Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(After review of safety events and have decided that further dose escalation of MEDI-507 as a single agent is not feasible.)
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00105313
First received: March 11, 2005
Last updated: June 12, 2007
Last verified: June 2007

March 11, 2005
June 12, 2007
February 2005
Not Provided
  • 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.
Not Provided
Complete list of historical versions of study NCT00105313 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia
A Phase I Open-Label Dose Escalation Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lymphoma
  • Leukemia
  • Cancer
Drug: MEDI-507
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
80
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00105313
MI-CP107
Not Provided
Not Provided
MedImmune LLC
Not Provided
Study Director: Luz Hammershaimb, MD MedImmune LLC
MedImmune LLC
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP