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RFT5-dgA Immunotoxin in Treating Patients With Metastatic Melanoma
This study is ongoing, but not recruiting participants.
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00331461
  Purpose

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

MedlinePlus related topics: Cancer Melanoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Evaluation of RFT5-dgA in Patients With Metastatic Melanoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Clinical response [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunologic response as measured by descriptive statistics [ Designated as safety issue: No ]
  • Foxp3 protein levels as measured by fluorescence-activated cell sorting (FACS) [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]

Estimated Enrollment: 41
Study Start Date: February 2006
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of metastatic melanoma

    • No local/regional disease amenable to surgical resection
  • Measurable disease
  • Progressive disease while on standard therapy

    • Prior interleukin-2 allowed but not required
  • No extensive lung disease involving > 15% of the lung by CT scan

PATIENT CHARACTERISTICS:

  • Life expectancy > 3 months
  • ECOG performance status 0-2
  • Creatinine ≤ 1.6 mg/dL
  • Bilirubin ≤ 2.0 mg/dL (< 3.0 mg/dL for patients with Gilbert's syndrome)
  • WBC ≥ 3,000/mm³
  • Platelet count ≥ 90,000/mm³
  • Albumin > 2.5 g/dL
  • AST/ALT < 2.5 times upper limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No concurrent uncontrolled illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Ongoing or active cardiac disease (i.e., symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia)
    • Psychiatric illness or social situation that would limit study compliance
  • Patients who are ≥ 50 years of age or who have a history of EKG abnormalities or symptoms of cardiac ischemia or arrhythmias must have a normal cardiac stress test AND LVEF ≥ 45% by echocardiogram
  • Hepatitis B surface antigen and hepatitis C antibody negative
  • HIV negative
  • No autoimmune disease or immunodeficiency
  • No other concurrent malignancies
  • Human antimurine antibody (HAMA) level ≤ 1 μg/mL
  • Willing to undergo leukapheresis

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 3 weeks since prior and no other concurrent systemic therapy for melanoma
  • No prior RFT5-dgA immunotoxin
  • No prior radiotherapy, including radiotherapy to the lungs, except for localized soft tissue radiotherapy
  • No concurrent systemic steroid therapy
  • No concurrent chronic anticoagulants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00331461

Locations
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
Sponsors and Collaborators
Investigators
Principal Investigator: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma

Study placed in the following topic categories:
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Nevus
Immunotoxins
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Nevi and Melanomas
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009