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RFT5-dgA Immunotoxin in Treating Patients With Metastatic Melanoma

2014-08-27 03:44:21 | BioPortfolio

Summary

RATIONALE: The RFT5-dgA immunotoxin can find tumor cells and kill them without harming normal cells. This may be an effective treatment for metastatic melanoma.

PURPOSE: This phase II trial is studying how well RFT5-dgA immunotoxin works in treating patients with metastatic melanoma.

Description

OBJECTIVES:

Primary

- Determine whether objective clinical responses can be obtained in patients with metastatic melanoma treated with RFT5-dgA immunotoxin.

Secondary

- Compare levels of CD4+CD25+ regulatory T cells in peripheral blood before and after treatment.

- Evaluate the toxicity profile of this regimen in these patients.

OUTLINE: Patients receive RFT5-dgA immunotoxin IV over 4 hours on days 1, 3, and 5. Treatment repeats approximately every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Blood samples are obtained at baseline and periodically during study treatment. Blood is examined for changes in T-regulatory cells, as assessed by the presence of CD3, CD4, and CD25 cells and protein expression (FOXP3) using flow cytometry.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Melanoma (Skin)

Intervention

RFT5-dgA immunotoxin, protein expression analysis, flow cytometry, laboratory biomarker analysis

Location

NCI - Surgery Branch
Bethesda
Maryland
United States
20892-1201

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:44:21-0400

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