Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia

Phase 1

Terminated

• Conditions: Lymphoma; Leukemia; Cancer

• Registration Number: NCT00105313
• Lead Sponsor: MedImmune LLC

Brief Summary

For primary objectives, we will determine the MTD and examine clinical responses and immune cell populations to determine an OBD, and describe the safety and tolerability of MEDI-507.

For the secondary objectives we will look at the antitumor activity of MEDI 507, PK, serum concentrations, and immunogenicity of MEDI-507, as well as time courses of depletion and recovery of CD2 positive and total T-Cell populations.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-03-11
• Study First Submitted QC: 2005-03-11
• Study First Posted: 2005-03-14
• Status Verified: 2007-06
• Last Update Submitted: 2007-06-12
• Last Update Posted: 2007-06-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the maximum tolerated dose (MTD) or the optimal biological dose
(OBD) of MEDI-507 based on safety and tolerability of MEDI-507 in patients with
CD-2 positive lymphoproliferative disorders.

Trial Locations

Locations (11)

USC/Norris Cancer Center; 🇺🇸 Los Angeles, California, United States

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

Georgetown University Medical Center, Lombardi Comprehensive Cancer Center; 🇺🇸 Washington, District of Columbia, United States

H. Lee Moffitt Cancer Ctr & Research Institute Div of Hem/Onc; 🇺🇸 Tampa, Florida, United States

University of Maryland School of Medicine, Greenebaum Cancer Center; 🇺🇸 Baltimore, Maryland, United States

Tufts New England Medical Center; 🇺🇸 Boston, Massachusetts, United States

Washington University; 🇺🇸 St. Louis, Missouri, United States

Nevada Cancer Institute; 🇺🇸 Las Vegas, Nevada, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

Kimmel Cancer Center, Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States

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