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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00105313
• Other study ID #: MI-CP107
• Status: Terminated
• Phase: Phase 1
• First received: March 11, 2005
• Last updated: June 12, 2007
• Start date: February 2005

Study information

• Verified date: June 2007
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Cancer
• Leukemia
• Lymphoma

Intervention

Drug:
• MEDI-507

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the maximum tolerated dose (MTD) or the optimal biological dose
Primary	(OBD) of MEDI-507 based on safety and tolerability of MEDI-507 in patients with
Primary	CD-2 positive lymphoproliferative disorders.