An Open, Single-center Study to Determine the Antibody Repsonse to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma

NCT ID: NCT02098291

Last Updated: 2014-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-04-30
• Study Completion Date: 2002-02-28

Brief Summary

This study was designed to determine the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advanced pancreatic cancer.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

G17DT

Group Type: EXPERIMENTAL

G17DT

Intervention Type: DRUG

Interventions

G17DT

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with histological or cytological confirmation of pancreatic carcinoma who were not suitable for pancreatic tumour resection with curative intent
• Patients who had not received chemotherapy in the previous month and who would either not receive chemotherapy in the period of study or who would commence gemcitabine treatment in week 4 of the study
• Male or female patients over 18 years of age
• Patients with a life expectancy of at least 2 months
• Patients must have given written informed consent
• Patients with a Karnofsky Performance Status score of ≥ 50%
• Patients who would not receive chemotherapy in the period of the Extension Survival Study, except for concomitant gemcitabine ongoing at visit (for extension study)

Exclusion Criteria

• History of other malignant disease except non-melanomatous skin carcinoma or in situ carcinoma of the uterine cervix
• Concomitant use or anticipated use in the period of the study of radiotherapy
• Chemotherapy in the previous month preceding screening, anticipated concomitant use of chemotherapy between screening and week 4 of the study or anticipated useof chemotherapeutic agents other than gemcitabine from week 4 for the period of the study
• Use in the past month or concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids
• Females who were pregnant, planning to become pregnant or lactating
• Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during the study
• Haematological indicators:

Haemoglobin <9.5g/dl White blood cell count <3.5 x 109/l Platelets <100 x 109/l

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Advances Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PC1

Identifier Type: -

Identifier Source: org_study_id