Clinical trial NCT00423254: Safety and Immune Response to a Multi-component Immune Based Therapy (MKC1106-PP) for Patients With Advanced Cancer.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Keywords: Cancer Vaccine
Lead sponsor: Mannkind Corporation
Sponsor class: INDUSTRY
First posted: 2007-01-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: 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
timeFrame: Every 6 Weeks
Secondary outcomes:
measure: to determine the blood plasmid levels by PCR analysis
timeFrame: Every 6 Weeks
measure: measure cytokine levels
timeFrame: Every 6 Weeks
measure: to describe any objective tumor responses to the treatment with MKC1106-PP
timeFrame: Every 6 Weeks
Other outcomes:
Locations:
city: Tuscon
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Washington
country: United States
facility: Lombardi Comprehensive Cancer Center at Georgetown
state: District of Columbia
city: Tampa
country: United States
facility: H Lee Moffitt Cancer Center University of So Florida
state: Florida
city: Sparks
country: United States
facility: Nevada Cancer Institute
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
References: