Study of CA-18C3 in Subjects With Advanced Hematologic Malignancies
This study has been completed.
Information provided by (Responsible Party):
First received: December 10, 2010
Last updated: October 17, 2012
Last verified: October 2012
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.
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
||Phase I Study of CA-18C3 in Subjects With Advanced Hematologic Malignancies
Primary Outcome Measures:
- 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:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2012 (Final data collection date for primary outcome measure)
A standard 3+3 design will be employed to determine maximum tolerated dose
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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260545
|MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 10, 2010
||October 17, 2012
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 24, 2017