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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00423254
Recruitment Status : Completed
First Posted : January 18, 2007
Last Update Posted : August 3, 2010
Sponsor:
Information provided by:
Mannkind Corporation

Study Description
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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.

Condition or disease Intervention/treatment 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 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Low Dose Cohort Biological: PSMA/PRAME
Low dose
Experimental: High Dose Cohort Biological: PSMA/PRAME
high dose


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. to determine the blood plasmid levels by PCR analysis [ Time Frame: Every 6 Weeks ]
  2. measure cytokine levels [ Time Frame: Every 6 Weeks ]
  3. to describe any objective tumor responses to the treatment with MKC1106-PP [ Time Frame: Every 6 Weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00423254


Locations
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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
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Responsible Party: Mihail Obrocea/Vice President-Oncology - Medical & Regulatory Affairs, MannKind Corporation
ClinicalTrials.gov Identifier: NCT00423254    
Other Study ID Numbers: MKC1106-PP-001
First Posted: January 18, 2007    Key Record Dates
Last Update Posted: August 3, 2010
Last Verified: August 2010
Keywords provided by Mannkind Corporation:
Cancer Vaccine
Additional relevant MeSH terms:
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Mesothelioma
Carcinoma
Sarcoma
Breast Neoplasms
Biliary Tract Neoplasms
Endometrial Neoplasms
Gallbladder Neoplasms
Pancreatic Neoplasms
Esophageal Neoplasms
Testicular Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplasms, Connective and Soft Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Endocrine Gland Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Adenoma
Neoplasms, Mesothelial