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A Phase II Trial of CG 8020 and CG 2505 in Patients With Nonresectable or Metastatic Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by:
Cell Genesys
ClinicalTrials.gov Identifier:
NCT00245362
First received: October 27, 2005
Last updated: NA
Last verified: October 2005
History: No changes posted
  Purpose

To evaluate the safety and effectiveness of CG8020 and CG2505.


Condition Intervention Phase
Metastatic Pancreatic Cancer
Nonresectable Pancreatic Cancer
 Biological: CG 8020 and CG 2505
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of CG 8020 and CG 2505 in Patients With Nonresectable or Metastatic Pancreatic Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cell Genesys:

Primary Outcome Measures:
  • Safety
  • Efficacy measured by clinical benefit response
  • Progression-free survivial
  • Overall survival

Estimated Enrollment: 50
Study Start Date: June 2002
Estimated Study Completion Date: June 2004
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245362

Locations
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
United States, Texas
US Oncology
Dallas, Texas, United States
Sponsors and Collaborators
Cell Genesys
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00245362     History of Changes
Other Study ID Numbers: P-0011
Study First Received: October 27, 2005
Last Updated: October 27, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Cell Genesys:
cancer vaccine
pancreatic cancer
metastatic pancreatic cancer
unresectable pancreatic cancer
immunotherapy

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013