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

Metastatic Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00245362
• Other study ID #: P-0011
• Status: Completed
• Phase: Phase 2
• First received: October 27, 2005
• Last updated: October 27, 2005
• Start date: June 2002
• Est. completion date: June 2004

Study information

• Verified date: October 2005
• Source: Cell Genesys
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and effectiveness of CG8020 and CG2505.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Nonresectable Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• CG 8020 and CG 2505

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	US Oncology	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Cell Genesys

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety
Primary	Efficacy measured by clinical benefit response
Primary	Progression-free survivial
Primary	Overall survival