Status:
COMPLETED
Study of MAGE-3/Melan-A/gp 100/NA17 and rhIL-12 With/Out Low Dose IL-2 in Metastatic Melanoma
Lead Sponsor:
University of Chicago
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Purpose of investigation: Primary hypotheses: Immunization of patients with 4 melanoma antigen peptides will induce augmented specific IFN-y-producing CD8+ T cells against all 4 antigens simultaneousl...
Detailed Description
Based on the above preclinical and Phase I results, a logical strategy for a second generation melanoma vaccine has emerged. A randomized Phase II study in metastatic melanoma patients will be underta...
Eligibility Criteria
Inclusion
- Histologically-confirmed melanoma with evidence of metastatic disease, either by radiologic or physical examination. In transit metastases are allowed. Biopsy should be performed to reconfirm the diagnosis in cases of doubt.
- Life expectancy of at least 12 weeks.
- Karnofsky performance status index \>/=70.
- Written informed consent
- Adequate hematopoietic, renal, and hepatic function
- LDH \<1.25 x ULN
- HLA typing: patient must express HLA-A2.
- Tumor biopsy: patient must agree to undergo biopsy of accessible tumor before and after therapy, when feasible, to study tumor cell properties and characteristics of immune cells.
Exclusion
- Significant cardiovascular disease, or cardiac arrhythmia requiring medical intervention.
- Pregnant or nursing women.
- Biological therapy in the 4 weeks prior to the start of dosing.
- Prior therapy with a melanoma vaccine containing MAGE-3, Melan-A, gplOO, NA17 peptides.
- Patients with intrinsic immunosuppression, including seropositivity for HIV antibody. Patient should be tested if risk factors are identified.
- Serious concurrent infection, including active tuberculosis, hepatitis B, or hepatitis C.
- Concurrent systemic corticosteroids (except physiologic replacement doses) or other immunosuppressive drugs (eg. cyclosporin A).
- Psychiatric illness that may make compliance to the clinical protocol unmanageable or may compromise the ability of the patient to give informed consent.
- Active or history of autoimmune disease including but not limited to: rheumatoid arthritis (RF-positive with current or recent flare), inflammatory bowel disease, systemic lupus erythematosis (clinical evidence with ANA 1:80 or greater), ankylosing spondylitis, scleroderma, multiple sclerosis, autoimmune hemolytic anemia, and immune thrombocytopenic purpura.
- Active gastrointestinal bleeding or uncontrolled peptic ulcer disease. Presence of untreated brain metastases. All patients must undergo brain imaging as part of the pre-study evaluation. Only patients with no brain metastases, or with brain lesions successfully treated by stereotactic radiation or surgical removal without recurrence at 28 day follow-up, will be eligible.
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00203879
Start Date
February 1 2002
End Date
May 1 2007
Last Update
September 5 2013
Active Locations (1)
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1
The University of Chicago
Chicago, Illinois, United States, 60637