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

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00423254
• Other study ID #: MKC1106-PP-001
• Status: Completed
• Phase: Phase 1
• First received: January 12, 2007
• Last updated: August 2, 2010
• Start date: February 2007
• Est. completion date: November 2009

Study information

• Verified date: August 2010
• Source: Mannkind Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anal Carcinoma
• Anus Neoplasms
• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Bone Sarcomas
• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Carcinoma of Unknown Origin, Primary
• Cervical Carcinoma
• Colorectal
• Endometrial Carcinoma
• Endometrial Neoplasms
• Esophageal Carcinoma
• Esophageal Neoplasms
• Gallbladder Cancer
• Gastric Cancer
• Liver Cancer
• Lung Neoplasms
• Melanoma
• Mesothelioma
• Neuroendocrine Cancer
• Osteosarcoma
• Ovarian
• Pancreatic Carcinoma
• Pancreatic Neoplasms
• Prostate
• Renal
• Sarcoma
• Small Cell Lung Carcinoma
• Soft Tissue Sarcomas
• Testicular Cancer
• Testicular Neoplasms
• Thyroid Cancer
• Thyroid Neoplasms

Intervention

Biological:
• PSMA/PRAME
Low dose
• PSMA/PRAME
high dose

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Nevada Cancer Institute	Sparks	Nevada
United States	H Lee Moffitt Cancer Center University of So Florida	Tampa	Florida
United States	Arizona Cancer Center	Tuscon	Arizona
United States	Lombardi Comprehensive Cancer Center at Georgetown	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Mannkind Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	to determine the blood plasmid levels by PCR analysis		Every 6 Weeks	No
Secondary	measure cytokine levels		Every 6 Weeks	No
Secondary	to describe any objective tumor responses to the treatment with MKC1106-PP		Every 6 Weeks	No