Hematologic/Blood Cancers
A Phase I, Multi-Center, Dose Escalation Study of CAT-8015 in Pediatric Patients With Refractory CD22+ Acute Lymphoblastic Leukemia (ALL) or Non-Hodgkin's Lymphoma (NHL)
NCI-08-C-0123, NCT00659425
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Investigator(s): |
Alan S. Wayne, M.D.
Principal Investigator
Phone: 301-496-4256
Fax: 301-451-7010
waynea@mail.nih.gov
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Pediatric Oncology
Phone: 301-496-4256
1-877-624-4878 (Toll free)
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Background:
- This is a Phase I trial of the recombinant immunotoxin CAT-8015 in children, adolescents, and young adults with refractory and relapsed CD22-positive lymphoid malignancies (acute lymphoblastic leukemia or non-Hodgkin lymphoma)
- Evidence for clinical activity and acceptable toxicity profile was demonstrated in a Phase I trial of a related agent, CAT-3888
- CAT-8015 is an affinity-matured version of CAT-3888 and differs from CAT-3888 by a change in three contiguous amino acids in the heavy chain fragment
Objectives:
- Estimate the maximum tolerated dose (MTD), defined as the highest dose that can be safely administered to a patient, and to establish a safe dose, based on the MTD, for subsequent clinical testing
- Characterize the tolerability and safety profile of CAT-8015
- Study the clinical pharmacology (pharmacokinetics and pharmacodynamics) of CAT-8015
- Observe anti-tumor activity of CAT-8015
- Assess the immunogenic potential of CAT-8015 through the measurement of neutralizing antibodies in patients
- Investigate the potential of biomarkers to predict any therapeutic or toxic response; biomarkers include CD22-expression levels and soluble CD22 levels
Key Eligibility Criteria:
- Patients 6 months to < 25 years of age
- All patients must have a histologically confirmed diagnosis of non-Hodgkin lymphoma or acute lymphoblastic leukemia
- Patients must have relapsed or refractory disease and have received at least one standard chemotherapy and one salvage regimen and have measurable or evaluable disease
- Patients must have evidence of CD22 positivity by at least one of the following criteria: > 15% of malignant cells from a site react with anti-CD22 by immunohistochemistry or > 30% of malignant cells from a site are CD22+ by FACS analysis
Study Outline:
- This is a Phase I multi-institution trial of intravenous CAT-8015 administered every other day for six doses
- Cycles may be repeated every 21 days
- Cohorts of one to six patients will be accrued at each dose level starting at 10 μg/kg (Cohort 2)
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 12/14/12
Updated: 1/28/11
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