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

Pancreatic Cancer Clinical Trial

— PC1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098291
• Other study ID #: PC1
• Status: Completed
• Phase: Phase 2
• First received: March 12, 2014
• Last updated: March 26, 2014
• Start date: April 1999
• Est. completion date: February 2002

Study information

• Verified date: March 2014
• Source: Cancer Advances Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2002
• Est. primary completion date: July 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• G17DT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Advances Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamic	Anti-Gastrin 17 antibodies were determined at baseline (week0) and measured at subsequent visits during the first 16 weeks after the first G17DT injection to determine the effect of jaundice on the ability of patients to generate antibodies.	Up to week 16	No
Secondary	Patient Survival	The vital status was monitored throughout the study and was followed up to the death of the last patient.	Up to week 139	No
Secondary	Number of Participants with Serious and Non-Serious Adverse Events	Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-exisiting illnesses, were assessed at each visit.	Up to week 60	Yes