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Sponsors and Collaborators: |
Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00618696 |
RATIONALE: Monoclonal antibodies can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Radioactive monoclonal antibodies, such as yttrium Y 90 monoclonal antibody, can find cancer cells and either kill them or carry cancer-killing substances to them without harming normal cells.
PURPOSE: This phase I trial is studying the side effects and best dose of a yttrium Y 90 monoclonal antibody and how much radiation is taken in by the organs in the body in treating patients with advanced leukemia or other hematologic disorder.
Condition | Intervention | Phase |
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Leukemia Myelodysplastic Syndromes |
Biological: anti-CD45 monoclonal antibody AHN-12 Other: pharmacological study Procedure: biopsy Procedure: radionuclide imaging Radiation: yttrium Y 90 anti-CD45 monoclonal antibody AHN-12 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | MT2005-13R - Phase I Open Label, Single Arm, Dose Escalation Trial to Evaluate the Biodistribution and Safety of AHN-12 in Patients With Advanced Leukemia |
Estimated Enrollment: | 18 |
Study Start Date: | July 2005 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of yttrium Y 90 anti-CD45 monoclonal antibody AHN-12 (^90Y-AHN-12).
Patients also undergo bone marrow biopsy 16-24 hours after infusion for dosimetry calculations. Patients with the expected biodistribution of ^111In-AHN-12, an estimated radiation-absorbed dose to the normal organ of < 20 Gy, an estimated radiation-absorbed dose to the red marrow of ≤ 13 Gy, and a negative human anti-mouse antibody at day 7 proceed to the therapy portion.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Acute lymphoblastic leukemia or acute myeloid leukemia (AML), meeting any of the following criteria:
PATIENT CHARACTERISTICS:
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to
No uncontrolled illness, including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, Minnesota | |
Masonic Cancer Center at University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 |
Principal Investigator: | Linda J. Burns, MD | Masonic Cancer Center, University of Minnesota |
Study ID Numbers: | CDR0000585145, UMN-2005LS039, UMN-MT2005-13R |
Study First Received: | February 19, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00618696 History of Changes |
Health Authority: | United States: Food and Drug Administration |
recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia secondary acute myeloid leukemia previously treated myelodysplastic syndromes blastic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia |
adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) |
Blast Crisis Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunologic Factors Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Leukemia, Myeloid Leukemia, Myeloid, Acute Recurrence Antibodies, Monoclonal Leukemia |
Antibodies Acute Myelocytic Leukemia Preleukemia Acute Myeloid Leukemia, Adult Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasm Metastasis Chronic Myelogenous Leukemia Bone Marrow Diseases Congenital Abnormalities Acute Lymphoblastic Leukemia Immunoglobulins |
Neoplasms by Histologic Type Disease Immunologic Factors Precancerous Conditions Hematologic Diseases Physiological Effects of Drugs Myelodysplastic Syndromes Pharmacologic Actions Antibodies, Monoclonal |
Leukemia Preleukemia Neoplasms Antibodies Pathologic Processes Syndrome Bone Marrow Diseases Immunoglobulins |