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

NCT00105313 — Phase 1, Terminated, 80 participants, MedImmune LLC

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

RegistryNCT00105313
StatusTerminated - After review of safety events and have decided that further dose escalation of MEDI-507 as a single agent is not feasible.
PhasePhase 1
Study typeInterventional; non randomized, single group, masking: none, treatment
Enrollment80 (Estimated)
SponsorMedImmune LLC (Industry)
ConditionsLymphoma, Leukemia, Cancer
InterventionsMEDI-507 (Drug)
Datesstart 2005-02-01, first posted 2005-03-14, last updated 2007-06-14
Locations11 sites in United States

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-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.

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+Arms and interventions

  • MEDI-507 (Drug)

+Outcome measures

Primary outcomes

  • 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.

+Eligibility

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.

+Locations (11)

FacilityCityCountryStatus
USC/Norris Cancer CenterLos Angeles, CaliforniaUnited States
Yale Cancer CenterNew Haven, ConnecticutUnited States
Georgetown University Medical Center, Lombardi Comprehensive Cancer CenterWashington D.C., District of ColumbiaUnited States
H. Lee Moffitt Cancer Ctr & Research Institute Div of Hem/OncTampa, FloridaUnited States
University of Maryland School of Medicine, Greenebaum Cancer CenterBaltimore, MarylandUnited States
Tufts New England Medical CenterBoston, MassachusettsUnited States
Washington UniversitySt Louis, MissouriUnited States
Nevada Cancer InstituteLas Vegas, NevadaUnited States
Wake Forest University Health SciencesWinston-Salem, North CarolinaUnited States
Kimmel Cancer Center, Thomas Jefferson UniversityPhiladelphia, PennsylvaniaUnited States
M.D. Anderson Cancer CenterHouston, TexasUnited States

+Investigators

My Notes