Clinical trial NCT00105313: Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia
Official title: A Phase I Open-Label Dose Escalation Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Lymphoma
Leukemia
Cancer
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2005-03-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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 thrombocytopenia).
* Have no prior treatment with MEDI-507.

Primary outcomes:
measure: To determine the maximum tolerated dose (MTD) or the optimal biological dose
measure: (OBD) of MEDI-507 based on safety and tolerability of MEDI-507 in patients with
measure: CD-2 positive lymphoproliferative disorders.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Norris Cancer Center
state: California
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center, Lombardi Comprehensive Cancer Center
state: District of Columbia
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Ctr & Research Institute Div of Hem/Onc
state: Florida
city: Baltimore
country: United States
facility: University of Maryland School of Medicine, Greenebaum Cancer Center
state: Maryland
city: Boston
country: United States
facility: Tufts New England Medical Center
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Philadelphia
country: United States
facility: Kimmel Cancer Center, Thomas Jefferson University
state: Pennsylvania
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: MedImmune LLC
name: Luz Hammershaimb, MD
role: STUDY_DIRECTOR
References: