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Adjuvant, Combined Interleukin 2 (Proleukin) and DTIC (Dacarbazine) in High-risk Melanoma Patients

NCT00553618 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-10-29

No results posted yet for this study

Summary

The purpose of this study is to see if the combination of the two cancer drugs, Dacarbazine (DTIC) and a low-dose of Proleukin (IL2), would provide a less toxic and more effective treatment for melanoma than currently available treatments for people with high-risk melanoma. Dacarbazine (DTIC) and Proleukin (IL2) are both FDA-approved drugs for the treatment of melanoma.

Conditions

Interventions

DRUG

Proleukin and Dacarbazine

IL-2 (Proleukin), injected just under the skin, at a dose of 12 million units on days 1-4 for each of the six months of therapy. Dacarbazine, administered as an IV infusion through a freely flowing IV, at a dose of 750 mg, repeated every four weeks.

Sponsors & Collaborators

  • James Graham Brown Cancer Center

    collaborator OTHER

  • University of Louisville

    lead OTHER

Principal Investigators

  • Jason A Chesney, MD · James Graham Brown Cancer Center, University of Louisville

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2025-08-31
Completion
2026-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00553618 on ClinicalTrials.gov