Safety and Immune Response to a Multi-component Immune Based Therapy (MKC1106-PP) for Patients With Advanced Cancer.
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
1 other identifier
interventional
12
1 country
5
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 large number of solid cancers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2007
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2007
CompletedFirst Posted
Study publicly available on registry
January 18, 2007
CompletedStudy Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedAugust 3, 2010
August 1, 2010
2.6 years
January 12, 2007
August 2, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
to determine the blood plasmid levels by PCR analysis
Every 6 Weeks
measure cytokine levels
Every 6 Weeks
to describe any objective tumor responses to the treatment with MKC1106-PP
Every 6 Weeks
Study Arms (2)
Low Dose Cohort
EXPERIMENTALHigh Dose Cohort
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Arizona Cancer Center
Tuscon, Arizona, 85724-5024, United States
Lombardi Comprehensive Cancer Center at Georgetown
Washington D.C., District of Columbia, 20057, United States
H Lee Moffitt Cancer Center University of So Florida
Tampa, Florida, 33612, United States
Nevada Cancer Institute
Sparks, Nevada, 89431, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 12, 2007
First Posted
January 18, 2007
Study Start
February 1, 2007
Primary Completion
September 1, 2009
Study Completion
November 1, 2009
Last Updated
August 3, 2010
Record last verified: 2010-08