Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
University of Nebraska |
---|---|
Information provided by: | University of Nebraska |
ClinicalTrials.gov Identifier: | NCT00574509 |
The purpose of this study is to assess the safety of 131I-anti-B1 Radioimmunotherapy when combined with high-dose BEAM or BEAC chemotherapy and hematopoietic stem cell transplantation. The study will also compare the difference in response rates and time to treatment failure between historical control patients receiving high-dose BEAM or BEAC chemotherapy with autologous hematopoietic stem cell transplant and patients receiving radioimmunotherapy and high-dose BEAM or BEAC chemotherapy with autologous hematopoietic stem cell transplant. Patients will receive escalating doses of radioimmunotherapy with anti-B1 radiolabeled with 131Iodine, high-dose carmustine, etoposide, cytarabine and Melphalan (BEAM) chemotherapy, and autologous hematopoietic stem cell transplant.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Radiation: 131Iodine-Anti-B1 Radioimmunotherapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | BEAM + 131Iodine-Anti-B1 Radioimmunotherapy and Autologous Hematopoietic Stem Cell Transplantation for the Treatment of Recurrent Non-Hodgkin's Lymphoma |
Enrollment: | 34 |
Study Start Date: | March 1996 |
Estimated Study Completion Date: | December 2015 |
Arms | Assigned Interventions |
---|---|
131I-Anti-B1: Experimental
BEAM + 131Iodine-Anti-B1 radioimmunotherapy and autologous HSCT
|
Radiation: 131Iodine-Anti-B1 Radioimmunotherapy
Dosimetric dose of 450 mg unlabeled Anti-B1 followed by 35 mg Anti-B1 which has been trace labeled with 5mCi of 131I-Anti-B1.
|
Thirty patients will be enrolled in this study. There will be two administrations of 131I-anti-B1 given to patients, the "dosimetric dose" and the "radioimmunotherapy dose". The dosimetric dose will consist of an infusion of unlabeled Anti-B1 (450 mg) immediately followed by an infusion of Anti-B1 (35 mg) which has been trace labeled with 5mCi of 131I-anti-B1. The total whole body dosimetry dose is then calculated over an approximated one-week time interval from the radioactive clearance data obtained by the Whole Body anterior and posterior gamma camera scans. Based upon dosimetric data calculations specific for each individual patient, a radioimmunotherapy dose will be given consisting of an infusion of unlabeled Anti-B1 (450 mg)immediately followed by an infusion of 35 mg Anti-B1 including a patient specific dose of 131Iodine-Anti-B1. Calculations will be made such that in a dose escation study, whole body radiation doses of 30, 45, 60, and 75cGy will result from the administration of the therapeutic activity of 131I-anti-B1. The amount of the unlabeled Anti-B1 administered is not calculated on a body surface area basis, but is given to provide an excess of Anti-B1 independent of tumor burden, splenic uptake, or other causes.
Ages Eligible for Study: | 19 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Nebraska | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198-7680 |
Principal Investigator: | Julie M Vose, MD | University of Nebraska |
Responsible Party: | University of Nebraska Medical Center ( Julie Vose, MD ) |
Study ID Numbers: | UNMC 165-96 |
Study First Received: | December 12, 2007 |
Last Updated: | December 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00574509 |
Health Authority: | United States: Food and Drug Administration |
NHL Non Hodgkins Lymphoma 131Iodine-Anti-B1 Radioimmunotherapy Autologous Hematopoietic Stem Cell Transplant AHSCT |
Lymphatic Diseases Immunoproliferative Disorders Iodine-131 anti-B1 antibody Lymphoma, small cleaved-cell, diffuse Iodine |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Recurrence |
Anti-Infective Agents Anti-Infective Agents, Local Neoplasms Neoplasms by Histologic Type Immune System Diseases Growth Substances |
Therapeutic Uses Physiological Effects of Drugs Trace Elements Micronutrients Pharmacologic Actions |