma (also known as immunocytoma and Waldenstrom's macroglobulinemia) - Marginal zone lymphomas: - MALT lymphomas - Monocytoid B-cell lymphomas - Splenic marginal zone lymphomas - Must have received 1-3 prior chemotherapy regimens PATIENT CHARACTERISTICS: Age - 18 and over Performance status - WHO 0-1 Life expectancy - At least 3 months Hematopoietic - Neutrophil count at least 1,500/mm^3* - Platelet count at least 100,000/mm^3* NOTE: *Lower values may be accepted if due to bone marrow involvement Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN)** - Alkaline phosphatase no greater than 2 times ULN** - AST or ALT no greater than 2 times ULN** - No history or clinical symptoms of hepatitis B or C NOTE: **Higher values may be accepted if due to liver involvement Renal - Creatinine no greater than 1.5 mg/dL Cardiovascular - LVEF at least 50% by MUGA - No myocardial infarction within the past 6 months - No clinically significant cardiovascular abnormalities - No New York Heart Association class II-IV heart disease - No severe arrhythmia - No uncontrolled hypertension Other - Not pregnant or nursing - Negative pregnant test - Fertile patients must use effective contraception during and for 6 months after the study - No prior history or clinical symptoms of HIV - No concurrent uncontrolled infection (NCI CTC grade 3-4) - No condition that would place the patient at undue risk or interfere with study results - No known type I hypersensitivity or anaphylactic reactions to murine proteins or any component of rituximab - No clinically significant neurological abnormality PRIOR CONCURRENT THERAPY: Biologic therapy - No prior rituximab unless there was a complete or partial response - At least 3 months since prior radioimmunotherapy Chemotherapy - See Disease Characteristics - No prior fludarabine - No prior cumulative dose of doxorubicin equivalent greater than 450 mg/m^2 - At least 4 weeks since prior chemotherapy Endocrine therapy - Not specified Radiotherapy - See Biologic therapy - At least 4 weeks since prior radiotherapy Surgery - At least 4 weeks since prior major thoracic and/or abdominal therapy and recovered Other - Recovered from prior therapy - At least 30 days since prior investigational drugs - No other concurrent investigational drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LuisFayad, Study Chair, M.D. Anderson Cancer Center
Arizona Clinical Research Center *Recruiting*
Tucson, Arizona, 85712
United States
Recruiting Manuel Modiano 520-290-2510
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting David Rizzieri 919-668-1000
New Mexico Oncology-Hematology Consultants, Limited *Recruiting*
Albuquerque, New Mexico, 87109
United States
Recruiting James Liebmann 505-243-4039
Rush Cancer Institute at Rush University Medical Center *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Stephanie Gregory 312-942-5982
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Luis Fayad 713-792-2860
Greater Baltimore Medical Center and Cancer Center *Recruiting*
Baltimore, Maryland, 21204-6881
United States
Recruiting Gary Cohen 443-849-3051
Additional Information:
Study ID Numbers: CDR0000269139; THERADEX-AZA-I-06,NOVUSPHARMA-AZA-I-06
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057772
Other Recurrent Diffuse Small Lymphocytic/marginal Zone Lymphoma Studies:
1. Radiolabeled Monoclonal Antibody in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
2. Rituximab With or Without Interleukin-12 in Treating Patients With Non-Hodgkin's Lymphoma
3. FR901228 in Treating Patients With Hematologic Cancer
4. Radioimmunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
5. Rituximab and Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Related Studies:
Other recurrent diffuse small lymphocytic/marginal zone lymphoma Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Combination Chemotherapy and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
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