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A Phase I Open-Label Dose Escalation Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia

Phase 1
18 Years
Not Enrolling
Lymphoma, Leukemia, Cancer

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Trial Information

A Phase I Open-Label Dose Escalation Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia

Inclusion Criteria

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

- Have no prior treatment with MEDI-507.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose (MTD) or the optimal biological dose

Principal Investigator

Luz Hammershaimb, MD

Investigator Role:

Study Director

Investigator Affiliation:

MedImmune LLC


United States: Food and Drug Administration

Study ID:




Start Date:

February 2005

Completion Date:

Related Keywords:

  • Lymphoma
  • Leukemia
  • Cancer
  • Leukemia
  • Lymphoma



Yale Cancer Center New Haven, Connecticut  06520-8028
Tufts New England Medical Center Boston, Massachusetts  02111
M.D. Anderson Cancer Center Houston, Texas  77030
Washington University St. Louis, Missouri  63110
USC/Norris Cancer Center Los Angeles, California  
Nevada Cancer Institute Las Vegas, Nevada  89135
Wake Forest University Health Sciences Winston-Salem, North Carolina  27157
Georgetown University Medical Center, Lombardi Comprehensive Cancer Center Washington, District of Columbia  20007
H. Lee Moffitt Cancer Ctr & Research Institute Div of Hem/Onc Tampa, Florida  33612
University of Maryland School of Medicine, Greenebaum Cancer Center Baltimore, Maryland  21201
Kimmel Cancer Center, Thomas Jefferson University Philadelphia, Pennsylvania  19107