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

This study has been completed.
Sponsor:
Information provided by:
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00423254
First received: January 12, 2007
Last updated: August 2, 2010
Last verified: August 2010
  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 1

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Sarcoma
Stomach Neoplasms
Carcinoma
Liver Neoplasms
Thyroid Neoplasms
Endometrial Neoplasms
Mesothelioma
Neoplasms, Mesothelial
Lung Neoplasms
Breast Neoplasms
Biliary Tract Neoplasms
Testicular Neoplasms
Small Cell Lung Carcinoma
Esophageal Neoplasms
Pancreatic Neoplasms
Osteosarcoma
Anus Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Neoplasms, Glandular and Epithelial
Liver Diseases
Endocrine Gland Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on September 30, 2014