Trials / Completed

CompletedNCT00017472

Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Acute Lymphoblastic Leukemia, or Acute Myeloid Leukemia

Phase I Study of Thrice Weekly Hu1D10*in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Acute Leukemia

Status: Completed
Phase: Phase 1
Study type: Interventional
Enrollment: 35 (estimated)

Sponsor: National Cancer Institute (NCI) · NIH
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have chronic lymphocytic leukemia, lymphocytic lymphoma, acute lymphoblastic leukemia, or acute myeloid leukemia.

Detailed description

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) or biological effective dose of monoclonal antibody Hu1D10 (apolizumab) in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma. II. Determine the safety of this drug, in terms of frequency and severity of treatment-related adverse events, in this patient population. SECONDARY OBJECTIVES: I. Determine whether this drug has anti-leukemia/lymphoma activity in patients expressing the Hu1D10 antigen. II. Determine the pharmacokinetics of this drug in this patient population. III. Determine whether the infusion-related toxicity of this drug is secondary to cytokine release in these patients. IV. Determine whether the intensity of 1D10 target antigen on tumor cells is related to clinical response and treatment toxicity in these patients. V. Determine the pharmacodynamics of this drug in this patient population. OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to diagnosis (chronic lymphocytic leukemia or small lymphocytic lymphoma vs acute lymphoblastic leukemia \[ALL\] or acute myeloid leukemia \[AML\]). Patients with ALL or AML are enrolled after the maximum tolerated dose (MTD) is determined. Patients receive apolizumab IV over at least 2 hours on days 1, 2, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with a complete or partial response who relapse after 2 months may receive an additional course of therapy provided they still express the 1D10 antigen. Cohorts of 3-6 patients receive escalating doses of MOAB Hu1D10 until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity (DLT). If no DLT is observed, the biological effective dose (BED) is determined in the above cohorts. The BED is defined as the dose at which at least 4 of 6 patients experience an acceptable minimum trough level and clinical response. An additional 24 patients (12 per stratum) are treated at the MTD. Patients are followed at 1 week, 1 and 2 months, and then every 3 months for 1 year. PROJECTED ACCRUAL: A total of 35 patients (12 per stratum) will be accrued for this study.

Conditions

Interventions

Type	Name	Description
BIOLOGICAL	apolizumab	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies

Timeline

Start date: 2001-04-01
Primary completion: 2006-04-01
First posted: 2003-01-27
Last updated: 2013-06-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00017472. Inclusion in this directory is not an endorsement.