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A Phase I Study to Evaluate Safety, Tolerability in Adults With Lymphoma

NCT00538096 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2008-09-05

No results posted yet for this study

Summary

* Evaluate the safety and tolerability of multiple doses of MEDI-538 by continuous IV infusion for 4 or 8 weeks in adult patients with B-cell NHL not eligible for curative therapy.
* Determine the maximum tolerated dose of MEDI-538 administered by continuous IV infusion.

Conditions

  • Lymphoma, B-Cell
  • Lymphoma, Non-Hodgkin

Interventions

DRUG

MEDI-538

1 of 3 target doses of MEDI-538 (5,μg/m2/24h) as a continuous IV infusion through a central line catheter. The initial treatment period will be 4 weeks in duration (Study Days 0-27), unless the patient discontinues treatment.

DRUG

MEDI-538

1 of 3 target doses of MEDI-538 (10,μg/m2/24h) as a continuous IV infusion through a central line catheter. The initial treatment period will be 4 weeks in duration (Study Days 0-27), unless the patient discontinues treatment.

DRUG

MEDI-538

1 of 3 target doses of MEDI-538 (15,μg/m2/24h) as a continuous IV infusion through a central line catheter. The initial treatment period will be 4 weeks in duration (Study Days 0-27), unless the patient discontinues treatment.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Karen L. Kaucic, M.D. · MedImmune LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-03-31
Completion
2010-05-31

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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 NCT00538096 on ClinicalTrials.gov