Back to resultsSafety and Immune Response to a Multi-component Immune Based Therapy (MKC1106-PP) for Patients With Advanced Cancer.
Primary Purpose
Ovarian, Melanoma, Renal
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PSMA/PRAME
PSMA/PRAME
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian focused on measuring Cancer Vaccine
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)
Sites / Locations
- Arizona Cancer Center
- Lombardi Comprehensive Cancer Center at Georgetown
- H Lee Moffitt Cancer Center University of So Florida
- Nevada Cancer Institute
- Dartmouth Hitchcock Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low Dose Cohort
High Dose Cohort
Arm Description
Outcomes
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
Secondary Outcome Measures
to determine the blood plasmid levels by PCR analysis
measure cytokine levels
to describe any objective tumor responses to the treatment with MKC1106-PP
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00423254
Brief Title
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
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mannkind Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Dose Cohort
Arm Type
Experimental
Arm Title
High Dose Cohort
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
PSMA/PRAME
Intervention Description
Low dose
Intervention Type
Biological
Intervention Name(s)
PSMA/PRAME
Intervention Description
high dose
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
to determine the blood plasmid levels by PCR analysis
Time Frame
Every 6 Weeks
Title
measure cytokine levels
Time Frame
Every 6 Weeks
Title
to describe any objective tumor responses to the treatment with MKC1106-PP
Time Frame
Every 6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Arizona Cancer Center
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85724-5024
Country
United States
Facility Name
Lombardi Comprehensive Cancer Center at Georgetown
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
H Lee Moffitt Cancer Center University of So Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Nevada Cancer Institute
City
Sparks
State/Province
Nevada
ZIP/Postal Code
89431
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Immune Response to a Multi-component Immune Based Therapy (MKC1106-PP) for Patients With Advanced Cancer.
We'll reach out to this number within 24 hrs