Study of CA-18C3 in Subjects With Advanced Hematologic Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01260545
Recruitment Status : Completed
First Posted : December 15, 2010
Last Update Posted : October 19, 2012
Information provided by (Responsible Party):
XBiotech, Inc.

Brief Summary:
The purpose of this study is to examine the safety and tolerability of CA-18C3 in subjects with hematologic malignancies, as well as look at the preliminary efficacy of IL-1alpha blockade.

Condition or disease Intervention/treatment Phase
Hematologic Malignancies Drug: CA-18C3 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Phase I Study of CA-18C3 in Subjects With Advanced Hematologic Malignancies
Study Start Date : April 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Experimental: Infusion
A standard 3+3 design will be employed to determine maximum tolerated dose
Drug: CA-18C3
2.5 mg/kg, 3.75 mg/kg IV (in the vein) on Day 1 of each 14 day cycle until the subject is no longer benefiting clinically or unacceptable toxicity occurs.

Primary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability of CA-18C3, as well as the pharmakokinetic properties of CA-18C3 in study participants. [ Time Frame: one year ]

    To determine the toxicities, including the dose limiting toxicity and maximum tolerated dose of CA-18C3 when administered intravenously at up to 3.75 mg/kg twice monthly in subjects with hematologic malignancies.

    To determine the pharmacokinetics (PK) of CA-18C3 following study drug administration

Secondary Outcome Measures :
  1. Number of participants with disease progression, stable disease, partial response or complete response of their disease while receiving CA-18C3. [ Time Frame: One year ]
    To observe the anti-tumor effects of CA-18C3, if any occur

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female subjects age ≥ 18 years of age
  • Subject must have a relapsed/refractory leukemia for which no standard therapies are anticipated to result in a durable remission. Subjects with previously treated high-risk myelodysplasia (MDS) (Intermediate 2 or high-risk by IPSS) and chronic myelomonocytic leukemia-2 (CMML-2 by WHO classification) are also candidates for this protocol. Relapsed/refractory leukemias include acute non-lymphocytic leukemia (AML) by WHO classification, acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), or chronic myelogenous leukemia (CML) in blast crisis. Subjects with myelofibrosis are also eligible. Untreated patients with above diagnoses considered unfit for standard therapy will also be eligible.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
  • Women of child bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative urine pregnancy test within 2 weeks prior to beginning treatment on this trial. Nursing subjects are excluded. Sexually active men must also use acceptable contraceptive methods for the duration of time on study. Pregnant and nursing subjects are excluded because the effects of CA-18C3 on a fetus or nursing child are unknown.
  • In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for non-cytotoxic agents. If the subject is on hydroxyurea to control peripheral blood leukemic cell counts, the subject must be off hydroxyurea for at least ¬48 hours before initiation of treatment on this protocol. Persistent clinically significant toxicities from prior chemotherapy must not be greater than grade 1.
  • Subjects must have the following clinical laboratory values (unless out of range values are considered to be the result of leukemic organ involvement):

    1. Serum creatinine ≤ 2.0 mg/dl.
    2. Total bilirubin ≤ 1.5x the upper limit of normal unless considered due to Gilbert's syndrome.
    3. Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) ≤ 3x the upper limit of normal unless considered due to organ leukemic involvement.
  • Signed and dated institutional review board (IRB)-approved informed consent before any protocol-specific screening procedures are performed.

Exclusion Criteria:

  • Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure.
  • Subjects receiving any other standard or investigational treatment for their hematologic malignancy.
  • Subjects who at the time of evaluation for participation in the study have evidence of active leukemic involvement in the brain or spinal cord (CNS).
  • Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
  • Subjects immunocompromised due to a process unrelated to leukemic disease or treatment, including subjects known to be infected with human immunodeficiency virus (HIV)
  • Subjects with detectable levels of endogenous antibodies to IL-1α at the time of screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01260545

United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
XBiotech, Inc.

Responsible Party: XBiotech, Inc. Identifier: NCT01260545     History of Changes
Other Study ID Numbers: 2010-PT015
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: October 19, 2012
Last Verified: October 2012

Additional relevant MeSH terms: