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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 |
Drug: anti-CD45 monoclonal antibody AHN-12 Drug: yttrium Y 90 anti-CD45 monoclonal antibody AHN-12 Procedure: biopsy Procedure: pharmacological study Procedure: radionuclide imaging |
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.
After completion of study treatment, patients are followed periodically for 1 year.
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 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: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00618696 |
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 Precancerous Conditions Chronic myelogenous leukemia Leukemia, Myeloid, Acute Acute lymphoblastic leukemia, adult Antibodies, Monoclonal Leukemia Preleukemia Neoplasm Metastasis Acute myeloid leukemia, adult Congenital Abnormalities Acute myelocytic leukemia |
Immunoglobulins Myelodysplastic syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Myelodysplastic Syndromes Myelodysplasia Acute myelogenous leukemia Leukemia, Myeloid Recurrence Antibodies Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases |
Neoplasms Pathologic Processes Disease Neoplasms by Histologic Type |
Immunologic Factors Syndrome Physiological Effects of Drugs Pharmacologic Actions |