2007-02
2009-09
2009-11
12
NCT00423254
Mannkind Corporation
Mannkind Corporation
INTERVENTIONAL
Safety and Immune Response to a Multi-component Immune Based Therapy (MKC1106-PP) for Patients With Advanced Cancer.
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.
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 antigens reside on cancer cells and can be recognized by specific T-cells which can ultimately attack and destroy the tumor.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2007-01-12 | N/A | 2010-08-02 |
2007-01-12 | N/A | 2010-08-03 |
2007-01-18 | N/A | 2010-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Low Dose Cohort | BIOLOGICAL: PSMA/PRAME
|
| EXPERIMENTAL: High Dose Cohort | BIOLOGICAL: PSMA/PRAME
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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