Clinical Trials Directory

Trials / Terminated

TerminatedNCT00014560

Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

Phase I Trial Of Intravenous Bispecific Antibody (4G7XH22) In Patients With Refractory Or Relapsed Non-Hodgkin's Lymphoma Or Chronic Lymphocytic Leukemia (CLL)

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
3 (actual)
Sponsor
Dartmouth-Hitchcock Medical Center · Academic / Other
Sex
All
Age
18 Years – 120 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: Antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of antibody therapy in treating patients who have refractory or relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose and dose-limiting toxicity of bispecific antibody 4G7xH22 in patients with relapsed or refractory non-Hodgkin's lymphoma or chronic lymphocytic leukemia. * Assess the clinical toxicity of this antibody in these patients. OUTLINE: This is a dose escalation study of bispecific antibody (BsAb) 4G7xH22. Patients receive sargramostim (GM-CSF) subcutaneously on day 1 and BsAb 4G7xH22 IV over 2 hours on day 2. Treatment repeats weekly for a total of 3 courses in the absence of unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BsAb 4G7xH22 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity. Patients are followed weekly for 4 weeks, monthly for 3 months, and then periodically for 1 year. PROJECTED ACCRUAL: Approximately 18 patients will be accrued for this study.

Conditions

Interventions

TypeNameDescription
BIOLOGICALbispecific antibody 4G7xH22
BIOLOGICALsargramostim

Timeline

Start date
2000-09-28
Primary completion
2003-02-14
Completion
2003-02-14
First posted
2003-07-30
Last updated
2018-05-03
Results posted
2013-08-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00014560. Inclusion in this directory is not an endorsement.