Trials / Completed
CompletedNCT00049712
Monoclonal Antibody Therapy in Treating Patients With Refractory Advanced Solid Tumors or Lymphoma
A Phase I Study Of Medi 522 In Patients With Advanced Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- University of Wisconsin, Madison · Academic / Other
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have refractory advanced solid tumors or lymphoma.
Detailed description
OBJECTIVES: * Determine the maximum tolerated dose (MTD) of monoclonal antibody anti-alpha V beta 3 integrin (MEDI 522) in patients with refractory advanced solid tumors or lymphoma. * Determine the safety and tolerability of this drug in these patients. * Demonstrate significant binding of this drug to its molecular target in vivo in these patients. * Determine the effects of this drug on angiogenesis in these patients. * Determine antitumor activity of this drug by measuring tumor size and glucose uptake in these patients. * Determine the pharmacokinetics of this drug in these patients. * Determine a recommended phase II dose of this drug based on either the MTD or the optimal biologic response in these patients. OUTLINE: This is a dose-escalation study. Patients receive monoclonal antibody anti-alpha V beta 3 integrin (Medi 522) IV over 30 minutes weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients receive escalating doses of Medi 522 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 6-30 patients will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | etaracizumab |
Timeline
- Start date
- 2002-10-01
- Primary completion
- 2006-02-01
- Completion
- 2006-02-01
- First posted
- 2003-01-27
- Last updated
- 2019-12-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00049712. Inclusion in this directory is not an endorsement.