Status:
COMPLETED
Safety and Immune Response to a Multi-component Immune Based Therapy (MKC1106-MT) for Patients With Melanoma.
Lead Sponsor:
Mannkind Corporation
Conditions:
Advanced Melanoma
Stage III and IV Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A dose comparison of a multi-component active immunotherapy designed to stimulate an immune reaction to specific tumor associated antigens which are highly expressed on melanomas.
Detailed Description
The multi-component active immunotherapy, MKC1106-MT, consists of 1 plasmid dose and 2 peptides doses designed to stimulate an immune reaction to two tumor associated antigens (Melan-A and tyrosinase)...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of locally advanced or metastatic melanoma (American Joint Committee on Cancer \[AJCC 6th edition\] stage IIIB, IIIC or IV) that is refractory to standard therapy or for which no curative standard therapy exists.
- Patients enrolled in the Phase 2 portion of the trial must have measurable disease by the RECIST criteria ECOG performance status of 0 or 1 Life expectancy = 3 months 18 years of age or older at screening evaluation Positive for HLA-A2, and more precisely, express A\*0201 as assessed by DNA typing Tumor material from prior biopsy / surgical resection available for analysis of expression of melanoma specific antigens Adequate bone marrow reserve as evidenced by: Absolute neutrophil count (ANC) = 1,000/?L \& Platelet count = 75,000/?L Adequate renal function as evidenced by: serum creatinine = 1.5 mg/dL Adequate hepatic function as evidenced by: Serum total bilirubin = 2.0 mg/dL \& SGOT/SGPT = 3 times the ULN for the reference lab (= 5 the ULN for the reference lab for subjects with known hepatic metastases) Subjects must have recovered to at least baseline or Grade 1 toxicity from the effects of any prior surgery, radiotherapy or other therapies including but not limited to chemotherapy Women of childbearing potential as well as fertile men and their partners must agree to use an effective method of contraception or to abstain from sexual intercourse during the clinical trial and for 90 days following the last dose of the investigational new drug Subjects must be able to provide informed consent for participation in the clinical trial before any protocol-specific clinical trial procedure is performed
Exclusion
- No systemic infection requiring treatment Symptomatic brain metastases and/or progression of CNS metastases within the past 4 weeks; patients with treated CNS metastases (by surgery and/or radiation), who are neurologically stable, and who are no longer taking glucocorticoids, are eligible Subjects with autoimmune disorders, including, but not limited to: systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, Sjogren's syndrome, mixed connective tissue disease, ankylosing spondylitis, Hashimoto's thyroiditis, bullous pemphigus, sarcoidosis, Behçet's syndrome, vasculitis, familial Mediterranean fever, Wegener's granulomatosis or Goodpasture's syndrome Positive HIV, hepatitis B or hepatitis C antibody test Subjects who underwent allogeneic transplant New York Heart Association Grade III or IV congestive heart failure Medical, sociological or psychological conditions that may compromise compliance or participation in the clinical trial or interfere with the interpretation of the results Subjects who have taken drugs that negatively affect immune function such as systemic corticosteroids or other immunomodulatory drugs including, but not limited to, interferon-alpha, interferon-beta, interleukin-2, etanercept, infliximab, tacrolimus, cyclosporine, mycophenolic acid, alefacept or efalizumab, within one month preceding the screening Subjects who are lactating, pregnant, or planning to become pregnant within three months of treatment completion Subjects who have received any investigational drug within the preceding four weeks of enrollment Subjects who have affected inguinal lymph nodes (metastatic process) or lack of inguinal lymph nodes (resection)
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00688090
Start Date
June 1 2008
End Date
May 1 2010
Last Update
August 3 2010
Active Locations (2)
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1
UCLA Medical Center
Los Angeles, California, United States, 90034
2
H Lee Moffitt Cancer Center University of So Florida
Tampa, Florida, United States, 33612