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

Sponsor:	Mannkind Corporation
Information provided by:	Mannkind Corporation
ClinicalTrials.gov Identifier:	NCT00423254

Purpose

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.

Condition	Intervention	Phase
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	Biological: PSMA/PRAME	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Anal Cancer Breast Cancer Cancer Esophageal Cancer Esophagus Disorders Liver Cancer Lung Cancer Melanoma Mesothelioma Pancreatic Cancer Soft Tissue Sarcoma Stomach Cancer Testicular Cancer Thyroid Cancer Thyroid Diseases

U.S. FDA Resources

Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:

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 [ Time Frame: Every 6 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

to determine the blood plasmid levels by PCR analysis [ Time Frame: Every 6 Weeks ] [ Designated as safety issue: No ]
measure cytokine levels [ Time Frame: Every 6 Weeks ] [ Designated as safety issue: No ]
to describe any objective tumor responses to the treatment with MKC1106-PP [ Time Frame: Every 6 Weeks ] [ Designated as safety issue: No ]

Enrollment:	12
Study Start Date:	February 2007
Study Completion Date:	November 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Low Dose Cohort	Biological: PSMA/PRAME Low dose
Experimental: High Dose Cohort	Biological: PSMA/PRAME high dose

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423254

Locations

United States, Arizona
Arizona Cancer Center
Tuscon, Arizona, United States, 85724-5024
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown
Washington, District of Columbia, United States, 20057
United States, Florida
H Lee Moffitt Cancer Center University of So Florida
Tampa, Florida, United States, 33612
United States, Nevada
Nevada Cancer Institute
Sparks, Nevada, United States, 89431
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756

Sponsors and Collaborators

Mannkind Corporation

More Information

No publications provided

Responsible Party:	Mihail Obrocea/Vice President-Oncology - Medical & Regulatory Affairs, MannKind Corporation
ClinicalTrials.gov Identifier:	NCT00423254 History of Changes
Other Study ID Numbers:	MKC1106-PP-001
Study First Received:	January 12, 2007
Last Updated:	August 2, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mannkind Corporation:

Cancer Vaccine

Additional relevant MeSH terms:

Anus Neoplasms
Breast Neoplasms
Carcinoma
Thyroid Neoplasms
Esophageal Diseases
Esophageal Neoplasms
Liver Neoplasms
Lung Neoplasms
Stomach Neoplasms
Melanoma
Mesothelioma
Osteosarcoma
Pancreatic Neoplasms
Testicular Neoplasms
Small Cell Lung Carcinoma

Gallbladder Neoplasms
Uterine Cervical Neoplasms
Endometrial Neoplasms
Biliary Tract Neoplasms
Sarcoma
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on February 09, 2012