Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.

NCT ID: NCT02098239

Last Updated: 2014-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-08-31
• Study Completion Date: 2002-05-31

Brief Summary

The study was designed to assess the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advances pancreatic cancer.

Detailed Description

Jaundiced patients with advanced pancreatic cancer (either locally, advanced or metastatic) were treated with G17DT either immediately (Group A), or following biliary stenting when jaundice had resolved (Group B). Patients not jaundiced at time of presentation were to enter Group B. Patients received 3 Intramuscular injections of G17DT at weeks 0, 1, and 3. A booster injection was offered to patients who had measurable anit-G17Dt antibodies but had anti-G17DT antibodies that fell below a pre-specified threshold after week 23. Patients were evaluated until study closure ort until patient death.

Conditions

Jaundice; Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Jaundiced patients with bilirubin value \>80 μmol/L. Received G17DT immediately prior to biliary stenting.

Group Type: ACTIVE_COMPARATOR

G17DT

Intervention Type: DRUG

Group B

Patients to be treated following biliary decompression or for immediate treatment if non-jaundiced. Received G17DT 2 weeks after biliary stenting when bilirubin was \<40 μmol/L.

Group Type: ACTIVE_COMPARATOR

G17DT

Intervention Type: DRUG

Interventions

G17DT

Intervention Type: DRUG

Other Intervention Names

Polyclonal Antibody Stimulator (PAS)

Eligibility Criteria

Inclusion Criteria

• Patients with a pancreatic adenocarcinoma (cytologically or histologically proven), not suitable for a potentially curative resection.
• If patients were jaundiced, bilirubin had to be >80 μmol/L.
• Male or female patients over 18 years of age.
• World Health Organization (WHO) performance status of 0 to 2.
• Patients with a life expectancy of at least 8 weeks.
• Patients must have given written informed consent.

Exclusion Criteria

• Patients undergoing a potentially curative resection.
• Jaundiced patients with a bilirubin value <80 μmol/L.
• Patients not considered fit for endoscopic or percutaneous biliary stenting.
• Patients receiving any other anti-cancer therapy.
• History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the cervix.
• Females who were pregnant, planning to become pregnant, or who were lactating.
• Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study.
• Previous G17DT treatment.
• Haematological indicators:

Haemoglobin (Hb) <10.0 g/dL. White cell count (WCC) <4.0×109/L. Platelets <100×109/L.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Advances Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PC2

Identifier Type: -

Identifier Source: org_study_id