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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00331461 |
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.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Drug: RFT5-dgA immunotoxin Procedure: flow cytometry Procedure: laboratory biomarker analysis Procedure: protein expression analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Evaluation of RFT5-dgA in Patients With Metastatic Melanoma |
Estimated Enrollment: | 41 |
Study Start Date: | February 2006 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of metastatic melanoma
Progressive disease while on standard therapy
PATIENT CHARACTERISTICS:
No concurrent uncontrolled illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
NCI - Surgery Branch | |
Bethesda, Maryland, United States, 20892-1201 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
Bethesda, Maryland, United States, 20892-1182 |
Principal Investigator: | Steven A. Rosenberg, MD, PhD | NCI - Surgery Branch |
Study ID Numbers: | CDR0000481137, NCI-06-C-0137, NCI-P6382 |
Study First Received: | May 30, 2006 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00331461 |
Health Authority: | United States: Food and Drug Administration |
stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma Nevus |
Immunotoxins Recurrence Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs |
Neoplasms, Nerve Tissue Nevi and Melanomas Pharmacologic Actions |