Back to resultsStudy to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia
Primary Purpose
Lymphoma, Leukemia, Cancer
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MEDI-507
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma
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.
Sites / Locations
- USC/Norris Cancer Center
- Yale Cancer Center
- Georgetown University Medical Center, Lombardi Comprehensive Cancer Center
- H. Lee Moffitt Cancer Ctr & Research Institute Div of Hem/Onc
- University of Maryland School of Medicine, Greenebaum Cancer Center
- Tufts New England Medical Center
- Washington University
- Nevada Cancer Institute
- Wake Forest University Health Sciences
- Kimmel Cancer Center, Thomas Jefferson University
- M.D. Anderson Cancer Center
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00105313
Brief Title
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
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Terminated
Why Stopped
After review of safety events and have decided that further dose escalation of MEDI-507 as a single agent is not feasible.
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
MedImmune LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Leukemia, Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MEDI-507
Primary Outcome Measure Information:
Title
To determine the maximum tolerated dose (MTD) or the optimal biological dose
Title
(OBD) of MEDI-507 based on safety and tolerability of MEDI-507 in patients with
Title
CD-2 positive lymphoproliferative disorders.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luz Hammershaimb, MD
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
USC/Norris Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Georgetown University Medical Center, Lombardi Comprehensive Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
H. Lee Moffitt Cancer Ctr & Research Institute Div of Hem/Onc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Maryland School of Medicine, Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Tufts New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Kimmel Cancer Center, Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia
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