Yttrium Y 90 Anti-CD19 Antibody BU-12 in Patients With Advanced Relapsed or Refractory Acute Lymphoblastic Leukemia or Chronic Lymphocytic Leukemia - Full Text View

Sponsors and Collaborators:	Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00643240

Purpose

RATIONALE: Radiolabeled monoclonal antibodies can find cancer cells and carry cancer-killing substances to them without harming normal cells. This may be effective treatment for leukemia.

PURPOSE: This phase I trial is studying the best dose of yttrium Y 90-labeled monoclonal antibody BU-12 in treating patients with advanced relapsed or refractory acute lymphoblastic leukemia or chronic lymphocytic leukemia.

Condition	Intervention	Phase
Leukemia	Other: pharmacological study Procedure: biopsy Procedure: radionuclide imaging Radiation: yttrium Y 90 anti-CD19 monoclonal antibody BU12	Phase I

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Nuclear Scans

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase I Open Label, Single Arm Escalation Trial to Evaluate the Biodistribution and Safety of BU-12 in Patients With Advanced Leukemia

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Biodistribution of indium-111 BU-12 [ Designated as safety issue: No ]

Secondary Outcome Measures:

Maximum tolerated dose of yttrium Y 90 anti-CD19 antibody BU-12 [ Designated as safety issue: Yes ]
Presence or absence of a human antibody to murine antibody at baseline, 28 and 60 days post therapy, and at 6 months post therapy [ Designated as safety issue: No ]
Response at day 28 and day 60 post therapy [ Designated as safety issue: No ]
Proportion of patients with each disease status [ Designated as safety issue: No ]
Time-to-event as measured from date of therapy [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	January 2008
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To determine the biodistribution of indium-111 BU-12 in patients with refractory CD19+ leukemia.

Secondary

To determine the maximum tolerated dose of yttrium Y 90 anti-CD19 antibody BU-12
Determine the human anti-mouse antibody (HAMA) response.
To define, preliminarily, the antitumor activity of yttrium Y 90 anti-CD19 antibody BU-12.

OUTLINE: Patients receive yttrium Y 90 anti-CD19 antibody BU-12/indium-111 BU-12 IV over 60 minutes on day 0 and undergo whole-body imaging on days 0, 1, 3, 4, and 7. Patients also undergo blood collection and bone marrow biopsy periodically for dosimetry calculations and pharmacokinetics.

After completion of study treatment, patients are followed periodically for 2 years.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed CD19-positive (> 25% by flow cytometry evaluation of bone marrow blasts) disease of 1 of the following types:
- Primary refractory or relapsed acute lymphoblastic leukemia (ALL) defined as persistent disease following a minimum of two different standard effective chemotherapy induction attempts at time of diagnosis or at relapse
- Chronic Lymphocytic leukemia (CLL) following blast crisis (≥15% bone marrow blasts following a minimum of one standard effective chemotherapy induction attempt)
Human anti-mouse antibody (HAMA) must be negative
Patients who have relapsed ≥ 60 days following an autologous or allogeneic transplant are eligible if all other eligibility criteria are met
No active CNS disease

PATIENT CHARACTERISTICS:

Inclusion criteria:

ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
Life expectancy > 8 weeks
Total bilirubin ≤ 2.5 times upper limit of normal (ULN)
AST and ALT ≤ 2.5 times ULN
Creatinine normal OR creatinine clearance ≥ 60 mL/min
LVEF ≥ 45% by MUGA/ECHO
Oxygen saturation on room air > 92% and no oxygen requirement
Not pregnant or nursing
Negative pregnancy test
Fertile patients mus use effective contraception

Exclusion criteria:

History of allergic reactions attributed to compounds of similar chemical or biologic composition to of yttrium Y 90 anti-CD19 antibody BU-12 or other agents used in study
Uncontrolled illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements
HIV-positive
Active graft-vs-host disease

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
More than 4 weeks since prior agents and recovered
At least 7 days since prior therapy with any biologic agent, defined as a growth factor or cytokine
At least 3 months since prior antibody or biologic anticancer therapy (e.g., alemtuzumab or epratuzumab)
No other concurrent investigational agents
Patients with peripheral blasts > 5,000/uL may receive concurrent hydroxyurea

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643240

Locations

United States, Minnesota
Masonic Cancer Center at University of Minnesota	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Brenda Weigel, MD

Masonic Cancer Center, University of Minnesota

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000590329, UMN-2006LS057, MT2006-09, UMN-0611M96887
Study First Received:	March 25, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00643240 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent adult acute lymphoblastic leukemia
recurrent childhood acute lymphoblastic leukemia
refractory chronic lymphocytic leukemia

Study placed in the following topic categories:

Acute Lymphoblastic Leukemia, Childhood
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Immunologic Factors
Recurrence
Antibodies, Monoclonal
Leukemia
Lymphatic Diseases

Antibodies
Chronic Lymphocytic Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-Cell
Lymphoproliferative Disorders
Leukemia, B-cell, Chronic
Lymphoma
Acute Lymphoblastic Leukemia
Immunoglobulins

Additional relevant MeSH terms:

Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

Antibodies, Monoclonal
Leukemia
Lymphatic Diseases
Neoplasms
Antibodies
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-Cell
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on May 07, 2009