Know Cancer

forgot password

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

Phase 1
18 Years
Not Enrolling
Hematologic Malignancies

Thank you

Trial Information

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

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

- Subjects with detectable levels of endogenous antibodies to IL-1α at the time of

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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.

Outcome Description:

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

Outcome Time Frame:

one year

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2011

Completion Date:

September 2012

Related Keywords:

  • Hematologic Malignancies
  • Neoplasms
  • Hematologic Neoplasms



MD Anderson Cancer Center Houston, Texas  77030-4096