Expired Study
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Cleveland, Ohio 44106


Purpose:

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances such as radioactive iodine to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibodies in treating patients who have large cell lymphoma that has been previously treated.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose of iodine I 131 monoclonal antibody Lym-1 in patients with previously treated diffuse large cell lymphoma. - Determine the safety of this drug in these patients. - Determine the response of patients to this drug. OUTLINE: This is a dose-escalation, multicenter study. Patients receive unlabeled monoclonal antibody Lym-1 IV over 40 minutes followed 15-30 minutes later by iodine I 131 monoclonal antibody Lym-1 IV over 2 minutes. Cohorts of 3-6 patients receive escalating doses of iodine I 131 monoclonal antibody Lym-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed weekly for 8 weeks and then every 3 months for 1 year. PROJECTED ACCRUAL: A total of 8-36 patients will be accrued for this study.


Criteria:

Inclusion Criteria - Histologic diagnosis of B-cell diffuse large cell lymphoma (REAL classification system) confirmed by an independent central pathology reviewer. - The tumor's B-cell phenotype will be confirmed by positive L-26 (CD20). - Previous treatment with 2 common combination chemotherapy regimens. Patients previously treated with unlabeled monoclonal antibody therapy are eligible. - Men or women at least 18 years of age. - Karnofsky Performance Score (KPS) estimated to be > 60 at the time of the scheduled therapeutic dose of 131I-Lym-1. - Life expectancy estimated to be at least 3 months from the time of the therapeutic dose of 131I Lym-1. - Measurable disease demonstrable by physical examination or computerized tomography (CT). - CT scan evidence of at least one indicator lesion with at least one diameter that measures > 2 cm. (The CT scan should be done within 2 weeks of the imaging study.) Exclusion Criteria - Inability or unwillingness to comply with the following: - Bone marrow biopsy - Return for follow-up visits - Remaining motionless for extended periods of time for imaging procedures - Serial blood/urine sampling (for dosimetry patients only) - Pregnancy (Women of childbearing potential must be practicing an effective method of contraception.) - Presence of a second malignancy except for basal cell skin carcinoma or carcinoma in-situ of the cervix - Presence of active lymphomatous meningitis or other CNS involvement with lymphoma. - HIV positive patients. - Prior total body irradiation, or a course of prior radiation > 3,000 cGy delivered to > 20% of the central marrow or the lumbar vertebrae within 6 months of screening. - Serum creatinine or total bilirubin > 2 x the upper limit of normal. - Aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase > 3 x the upper limit of normal. - Significant marrow lymphoma (defined as lymphoma cells constituting greater than 20% of the hematopoietic marrow elements from an iliac crest biopsy). A prior bone marrow biopsy is acceptable if it meets the following criteria: - If there is prior bone marrow involvement, the biopsy must be performed within 45 days of screening. - If there is no prior bone marrow involvement, the biopsy must be performed within 90 days of screening - WBC count < 3,500/mm3, granulocyte count < 1,500/mm3, or platelet count < 125,000/mm3. - Positive human anti-mouse antibodies (HAMA) serum values, defined as > 74 ng/mL at screening. - Patients who have not recovered from toxicities of most recent anti-lymphoma therapy. - Treatment with: - Colony stimulating factor G-CSF or GM-CSF within 120 hours of screening laboratory assessment. - Erythropoietin (EPO) within a month of screening laboratory assessment - Whole blood or platelet transfusion within 120 hours of screening laboratory assessment - History or electrocardiographic (ECG) evidence of Q-wave myocardial infarction within 6 months of screening or congestive heart failure (CHF; NYHA Stage III or IV). - Known hypersensitivity to iodine or iodine-containing organic substances. - Patients who require therapy with anticoagulants or antiplatelet drugs which cannot be discontinued during the study. - Patients who are known to have antiplatelet antibodies.


NCT ID:

NCT00028613


Primary Contact:

Study Chair
Omer N. Koc, MD
Case Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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