Status:
COMPLETED
Safety and Immune Response to a Multi-component Immune Based Therapy (MKC1106-PP) for Patients With Advanced Cancer.
Lead Sponsor:
Mannkind Corporation
Conditions:
Ovarian
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The present clinical trial is 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 a...
Detailed Description
The majority of tumors are ignored by the immune system and it was thought for a long time that tumor antigens did not exist. However, recently a number of tumor antigens have been described. These an...
Eligibility Criteria
Inclusion
- 18 years of age or older Advanced, refractory solid malignancy that is histologically proven Measurable disease ECOG performance status of 0, 1 or 2 Adequate bone marrow reserve as evidenced by a Absolute neutrophil count (ANC) = 1,500/microL; Platelet count = 100,000/microL Adequate renal and hepatic function as evidenced by a serum creatinine = 1.5 mg/dL; Serum total bilirubin = 2.0 mg/dL; Alkaline phosphatase = 3X the ULN for the reference lab (= 5 the ULN for the reference lab for subjects with known hepatic metastases); SGOT/SGPT = 3X the ULN for the reference lab (= 5 the ULN for the reference lab for subjects with known hepatic metastases)
Exclusion
- Symptomatic central nervous system (CNS) metastases Any autoimmune disorder Positive HIV, hepatitis B or hepatitis C antibody test Any allogeneic transplant Congestive heart failure Affected inguinal lymph nodes (metastatic process) or lack inguinal lymph nodes (resection)
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00423254
Start Date
February 1 2007
End Date
November 1 2009
Last Update
August 3 2010
Active Locations (5)
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1
Arizona Cancer Center
Tuscon, Arizona, United States, 85724-5024
2
Lombardi Comprehensive Cancer Center at Georgetown
Washington D.C., District of Columbia, United States, 20057
3
H Lee Moffitt Cancer Center University of So Florida
Tampa, Florida, United States, 33612
4
Nevada Cancer Institute
Sparks, Nevada, United States, 89431