Status:
COMPLETED
RFT-5-dgA in Patients With Metastatic Melanoma
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Background: * CD4+ cells are white blood cells that regulate the immune system by controlling the strength and quality of the immune response. * CD25+ cells are a subset of CD4+ cells that suppress o...
Detailed Description
Background: * RFT5-dgA is an immunotoxin comprised of the IL-2Ra-specific murine IgG1 antibody RFT5 linked to deglycosylated ricin A chain (dgA) via the sterically hindered heterobifunctional disulfi...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients age greater than 18 with measurable metastatic melanoma that have an expected survival of greater than three months will be considered. Patients with resectable local/regional disease would undergo standard treatment with surgical resection and will not be eligible.
- Patients must be able to understand and give informed consent.
- Patients must have progressed while receiving standard therapy which may include IL-2; however, prior IL-2 therapy is not a requirement for enrollment.
- Serum creatinine of 1.6 mg/dl or less.
- Total bilirubin 2.0 mg/dl or less, except for patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.
- WBC 3000/mm(3) or greater.
- Platelet count 90,000 mm(3) or greater
- Serum albumin greater than 2.5 g/dl,
- Serum AST/ALT less then 2.5 times normal,
- ECOG performance status of 0 or 1 or 2.
- For patients greater than 50 years of age or who have a history of cardiovascular disease a thallium stress test is required with EF greater than or equal to 45%.
- Patients of both genders must be willing to practice effective birth control during this trial.
- Patients must be willing to undergo leukapheresis.
- EXCLUSION CRITERIA:
- Patients will be excluded:
- who are undergoing or have undergone in the past 3 weeks any other systemic form of therapy for their cancer.
- who received RFT5-dgA on another trial.
- who have uncontrolled concurrent illness including, but not limited to: ongoing or active infection; ongoing or active cardiac disease, such as symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance with study requirements.
- who require systemic steroid therapy upon entry into the trial.
- who are pregnant or breast-feeding.
- who are known to be positive for hepatitis B(s)AG, hepatitis C or HIV antibody (because of possible immune effects of these conditions).
- who require chronic anticoagulation.
- who are 50 years old or greater who do not have a normal stress cardiac test (stress thallium, stress MUGA, dobutamine echocardiogram, or other stress test) with a LVEF less than 45%.
- who have history of EKG abnormalities, symptoms of cardiac ischemia or arrhythmias who do not have a normal stress cardiac test (stress thallium, stress MUGA, dobutamine echocardiogram, or other stress test) with a LVEF lea than 45%.
- who have any autoimmune diseases or immunodeficiency (including HIV),or other concurrent malignancies.
- Who have HAMA levels greater than 1 ug/mL.
- Who have had prior radiotherapy including radiotherapy to the lung, except for patients who have undergone localized soft tissue radiotherapy.
- Who have extensive lung disease where greater than 15% of the lung is involved based on CT evaluation.
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00314093
Start Date
April 1 2006
End Date
November 1 2008
Last Update
November 12 2019
Active Locations (1)
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1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892