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

NCT00105313 | Terminated Phase 1

• 1 other identifier: MI-CP107
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 11

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.

Conditions

Lymphoma; Leukemia; Cancer

Outcome Measures

Primary Outcomes (3)

• 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.

Interventions

MEDI-507 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Individuals may be eligible for this study if they are 18 years of age or older and: * Have one of the following types of T-Cell Lymphoproliferative disorders such as Cutaneous T-cell Lymphoma (CTCL), Peripheral T-cell Lymphoma (PCTL), Large Cell Lymphoma (LGL), or Adult T-cell Lymphoma (ATL). Patients should have disease that is resistant or refractory to the front-line therapy, except ATL patients for whom there is no standard therapy. * At least 30% of tumor cells must be CD2 positive. * Karnofsky Performance status of greater than or equal to 70% (able to care for themselves; but unable to carry on normal activity or to do active work). * At least 3 weeks must have passed since prior systemic cytotoxic chemotherapy, prolonged or cytolytic steroid therapy or major surgery, and all treatment-related toxicities must have resolved prior to the first MEDI-507 administration (except thrombocytopenia). * Have no prior treatment with MEDI-507.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (11)

USC/Norris Cancer Center

Los Angeles, California, 90033, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520, United States

Location

Georgetown University Medical Center, Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

H. Lee Moffitt Cancer Ctr & Research Institute Div of Hem/Onc

Tampa, Florida, 33612, United States

Location

University of Maryland School of Medicine, Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Tufts New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27517, United States

Location

Kimmel Cancer Center, Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lymphoma; Leukemia; Neoplasms

Interventions

siplizumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases

Study Officials

• Luz Hammershaimb, MD

  MedImmune LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 11, 2005
• First Posted: March 14, 2005
• Study Start: February 1, 2005
• Last Updated: June 14, 2007

Record last verified: 2007-06

Locations

US (11)