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

Phase 1

Completed

• Conditions: Renal; Ovarian; Melanoma; Mesothelioma; Breast Carcinoma; Esophageal Carcinoma; Gastric Cancer; Pancreatic Carcinoma; Neuroendocrine Cancer; Liver Cancer
• Interventions: Biological: PSMA/PRAME

• Registration Number: NCT00423254
• Lead Sponsor: Mannkind Corporation

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2007-01-12
• Study First Submitted QC: 2007-01-12
• Study First Posted: 2007-01-18
• Study Start: 2007-02
• Primary Completion: 2009-09
• Study Completion: 2009-11
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-02
• Last Update Posted: 2010-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low Dose Cohort	PSMA/PRAME	-
High Dose Cohort	PSMA/PRAME	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (5)

Nevada Cancer Institute; 🇺🇸 Sparks, Nevada, United States

Arizona Cancer Center; 🇺🇸 Tuscon, Arizona, United States

Lombardi Comprehensive Cancer Center at Georgetown; 🇺🇸 Washington, District of Columbia, United States

H Lee Moffitt Cancer Center University of So Florida; 🇺🇸 Tampa, Florida, United States

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States