Gastric Cancer Clinical Trial
Official title:
A Phase I Multicenter, Open Label, Clinical Trial of Immune Response, Safety and Tolerability of DNA Vector pPRA-PSM With Synthetic Peptides E-PRA and E-PSM in Subjects With Advance Solid Malignancies
Verified date | August 2010 |
Source | Mannkind Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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 large number of solid cancers.
Status | Completed |
Enrollment | 12 |
Est. completion date | November 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 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 Criteria: 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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Nevada Cancer Institute | Sparks | Nevada |
United States | H Lee Moffitt Cancer Center University of So Florida | Tampa | Florida |
United States | Arizona Cancer Center | Tuscon | Arizona |
United States | Lombardi Comprehensive Cancer Center at Georgetown | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Mannkind Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the immunologic response to the treatment with MKC1106-PP regimen and 2) to determine the safety and adverse event profile of MKC1106-PP | Every 6 Weeks | No | |
Secondary | to determine the blood plasmid levels by PCR analysis | Every 6 Weeks | No | |
Secondary | measure cytokine levels | Every 6 Weeks | No | |
Secondary | to describe any objective tumor responses to the treatment with MKC1106-PP | Every 6 Weeks | No |
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