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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma  Monoclonal Antibody Therapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma
Monoclonal Antibody Therapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma
For Condition: recurrent diffuse small lymphocytic/marginal zone lymphoma,recurrent grade I follicular small cleaved cell lymphoma,recurrent grade II follicular mixed cell lymphoma
Status: Completed
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies such as epratuzumab and rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have refractory or recurrent non-Hodgkin's lymphoma.
Details: OBJECTIVES: - Determine the response rate of patients with refractory or recurrent low-grade CD20-positive B-cell non-Hodgkin's lymphoma treated with epratuzumab and rituximab. - Determine the time to progression, duration of response, and survival of patients treated with this regimen. - Determine the safety profile of this regimen in these patients. - Determine the immunogenicity and pharmacokinetics of this regimen in these patients. OUTLINE: This is an open-label, multicenter study. Patients are stratified according to gender and age (under 65 vs 65 and over). Patients receive epratuzumab IV over 1 hour followed 1-24 hours later by rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks and then every 3 months for at least 1 year. PROJECTED ACCRUAL: A total of 50 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 low-grade B-cell non-Hodgkin's lymphoma (NHL) - CD20-positive - Recurrent or refractory disease - Failed at least 1 prior chemotherapy regimen for NHL - Partial or complete response after prior rituximab with a time to progression of at least 12 months OR no prior rituximab - No evidence of rapid disease progression or symptoms indicative of disease progression requiring rapid intervention within the past 2 weeks, including: - Severe shortness of breath - Severe pain - Gastrointestinal or genitourinary obstruction - Bidimensionally measurable disease by CT scan - At least 1 lesion at least 1.5 cm - No prior or concurrent known or suspected transformed lymphoma - No pleural effusion with positive cytology for lymphoma - No primary or secondary CNS lymphoma NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - At least 4 months Hematopoietic - Absolute neutrophil count at least 1,000/mm^3* - Platelet count at least 50,000/mm^3* NOTE: *More than 4 weeks since prior transfusions or growth factor support Hepatic - Bilirubin no greater than 2 times upper limit of normal (ULN) - AST and ALT less than 5 times ULN - Hepatitis B surface antigen negative - Hepatitis C virus negative Renal - Creatinine no greater than 2 times ULN Pulmonary - See Disease Characteristics Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study - HIV negative - No known human anti-chimeric antibody/human anti-human antibody positivity - No other malignancy within the past 3 years except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I prostate cancer - No serious nonmalignant condition or infection that would preclude study participation - No known Type I hypersensitivity or anaphylactic reactions to murine proteins PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - See Patient Characteristics-Hematopoietic - No prior antibody therapy for lymphoma (except rituximab) Chemotherapy - See Disease Characteristics Endocrine therapy - At least 2 weeks since prior steroids - No concurrent steroids except low-dose (no more than 20 mg/day of prednisone or equivalent) for non-lymphoma-related conditions Radiotherapy - No prior radiotherapy to the measurable lesion(s) (unless clearly progressing and/or gallium scan positive) Surgery - More than 4 weeks since prior major surgery, unless fully recovered Other - At least 30 days since prior clinical trial participation - At least 30 days since prior investigational therapy - No other concurrent clinical trial enrollment - No other concurrent investigational agents - No other concurrent anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChristosEmmanouilides, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000270432; AMGEN-20010138,UCLA-0109058
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054379
Other Recurrent Grade Ii Follicular Mixed Cell Lymphoma Studies:
1. Radiation Therapy and Cyclophosphamide Plus Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Hodgkin's Disease or Non-Hodgkin's Lymphoma
2. Comparison of Fludarabine Plus Total-body Irradiation With Combination Chemotherapy Followed by Donor Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
3. Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia
4. Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
5. Radiolabeled Monoclonal Antibody, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory B-Cell Cancer
Related Studies:
Other recurrent grade II follicular mixed cell lymphoma Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Monoclonal Antibody Therapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma
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