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Pilot hu14.18-IL2 in Resectable Recurrent Stage III or Stage IV Melanoma

NCT00590824 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2019-11-21

Study results available
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Summary

Evaluate the antitumor activity of hu14.18-IL2 in the minimal residual disease setting. Evaluate the time to recurrence and overall survival of patients treated with hu14.18-IL2.

Conditions

Interventions

DRUG

hu14.18-IL2

6 mg/m2 hu14.18-IL2 administered via IV on days 1, 2, and 3 of a 28-day course followed by surgery and up to 2 additional courses of hu14.18-IL2

DRUG

hu14.18-IL2

Surgery followed by 3 courses of 6 mg/m2 hu14.18-IL2 administered via IV on days 1, 2, and 3 of a 28-day course

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • EMD Serono

    collaborator INDUSTRY

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Paul M Sondel, MD, PhD · University of Wisconsin, Madison

  • Mark R Albertini, MD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-17
Primary Completion
2018-09-20
Completion
2018-09-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00590824 on ClinicalTrials.gov