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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-11-30

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.

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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.

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low Dose Cohort

Group Type EXPERIMENTAL

PSMA/PRAME

Intervention Type BIOLOGICAL

Low dose

High Dose Cohort

Group Type EXPERIMENTAL

PSMA/PRAME

Intervention Type BIOLOGICAL

high dose

Interventions

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PSMA/PRAME

Low dose

Intervention Type BIOLOGICAL

PSMA/PRAME

high dose

Intervention Type BIOLOGICAL

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No