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

NCT ID: NCT00105313

Last Updated: 2007-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Brief Summary

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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

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Conditions

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Lymphoma Leukemia Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MEDI-507

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedImmune LLC

INDUSTRY

Sponsor Role lead

Principal Investigators

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Luz Hammershaimb, MD

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

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USC/Norris Cancer Center

Los Angeles, California, United States

Site Status

Yale Cancer Center

New Haven, Connecticut, United States

Site Status

Georgetown University Medical Center, Lombardi Comprehensive Cancer Center

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

Site Status

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

Tampa, Florida, United States

Site Status

University of Maryland School of Medicine, Greenebaum Cancer Center

Baltimore, Maryland, United States

Site Status

Tufts New England Medical Center

Boston, Massachusetts, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Nevada Cancer Institute

Las Vegas, Nevada, United States

Site Status

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Kimmel Cancer Center, Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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MI-CP107

Identifier Type: -

Identifier Source: org_study_id