A Phase I Open-Label Dose Escalation Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia
| Registry | NCT00105313 |
|---|---|
| Status | Terminated - After review of safety events and have decided that further dose escalation of MEDI-507 as a single agent is not feasible. |
| Phase | Phase 1 |
| Study type | Interventional; non randomized, single group, masking: none, treatment |
| Enrollment | 80 (Estimated) |
| Sponsor | MedImmune LLC (Industry) |
| Conditions | Lymphoma, Leukemia, Cancer |
| Interventions | MEDI-507 (Drug) |
| Dates | start 2005-02-01, first posted 2005-03-14, last updated 2007-06-14 |
| Locations | 11 sites in United States |
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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.
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| USC/Norris Cancer Center | Los Angeles, California | United States | |
| Yale Cancer Center | New Haven, Connecticut | United States | |
| Georgetown University Medical Center, Lombardi Comprehensive Cancer Center | Washington D.C., District of Columbia | United States | |
| H. Lee Moffitt Cancer Ctr & Research Institute Div of Hem/Onc | Tampa, Florida | United States | |
| University of Maryland School of Medicine, Greenebaum Cancer Center | Baltimore, Maryland | United States | |
| Tufts New England Medical Center | Boston, Massachusetts | United States | |
| Washington University | St Louis, Missouri | United States | |
| Nevada Cancer Institute | Las Vegas, Nevada | United States | |
| Wake Forest University Health Sciences | Winston-Salem, North Carolina | United States | |
| Kimmel Cancer Center, Thomas Jefferson University | Philadelphia, Pennsylvania | United States | |
| M.D. Anderson Cancer Center | Houston, Texas | United States |