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Study of ONTAK® to Treat Cutaneous T-Cell Lymphoma (CTCL)

NCT00211198 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2008-03-05

No results posted yet for this study

Summary

The purpose of this research study is to evaluate how effective ONTAK is in the treatment of cutaneous T-cell Lymphoma (CTCL) and determine whether the presence of a type of protein called CD25 on the cancer cells makes a difference in how the body responds to the treatment.

The hypothesis is that there is no difference in response rate for patients whose tumor cells are CD25 positive or negative.

Conditions

  • Lymphoma, T-Cell, Cutaneous

Interventions

DRUG

ONTAK (denileukin difitox, DAB389IL-2)

Sponsors & Collaborators

  • Tufts Medical Center

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Ligand Pharmaceuticals

    collaborator INDUSTRY

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Francine Foss, M.D. · Yale University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-05-31
Primary Completion
2005-01-31
Completion
2006-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00211198 on ClinicalTrials.gov