Back to resultsA Phase II Trial of CG 8020 and CG 2505 in Patients With Nonresectable or Metastatic Pancreatic Cancer
Primary Purpose
Metastatic Pancreatic Cancer, Nonresectable Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CG 8020 and CG 2505
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Pancreatic Cancer focused on measuring cancer vaccine, pancreatic cancer, metastatic pancreatic cancer, unresectable pancreatic cancer, immunotherapy
Eligibility Criteria
Inclusion Criteria: Histologic or cytologic diagnosis of nonresectable or metastatic pancreatic adenocarcinoma Chemotherapy naïve or chemotherapy experienced pancreatic cancer Exclusion Criteria: Prior cancer vaccines or gene therapy History of clinically significant autoimmune disease (eg, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis) History of another malignancy in the past five years, except adequately treated non-melanomatous skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix, unless approved by the Medical Monitor
Sites / Locations
- Johns Hopkins University School of Medicine
- US Oncology
Outcomes
Primary Outcome Measures
Safety
Efficacy measured by clinical benefit response
Progression-free survivial
Overall survival
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00245362
Brief Title
A Phase II Trial of CG 8020 and CG 2505 in Patients With Nonresectable or Metastatic Pancreatic Cancer
Official Title
A Phase II Trial of CG 8020 and CG 2505 in Patients With Nonresectable or Metastatic Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2005
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Cell Genesys
4. Oversight
5. Study Description
Brief Summary
To evaluate the safety and effectiveness of CG8020 and CG2505.
Detailed Description
To evaluate clinical and laboratory safety of CG 8020 and CG 2505 and to evaluate the efficacy of CG 8020 and CG 2505 as measured by clinical benefit response, progression-free survival, survival and CA 19-9 serum marker levels in chemotherapy naive or experienced patients with nonresectable or metastatic adenocarcinoma of the pancreas
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Cancer, Nonresectable Pancreatic Cancer
Keywords
cancer vaccine, pancreatic cancer, metastatic pancreatic cancer, unresectable pancreatic cancer, immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
CG 8020 and CG 2505
Primary Outcome Measure Information:
Title
Safety
Title
Efficacy measured by clinical benefit response
Title
Progression-free survivial
Title
Overall survival
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologic or cytologic diagnosis of nonresectable or metastatic pancreatic adenocarcinoma
Chemotherapy naïve or chemotherapy experienced pancreatic cancer
Exclusion Criteria:
Prior cancer vaccines or gene therapy
History of clinically significant autoimmune disease (eg, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis)
History of another malignancy in the past five years, except adequately treated non-melanomatous skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix, unless approved by the Medical Monitor
Facility Information:
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
US Oncology
City
Dallas
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase II Trial of CG 8020 and CG 2505 in Patients With Nonresectable or Metastatic Pancreatic Cancer
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