Safety and Immune Response to a Multi-component Immune Based Therapy (MKC1106-PP) for Patients With Advanced Cancer.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Ovarian, Melanoma, Renal, Prostate, Colorectal, Endometrial Carcinoma, Cervical Carcinoma, Testicular Cancer, Thyroid Cancer, Small Cell Lung Carcinoma, Mesothelioma, Breast Carcinoma, Esophageal Carcinoma, Gastric Cancer, Pancreatic Carcinoma, Neuroendocrine Cancer, Liver Cancer, Gallbladder Cancer, Biliary Tract Cancer, Anal Carcinoma, Bone Sarcomas, Soft Tissue Sarcomas, Carcinoma of Unknown Origin, Primary

Intervention / Treatment
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* Biological: PSMA/PRAME
* Biological: PSMA/PRAME


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Dose Cohort<br> | Biological: PSMA/PRAME<br>* Low dose<br>|
| Experimental: High Dose Cohort<br> | Biological: PSMA/PRAME<br>* high dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Vaccine