Status:
COMPLETED
Immunotherapy of Melanoma With Tumor Antigen RNA and Small Inhibitory RNA Transfected Autologous Dendritic Cells
Lead Sponsor:
Scott Pruitt
Conditions:
Metastatic Melanoma
Absence of CNS Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Transfection with siRNA targeting the immunoproteasome alters proteasome-mediated antigen processing by the dendritic cell, generating TAA-derived peptides that we hypothesize, based on preclinical re...
Eligibility Criteria
Inclusion
- Patients with confirmed metastatic melanoma.
- Karnofsky performance status greater than or equal to 70%.
- Estimated life expectancy \> 6 months.
- Age \> 18 years.
- Adequate hematologic function
- Adequate renal and hepatic function
- Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.
- Ability to return to Duke University Medical Center for adequate follow-up as required by this protocol.
Exclusion
- Subjects undergoing concurrent chemotherapy, radiation therapy, or immunotherapy will be excluded.
- The subject has previously irradiated, surgically treated, or newly diagnosed central nervous system (CNS) metastases will be excluded (Pre-enrollment head CT is not required if not indicated by clinical signs or symptoms).
- Subjects with a history of autoimmune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis will be excluded.
- Subjects with serious concurrent chronic or acute illness such as pulmonary (asthma or COPD), cardiac (NYHA class III or IV) or hepatic disease, or other illness considered by the principal investigator to constitute an unwarranted high risk for investigational drug administration will be excluded.
- Subjects with medical or psychological impediment to probable compliance with the protocol will be excluded.
- Subjects with concurrent second malignancy other than melanoma or non-melanoma skin cancer will be excluded. In the event of prior non-melanoma malignancies treated surgically, the subject must be considered NED (no evidence of disease) for a minimum of 3 years prior to enrollment.
- Presence of an active acute or chronic infection, including symptomatic urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot) or viral hepatitis (as determined by HBsAg and Hepatitis C serology) will lead to subject exclusion.
- Subjects receiving steroid therapy (or other immunosuppressive agents such as azathioprine or cyclosporine A) are excluded on the basis of potential immune suppression.
- Subjects with inadequate peripheral vein access to undergo leukapheresis will be excluded.
- Female subjects with a positive pregnancy test, as well as those who have not previously undergone hysterectomy and/or bilateral oophorectomy and are unwilling to utilize a medically approved form of contraception, from the time of enrollment until 6 weeks after the final immunization, will be excluded.
- Male subjects, not previously surgically sterilized, who are unwilling to use a condom with spermicide during any sexual activity occurring over the entire immunization period and for the 6 weeks that immediately follow the final immunization will be excluded.
- Subjects with a documented history of severe allergic reaction to beta-lactams, eggs or soy products.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00672542
Start Date
January 1 2008
End Date
July 1 2013
Last Update
January 23 2014
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710