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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma  Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma
Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma
For Condition: recurrent diffuse small lymphocytic/marginal zone lymphoma,recurrent grade II follicular mixed cell lymphoma,recurrent grade I follicular small cleaved cell lymphoma
Status: No longer recruiting
Sponsor(s): University of Nebraska ,
Synopsis: RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase III trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
Details: OBJECTIVES: I. Determine the efficacy and safety of iodine I 131 monoclonal antibody anti-B1 in patients with relapsed or refractory, low grade or transformed low grade B-cell non-Hodgkin's lymphoma. PROTOCOL OUTLINE: On day 1, patients receive unlabeled monoclonal antibody anti-B1 (MOAB anti-B1) IV over 1 hour followed by a tracer dose of iodine I 131 MOAB anti-B1 IV over 30 minutes to determine biodistribution and a therapeutic dose of iodine I 131 MOAB anti-B1. Patients receive unlabeled MOAB anti-B1 IV over 1 hour followed by a therapeutic dose of iodine I 131 MOAB anti-B1 IV over 30 minutes on day 8. Patients are followed at weeks 13 and 25 and then every 6 months for up to 2 years. PROJECTED ACCRUAL: Not specified
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 19 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven relapsed or refractory, low grade or transformed low grade B-cell non-Hodgkin's lymphoma including the following: Small lymphocytic; Follicular small cleaved cell; Follicular mixed small cleaved and large cell (less than 50% large cell component) - Tumor must be positive for CD20 antigen - Relapse or disease progression following at least 1 chemotherapy regimen or failure to achieve an objective response (complete or partial response) on prior chemotherapy regimen - No disease progression, within 1 year of irradiation, arising in a field previously irradiated with more than 3500 cGy - Mean of no greater than 25% intratrabecular marrow space involved with lymphoma on bilateral iliac crest bone marrow biopsy [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.] --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior immunotherapy or cytokine treatment and recovered; No prior hematologic stem cell transplantation - Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy (at least 6 weeks since prior nitrosoureas) and recovered - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics; At least 4 weeks since prior radiotherapy and recovered; No prior radioimmunotherapy - Surgery: Not specified - Other: No concurrent IV antibiotics --Patient Characteristics-- - Age: 19 and over - Performance status: Karnofsky 60-100% - Life expectancy: At least 3 months - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN); AST less than 5 times ULN - Renal: Creatinine less than 1.5 times ULN; No active obstructive hydronephrosis - Cardiovascular: No New York Heart Association class III or IV heart disease - Other: No active infection requiring IV antibiotics; No other concurrent illness that would preclude evaluation; No prior malignancy within the past 5 years except adequately treated skin cancer, carcinoma in situ of the cervix, or lymphoma; HIV negative; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 6 months after study; No prior allergic reaction to iodine other than IV iodine containing contrast materials; Human antimouse antibody negative
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JulieVose, Study Chair, University of Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Additional Information:
Study ID Numbers: CDR0000067534; UNMC-259-98,COULTER-CP-98-020
Study Start Date: September 2001
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004874
Other Recurrent Grade I Follicular Small Cleaved Cell Lymphoma Studies:
1. Interferon alfa-2b Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Hodgkin's Disease or Non- Hodgkin's Lymphoma
2. Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Acute Lymphoblastic Leukemia, or Acute Myeloid Leukemia
3. Thalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
4. Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
5. 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
Related Studies:
Other recurrent grade I follicular small cleaved cell lymphoma Clinical Trials
Other Nebraska Clinical Trials
Other Omaha Clinical Trials
Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma
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