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

NCT ID: NCT00245362

Last Updated: 2005-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2004-06-30

Brief Summary

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To evaluate the safety and effectiveness of CG8020 and CG2505.

Detailed Description

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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

Conditions

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Metastatic Pancreatic Cancer Nonresectable Pancreatic Cancer

Keywords

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cancer vaccine pancreatic cancer metastatic pancreatic cancer unresectable pancreatic cancer immunotherapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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CG 8020 and CG 2505

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cell Genesys

INDUSTRY

Sponsor Role lead

Locations

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Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status

US Oncology

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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P-0011

Identifier Type: -

Identifier Source: org_study_id